Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: The EnAKT LKD Cluster Randomized Clinical Trial.

Importance: Patients with advanced chronic kidney disease (CKD) have the best chance for a longer and healthier life if they receive a kidney transplant. However, many barriers prevent patients from receiving a transplant. Objectives: To evaluate the effect of a multicomponent intervention designed to target several barriers that prevent eligible patients from completing key steps toward receiving a kidney transplant. Design, Setting, and Participants: This pragmatic, 2-arm, parallel-group, open-label, registry-based, superiority, cluster randomized clinical trial included all 26 CKD programs in Ontario, Canada, from November 1, 2017, to December 31, 2021. These programs provide care for patients with advanced CKD (patients approaching the need for dialysis or receiving maintenance dialysis). Interventions: Using stratified, covariate-constrained randomization, allocation of the CKD programs at a 1:1 ratio was used to compare the multicomponent intervention vs usual care for 4.2 years. The intervention had 4 main components, (1) administrative support to establish local quality improvement teams; (2) transplant educational resources; (3) an initiative for transplant recipients and living donors to share stories and experiences; and (4) program-level performance reports and oversight by administrative leaders. Main Outcomes and Measures: The primary outcome was the rate of steps completed toward receiving a kidney transplant. Each patient could complete up to 4 steps: step 1, referred to a transplant center for evaluation; step 2, had a potential living donor contact a transplant center for evaluation; step 3, added to the deceased donor waitlist; and step 4, received a transplant from a living or deceased donor. Results: The 26 CKD programs (13 intervention, 13 usual care) during the trial period included 20 375 potentially transplant-eligible patients with advanced CKD (intervention group [n = 9780 patients], usual-care group [n = 10 595 patients]). Despite evidence of intervention uptake, the step completion rate did not significantly differ between the intervention vs usual-care groups: 5334 vs 5638 steps; 24.8 vs 24.1 steps per 100 patient-years; adjusted hazard ratio, 1.00 (95% CI, 0.87-1.15). Conclusions and Relevance: This novel multicomponent intervention did not significantly increase the rate of completed steps toward receiving a kidney transplant. Improving access to transplantation remains a global priority that requires substantial effort. Trial Registration: ClinicalTrials.gov Identifier: NCT03329521.

Storytelling for impact: the creation of a storytelling program for patient partners in research.

Storytelling is a powerful means to evoke empathy and understanding among people. When patient partners, which include patients, family members, caregivers and organ donors, share their stories with health professionals, this can prompt listeners to reflect on their practice and consider new ways of driving change in the healthcare system. However, a growing number of patient partners are asked to 'share their story' within health care and research settings without adequate support to do so. This may ultimately widen, rather than close, the gap between healthcare practitioners and people affected by chronic disease in this new era of patient and public involvement in research. To better support patient partners with storytelling in the context of a patient-oriented research network, Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD) Network adapted an existing in-person storytelling workshop for patient educators within a hospital setting. The result is a 6-week virtual program called Storytelling for Impact, which guides patients, family members, caregivers and organ donors in developing impactful stories and sharing them at health care and research events, e.g., conferences. The online series of synchronous workshops is co-facilitated by story coaches, who are program alumni and Can-SOLVE CKD staff with trained storytelling experience. Each story follows a structure that includes a call to action, which aims to positively impact the priority-setting and delivery of care and research in Canada. The program has been a transformational process for many who have completed it, and numerous other health organizations have expressed interest in sharing this tool with their own patient partners. As result, we have also created an asynchronous online program that can be used by other interested parties outside our network. Patient partners who share their stories can be powerful mediators for inspiring changes in the health care and research landscape, with adequate structured support. We describe two novel programs to support patient partners in impactful storytelling, which are applicable across all health research disciplines. Additional resources are required for sustainability and scale up of training, by having alumni train future storytellers.

Storytelling is a powerful means to evoke empathy and understanding among people. When patient partners share their stories with health professionals, this can prompt listeners to reflect on their practice and consider new ways of improving the healthcare system. However, as a growing number of patient partners are asked to 'share their story' within health care and research settings, there is often not enough tools and resources to support them in preparing their stories in a way that will be impactful for the audience members. Our kidney research network sought to create a novel in-person storytelling program to address this gap within our health research context. The result is a 6-week program called Storytelling for Impact, which guides patient partners­which includes patients, family members, caregivers and organ donors­in developing impactful stories and sharing them in a formal setting. The program is led by story coaches, who are patient partners and staff with trained storytelling experience. Participants are encouraged to include a call to action in their story, which aims to outline clear ways in which health professionals can facilitate positive change in health research or care. Many participants have described the program as transformational, and numerous other health organizations have expressed interest in sharing this tool with their own patient partners. As a result, we have also created a second online program that can be used by other interested parties outside our network. This paper highlights the adaptation process, content, participant feedback and next steps for the program.

The dynamic nature of patient engagement within a Canadian patient-oriented kidney health research network: Perspectives of researchers and patient partners.

INTRODUCTION: Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD) is a pan-Canadian health research network that engages patients as partners across 18 unique projects and core infrastructure. In this qualitative study, we explored how research teams integrated patient partners into network research activities to inform our patient engagement approach. METHODS: To capture a breadth of perspectives, this qualitative descriptive study purposively sampled researchers and patient partners across 18 network research teams. We conducted 4 focus groups (2 patients and 2 researchers; n = 26) and 28 individual telephone interviews (n = 12 patient partners; n = 16 researchers). Transcripts were coded in duplicate, and themes were developed through an inductive, thematic analysis approach. RESULTS: We included 24 patient partners and 24 researchers from 17 of the 18 projects and all core committees within the network. Overarching concepts relate participants' initial impressions and uncertainty about patient engagement to an evolving appreciation of its value, impact and sustainability. We identified four themes with subthemes that characterized the dynamic nature of patient engagement and how participants integrated patients across network initiatives: (1) Reinforcing a shared purpose (learning together, collective commitment, evolving attitudes); (2) Fostering a culture of responsive and innovative research (accessible supports, strengthened process and product); (3) Aligning priorities, goals and needs (amenability to patient involvement, mutually productive relationships, harmonizing expectations); (4) Building a path to sustainability (value creation, capacity building, sustaining knowledge use). CONCLUSIONS: Our findings demonstrate the dynamic and adaptive processes related to patient engagement within a national, patient-oriented kidney health research network. Optimization of support structures and capacity are key factors to promote sustainability of engagement processes within and beyond the network. PATIENT OR PUBLIC CONTRIBUTION: This project was conceived in collaboration with a Can-SOLVE CKD patient partner (N. F.), with lived experience of kidney failure. He also co-designed the study's protocol, led focus groups and researcher interviews, and contributed to data analysis. L. G. has lived experience as a caregiver for a person with CKD and facilitated patient partner focus groups. The patient partners, both of whom are listed authors, provided important insights that shaped our interpretation and presentation of study findings.

Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD): Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial.

