2023 Inaugural Healthcare Delivery Science: Innovation and Partnerships for Health Equity Research (DESCIPHER) Symposium.

Introduction: This article provides an overview of presentations and discussions from the inaugural Healthcare Delivery Science: Innovation and Partnerships for Health Equity Research (DESCIPHER) Symposium. Methods: The symposium brought together esteemed experts from various disciplines to explore models for translating evidence-based interventions into practice. Results: The symposium highlighted the importance of disruptive innovation in healthcare, the need for multi-stakeholder engagement, and the significance of family and community involvement in healthcare interventions. Conclusions: The article concluded with a call to action for advancing healthcare delivery science to achieve health equity.

A structured approach to applying systems analysis methods for examining implementation mechanisms.

BACKGROUND: It is challenging to identify and understand the specific mechanisms through which an implementation strategy affects implementation outcomes, as implementation happens in the context of complex, multi-level systems. These systems and the mechanisms within each level have their own dynamic environments that change frequently. For instance, sequencing may matter in that a mechanism may only be activated indirectly by a strategy through another mechanism. The dosage or strength of a mechanism may vary over time or across different health care system levels. To elucidate the mechanisms relevant to successful implementation amidst this complexity, systems analysis methods are needed to model and manage complexity. METHODS: The fields of systems engineering and systems science offer methods-which we refer to as systems analysis methods-to help explain the interdependent relationships between and within systems, as well as dynamic changes to systems over time. When applied to studying implementation mechanisms, systems analysis methods can help (i) better identify and manage unknown conditions that may or may not activate mechanisms (both expected mechanisms targeted by a strategy and unexpected mechanisms that the methods help detect) and (ii) flexibly guide strategy adaptations to address contextual influences that emerge after the strategy is selected and used. RESULTS: In this paper, we delineate a structured approach to applying systems analysis methods for examining implementation mechanisms. The approach includes explicit steps for selecting, tailoring, and evaluating an implementation strategy regarding the mechanisms that the strategy is initially hypothesized to activate, as well as additional mechanisms that are identified through the steps. We illustrate the approach using a case example. We then discuss the strengths and limitations of this approach, as well as when these steps might be most appropriate, and suggest work to further the contributions of systems analysis methods to implementation mechanisms research. CONCLUSIONS: Our approach to applying systems analysis methods can encourage more mechanisms research efforts to consider these methods and in turn fuel both (i) rigorous comparisons of these methods to alternative mechanisms research approaches and (ii) an active discourse across the field to better delineate when these methods are appropriate for advancing mechanisms-related knowledge.

Advancing rapid cycle research in cancer care delivery: a National Cancer Institute workshop report.

Generating actionable research findings quickly and efficiently is critical for improving the delivery of cancer-related care and outcomes. To address this issue, the National Cancer Institute convened subject matter experts, researchers, clinicians, and patients for a 2-day virtual meeting in February 2022. The purpose of this meeting was to identify how rapid cycle interventional research methods can be used to generate findings useful in improving routine clinical practice. The meeting yielded an initial conceptualization of rapid cycle interventional research as being comprised of 6 key elements: use of iterative study designs; reliance on proximal primary outcomes; early and continued engagement with community and clinical partners; use of existing data sources to measure primary outcomes; facilitative features of the study setting and context; and consideration of appropriate rigor relative to intended use of findings. The meeting also identified the types of study designs that can be leveraged to conduct rapid cycle interventional research and provided examples of these; considered this approach from the perspective of key partners; described the clinical and data infrastructure, research resources, and key collaborations needed to support this work; identified research topics best addressed using this approach; and considered needed methodological advances. The National Cancer Institute is committed to exploring opportunities to encourage further development and application of this research approach as a means for better promoting improvements in the delivery of cancer-related care.

A study protocol for a cluster randomized pragmatic trial for comparing strategies for implementing primary HPV testing for routine cervical cancer screening in a large health care system.

