Patient Perspectives on a Tailored Self-Management Education and Support Intervention for Low-Income Seniors With Chronic Health Conditions.

Background: The Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study (ACCESS) was a 2 x 2 factorial randomized trial that tested the impact of a tailored self-management education support (SMES) program, which demonstrated a 22% reduction in adverse clinical events. We sought to qualitatively explore participants' perspectives on the SMES intervention, and the ways in which it may have improved self-management skills. Methods: We used a qualitative descriptive approach and conducted individual semistructured interviews. We conducted inductive and deductive thematic analysis using NVivo 12 (QSR International, Burlington, MA). Results: We interviewed 20 participants who had recently completed the 3-year SMES intervention. The following 3 main themes emerged from the data: (i) empowerment; (ii) intervention acceptability; and (iii) suggestions for improvement. Regarding empowerment, we identified subthemes of health literacy, self-efficacy, self-management, and active role in health. Several participants reported that empowerment promoted health behaviour change or improved confidence in self-management. Regarding acceptability, we identified subthemes of ease of use and presentation style. Most participants expressed positive feelings toward the intervention and felt that it was easy to understand. Finally, we identified subthemes of learning style, content, and engagement strategies, within the theme of suggestions for improvement. Some participants said that the messages were too general and did not fully address the complex health concerns they had. Conclusions: Our results highlighted key strategies to promote patient engagement and self-management behaviours and demonstrated how they may have been used to improve clinical endpoints. Additionally, we demonstrated the novel use of marketing principles in SMES interventions.

Contexte: L'étude ACCESS (pour Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study) était un essai à répartition aléatoire avec un plan factoriel 2 x 2 qui a mesuré l'effet d'un programme personnalisé de soutien à la formation sur l'autogestion dans laquelle une réduction de 22 % des événements cliniques défavorables a été observée. Notre objectif était de réaliser une exploration qualitative du point de vue des patients au sujet de l'intervention et des façons dont elle a permis d'améliorer leurs habiletés d'autogestion. Méthodologie: Nous avons utilisé une approche descriptive et qualitative et nous avons mené des entretiens individuels semi-structurés auprès des participants. Des analyses thématiques inductive et déductive ont été réalisées avec NVivo 12 (QSR International, Burlington MA). Résultats: Des entretiens ont été menés auprès de 20 personnes ayant récemment terminé l'intervention de 3 ans. Les données recueillies ont permis de cerner 3 thèmes principaux : (i) l'autonomisation; (ii) l'acceptabilité de l'intervention; et (iii) les suggestions pour l'amélioration du programme. En ce qui concerne l'autonomisation des patients, nous avons relevé les sous-thèmes de la littératie dans le domaine de la santé, de l'auto-efficacité, de l'autogestion et de la participation active dans le domaine de la santé. Plusieurs participants ont mentionné que l'autonomisation avait favorisé des changements de comportements liés à la santé ou avait amélioré leur niveau de confiance quant à leur autogestion. Pour ce qui est de l'acceptabilité, nous avons noté les sous-thèmes de la facilité d'utilisation et du style des présentations. La plupart des participants ont exprimé une opinion favorable au sujet de l'intervention et la trouvaient facile à comprendre. En dernier lieu, nous avons relevé les thèmes des styles d'apprentissage, du contenu et des stratégies de mobilisation, que nous avons regroupés sous le thème des suggestions d'amélioration. Certains participants ont mentionné que les messages étaient trop généraux et n'abordaient pas leurs préoccupations complexes liées à la santé. Conclusions: Les résultats que nous avons obtenus ont mis en évidence des stratégies clés pour favoriser la participation des patients et leurs comportements d'autogestion et la façon dont elles ont pu améliorer les résultats cliniques de patients. De plus, nous avons démontré une nouvelle utilisation de principes tirés du domaine du marketing dans des interventions de soutien à la formation sur l'autogestion.

The Development of a Conceptual Framework for Providing Tailored Diabetes Care for Individuals Experiencing Homelessness: A Qualitative Study.