Background: Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) is a quality improvement intervention designed to enhance access to kidney transplantation and living kidney donation. We conducted a cluster-randomized clinical trial to evaluate the effect of the intervention versus usual care on completing key steps toward receiving a kidney transplant. Objective: To prespecify the statistical analysis plan for the EnAKT LKD trial. Design: The EnAKT LKD trial is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized, superiority, clinical trial. Randomization was performed at the level of the chronic kidney disease (CKD) programs (the "clusters"). Setting: Twenty-six CKD programs in Ontario, Canada. Participants: More than 10 000 patients with advanced CKD (ie, patients approaching the need for dialysis or receiving maintenance dialysis) with no recorded contraindication to receiving a kidney transplant. Methods: The trial data (including patient characteristics and outcomes) will be obtained from linked administrative health care databases (the "registry"). Stratified covariate-constrained randomization was used to allocate the 26 CKD programs (1:1) to provide the intervention or usual care from November 1, 2017, to December 31, 2021 (4.17 years). CKD programs in the intervention arm received the following: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. Outcomes: The primary outcome is completing key steps toward receiving a kidney transplant, where up to 4 unique steps per patient will be considered: (1) patient referred to a transplant center for evaluation, (2) a potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient, (3) patient added to the deceased donor transplant waitlist, and (4) patient receives a kidney transplant from a living or deceased donor. Analysis plan: Using an intent-to-treat approach, the primary outcome will be analyzed using a patient-level constrained multistate model adjusting for the clustering in CKD programs. Trial Status: The EnAKT LKD trial period is November 1, 2017, to December 31, 2021. We expect to analyze and report the results once the data for the trial period is available in linked administrative health care databases. Trial Registration: The EnAKT LKD trial is registered with the U.S. National Institute of Health at clincaltrials.gov (NCT03329521 available at https://clinicaltrials.gov/ct2/show/NCT03329521). Statistical Analytic Plan: Version 1.0 August 26, 2022.

Contexte: EnAKT LKD est une intervention d'amélioration de la qualité visant à améliorer l'accès à la transplantation rénale et au don vivant de rein. Nous avons mené un essai clinique randomisé par grappes afin d'évaluer l'effet de l'intervention, par rapport aux soins habituels, sur le taux d'étapes clés réalisées dans le processus de réception d'une greffe de rein. Objectif: Exposer les grandes lignes du plan d'analyse statistique de l'essai EAKT LKD. Conception: EAKT LKD est un essai clinique pragmatique ouvert, à deux bras, en groupes parallèles, basé sur un registre, et randomisé en grappes. La randomisation a été réalisée au niveau des programmes d'insuffisance rénale chronique (IRC) (les « grappes ¼). Cadre: 26 programmes d'IRC en Ontario (Canada). Sujets: Plus de 10 000 patients atteints d'IRC de stade avancé (des patients approchant le besoin de dialyse ou recevant une hémodialyse d'entretien) sans contre-indication documentée à la greffe rénale. Méthodologie: Les données de l'essai (y compris les caractéristiques et les résultats des patients) seront obtenues à partir de bases de données administratives en santé (le « registre ¼). La randomisation stratifiée avec contraintes de covariables a servi à répartir les 26 programmes d'IRC (1:1) selon qu'ils allaient fournir l'intervention ou les soins habituels entre le 1er novembre 2017 et le 31 décembre 2021 (4,17 ans). Les programmes d'IRC du bras d'intervention ont eu droit au soutien suivant: (1) des équipes locales d'amélioration de la qualité et du soutien administratif; (2) de l'information et des ressources sur mesure pour le personnel, les patients et les donneurs vivants; (3) du soutien de la part de receveurs et de donneurs vivants; et (4) des rapports sur le rendement au niveau du programme et une surveillance assurée par les chefs de programme. Résultats: Le principal critère d'évaluation est le taux d'étapes clés accomplies vers la réception d'une greffe de rein, où jusqu'à quatre étapes uniques par patient seront comptabilisées: (1) le patient est aiguillé vers un centre de transplantation pour évaluation; (2) un possible donneur vivant de rein contacte un centre de transplantation pour un receveur en particulier et amorce son évaluation; (3) le patient est ajouté à la liste d'attente pour une transplantation d'un donneur décédé, et (4) le patient reçoit une greffe de rein d'un donneur vivant ou décédé. Plan d'analyse: Selon une approche fondée sur l'intention de traiter, le critère d'évaluation principal sera analysé au niveau du patient en utilisant un modèle multiétats contraint, corrigé dans les programmes d'IRC en fonction du regroupement. Statut de l'essai: L'essai EnAKT LKD s'est tenu du 1er novembre 2017 au 31 décembre 2021. Nous analyserons les résultats et en rendrons compte dès que les données seront disponibles dans les bases de données administratives couplées du système de santé.

Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1): a pragmatic stepped-wedge, cluster randomized controlled registry trial.

BACKGROUND: The shortage of available organs for life-saving transplants persists worldwide. While a majority support donating their organs or tissue when they die, many have not registered their wish to do so. When registered, next of kin are much more likely to follow-through with the decision to donate. In many countries, most people visit their family physician office each year and this setting is a promising, yet underused, site where more people could register for deceased organ donation. Our primary aim was to evaluate the effectiveness of an intervention to promote organ donation registration in family physician's offices. METHODS: We developed an intervention to address barriers and enablers to organ donation registration that involved physician office reception staff inviting patients to register on a tablet in the waiting room while they waited for their appointment. We conducted a cross-sectional stepped-wedge cluster randomized controlled registry trial to evaluate the intervention. We recruited six family physician offices in Canada. All offices began with usual care and then every two weeks, one office (randomly assigned) started the intervention until all offices delivered the intervention. The primary outcome was registration for deceased organ donation in the provincial organ registration registry, assessed within the 7 days of the physician visit. At the end of the trial, we also conducted interviews with clinic staff to assess any barriers and enablers to delivering the intervention. RESULTS: The trial involved 24,616 patient visits by 13,562 unique patients: 12,484 visits in the intervention period and 12,132 in the control period. There was no statistically significant difference in the percentage of patients registered for deceased organ donation in the intervention versus control period (48.0% vs 46.2%; absolute difference after accounting for the secular trend: 0.12%; 95% CI: - 2.30, 2.54; p=0.92). Interviews with clinic staff indicated location of the tablet within a waiting room, patient rapport, existing registration, confidence and motivation to deliver the intervention and competing priorities as barriers and enablers to delivery. CONCLUSIONS: Our intervention did not increase donor registration. Nonetheless, family physician offices may still remain a promising setting to develop and evaluate better interventions to increase organ donation registration. TRIAL REGISTRATION: NCT03213171.

Program Report: Can-SOLVE CKD Network Presents an Inclusive Method for Developing Patient-Oriented Research Tools.

PURPOSE OF PROGRAM: Given the growing interest in patient-oriented research (POR) initiatives, there is a need to provide relevant training and education on how to engage with patients as partners on research teams. SOURCES OF INFORMATION: As part of its mandate to develop appropriate training materials, the patient-oriented renal research network, Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD), established a training and Mentorship Committee (TMC). METHODS: The committee brings together a unique combination of Indigenous and non-Indigenous patient partners (including caregivers, family members, and living donors), researchers, as well as patient engagement and knowledge translation experts, combining a multitude of perspectives and expertise. Following an assessment of training needs within the network, the TMC undertook the co-development of 5 learning modules to address the identified gaps. Subsequently, the committee divided into working groups tasked with developing content using a consultive and iterative approach informed by the DoTTI framework for building web-based tools for patients. In addition, the TMC embodied the guiding principles of inclusiveness, support, mutual respect, and co-building as set out by the Patient Engagement Framework through the Strategy for Patient-Oriented Research (SPOR) of the Canadian Institutes of Health Research. KEY FINDINGS: The 5 new modules include: A Patient Engagement Toolkit, Storytelling for Impact, Promoting Kidney Research in Canada (KidneyPRO), Wabishki Bizhiko Skaanj Learning Pathway, and Knowledge Translation. The TMC's approach to developing these modules demonstrates how a diverse group of stakeholders working together can create tools to support high-quality POR. This also provides a roadmap for other health research entities interested in developing similar tools within their unique domains. LIMITATIONS: The landscape of patient engagement in research is constantly evolving. This underscores the need for sustained resources to keep POR tools and training relevant and up-to-date. Sustaining such resources may not be feasible for all research entities. IMPLICATIONS: Collaborative approaches integrating patients in the development of POR tools ensure the content is relevant and meaningful to patients. Broader adoption of such approaches has great potential to address existing gaps and enhance the Canadian POR landscape.