BACKGROUND: Limited guidance exists regarding implementation strategies that best facilitate cancer screening practice substitution and achieve optimal stakeholder-centered outcomes. Here we describe the protocol for a randomized pragmatic trial comparing two implementation strategies to facilitate substitution of primary HPV screening for Pap and HPV co-testing to perform routine cervical cancer screening of women aged 30-65 years at Kaiser Permanente Southern California (KPSC). METHODS: Twelve service areas within KPSC will be randomized to a "centrally-administered system-wide implementation + local-tailored implementation" strategy or a "centrally-administered system-wide implementation only" strategy. The centrally-administered strategy comprises clinician and staff educational activities. Sites in the local-tailored arm will then conduct a structured local needs assessment followed by site-specific selection and deployment of implementation interventions. Surveys and interviews will be conducted among women and providers from the primary care and ob/gyn departments prior to the system-wide transition, shortly after the transition, and after the completion of local-tailored interventions. A stakeholder advisory committee will assist with study design, defining stakeholder-centered outcomes, and developing data collection tools. RESULTS: The primary outcome of interest is uptake of primary HPV screening. Secondary provider-centered outcomes include provider knowledge, delivery of patient education, satisfaction with the practice substitution process, and resistance to primary HPV screening. Secondary patient-centered outcomes include patient knowledge, stigma, and satisfaction with the screening process. Intervention fidelity will also be measured via surveys. CONCLUSIONS: Findings from this study will help inform future use of a local-tailored implementation strategy for adopting primary HPV screening at large health care systems. Findings may also be applicable to other types of practice substitution.

How successful was the use of a community of practice for the implementation of evidence-based practices for heart failure within the United States Department of Veterans Affairs: Insights from a formative evaluation.

BACKGROUND: Communities of Practice (CoPs) are a promising approach to facilitate the implementation of evidence-based practices (EBPs) to improve care for chronic conditions like heart failure (HF). CoPs involve a complex process of acquiring and converting both explicit and tacit knowledge into clinical activities. This study describes the conceptualization, creation, capacity-building and dissemination of a CoP sustained over 9 years, and evaluates its value and impact on EBP. METHODS: In July 2006, a CoP called the Heart Failure Provider Network (HF Network) was established within the United States Department of Veterans Affairs (VA) with the overarching goal of improving the quality of care for HF patients. We assessed (formative) the HF Network in terms of its various activities (inputs) and proximal impacts (mediators) at the individual level, and its distal impacts (outcomes) at the site level including implementation of new/improved EBPs at the systemwide level. RESULTS: The HF Network membership grew steadily over the 9 years. The CoP has involved a total of 1341 multidisciplinary and multilevel members at all 144 VA Health Care Systems (sites). Most members were practising clinicians (n = 891, 66.4%), followed by administrators (n = 342, 25.5%), researchers (n = 70, 5.2%) and others (n = 38, 2.8%). Participation was assessed to be "active" for 70.6% versus "passive" for 29.4% of members. The distribution of active members (clinicians 64.7%, administrators 21.6%) was similar to the distribution of overall membership. CONCLUSIONS: Survey respondents perceived the HF Network as useful in terms of its varied activities and resources relevant for patient care. Strong evidence shows that these members, particularly those who considered themselves influential in improving quality of care, noted multiple benefits of membership, which included confirmation of their own clinical practices, evidence-based changes to their practice and help in understanding facilitators and barriers in setting up or running HF clinics and other programmes. Such CoPs have strong impacts on the quality of care being delivered for both mandated and non-mandated initiatives.

The Knowledge Assessment of Renal Transplantation (KART) 2.0: Development and Validation of CKD and Transplant Knowledge Scales.

BACKGROUND AND OBJECTIVES: Many individuals with kidney disease, particularly those belonging to racial and ethnic minority groups and whose primary language is not English, lack knowledge related to kidney disease symptoms, physiologic functions of the kidney, and benefits and risks of kidney transplantation. Valid instruments to assess patients' knowledge of CKD and kidney transplantation are needed. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Using a sample of 977 patients with stages 3-5 CKD in the Kaiser Permanente health system, we developed the Knowledge Assessment of Renal Transplantation (KART) 2.0 instrument. We conducted cognitive interviews followed by item response theory (IRT) to reduce 48 candidate items. Construct validity was tested by examining differences in scores between patients who spent <1 and ≥1 hour receiving CKD and transplant education. RESULTS: Cognitive interviews modified four items and omitted 11. IRT analyses resulted in two scales: the KART 2.0-Transplant Knowledge Scale (16 items; Cronbach's α=0.8) and the KART 2.0-CKD Knowledge Scale (nine items; Cronbach's α=0.79). Differential item functioning showed that the scales were unbiased to capture knowledge across self-identified race, primary language, CKD stage, and sex. Both scales distinguished patients who had spent <1 and ≥1 hour speaking with health professionals (effect size [ES]=0.33 [transplant], 0.54 [CKD]; P<0.001 for both), reading about kidney disease (ES=0.45 [transplant], 0.62 [CKD]; P<0.001), reading about kidney transplantation (ES=0.67 [transplant], 0.69 [CKD]; P<0.001), and reading about living donor kidney transplant (ES=0.76 [transplant], 0.62 [CKD]; P<0.001). CONCLUSIONS: The KART 2.0 is a valid tool to assess patients' knowledge of CKD and kidney transplantation.