Homelessness results in barriers to effective diabetes self-management. Programs targeting individuals facing homelessness have refined strategies to address these barriers. We sought to develop a framework to characterize these strategies that could help multidisciplinary providers to better support these individuals. Semi-structured interviews were conducted with a purposive sample of health and social care providers working in diabetes or homelessness in five Canadian cities (n=96). Interview transcripts were analyzed through qualitative thematic analysis. Providers described three groups of approaches that enabled care for this population. Person-centered provider behaviours: This included tailoring care plans to accommodate individuals' situational constraints. Lower-barrier organizational structure: Providers developed specialized organizational processes to increase accessibility. Bridging to larger care systems: Strategies included providing access to support workers. Across diverse program structures, similar approaches are used to enhance diabetes care for individuals who are experiencing homelessness, highlighting tangible opportunities for mainstream services to better engage with this population.

Factors Affecting the Reception of Self-Management Health Education: A Cross-Sectional Survey Assessing Perspectives of Lower-Income Seniors with Cardiovascular Conditions.

Introduction: Self-management education and support (SMES) programs can prevent adverse chronic disease outcomes, but factors modifying their reception remain relatively unexplored. We examined how perceptions of an SMES program were influenced by the mode of delivery, and co-receipt of a paired financial benefit. Methods and Patients: Using a cross-sectional survey, we evaluated the perceived helpfulness of a SMES program among 446 low-income seniors at high risk for cardiovascular events in Alberta, Canada. Secondary outcomes included frequency of use, changes in perspectives on health, satisfaction with the program, and comprehensibility of the material. Participants received surveys after engaging with the program for at least 6 months. We used modified Poisson regression to calculate relative risks. Open-ended questions were analyzed inductively. Results: The majority of participants reported that the SMES program was helpful (>80%). Those who also received the financial benefit (elimination of medication copayments) were more likely to report that the SMES program was helpful (RR 1.24, 95% CI 1.11-1.39). Those who received the program electronically were more likely to use the program weekly (RR 1.51, 1.25-1.84). Both those who received the intervention electronically (RR 1.18, 1.06-1.33), and those who also received copayment elimination (RR 1.17, 1.05-1.31) were more likely to state that the program helped change their perspectives on health. Conclusion: When designing SMES programs, providing the option for electronic delivery appears to promote greater use for seniors. The inclusion of online-delivery and co-receipt of tangible benefits when designing an SMES program for seniors results in favorable reception and could facilitate sustained adherence to health behavior recommendations. Participants also specifically expressed that what they enjoyed most was that the SMES program was informative, helpful, engaging, and supportive.

Healthy food prescription incentive programme for adults with type 2 diabetes who are experiencing food insecurity: protocol for a randomised controlled trial, modelling and implementation studies.

INTRODUCTION: The high cost of many healthy foods poses a challenge to maintaining optimal blood glucose levels for adults with type 2 diabetes mellitus who are experiencing food insecurity, leading to diabetes complications and excess acute care usage and costs. Healthy food prescription programmes may reduce food insecurity and support patients to improve their diet quality, prevent diabetes complications and avoid acute care use. We will use a type 2 hybrid-effectiveness design to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of a healthy food prescription incentive programme for adults experiencing food insecurity and persistent hyperglycaemia. A randomised controlled trial (RCT) will investigate programme effectiveness via impact on glycosylated haemoglobin (primary outcome), food insecurity, diet quality and other clinical and patient-reported outcomes. A modelling study will estimate longer-term programme effectiveness in reducing diabetes-related complications, resource use and costs. An implementation study will examine all RE-AIM domains to understand determinants of effective implementation and reasons behind programme successes and failures. METHODS AND ANALYSIS: 594 adults who are experiencing food insecurity and persistent hyperglycaemia will be randomised to a healthy food prescription incentive (n=297) or a healthy food prescription comparison group (n=297). Both groups will receive a healthy food prescription. The incentive group will additionally receive a weekly incentive (CDN$10.50/household member) to purchase healthy foods in supermarkets for 6 months. Outcomes will be assessed at baseline and follow-up (6 months) in the RCT and analysed using mixed-effects regression. Longer-term outcomes will be modelled using the UK Prospective Diabetes Study outcomes simulation model-2. Implementation processes and outcomes will be continuously measured via quantitative and qualitative data. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of Calgary and the University of Alberta. Findings will be disseminated through reports, lay summaries, policy briefs, academic publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT04725630. PROTOCOL VERSION: Version 1.1; February 2022.

Pharmacist and patient perspectives on recruitment strategies for randomized controlled trials: a qualitative analysis.