OBJECTIF DU PROGRAM: L'intérêt croissant pour les initiatives de recherche axée sur le patient met en évidence le besoin de sensibiliser les chercheurs et d'offrir une formation pertinente sur les façons d'impliquer les patients comme partenaires dans les équipes de recherche. SOURCES: Dans le cadre de son mandat consistant à élaborer des documents de formation appropriés, le réseau dédié à l'avancement de la recherche en santé rénale axée sur le patient, le réseau CAN-SOLVE CKD (Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease), a créé un Comité de formation et de mentorat (CFM). MÉTHODOLOGIE: Le CFM réunit une combinaison unique de patients partenaires autochtones et non autochtones (incluant soignants, membres des familles, donneurs vivants), des chercheurs et des experts de l'application des connaissances et de l'implication des patients à la recherche, ce qui permet de conjuguer une multitude de points de vue et d'expertises. Après une évaluation des besoins en formation dans le réseau, le CFM a entrepris l'élaboration conjointe de cinq modules d'apprentissage pour combler les lacunes mises en évidence. Le comité s'est ensuite divisé en groupes de travail chargés d'en élaborer les contenus par le biais d'une approche consultative et itérative guidée par le cadre de perfectionnement DoTTI pour la création d'outils Web destinés aux patients. De plus, le CFM a intégré les principes directeurs d'inclusion, de soutien, de respect mutuel et de co-création énoncés dans le Cadre d'engagement des patients de la stratégie de recherche axée sur le patient (RAP) des Instituts de recherche en santé du Canada. PRINCIPAUX RÉSULTATS: Les cinq nouveaux modules sont: une trousse d'outils sur l'implication des patients, le partage de récits qui ont un impact, la promotion de la recherche dans le domaine rénal au Canada (KidneyPRO -Promoting Kidney Research in Canada), le cheminement d'apprentissage Wabishki Bizhiko Skaanj et l'application des connaissances. L'approche adoptée par le CFM pour développer ces modules a montré comment un groupe diversifié d'intervenants qui travaille ensemble peut mener à la création d'outils pour soutenir une RAP d'excellente qualité. Ces travaux ont également fourni une feuille de route pour d'autres entités de recherche en santé qui souhaiteraient élaborer des outils similaires dans leurs domaines respectifs. LIMITES: L'implication des patients dans la recherche est en constante évolution. Cette étude souligne le besoin de ressources durables pour garder les outils et les formations en RAP pertinents et à jour. Le maintien de telles ressources pourrait ne pas être possible pour toutes les entités de recherche. IMPLICATIONS: Les approches collaboratives qui impliquent les patients dans le développement d'outils de RAP garantissent que les contenus soient pertinents et significatifs pour les patients. L'adoption à plus grande échelle de telles approches a le potentiel de combler les lacunes existantes et d'améliorer le domaine de la RAP au Canada.

A Quality Improvement Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) in Patients With Chronic Kidney Disease: Clinical Research Protocol of a Cluster-Randomized Clinical Trial.

BACKGROUND: Many patients with kidney failure will live longer and healthier lives if they receive a kidney transplant rather than dialysis. However, multiple barriers prevent patients from accessing this treatment option. OBJECTIVE: To determine if a quality improvement intervention provided in chronic kidney disease (CKD) programs (vs. usual care) enables more patients with no recorded contraindications to kidney transplant to complete more steps toward receiving a kidney transplant. DESIGN: This protocol describes a pragmatic 2-arm, parallel-group, open-label, registry-based, cluster-randomized clinical trial-the Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) trial. SETTING: All 26 CKD programs in Ontario, Canada, with a trial start date of November 1, 2017. The original end date of March 31, 2021 (3.4 years) has been extended to December 31, 2021 (4.1 years) due to the COVID-19 pandemic. PARTICIPANTS: During the trial, the 26 CKD programs are expected to care for more than 10 000 adult patients with CKD (including patients approaching the need for dialysis and patients receiving dialysis) with no recorded contraindications to a kidney transplant. INTERVENTION: Programs were randomly allocated to provide a quality improvement intervention or usual care. The intervention has 4 main components: (1) local quality improvement teams and administrative support; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. PRIMARY OUTCOME: The primary outcome is the number of key steps completed toward receiving a kidney transplant analyzed at the cluster level (CKD program). The following 4 unique steps per patient will be counted: (1) patient referred to a transplant center for evaluation, (2) at least one living kidney donor candidate contacts a transplant center for an intended recipient and completes a health history questionnaire to begin their evaluation, (3) patient added to the deceased donor transplant wait list, and (4) patient receives a kidney transplant from a living or deceased donor. PLANNED PRIMARY ANALYSIS: Study data will be obtained from Ontario's linked administrative healthcare databases. An intent-to-treat analysis will be conducted comparing the primary outcome between randomized groups using a 2-stage approach. First stage: residuals are obtained from fitting a regression model to individual-level variables ignoring intervention and clustering effects. Second stage: residuals from the first stage are aggregated at the cluster level as the outcome. LIMITATIONS: It may not be possible to isolate independent effects of each intervention component, the usual care group could adopt intervention components leading to contamination bias, and the relatively small number of clusters could mean the 2 arms are not balanced on all baseline prognostic factors. CONCLUSIONS: The EnAKT LKD trial will provide high-quality evidence on whether a multi-component quality improvement intervention helps patients complete more steps toward receiving a kidney transplant. TRIAL REGISTRATION: Clinicaltrials.gov; identifier: NCT03329521.