Potentially Harmful Medication Dispenses After a Fall or Hip Fracture: A Mixed Methods Study of a Commonly Used Quality Measure.

BACKGROUND: High-risk medication dispenses to patients with a prior fall or hip fracture represent a potentially dangerous disease-drug interaction among older adults. The research team quantified the prevalence, identified risk factors, and generated patient and provider insights into high-risk medication dispenses in a large, community-based integrated health system using a commonly used quality measure. METHODS: This was a mixed methods study with a convergent design combining a retrospective cohort study using electronic health record (EHR) data, individual interviews of primary care physicians, and a focus group of patient advisors. RESULTS: Of 113,809 patients ≥ 65 years with a fall/fracture in 2009-2015, 35.4% had a potentially harmful medication dispensed after their fall/fracture. Most medications were prescribed by primary care providers. Older age, male gender, and race/ethnicity other than non-Hispanic White were associated with a reduced risk of high-risk medication dispenses. Patients with a pre-fall/fracture medication dispense were substantially more likely to have a post-fall/fracture medication dispense (hazard ratio [HR] = 13.26, 95% confidence interval [CI] = 12.91-13.61). Both patients and providers noted that providers may be unaware of patient falls due to inconsistent assessments and patient reluctance to disclose falls. Providers also noted the lack of a standard location to document falls and limited decision support alerts within the EHR. CONCLUSION: High-risk medication dispenses are common among older patients with a history of falls/fractures. Future interventions should explore improved assessment and documentation of falls, decision support, clinician training strategies, patient educational resources, building trusting patient-clinician relationships to facilitate long-term medication discontinuation among persistent medication users, and a focus on fall prevention.

Implementation fidelity of a nurse-led RCT-tested complex intervention, care coordination for health promotion and activities in Parkinson's disease (CHAPS) in meeting challenges in care management.

BACKGROUND: Parkinson's disease (PD) complexity poses challenges for individuals with Parkinson's, providers, and researchers. A recent multisite randomized trial of a proactive, telephone-based, nurse-led care management intervention - Care Coordination for Health Promotion and Activities in Parkinson's Disease (CHAPS) - demonstrated improved PD care quality. Implementation details and supportive stakeholder feedback were subsequently published. To inform decisions on dissemination, CHAPS Model components require evaluations of their fidelity to the Chronic Care Model and to their implementation. Additionally, assessment is needed on whether CHAPS addresses care challenges cited in recent literature. METHODS: These analyses are based on data from a subset of 140 intervention arm participants and other CHAPS data. To examine CHAPS Model fidelity, we identified CHAPS components corresponding to the Chronic Care Model's six essential elements. To assess implementation fidelity of these components, we examined data corresponding to Hasson's modified implementation fidelity framework. Finally, we identified challenges cited in current Parkinson's care management literature, grouped these into themes using open card sorting techniques, and examined CHAPS data for evidence that CHAPS met these challenges. RESULTS: All Chronic Care Model essential elements were addressed by 17 CHAPS components, thus achieving CHAPS Model fidelity. CHAPS implementation fidelity was demonstrated by adherence to content, frequency, and duration with partial fidelity to telephone encounter frequency. We identified potential fidelity moderators for all six of Hasson's moderator types. Through card sorting, four Parkinson's care management challenge themes emerged: unmet needs and suggestions for providers (by patient and/or care partner), patient characteristics needing consideration, and standardizing models for Parkinson's care management. CHAPS activities and stakeholder perceptions addressed all these themes. CONCLUSIONS: CHAPS, a supportive nurse-led proactive Parkinson's care management program, improved care quality and is designed to be reproducible and supportive to clinicians. Findings indicated CHAPS Model fidelity occurred to the Chronic Care Model and fidelity to implementation of the CHAPS components was demonstrated. Current Parkinson's care management challenges were met through CHAPS activities. Thus, dissemination of CHAPS merits consideration by those responsible for implementing changes in clinical practice and reaching people in need. TRIAL REGISTRATION: ClinicalTrials.gov as NCT01532986 , registered on January 13, 2012.