BACKGROUND: Although recruitment is a major challenge for most randomized controlled trials, few report on the difficulties of recruitment, or how it might be enhanced. The objective of our study was to qualitatively explore the experiences of both patients and pharmacists related to recruitment for ACCESS, a large trial involving low-income seniors, given that two of our most successful recruitment strategies were direct patient recruitment materials and use of community pharmacists. METHODS: Using qualitative descriptive methods, we collected data from pharmacists and study participants. Pharmacists were asked about their impressions of the study, as well as challenges they faced and methods they used to recruit potential participants. Focus groups with trial participants centered on the patient recruitment materials. Interviews and focus groups were recorded, transcribed and analyzed using thematic analysis. RESULTS: Pharmacists noted that their first impressions of the study were positive as they described being enticed to help the study team by the potential benefit of copayment elimination for their patients and the low time commitment. Pharmacists noted they were more likely to recruit if they were well informed on the study, as they could answer their patients' questions. Participants noted that their primary motivations for participating were the tangible benefits of free medications and the intrinsic value of participating in research. CONCLUSIONS: We noted that recruitment through pharmacies was an effective method as most patients have trusting relationships with their pharmacist. To optimize recruitment through pharmacies, study procedures should be straightforward, and pharmacists need to be equipped with good knowledge of the study. When promoting a study to potential participants, messaging should ensure the individuals are aware of the tangible benefits of participation while still presenting a full overview of the trial. TRIAL REGISTRATION: Trial Registration Number: NCT02579655 - initially registered Oct 19, 2015.

Exploring patient and pharmacist perspectives on complex interventions for cardiovascular prevention: A qualitative descriptive process evaluation.

BACKGROUND: The Assessing outcomes of enhanced Chronic disease Care through patient Education and a value-baSed formulary Study (ACCESS) is a randomized controlled trial evaluating two interventions targeting barriers to care among those at high risk of cardiovascular disease: copayment elimination for cardioprotective medications, and a tailored self-management support programme. We designed a process evaluation to better understand participant perspectives on the interventions. DESIGN: We used a qualitative descriptive study design, collecting patient and pharmacist feedback via individual semi-structured telephone interviews and in-person focus groups. Data were analysed inductively using thematic analysis. RESULTS: Fifty-three patients (39 interviews and 14 in two focus groups) and 20 pharmacists participated. Copayment elimination provided quality of life benefits: minimizing the need to 'cut-back', allowing 'peace of mind' and providing emotional support. Health-related benefits included: improving adherence to covered medications, and helping to afford non-covered goods. The only criticism was that not all medications and testing supplies were covered. Patients reported that the educational materials provided helpful information, acted as a reminder, improved confidence, improved adherence to medication, and helped initiate conversations with providers about indicated medication. Some participants felt that the educational materials were repetitive, overly medication-focused and not tailored enough. Pharmacists felt that their patients benefitted from both interventions, which improved patient adherence and communication with their patients. CONCLUSION: The success of interventions intended to change behaviour is largely dependent upon participant's feelings that the intervention is helpful. This process evaluation provided insights into participants' perceptions on these interventions. Reception of both was largely positive with a few criticisms noted.

Cost analysis and efficacy of recruitment strategies used in a large pragmatic community-based clinical trial targeting low-income seniors: a comparative descriptive analysis.

OBJECTIVE: One of the most challenging parts of running clinical trials is recruiting enough participants. Our objective was to determine which recruitment strategies were effective in reaching specific subgroups. STUDY DESIGN AND SETTING: We assessed the efficacy and costs of the recruitment strategies used in the Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study (ACCESS) in Alberta, Canada. RESULTS: Twenty percent of the study budget ($354,330 CAD) was spent on recruiting 4013 participants, giving an average cost per enrolled of $88 CAD. Pharmacies recruited the most participants (n = 1217), at a cost of $128/enrolled. "Paid media" had the highest cost ($806/enrolled), whereas "word of mouth" and "unpaid media" had the lowest (~$3/enrolled). Participants enrolled from "seniors outreach" had the lowest baseline quality of life and income, while participants from "word of mouth" had the lowest educational attainment. CONCLUSION: The "health care providers" strategies were especially successful - at a moderate cost per enrolled. The "media" strategies were less effective, short lasting, and more costly. No strategy was singularly effective in recruiting our targeted groups, emphasizing the importance of utilizing a variety of strategies to reach recruitment goals. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02579655 . Registered on 19 October 2015.