CONTEXTE: Plusieurs patients atteints d'insuffisance rénale vivront plus longtemps et en meilleure santé s'ils reçoivent une greffe de rein plutôt que des traitements de dialyze. De nombreux obstacles empêchent cependant les patients d'accéder à la transplantation. OBJECTIF: Déterminer si une intervention visant l'amélioration de la qualité menée dans les programs d'insuffisance rénale chronique (IRC) permettrait à davantage de patients sans contre-indications à une greffe d'aller plus loin (comparativement aux soins habituels) dans le processus menant à la transplantation. TYPE D'ÉTUDE: Ce protocole décrit un essai clinique pragmatique ouvert, à deux bras, en groupes parallèles, à répartition aléatoire en grappes et fondé sur un registre ­ l'essai Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD). CADRE: Les 26 programs d'IRC de l'Ontario (Canada). L'essai a débuté le 1er novembre 2017 et devait initialement se terminer le 31 mars 2021 (3,4 ans); cette date a été reportée au 31 décembre 2021 (4,1 ans) en raison de la pandémie de COVID-19. SUJETS: Au cours de l'essai, on estime que les 26 programs d'IRC prendront en charge plus de 10 000 adultes atteints d'IRC (y compris des patients approchant le besoin de dialyze et des patients dialysés) sans contre-indications à une greffe. INTERVENTIONS: Les programs ont été répartis aléatoirement pour intégrer une intervention d'amélioration de la qualité ou pour prodiguer les soins habituels. L'intervention consiste en quatre composantes principales: (1) des équipes locales d'amélioration de la qualité et de soutien administratif; (2) de l'information et des ressources sur mesure pour le personnel, les patients et les donneurs vivants; (3) du soutien pour les receveurs et les donneurs vivants; et (4) des rapports sur le rendement au niveau du program et une surveillance assurée par les chefs de program. PRINCIPAUX RÉSULTATS: Le principal critère d'évaluation est le nombre d'étapes clés complétées en vue de la réception d'une greffe de rein tel qu'analysé au niveau de la grappe (program d'IRC). Pour chaque patient, quatre étapes spécifiques seront comptabilisées: (I) le patient est aiguillé vers un center de transplantation pour évaluation; (II) au moins un donneur vivant de rein contacte un center de transplantation pour un receveur en particulier et amorce son évaluation en remplissant un questionnaire sur ses antécédents médicaux; (III) le patient est ajouté à la liste d'attente pour une transplantation d'un donneur décédé, et (IV) le patient reçoit une greffe de rein d'un donneur vivant ou décédé. PRINCIPALE ANALYZE ENVISAGÉE: Les données sont tirées des bases de données administratives du système de santé ontarien. Une analyze en intention de traiter sera effectuée en comparant le principal critère d'évaluation entre les groupes répartis aléatoirement à l'aide d'une approche en deux étapes. Première étape: obtention de valeurs résiduelles en adaptant un modèle de régression aux variables de niveau individuel et en ignorant les effets de l'intervention et du regroupement. Deuxième étape: les valeurs résiduelles de la première étape agrégées au niveau du groupe constitueront le résultat. LIMITES: Il pourrait ne pas être possible d'isoler les effets indépendants de chaque composante de l'intervention. L'équipe prodiguant les soins habituels pourrait adopter des composantes de l'intervention menant à un biais de contamination. Le nombre relativement faible de groupes pourrait signifier que les deux bras ne sont pas équilibrés sur tous les facteurs pronostiques de base. CONCLUSION: L'essai EnAKT LKD fournira des données de haute qualité sur la question de savoir si une intervention à composantes multiples visant l'amélioration de la qualité aide effectivement les patients à franchir davantage d'étapes vers une transplantation rénale.

Outcomes of an Inpatient Dialysis Start in Patients With Kidney Graft Failure: A Population-Based Multicentre Cohort Study.

BACKGROUND: The frequency and outcomes of starting maintenance dialysis in the hospital as an inpatient in kidney transplant recipients with graft failure are poorly understood. OBJECTIVE: To determine the frequency of inpatient dialysis starts in patients with kidney graft failure and examine whether dialysis start status (hospital inpatient vs outpatient setting) is associated with all-cause mortality and kidney re-transplantation. DESIGN: Population-based cohort study. SETTING: We used linked administrative healthcare databases from Ontario, Canada. PATIENTS: We included 1164 patients with kidney graft failure from 1994 to 2016. MEASUREMENTS: All-cause mortality and kidney re-transplantation. METHODS: The cumulative incidence function was used to calculate the cumulative incidence of all-cause mortality and kidney re-transplantation, accounting for competing risks. Subdistribution hazard ratios from the Fine and Gray model were used to examine the relationship between inpatient dialysis starts (vs outpatient dialysis start [reference]) and the dependent variables (ie, mortality or re-transplant). RESULTS: We included 1164 patients with kidney graft failure. More than half (55.8%) of patients with kidney graft failure, initiated dialysis as an inpatient. Compared with outpatient dialysis starters, inpatient dialysis starters had a significantly higher cumulative incidence of mortality and a significantly lower incidence of kidney re-transplantation (P < .001). The 10-year cumulative incidence of mortality was 51.9% (95% confidence interval [CI]: 47.4, 56.9%) (inpatient) and 35.3% (95% CI: 31.1, 40.1%) (outpatient). After adjusting for clinical characteristics, we found inpatient dialysis starters had a significantly increased hazard of mortality in the first year after graft failure (hazard ratio: 2.18 [95% CI: 1.43, 3.33]) but at 1+ years there was no significant difference between groups. LIMITATIONS: Possibility of residual confounding and unable to determine inpatient dialysis starts that were unavoidable. CONCLUSIONS: In this study we identified that most patients with kidney graft failure had inpatient dialysis starts, which was associated with an increased risk of mortality. Further research is needed to better understand the reasons for an inpatient dialysis start in this patient population.

CONTEXTE: On en sait peu sur la fréquence à laquelle est amorcé un traitement de dialyse d'entretien pendant l'hospitalisation des patients qui subissent une défaillance du greffon rénal. On en sait également peu sur les issues liées à cette procédure. OBJECTIFS: Déterminer la fréquence à laquelle un traitement de dialyse est amorcé pendant l'hospitalisation des patients qui subissent une défaillance du greffon, et vérifier si le statut du patient avant le traitement (hospitalisé vs ambulatoire) est associé à la mortalité toutes causes confondues et à la retransplantation. TYPE D'ÉTUDE: Étude de cohorte basée sur la population. CADRE: Nous avons utilisé les bases de données couplées du système de santé de l'Ontario (Canada). SUJETS: Ont été inclus 1 164 patients ayant subi une défaillance du greffon rénal entre 1994 et 2016. MESURES: La mortalité toutes causes confondues et la retransplantation d'un rein. MÉTHODOLOGIE: La fonction d'incidence cumulative a été utilisée pour calculer l'incidence cumulative de la mortalité toutes causes confondues et de la retransplantation, en tenant compte des risques concurrents. Les rapports de risque de sous-distribution du modèle Fine et Gray ont été employés pour examiner le lien entre l'amorce de la dialyse pendant l'hospitalisation (par rapport à l'amorce en ambulatoire [référence]) et les variables dépendantes (mortalité et retransplantation). RÉSULTATS: L'étude porte sur 1 164 patients ayant subi une défaillance du greffon. Plus de la moitié des patients inclus (55,8 %) avaient amorcé la dialyse pendant l'hospitalisation. Comparativement aux patients ayant amorcé la dialyse en ambulatoire, les patients hospitalisés ont montré une incidence cumulative significativement plus élevée de mortalité et une incidence significativement plus faible de retransplantation d'un rein (p<0,001). L'incidence cumulative de mortalité après 10 ans se situait à 51,9 % (IC 95 %: 47,4-56,9 %) pour les patients hospitalisés et à 35,3 % (IC 95 %: 31,1-40,1 %) pour les patients ambulatoires. Après l'ajustement en fonction des caractéristiques cliniques, nous avons constaté que les patients qui avaient amorcé la dialyse à l'hôpital avaient un risque significativement plus élevé de décéder dans l'année suivant la défaillance du greffon (rapport de risque: 2,18 [IC 95 %: 1,43-3,33]), mais aucune différence significative n'était observable entre les deux groupes au-delà d'un an. LIMITES: Possibilité de facteurs de confusion résiduels et incapacité de déterminer les amorces de dialyse inévitables chez des patients hospitalisés. CONCLUSION: Nous avons constaté que la plupart des patients ayant subi une défaillance du greffon avaient amorcé la dialyse pendant l'hospitalisation, et que cette procédure était associée à un risque accru de mortalité. Des recherches supplémentaires sont nécessaires pour mieux comprendre les raisons qui mènent à une amorce de dialyse pendant l'hospitalisation chez ces patients.

A RAND-Modified Delphi on Key Indicators to Measure the Efficiency of Living Kidney Donor Candidate Evaluations.