Reflections on 10 years of effectiveness-implementation hybrid studies.

This article provides new reflections and recommendations from authors of the initial effectiveness-implementation hybrid study manuscript and additional experts in their conceptualization and application. Given the widespread and continued use of hybrid studies, critical appraisals are necessary. The article offers reflections across five conceptual and methodological areas. It begins with the recommendation to replace the term "design" in favor of "study." The use of the term "design" and the explicit focus on trial methodology in the original paper created confusion. The essence of hybrid studies is combining research questions concerning intervention effectiveness and implementation within the same study, and this can and should be achieved by applying a full range of research designs. Supporting this recommendation, the article then offers guidance on selecting a hybrid study type based on evidentiary and contextual information and stakeholder concerns/preferences. A series of questions are presented that have been designed to help investigators select the most appropriate hybrid type for their study situation. The article also provides a critique on the hybrid 1-2-3 typology and offers reflections on when and how to use the typology moving forward. Further, the article offers recommendations on research designs that align with each hybrid study type. Lastly, the article offers thoughts on how to integrate costs analyses into hybrid studies.

Influencing Factors Associated with Implementation of INTERACT (Interventions to Reduce Acute Care Transfers) in VA Community Living Centers (CLCs) Using the Consolidated Framework.

Our objective was to identify the influencing factors associated with the implementation of the INTERACT (Interventions to Reduce Acute Care Transfers) Quality Improvement program within a national healthcare system. INTERACT focuses on early identification and management of changes in residents' condition leading to a reduction in potentially preventable hospital transfers. The Consolidated Framework was used to evaluate implementation data from eight VA Community Living Centers. Qualitative implementation data suggest two influencing Consolidated Framework domains had a strong influence: 1) key attributes of the intervention (e.g., adaptability or complexity) and 2) internal organizational factors (e.g., culture or compatibility). Using the Consolidated Framework can assist future adaptations to this and other complex quality improvement initiatives.

Laboratory monitoring to reduce adverse drug-related events: a mixed methods study.

BACKGROUND: Therapy with angiotensinconverting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) requires laboratory monitoring to avoid hyperkalemia and acute kidney failure. OBJECTIVE: To assess the frequency of recommended annual serum potassium and creatinine monitoring and determine potential factors associated with care gaps among adults dispensed an ACEI or ARB. METHODS: This mixed-methods study integrated findings from a retrospective cohort study and individual patient interviews. Adults aged 21 years and over within Kaiser Permanente Southern California with at least 180 treatment days of an ACEI and/or ARB in 2015 were included. Patients invited for qualitative interviews included those who did and did not complete the recommended laboratory tests. We assessed the proportion of patients completing both recommended laboratory tests, factors associated with not receiving laboratory monitoring, and patients' insights into barriers and facilitators of recommended monitoring. RESULTS: Of 437,544 patients who received an ACEI or ARB, 9.0% did not receive both a serum potassium and creatinine laboratory test during treatment (defined as a care gap). Lower risk of a care gap was observed for patients with increasing age (rate ratio [RR] per 10-year increase = 0.78, 95% CI = 0.77-0.79); diabetes mellitus (RR = 0.62, 95% CI = 0.60-0.64); hypertension (RR = 0.71, 95% CI = 0.71-0.74); Charlson Comorbidity Index score of at least 2 (RR = 0.62, 95% CI = 0.60-0.64); those who changed medication classes (RR = 0.53, 95% CI = 0.51-0.56); and patients with a cardiologist (RR = 0.81, 95% CI = 0.73-0.90) or nephrologist (RR = 0.60, 95% CI = 0.52-0.69) as their prescribing provider. Twenty-five patients completed the qualitative interviews. Patients often lacked knowledge about the need for laboratory monitoring, cited logistical barriers to accessing the laboratory, and deemed the reminders they received through an outpatient safety program as a facilitator to completing tests. CONCLUSIONS: Given the large patient population on ACEI and ARB medications, monitoring and support strategies such as electronic clinical surveillance could be important in addressing care gaps and potentially reducing adverse drug effects. DISCLOSURES: This project was supported by grant number R01HS024437 from the Agency for Healthcare Research and Quality. The funder had no role in the design of the study; collection, analyses, or interpretation of the data, or decision to submit this manuscript for publication. Harrison, Reynolds, Hahn, Munoz-Plaza, Yi, Fischer, Luong, Sim, Brettler, Handler, and Mittman are employees of the Southern California Permanente Medical Group. Danworth was employed by the Southern California Permanente Medical Group at the time of this study. Singh was partially supported by the Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (CIN13-413). Reynolds reports grants from Novartis, Amgen Inc., and Vital Strategies, Resolve to Save Lives, unrelated to this work. Yi reports grants from Novartis unrelated to this work. Kanter has nothing to disclose.

De-implementation and substitution of clinical care processes: stakeholder perspectives on the transition to primary human papillomavirus (HPV) testing for cervical cancer screening.

BACKGROUND: New cervical cancer screening guidelines recommend primary human papillomavirus (HPV) testing for women age 30-65 years. Healthcare organizations are preparing to de-implement the previous recommended strategies of Pap testing or co-testing (Pap plus HPV test) and substitute primary HPV testing. However, there may be significant challenges to the replacement of this entrenched clinical practice, even with an evidence-based substitution. We sought to identify stakeholder-perceived barriers and facilitators to this substitution within a large healthcare system, Kaiser Permanente Southern California. METHODS: We conducted semi-structured qualitative interviews with clinician, administrative, and patient stakeholders regarding (a) acceptability and feasibility of the planned substitution; (b) perceptions of barriers and facilitators, with an emphasis on those related to the de-implementation/implementation cycle of substitution; and (c) perceived readiness to change. Our interview guide was informed by the Consolidated Framework for Implementation Research (CFIR). Using a team coding approach, we developed an initial coding structure refined during iterative analysis; the data were subsequently organized thematically into domains, key themes, and sub-themes using thematic analysis, followed by framework analysis informed by CFIR. RESULTS: We conducted 23 interviews: 5 patient and 18 clinical/administrative. Clinicians perceived that patients feel more tests equals better care, and clinicians and patients expressed fear of missed cancers ("…it'll be more challenging convincing the patient that only one test is…good enough to detect cancer."). Patients perceived practice changes resulting in "less care" are driven by the desire to cut costs. In contrast, clinicians/administrators viewed changing from two tests to one as acceptable and a workflow efficiency ("…It's very easy and half the work."). Stakeholder-recommended strategies included focusing on the increased efficacy of primary HPV testing and developing clinician talking points incorporating national guidelines to assuage "cost-cutting" fears. CONCLUSIONS: Substitution to replace an entrenched clinical practice is complex. Leveraging available facilitators is key to ease the process for clinical and administrative stakeholders-e.g., emphasizing the efficiency of going from two tests to one. Identifying and addressing clinician and patient fears regarding cost-cutting and perceived poorer quality of care is critical for substitution. Multicomponent and multilevel strategies for engagement and education will be required. TRIAL REGISTRATION: ClinicalTrials.gov, # NCT04371887.

Combining Improvement and Implementation Sciences and Practices for the Post COVID-19 Era.

Health services made many changes quickly in response to the SARS-CoV-2 pandemic. Many more are being made. Some changes were already evaluated, and there are rigorous research methods and frameworks for evaluating their local implementation and effectiveness. But how useful are these methods for evaluating changes where evidence of effectiveness is uncertain, or which need adaptation in a rapidly changing situation? Has implementation science provided implementers with tools for effective implementation of changes that need to be made quickly in response to the demands of the pandemic? This perspectives article describes how parts of the research and practitioner communities can use and develop a combination of implementation and improvement to enable faster and more effective change in the future, especially where evidence of local effectiveness is limited. We draw on previous reviews about the advantages and disadvantages of combining these two domains of knowledge and practice. We describe a generic digitally assisted rapid cycle testing (DA-RCT) approach that combines elements of each in order to better describe a change, monitor outcomes, and make adjustments to the change when implemented in a dynamic environment.

A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders.