BACKGROUND AND OBJECTIVES: Many patients, providers, and potential living donors perceive the living kidney donor evaluation process to be lengthy and difficult to navigate. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We sought consensus on key terms and process and outcome indicators that can be used to measure how efficiently a transplant center evaluates persons interested in becoming a living kidney donor. Using a RAND-modified Delphi method, 77 participants (kidney transplant recipients or recipient candidates, living kidney donors or donor candidates, health care providers, and health care administrators) completed an online survey to define the terms and indicators. The definitions were then further refined during an in-person meeting with ten stakeholders. RESULTS: We identified 16 process indicators (e.g., average time to evaluate a donor candidate), eight outcome indicators (e.g., annual number of preemptive living kidney donor transplants), and two measures that can be considered both process and outcome indicators (e.g., average number of times a candidate visited the transplant center for the evaluation). Transplant centers wishing to implement this set of indicators will require 22 unique data elements, all of which are either readily available or easily collected prospectively. CONCLUSIONS: We identified a set of indicators through a consensus-based approach that may be used to monitor and improve the performance of a transplant center in how efficiently it evaluates persons interested in becoming a living kidney donor.

Program Report: KidneyPRO, a Web-based Training Module for Patient Engagement in Kidney Research.

PURPOSE OF REPORT: Over the recent years, there has been increasing support and traction for patient-oriented research (POR). Such an approach ensures that health research is focused on what matters most: improving outcomes for patients. Yet the realm of health research remains enigmatic for many patients in Canada who are not familiar with research terms and practices, highlighting the need for focused capacity-building efforts, including the development of novel educational tools to support patients to meaningfully engage in the research enterprise. The need for disease-specific training in POR was identified by the network dedicated to advancing patient-oriented kidney research in Canada, Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD), during the early years of the network's inception. In this report, we describe the development of KidneyPRO, an online learning module that orients patients and families to kidney research in Canada, and outlines ways to get involved. In line with the Patient Engagement framework of the Strategy for Patient Oriented Research, KidneyPRO was co-developed with the network's patient partners. SOURCES OF INFORMATION: The need for KidneyPRO was identified through a review of feedback from network participants of Canadian Institutes of Health Research's (CIHR) Foundations in Patient-Oriented Research Module 2-Health Research in Canada and a network-wide survey of Can-SOLVE CKD that was conducted in June 2017 and assessed training needs of key stakeholders. This 2017 survey ranked the need for tools providing introductory knowledge on Canadian kidney research as third in the network's top 5 capacity-building priorities. METHODS: At Can-SOLVE CKD, a dedicated multi-stakeholder team was formed from the Training & Mentorship Committee (the network's core infrastructure for POR capacity building) to determine the learning objectives, content, and user interface. The team consisted of 3 patient partners, Director of Research for the Kidney Foundation of Canada, a kidney clinician-scientist, the network's Patient Partnerships & Training Lead, Can-SOLVE CKD's Indigenous People's Engagement and Research Council Coordinator, and a project coordinator. With permission, content from CIHR's Foundations in Patient-Oriented Research, along with resources from the Kidney Foundation of Canada's research arm and network project teams, was used to form the basis of the tool. The working group adapted a DoTTI (Design and develOpment, Testing early iterations, Testing for Effectiveness, Integration, and implementation) framework and iteratively identified, created, and refined the content and user interface in consultation with the Training and Mentorship Committee and the Can-SOLVE CKD Patient Governance Circle. KEY FINDINGS: In this article, we describe the development, deployment, and evaluation of KidneyPRO, a web-based training module that helps patients understand general, patient-oriented, and kidney-specific research within Canada. KidneyPRO aims to support patient engagement in studies as partners and/or participants and empower them to take part in the research process in an active and meaningful way. It was co-designed and vetted by patients, which helps to ensure clear, useful content and a user-friendly interface. In addition, the module includes links to kidney research opportunities within the Can-SOLVE CKD Network and beyond. A literature review established that KidneyPRO fills an important gap in kidney-specific POR. Ongoing collection of website metrics and postcompletion surveys from users will be used to evaluate the effectiveness of the tool. LIMITATIONS: As an online tool, people who do not have adequate Internet access will not be able to use KidneyPRO. Currently, the tool is not compliant with all Web Content Accessibility Guidelines. Given how the landscape of patient partnership in research is constantly evolving, the content in KidneyPRO needs to be updated on a regular basis. IMPLICATIONS: Canadians with or at high risk of CKD now have access to an educational tool when seeking to engage as partners and/or participants in innovative kidney research.

OBJET DU RAPPORT: Depuis quelques années, la recherche axée sur le patient (RAP) bénéficie d'un soutien et d'un attrait croissant. Cette approche permet de garantir que la recherche se concentre sur ce qui compte vraiment: améliorer les résultats des patients. La recherche en santé demeure toutefois énigmatique pour les nombreux patients canadiens qui ne sont pas familiers avec la terminologie et les pratiques de la recherche. Ce constat met en évidence le besoin d'efforts ciblés pour renforcer les capacités, notamment en développant des outils éducatifs pour inciter les patients à s'impliquer significativement dans la recherche. Le besoin de formation spécifique aux maladies rénales dans la RAP a été identifié par Can-SOLVE CKD, le réseau dédié à l'avancement de la recherche en santé rénale axée sur le patient au Canada, dès les premières années de sa création. Dans ce rapport, nous discutons du développement de KidneyPRO, un module d'apprentissage en ligne qui oriente les patients et les familles vers la recherche en santé rénale au Canada et qui présente les différentes façons de s'impliquer. Conformément au Cadre d'engagement des patients de la Stratégie de recherche axée sur le patient, KidneyPRO a été élaboré avec la participation des patients-partenaires du réseau. SOURCES: Le besoin pour un outil comme KidneyPRO a été établi grâce à l'examen des commentaires des participants au module 2 des fondements de la recherche axée sur le patient des IRSC et d'un sondage évaluant les besoins de formation des principaux intervenants mené en juin 2017 dans l'ensemble du réseau Can-SOLVE CKD. Ce sondage a permis de classer le besoin d'outils fournissant des connaissances de base sur la recherche en santé rénale au Canada au troisième rang des cinq principales priorités du réseau en matière de renforcement des capacités. MÉTHODOLOGIE: Chez Can-SOLVE CKD, une équipe multipartite dédiée a été constituée au sein du comité de formation et de mentorat (la principale infrastructure du réseau en matière de renforcement des capacités dans la RAP) pour établir les objectifs d'apprentissage, le contenu et l'interface utilisateur de KidneyPRO. Cette équipe était constituée de trois patients-partenaires, du directeur de la recherche de la Fondation canadienne du rein, d'un chercheur clinicien en santé rénale, du responsable chez Can-SOLVE CKD de la formation et des partenariats avec les patients, du coordonnateur du Conseil de la recherche et de l'engagement des peuples autochtones (CREPC) de Can-SOLVE CKD, et d'un coordonnateur de projet. Avec les autorisations requises, le contenu des Fondations pour la recherche axée sur le patient des IRSC, de même que les ressources du bras de recherche de la Fondation canadienne du rein et des équipes de projet de Can-SOLVE CKD ont été utilisés pour constituer la base de l'outil. Le groupe de travail a adapté un cadre de perfectionnement DoTTI (Design and develOpment, Testing early iterations, Testing for Effectiveness, Integration and implementation) puis déterminé, créé et raffiné de manière itérative le contenu et l'interface utilisateur de l'outil en collaboration avec le Comité de formation et de mentorat et le Conseil des patients de Can-SOLVE CKD. PRINCIPAUX RÉSULTATS: Cet article décrit le développement, le déploiement et l'évaluation de KidneyPRO, un module d'apprentissage en ligne qui aide les patients canadiens à comprendre la recherche tant générale que centrée sur les patients ou spécifique aux maladies rénales. KidneyPRO est conçu pour soutenir l'engagement des patients en recherche, comme partenaires et/ou participants, et leur donner les moyens de s'impliquer activement et significativement dans le processus. L'outil a été co-créé et validé par les patients, ce qui contribue à garantir un contenu clair et pertinent, et une interface facile à utiliser. Le module comprend également des liens vers les différentes avenues de la recherche dans le réseau Can-SOLVE CKD et ailleurs. Une revue de la littérature a permis de confirmer que KidneyPRO comble un important vide de la RAP en santé rénale. L'efficacité de l'outil sera évaluée par la collecte de données en continu sur le site Web et par des questionnaires de suivi proposés aux patients. LIMITES: KidneyPRO étant un outil en ligne, son utilisation pourrait constituer un enjeu pour les personnes dont l'accès à internet est inadéquat. Aussi, l'outil n'est toujours pas conforme à toutes les directives pour l'accessibilité aux contenus Web. Enfin, la situation des partenariats avec les patients en recherche étant en constante évolution, le contenu de KidneyPRO doit être mis à jour régulièrement. CONCLUSION: Les Canadiens atteints ou susceptibles d'évoluer vers l'insuffisance rénale chronique ont désormais accès à un outil éducatif lorsqu'ils cherchent à s'impliquer comme partenaires ou participants à des études innovantes en santé rénale.