BACKGROUND: Treatment of a child who has an anxiety disorder usually begins with the question of which treatment to start first, medication or psychotherapy. Both have strong empirical support, but few studies have compared their effectiveness head-to-head, and none has investigated what to do if the treatment tried first isn't working well-whether to optimize the treatment already begun or to add the other treatment. METHODS: This is a single-blind Sequential Multiple Assignment Randomized Trial (SMART) of 24 weeks duration with two levels of randomization, one in each of two 12-week stages. In Stage 1, children will be randomized to fluoxetine or Coping Cat Cognitive Behavioral Therapy (CBT). In Stage 2, remitters will continue maintenance-level therapy with the single-modality treatment received in Stage 1. Non-remitters during the first 12 weeks of treatment will be randomized to either [1] optimization of their Stage 1 treatment, or [2] optimization of Stage 1 treatment and addition of the other intervention. After the 24-week trial, we will follow participants during open, naturalistic treatment to assess the durability of study treatment effects. Patients, 8-17 years of age who are diagnosed with an anxiety disorder, will be recruited and treated within 9 large clinical sites throughout greater Los Angeles. They will be predominantly underserved, ethnic minorities. The primary outcome measure will be the self-report score on the 41-item youth SCARED (Screen for Child Anxiety Related Disorders). An intent-to-treat analysis will compare youth randomized to fluoxetine first versus those randomized to CBT first ("Main Effect 1"). Then, among Stage 1 non-remitters, we will compare non-remitters randomized to optimization of their Stage 1 monotherapy versus non-remitters randomized to combination treatment ("Main Effect 2"). The interaction of these main effects will assess whether one of the 4 treatment sequences (CBT➔CBT; CBT➔med; med➔med; med➔CBT) in non-remitters is significantly better or worse than predicted from main effects alone. DISCUSSION: Findings from this SMART study will identify treatment sequences that optimize outcomes in ethnically diverse pediatric patients from underserved low- and middle-income households who have anxiety disorders. TRIAL REGISTRATION: This protocol, version 1.0, was registered in ClinicalTrials.gov on February 17, 2021 with Identifier: NCT04760275 .

Patient and Physician Perspectives of Deprescribing Potentially Inappropriate Medications in Older Adults with a History of Falls: a Qualitative Study.

BACKGROUND: High-risk medications pose serious safety risks to older adults, including increasing the risk of falls. Deprescribing potentially inappropriate medications (PIMs) in older adults who have experienced a fall is a key element of fall reduction strategies. However, continued use of PIMs in older adults is common, and clinicians may face substantial deprescribing barriers. OBJECTIVE: Explore patient and clinician experiences with and perceptions of deprescribing PIMs in patients with a history of falls. DESIGN: We led guided patient feedback sessions to explore deprescribing scenarios with patient stakeholders and conducted semi-structured interviews with primary care physicians (PCPs) to explore knowledge and awareness of fall risk guidelines, deprescribing experiences, and barriers and facilitators to deprescribing. PARTICIPANTS: PCPs from Kaiser Permanente Southern California (KPSC) and patient members of the KPSC Regional Patient Advisory Committee. APPROACH: We used maximum variation sampling to identify PCPs with patients who had a fall, then categorized the resulting PIM dispense distribution for those patients into high and low frequency. We analyzed the data using a hybrid deductive-inductive approach. Coders applied initial deductively derived codes to the data, simultaneously using an open-code inductive approach to capture emergent themes. KEY RESULTS: Physicians perceived deprescribing discussions as potentially contentious, even among patients with falls. Physicians reported varying comfort levels with deprescribing strategies: some felt that the conversations might be better suited to others (e.g., pharmacists), while others had well-planned negotiation strategies. Patients reported lack of clarity as to the reasons and goals of deprescribing and poor understanding of the seriousness of falls. CONCLUSIONS: Our study suggests that key barriers to deprescribing include PCP trepidation about raising a contentious topic and insufficient patient awareness of the potential seriousness of falls. Findings suggest the need for multifaceted, multilevel deprescribing approaches with clinician training strategies, patient educational resources, and a focus on building trusting patient-clinician relationships.

Stakeholder perceptions of components of a Parkinson disease care management intervention, care coordination for health promotion and activities in Parkinson's disease (CHAPS).

BACKGROUND: A recent nurse-led proactive care management intervention, Care Coordination for Health Promotion and Activities in Parkinson Disease (CHAPS), improved care quality when compared to usual care in a randomized controlled trial. Therefore, stakeholder (patient participants, nurse care managers, and Parkinson disease (PD) specialists) perceptions of key intervention components merit evaluation to inform decisions about dissemination. METHODS: This multi-site study occurred in five southwest United States Veterans Health Administration medical centers. Stakeholders were surveyed on their perceptions of CHAPS including the CHAPS Assessment, CHAPS nurse care managers, the Siebens Domain Management Model™ (a practical clinical model), and the Siebens Health Care Notebook (Notebook) (self-care tool). Participants' electronic medical records were abstracted for perceptions of the Notebook. Statistical analysis software was used to provide summary statistics; open card sorting methodology was used to identify themes and attributes in qualitative data including usability of some components. RESULTS: Participants, overall, highly rated their medication self-management, acknowledged some challenges with the CHAPS self-care tools, reported knowledge of PD specialist follow-up and PD red flags, and rated CHAPS nurse care managers as helpful. Nurse care manager responses indicated the CHAPS Assessment and Program highly facilitated care of their patients. Most all PD specialists would refer other patients to CHAPS. Nurse care manager and PD specialist responses indicated improved participant management of their PD. Three themes emerged in participant perceptions of the Notebook: Notebook Assets (e.g., benefits and features-liked); Deferring Notebook Review (e.g., no time to review); and Reasons for Not Using (e.g., participant preference). Shared attributes regarding the Siebens Domain Management Model and Notebook usability, reported by nurse care managers, were user-friendly, person/patient-centered, and organized. Some challenges to their use were also reported. CONCLUSIONS: Overall, stakeholder perceptions of the proactive nurse-led CHAPS intervention indicated its value in the care of individuals with PD. Responses about the CHAPS Assessment, Siebens Domain Management Model, and Notebook self-care tool signified their usefulness. Stakeholders' constructive suggestions indicated their engagement in CHAPS. These findings support CHAPS dissemination and contribute to research in care management. TRIAL REGISTRATION: ClinicalTrials.gov as NCT01532986 , registered on January 13, 2012.

Improving Comparative Effectiveness Research of Complex Health Interventions: Standards from the Patient-Centered Outcomes Research Institute (PCORI).

INTRODUCTION: Complex health interventions (CHIs) are increasingly studied in comparative effectiveness research (CER), and there is a need for improvements in CHI research practices. The Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee (MC) launched an effort in 2016 to develop formal guidance on this topic. OBJECTIVE: To develop a set of minimal standards for scientifically valid, transparent, and reproducible CER studies of CHIs. The standards are intended to apply to research examining a broad range of healthcare interventions including delivery system, behavior change, and other non-pharmacological interventions. METHODS: We conducted a literature review, reviewed existing methods guidance, and developed standards through an iterative process involving the MC, two panels of external research methods experts, and a 60-day public comment period. The final standards were approved by the PCORI MC and adopted by the PCORI Board of Governors on April 30, 2018. RESULTS: The final standards include the following: (1) fully describe the intervention and comparator and define their core functions, (2) specify the hypothesized causal pathways and their theoretical basis, (3) specify how adaptations to the form of the intervention and comparator will be allowed and recorded, (4) plan and describe a process evaluation, and (5) select patient outcomes informed by the causal pathway. DISCUSSION: The new standards offer three major contributions to research: (1) they provide a simple framework to help investigators address the major methodological features of a CHI study, (2) they emphasize the importance of the causal model and the need to understand how a CHI achieves its effects rather than simply measuring these effects, and (3) they require description of a CHI using the concepts of core functions and forms. While these standards apply formally to PCORI-funded CER studies, they have broad applicability.

Findings and lessons learnt from early termination of a pragmatic comparative effectiveness trial of video consultations in home-based palliative care.