Partnering with Patients, Families, and Caregivers in Nephrology Nursing Research.

Nurses value patient- and family-centered care as one of the most important elements of nursing, and as such, these foundations are embedded into nursing practice and theory. Patient engagement in health research, as an evolution of patient- and family-centered care, has emerged as a critical new way of doing research over the last several years. However, the benefit, value, and exploration of ways in which patient partnerships can be built within the context of nephrology nursing research are still relatively new. This article describes patient-centered outcomes research, discusses how patients can be involved throughout the research process, and provides examples for effective partnerships in nephrology nursing research.

Clinical care gaps and solutions in diabetes and advanced chronic kidney disease: a patient-oriented qualitative research study.

BACKGROUND: Patients with diabetes and advanced chronic kidney disease face a high health care burden. As part of a patient-oriented research initiative to identify ways to better support patients' diabetes care, we explored their health care experience and solutions for patient-centred diabetes care. METHODS: We engaged 2 patients with advanced kidney disease and diabetes to join our multidisciplinary team as full research partners. They were involved in our design and conduct of the study, the analysis of the results and knowledge translation. We conducted qualitative interviews (1:1 semistructured interviews and focus groups) with patients with a history of both diabetes (type 1 or 2) and advanced kidney disease including those using dialysis. We identified overarching themes using individual and team analysis and conducted interviews until data saturation was reached. RESULTS: Twelve participants were interviewed between October 2017 and February 2018. Six people were interviewed in 2 separate focus groups (consisting of 4 and 2 participants) and 6 participated in 1:1 interviews with our team. Participants described being burdened by medical appointments, strict conflicting diets, costly diabetes therapies and fragmented, siloed health care. They indicated that self-management support, education and coordinated diabetes care might better support their diabetes care. INTERPRETATION: Patients with complex medical comorbidities face many challenges traversing a health care system organized around single diseases. Researchers and policy-makers should study and develop patient-centred diabetes care strategies to better support these high-risk patients.

Co-building a patient-oriented research curriculum in Canada.

PLAIN ENGLISH SUMMARY: Foundations in Patient-Oriented Research is a course designed and piloted in Canada to help patients, researchers, health care professionals and health system decision-makers gain an introductory understanding of patient-oriented research, the research enterprise, and how to work in a team. The course curriculum was co-developed by a diverse group of people with different lived experiences and relevant expertise. The course is meant to be delivered in a 'co-learning format' with classes comprised of all the above stakeholder groups learning together. The purpose of this study was to explore the experiences of the project leaders, developers, facilitators and patient co-facilitators who were involved in the process of co-developing, piloting and revising the curriculum.Our findings suggest that co-developing a patient-oriented research curriculum increases its quality, uptake and credibility. The co-development process not only resulted in training that benefited the target learners, but it provided valuable learning experiences about patient-oriented research for the project leaders, developers, facilitators and patient co-facilitators. These findings and the resulting recommendations may provide guidance for other learning and development groups wishing to undertake a similar project. ABSTRACT: Background Foundations in Patient-Oriented Research is a course designed and piloted in Canada to build mutually beneficial relationships for conducting patient-oriented research by ensuring that relevant stakeholders - patients, researchers, health care professionals and health system decision-makers - have a common foundational understanding of patient-oriented research, the research enterprise, and team dynamics. The curriculum was co-developed by a group of patients, researchers, patient engagement experts and curriculum development experts and involved consultations with broader groups of the relevant stakeholders mentioned above. It was designed to be delivered in a 'co-learning format' with classes comprised of all stakeholder groups learning together. The purpose of this study was to explore the experiences of individuals involved in the process of co-developing, piloting and revising Foundations in Patient-Oriented Research. Methods An embedded case study was conducted with individuals who were involved in the co-development, pilot and revision of Foundations in Patient-Oriented Research. These individuals took on different roles during the curriculum development process, including project co-lead, developer, facilitator, and patient co-facilitator. The constant comparison method was used to inductively develop themes from the two focus group sessions. Results Discussions from the focus groups revealed the value of co-building the content, co-facilitating the course sessions, and the importance of the co-learning format. The training itself was perceived as valuable and the systematic approach to co-development was perceived as a success. Several barriers were identified, including the amount of resources, time and commitment required to complete the project. There was a notable tension between maintaining the integrity of the content and having the freedom to adapt it to local contexts. Over the course of the project, the project co-leads, developers and facilitators found that their own understanding of patient-oriented research deepened. Conclusions The findings of this study suggest that co-developing a patient-oriented research curriculum increases its quality, uptake and credibility. The co-development process not only resulted in training that benefited the target learners, but also built capacity for patient-oriented research within the project co-leads, developers, facilitators and patient co-facilitators. Our findings and recommendations may provide guidance for other learning and development groups wishing to undertake a similar project.

Cultivating Innovative Pragmatic Cluster-Randomized Registry Trials Embedded in Hemodialysis Care: Workshop Proceedings From 2018.

Hemodialysis is a life-sustaining treatment for persons with kidney failure. However, those on hemodialysis still face a poor quality of life and a short life expectancy. High-quality research evidence from large randomized controlled trials is needed to identify interventions that improve the experiences, outcomes, and health care of persons receiving hemodialysis. With the support of the Canadian Institutes of Health Research and its Strategy for Patient-Oriented Research, the Innovative Clinical Trials in Hemodialysis Centers initiative brought together Canadian and international kidney researchers, patients, health care providers, and health administrators to participate in a workshop held in Toronto, Canada, on June 2 and 3, 2018. The workshop served to increase knowledge and awareness about the conduct of innovative, pragmatic, cluster-randomized registry trials embedded into routine hemodialysis care and provided an opportunity to discuss and build support for new trial ideas. The workshop content included structured presentations, facilitated group discussions, and expert panel feedback. Partnerships and promising trial ideas borne out of the workshop will continue to be developed to support the implementation of future large-scale trials.