BACKGROUND: Health systems need evidence about how best to deliver home-based palliative care (HBPC) to meet the growing needs of seriously ill patients. We hypothesised that a tech-supported model that aimed to promote timely inter-professional team coordination using video consultation with a remote physician while a nurse is in the patient's home would be non-inferior compared with a standard model that includes routine home visits by nurses and physicians. METHODS: We conducted a pragmatic, cluster randomised non-inferiority trial across 14 sites (HomePal Study). Registered nurses (n=111) were randomised to the two models so that approximately half of the patients with any serious illness admitted to HBPC and their caregivers were enrolled in each study arm. Process measures (video and home visits and satisfaction) were tracked. The primary outcomes for patients and caregivers were symptom burden and caregiving preparedness at 1-2 months. RESULTS: The study was stopped early after 12 months of enrolment (patients=3533; caregivers=463) due to a combination of low video visit uptake (31%), limited substitution of video for home visits, and the health system's decision to expand telehealth use in response to changes in telehealth payment policies, the latter of which was incompatible with the randomised design. Implementation barriers included persistent workforce shortages and inadequate systems that contributed to scheduling and coordination challenges and unreliable technology and connectivity. CONCLUSIONS: We encountered multiple challenges to feasibility, relevance and value of conducting large, multiyear pragmatic randomised trials with seriously ill patients in the real-world settings where care delivery, regulatory and payment policies are constantly shifting.

Quality and extent of implementation of a nurse-led care management intervention: care coordination for health promotion and activities in Parkinson's disease (CHAPS).

BACKGROUND: A recent nurse-led, telephone-administered 18-month intervention, Care Coordination for Health Promotion and Activities in Parkinson's Disease (CHAPS), was tested in a randomized controlled trial and improved care quality. Therefore, intervention details on nurse care manager activity (types and frequencies) and participant actions are needed to support potential dissemination. Activities include nurse care manager use of a holistic organizing framework, identification of Parkinson's disease (PD)-related problems/topics, communication with PD specialists and care coordination, participant coaching, and participant self-care actions including use of a notebook self-care tool. METHODS: This article reports descriptive data on the CHAPS intervention. The study setting was five sites in the Veterans Affairs Healthcare System. Sociodemographic data were gathered from surveys of study participants (community-dwelling veterans with PD). Nurse care manager intervention activities were abstracted from electronic medical records and logbooks. Statistical analysis software was used to provide summary statistics; closed card sorting was used to group some data. RESULTS: Intervention participants (n = 140) were primarily men, mean age 69.4 years (standard deviation 10.3) and community-dwelling. All received the CHAPS Initial Assessment, which had algorithms designed to identify 31 unique CHAPS standard problems/topics. These were frequently documented (n = 4938), and 98.6% were grouped by assigned domain from the Organizing Framework (Siebens Domain Management Model™). Nurse care managers performed 27 unique activity types to address identified problems, collaborating with participants and PD specialists. The two most frequent unique activities were counseling/emotional support (n = 387) and medication management (n = 349). Both were among 2749 total performed activities in the category Implementing Interventions (coaching). Participants reported unique self-care action types (n = 23) including use of a new notebook self-care tool. CONCLUSIONS: CHAPS nurse care managers implemented multiple activities including participant coaching and care coordination per the CHAPS protocol. Participants reported various self-care actions including use of a personalized notebook. These findings indicate good quality and extent of implementation, contribute to ensuring reproducibility, and support CHAPS dissemination as a real-world approach to improve care quality. TRIAL REGISTRATION: ClinicalTrials.gov as NCT01532986 , registered on January 13, 2012.

Embedded Research in the Learning Healthcare System: Ongoing Challenges and Recommendations for Researchers, Clinicians, and Health System Leaders.

Embedded research is an innovative means to improve performance in the learning healthcare system (LHS). However, few descriptions of successful embedded research programs have been published. In this perspective, we describe the Care Improvement Research Team, a mature partnership between researchers and clinicians at Kaiser Permanente Southern California. The program supports a core team of researchers and staff with dedicated resources to partner with health system leaders and practicing clinicians, using diverse methods to identify and rectify gaps in clinical practice. For example, recent projects helped clinicians to provide better care by reducing prescribing of unnecessary antibiotics for acute sinusitis and by preventing readmissions among the elderly. Embedded in operational workgroups, the team helps formulate research questions and enhances the rigor and relevance of data collection and analysis. A recent business-case analysis cited savings to the organization of over $10 million. We conclude that embedded research programs can play a key role in fulfilling the promise of the LHS. Program success depends on dedicated funding, robust data systems, and strong relationships between researchers and clinical stakeholders. Embedded researchers must be responsive to health system priorities and timelines, while clinicians should embrace researchers as partners in problem solving.