L'hémodialyse constitue un traitement essentiel au maintien de la vie pour les personnes atteintes d'insuffisance rénale. Les patients hémodialysés voient cependant leur qualité et leur espérance de vie réduites. Des données de recherches probantes, provenant de vastes essais cliniques contrôlés à répartition aléatoire, sont nécessaires pour améliorer l'expérience, les résultats et les soins des patients hémodialysés. Grâce au soutien des Instituts de recherche en santé du Canada (IRSC) et de leur Stratégie de recherche axée sur le patient (SRAP), l'initiative sur les essais cliniques novateurs (ECN) en centres d'hémodialyse a réuni divers intervenants en santé rénale (chercheurs, patients, fournisseurs de soins et administrateurs), du Canada et de partout dans le monde, lors d'un colloque qui s'est tenu à Toronto les 2 et 3 juin 2018. Ce colloque a permis d'accroître la sensibilisation et les connaissances sur la conduite d'essais cliniques novateurs, répartis en grappes, pragmatiques et intégrés aux soins d'hémodialyse de routine. Cette rencontre a également fourni une occasion de discuter de nouvelles idées d'essais cliniques et de susciter les appuis nécessaires à leur réalisation. Le colloque s'est déroulé sous forme de présentations structurées, de discussions animées en groupe et de rétroaction de la part d'un comité d'experts. Les idées de recherche prometteuses et les partenariats issus de ce colloque continueront d'être développés pour soutenir la réalisation d'essais cliniques futurs de grande envergure.

Barriers to Education and Shared Decision Making in the Chronic Kidney Disease Population: A Narrative Review.

PURPOSE OF REVIEW: Provision of education to inform decision making for renal replacement therapy (RRT) is a key component in the management of chronic kidney disease (CKD), yet patients report suboptimal satisfaction with the process of selecting a dialysis modality. Our purpose is to review the influencers of RRT decision making in the CKD population, which will better inform the process of shared decision making between clinicians and patients. SOURCES OF INFORMATION: PubMed and Google Scholar. METHODS: A narrative review was performed using the main terms "chronic kidney disease," "CKD," "dialysis," "review," "decision-making," "decision aids," "education," and "barriers." Only articles in English were accessed. The existing literature was critically analyzed from a theoretical and contextual perspective and thematic analysis was performed. KEY FINDINGS: Eight common themes were identified as influencers for decision making. "Patient-focused" themes including social influence, values and beliefs, comprehension, autonomy and sociodemographics, and "clinician-focused" themes including screening, communication, and engagement. Early predialysis education and decision aids can effectively improve decision making. Patient-valued outcomes need to be more fully integrated into clinical guidelines. LIMITATIONS: This is not a systematic review; therefore, no formal tool was utilized to evaluate the rigor and quality of studies included and findings may not be generalizable. IMPLICATIONS: Standardized comprehensive RRT education programs through multidisciplinary health teams can help optimize CKD patient education and shared decision making. Involving patients in the research process itself and implementing patient values and preferences into clinical guidelines can help to achieve a patient-centered model of care.

CONTEXTE MOTIVANT LA REVUE: La transmission d'informations en vue d'éclairer la prise de décision en matière de thérapie de remplacement rénal (TRR) est un élément clé de la prise en charge des patients atteints d'insuffisance rénale chronique (IRC). Malgré cela, les patients rapportent des niveaux sous-optimaux de satisfaction en regard du processus de sélection d'une modalité de dialyse. Notre objectif est d'examiner les facteurs influençant la prise de décision dans le choix d'une TRR chez une population de patients atteints d'IRC, ce qui aura pour effet de mieux guider le processus de prise de décision partagée entre les cliniciens et les patients. SOURCES: Les bases de données PubMed et Google Scholar. MÉTHODOLOGIE: On a procédé à un examen narratif de la littérature à l'aide des principaux termes suivants : insuffisance rénale chronique (chronic kidney disease), IRC (CKD), dialyse (dialysis), revue (review), prise de décision (decision making), aides à la décision (decision aids), éducation (education), et obstacles (barriers). Seuls les articles en anglais ont été consultés. La littérature existante a fait l'objet d'une critique rigoureuse d'un point de vue théorique et contextuel, et une analyse thématique a été réalisée. PRINCIPAUX RÉSULTATS: Nous avons relevé huit thèmes communs influençant la prise de décision. Ces thèmes se divisent en deux catégories : i) les thèmes liés au patient, soit l'influence sociale, ses valeurs et croyances, sa compréhension, son autonomie et ses caractéristiques socio-démographiques, et; ii) les thèmes liés au clinicien, soit le dépistage, la communication et son implication. Informer le patient et lui fournir des aides à la décision tôt dans le processus pré-dialyse s'avère efficace pour faciliter la prise de décision. Les résultats attendus par les patients devraient être mieux intégrés aux protocoles cliniques. LIMITES: Cet examen ne constitue pas une revue systématique. Dès lors, aucun outil officiel n'a été employé pour évaluer la rigueur et la qualité des études retenues. Les résultats pourraient ne pas être généralisables. IMPLICATIONS: En matière de TRR, des programmes informatifs complets et normalisés, offerts par l'entremise d'équipes pluridisciplinaires en santé, pourraient contribuer à optimiser la transmission d'informations aux patients atteints d'IRC et éclairer la prise de décision partagée. La participation des patients au processus de recherche et l'intégration de leurs valeurs et de leurs préférences dans les protocoles cliniques pourraient favoriser l'élaboration d'un modèle de soins mieux axé sur le patient.

Educational Support Around Dialysis Modality Decision Making in Patients With Chronic Kidney Disease: Qualitative Study.

BACKGROUND: Patients with chronic kidney disease (CKD) are asked to choose a renal replacement therapy or conservative management. Education and knowledge transfer play key roles in this decision-making process, yet they remain a partially met need. OBJECTIVE: We sought to understand the dialysis modality decision-making process through exploration of the predialysis patient experience to better inform the educational process. DESIGN: Qualitative descriptive study. SETTING: Kidney Care Centre of London Health Sciences Centre in London, Ontario, Canada. PATIENTS: Twelve patients with CKD, with 4 patients on in-center hemodialysis, home hemodialysis, and peritoneal dialysis, respectively. MEASUREMENTS: Not applicable. METHODS: We conducted semistructured interviews with each participant, along with any family members who were present. Interviews were transcribed verbatim. Conventional content analysis was used to analyze the transcripts for common themes. Representative quotes were decided via team consensus. A patient collaborator was part of the research team. RESULTS: Three themes influenced dialysis modality decision making: (i) Patient Factors: individualization, autonomy, and emotions; (ii) Educational Factors: tailored education, time and preparation, and available resources; and (iii) Support Systems: partnership with health care team, and family and friends. LIMITATIONS: Sample not representative of wider CKD population. Limited number of eligible patients. Poor recall may affect findings. CONCLUSIONS: Modality decision making is a complex process, influenced by the patient's health literacy, willingness to accept information, predialysis lifestyle, support systems, and values. Patient education requires the flexibility to individualize the delivery of a standardized CKD curriculum in partnership with a patient-health care team, to fulfill the goal of informed, shared decision making.

CONTEXTE: Les patients atteints d'insuffisance rénale chronique (IRC) sont appelés à choisir entre une thérapie de remplacement rénal ou un traitement conservateur. La transmission d'informations et le transfert des connaissances jouent un rôle de premier plan dans ce processus de prise de décision, mais ces éléments demeurent à ce jour des besoins partiellement comblés. OBJECTIF: Nous avons cherché à comprendre le processus de prise de décision dans le choix d'une modalité de dialyse en explorant l'expérience des patients pré-dialyse, de façon à mieux éclairer la démarche éducative. TYPE D'ÉTUDE: Une étude qualitative et descriptive. CADRE: Le Kidney Care Centre du London Health Sciences Centre de London en Ontario (Canada). SUJETS: Un total de douze patients atteints d'IRC, soit quatre patients pour chacune des modalités de dialyse : hémodialyse en centre, hémodialyse à domicile et dialyse péritonéale. MESURES: Ne s'applique pas. MÉTHODOLOGIE: Nous avons procédé à des entretiens semi-structurés avec chacun des participants, de même qu'avec les membres de leur famille qui étaient présents. Les entrevues ont été transcrites textuellement. L'analyse de contenu a été employée pour retracer les thèmes communs dans les transcriptions. Les extraits représentatifs ont été établis par consensus des membres de l'équipe. Un patient collaborateur faisait partie de l'équipe de recherche. RÉSULTATS: Trois grands thèmes ont influencé la prise de décision quant au choix d'une modalité de dialyse : (i) des facteurs liés au patient : la personnalisation, l'autonomie et les émotions; (ii) des facteurs liés à l'information : information personnalisée, exigence en temps et en préparation, ressources disponibles, et; (iii) le réseau de soutien : la collaboration avec l'équipe de soins, la famille et les ami(e)s. LIMITES: L'échantillon n'est pas représentatif de l'ensemble de la population des patients atteints d'IRC. Les résultats pourraient également être affectés par le nombre limité de patients admissibles et par de possibles défaillances de mémoire de la part des répondants. CONCLUSION: La prise de décision quant au choix d'une modalité de remplacement rénal est un processus complexe influencé par les connaissances du patient en matière de santé, de même que par sa disposition à accepter l'information, son mode de vie pré-dialyse, son réseau de soutien et ses valeurs. L'éducation des patients demande la flexibilité nécessaire pour personnaliser la prestation d'un programme informatif normalisé sur l'IRC en partenariat avec l'équipe de soins; de manière à réaliser l'objectif d'une prise de décision éclairée et partagée.

Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1 trial): study protocol for a pragmatic, stepped-wedge, cluster randomized controlled registry.

BACKGROUND: There is a worldwide shortage of organs available for transplant, leading to preventable mortality associated with end-stage organ disease. While most citizens in many countries with an intent-to-donate "opt-in" system support organ donation, registration rates remain low. In Canada, most Canadians support organ donation but less than 25% in most provinces have registered their desire to donate their organs when they die. The family physician office is a promising yet underused setting in which to promote organ donor registration and address known barriers and enablers to registering for deceased organ and tissue donation. We developed a protocol to evaluate an intervention to promote registration for organ and tissue donation in family physician waiting rooms. METHODS/DESIGN: This protocol describes a planned, stepped-wedge, cluster randomized registry trial in six family physician offices in Ontario, Canada to evaluate the effectiveness of reception staff providing patients with a pamphlet that addresses barriers and enablers to registration including a description of how to register for organ donation. An Internet-enabled tablet will also be provided in waiting rooms so that interested patients can register while waiting for their appointments. Family physicians and reception staff will be provided with training and/or materials to support any conversations about organ donation with their patients. Following a 2-week control period, the six offices will cross sequentially into the intervention arm in randomized sequence at 2-week intervals until all offices deliver the intervention. The primary outcome will be the proportion of patients visiting the office who are registered organ donors 7 days following their office visit. We will evaluate this outcome using routinely collected registry data from provincial administrative databases. A post-trial qualitative evaluation process will assess the experiences of reception staff and family physicians with the intervention and the stepped-wedge trial design. DISCUSSION: Promoting registration for organ donation in family physician offices is a potentially useful strategy for increasing registration for organ donation. Increased registration may ultimately help to increase the number of organs available for transplant. The results of this trial will provide important preliminary data on the effectiveness of using family physician offices to promote registration for organ donation. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03213171 . Registered on 11 July 2017.

Increasing the Rate of Living Donor Kidney Transplantation in Ontario: Donor- and Recipient-Identified Barriers and Solutions.

PURPOSE OF REVIEW: To hear from living kidney donors and recipients about what they perceive are the barriers to living donor kidney transplantation, and how patients can develop and lead innovative solutions to increase the rate and enhance the experiences of living donor kidney transplantation in Ontario. SOURCES OF INFORMATION: A one-day patient-led workshop on March 10th, 2016 in Toronto, Ontario. METHODS: Participants who were previously engaged in priority-setting exercises were invited to the meeting by patient lead, Sue McKenzie. This included primarily past kidney donors, kidney transplant recipients, as well as researchers, and representatives from renal and transplant health care organizations across Ontario. KEY FINDINGS: Four main barriers were identified: lack of education for patients and families, lack of public awareness about living donor kidney transplantation, financial costs incurred by donors, and health care system-level inefficiencies. Several novel solutions were proposed, including the development of a peer network to support and educate patients and families with kidney failure to pursue living donor kidney transplantation; consistent reimbursement policies to cover donors' out-of-pocket expenses; and partnering with the paramedical and insurance industry to improve the efficiency of the donor and recipient evaluation process. LIMITATIONS: While there was a diversity of experience in the room from both donors and recipients, it does not provide a complete picture of the living kidney donation process for all Ontario donors and recipients. The discussion was provincially focused, and as such, some of the solutions suggested may already be in practice or unfeasible in other provinces. IMPLICATIONS: The creation of a patient-led provincial council was suggested as an important next step to advance the development and implementation of solutions to overcome patient-identified barriers to living donor kidney transplantation.

OBJECTIFS DE LA REVUE: Obtenir l'avis des donneurs de rein et des receveurs d'une greffe ontariens sur ce qu'ils considèrent comme des obstacles aux transplantations rénales provenant d'un donneur vivant, et sur la manière dont les patients pourraient élaborer et mener à bien des solutions innovantes pour accroître le nombre de greffes et améliorer l'expérience d'un donneur vivant à la suite d'une transplantation rénale. SOURCES: Les données ont été recueillies lors d'un atelier d'une journée dirigé par les patients, qui s'est tenu le 10 mars 2016 à Toronto (Ontario). MÉTHODOLOGIE: Les participants, qui s'étaient préalablement livrés à des exercices visant à définir des priorités, ont été invités à prendre part à l'atelier présidé par Sue McKenzie, une patiente. Le groupe de participants était constitué en premier lieu de donneurs de reins et de receveurs d'une greffe, mais également de chercheurs et de représentants de divers organismes en soins de santé rénale et en transplantation de partout en Ontario. PRINCIPALES CONCLUSIONS: Quatre principaux obstacles ont été identifiés : le manque d'information destinée aux patients et à leurs familles, le manque de sensibilisation auprès du public relativement aux donneurs vivants, les frais financiers encourus par les donneurs et, de façon globale, les inefficacités en matière de soins dans le système de santé. Plusieurs solutions ont été proposées lors de l'atelier, notamment l'élaboration d'un réseau de pairs visant à supporter les patients souffrant d'insuffisance rénale ainsi que leur famille et à les informer au sujet de la transplantation avec un donneur vivant. On a également proposé l'adoption de politiques de remboursement pour couvrir les frais encourus par les donneurs et l'établissement de partenariats entre le paramédical et les compagnies d'assurances afin d'améliorer l'efficacité du processus d'évaluation donneur-receveur. LIMITES: Malgré la diversité des expériences vécues par les donneurs et les receveurs présents dans la salle, l'ensemble des réponses ne fournit pas un portrait complet du processus de don de rein vivant qui soit représentatif de tous les donneurs et receveurs de l'Ontario. La discussion portait sur des obstacles et des solutions spécifiques à la situation en Ontario. Par conséquent, il est possible que certaines des solutions apportées soient déjà en pratique ou au contraire, s'avèrent impossibles dans d'autres provinces. CONCLUSIONS: La création d'un conseil provincial, mené par un patient ou une patiente, a été proposée comme étant la prochaine étape cruciale pour faire progresser la conception et la mise en œuvre de solutions concrètes permettant de surmonter les obstacles à la transplantation rénale avec donneur vivant qu'ont identifiés les patients.