Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA).

BACKGROUND: Involving patient and community stakeholders in clinical trials adds value by ensuring research prioritizes patient goals both in conduct of the study and application of the research. The use of stakeholder committees and their impact on the conduct of a multicenter clinical trial have been underreported clinically and academically. The aim of this study is to describe how Study Advisory Committee (SAC) recommendations were implemented throughout the Emergency Medicine Palliative Care Access (EMPallA) trial. EMPallA is a multi-center, pragmatic two-arm randomized controlled trial (RCT) comparing the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. METHODS: A SAC consisting of 18 individuals, including patients with palliative care experience, members of healthcare organizations, and payers was convened for the EMPallA trial. The SAC engaged in community-based participatory research and assisted in all aspects from study design to dissemination. The SAC met with the research team quarterly and annually from project inception to dissemination. Using meeting notes and recordings we completed a qualitative thematic analysis using an iterative process to develop themes and subthemes to summarize SAC recommendations throughout the project's duration. RESULTS: The SAC convened 16 times between 2017 and 2020. Over the course of the project, the SAC provided 41 unique recommendations. Twenty-six of the 41 (63%) recommendations were adapted into formal Institutional Review Board (IRB) study modifications. Recommendations were coded into four major themes: Scientific, Pragmatic, Resource and Dissemination. A majority of the recommendations were related to either the Scientific (46%) or Pragmatic (29%) themes. Recommendations were not mutually exclusive across three study phases: Preparatory, execution and translational. A vast majority (94%) of the recommendations made were related to the execution phase. Major IRB study modifications were made based on their recommendations including data collection of novel dependent variables and expanding recruitment to Spanish-speaking patients. CONCLUSIONS: Our study provides an example of successful integration of a SAC in the conduct of a pragmatic, multi-center RCT. Future trials should engage with SACs in all study phases to ensure trials are relevant, inclusive, patient-focused, and attentive to gaps between health care and patient and family needs. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT03325985, 10/30/2017.

Clinical research should involve patient and community stakeholder perspectives to make sure the study addresses questions important to the studied population. One way to do this is by creating a group of stakeholders who can advise on the conduct of a study. We assembled a Study Advisory Committee (SAC) for the Emergency Medicine Palliative Care Access (EMPallA) trial. The purpose of this clinical trial is to compare the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. This paper describes how the SACs involvement translated into direct impacts on the EMPallA trial. The trial research team held regular meetings with the SAC throughout the trial process. Their involvement led to many significant changes in the trial, such as  expanding recruitment inclusion criteria (Spanish-speaking patients), and including survey instruments to measure lonelines and caregiver burden. The SAC also devised strategies to overcome patient and caregiver recruitment and retention challenges, including the creation of patient-friendly materials and training for research coordinators. This study provides a successful example of how actively engaging patient and community stakeholders, through committee engagement, can promote patient priorities in all phases of a trial while facilitating patient recruitment and retention.

What's in This For You? What's in This For Me?: A Win-Win Perspective of Involving Study Advisory Committee Members in Palliative Care Research.

Study advisory committees (SACs) provide critical value to clinical trials by providing unique perspectives that pull from personal and professional experiences related to the trial's healthcare topic. The Emergency Medicine Palliative Care Access (EMPallA) study had the privilege of convening a 16-person SAC from the project's inception to completion. The study team wanted to understand the impact this project had on the SAC members. In this narrative, we use reflective dialogue to share SAC members' lived experiences and the impact the EMPallA study has had on members both personally and professionally. We detail the (1) benefits SAC members, specifically patients, and caregivers, have had through working on this project. (2) The importance of recruiting diverse SAC members with different lived experiences and leveraging their feedback in clinical research. (3) Value of community capacity building to ensure the common vision of the clinical trial is promoted.

Multi-Sector Assessment and Client-Perception of Social Need at Long-Term Follow-Up of a Group-Randomized Trial of Community-Engaged Collaborative Care for Adults with Depression.

Understanding client perceptions of need for underlying social determinant support may improve services for depression care. This secondary analysis examines perceptions of "social needs" related to housing and employment, financial, and legal (EFL) concerns among individuals with depression. Data were analyzed from Community Partners in Care, a randomized comparative effectiveness trial of multi-sector collaborative care for depression among a sample of people who were predominantly racial/ethnic minorities and low-income. Adults with depression (n = 980) in both interventions were surveyed at 36-month follow-up for (1) being asked about and (2) having social needs for housing or EFL concerns. In multivariate models, life difficulty and mental health visits in non-healthcare sectors predicted being asked about housing and EFL. Lower social determinants of health-related life satisfaction increased the odds of having unmet housing and EFL needs. These findings underscore the role of non-healthcare organizations as community resources for depression care and in screening and addressing social needs.

Life Events, Barriers to Care, and Outcomes Among Minority Women Experiencing Depression: A Longitudinal, Mixed-Method Examination.

ABSTRACT: The long-term course of depression is not well-understood among minority women. We assessed depression trajectory, barriers to depression care, and life difficulties among minority women accessing health and social service programs as part of the Community Partners in Care study. Data include surveys ( N = 339) and interviews ( n = 58) administered at 3-year follow-up with African American and Latina women with improved versus persistent depression. The majority of the sample reported persistent depression (224/339, 66.1%), ≥1 barrier to mental health care (226/339, 72.4%), and multiple life difficulties (mean, 2.7; SD, 2.3). Many barriers to care ( i.e. , related to stigma and care experience, finances, and logistics) and life difficulties ( i.e. , related to finances, trauma, and relationships) were more common among individuals reporting persistent depression. Results suggest the importance of past experiences with depression treatment, ongoing barriers to care, and negative life events as contributors to inequities in depression outcomes experienced by minority women.

Pragmatic Considerations in Incorporating Stakeholder Engagement Into a Palliative Care Transitions Study.

BACKGROUND: Stakeholder involvement in health care research has been shown to improve research development, processes, and dissemination. The literature is developing on stakeholder engagement methods and preliminarily validated tools for evaluating stakeholder level of engagement have been proposed for specific stakeholder groups and settings. OBJECTIVES: This paper describes the methodology for engaging a Study Advisory Committee (SAC) in research and reports on the use of a stakeholder engagement survey for measuring level of engagement. METHODS: Stakeholders with previous research connections were recruited to the SAC during the planning process for a multicenter randomized control clinical trial, which is ongoing at the time of this writing. All SAC meetings undergo qualitative analysis, while the Stakeholder Engagement Survey instrument developed by the Patient-Centered Outcomes Research Institute (PCORI) is distributed annually for quantitative evaluation. RESULTS: The trial's SAC is composed of 18 members from 3 stakeholder groups: patients and their caregivers; patient advocacy organizations; and health care payers. After an initial in-person meeting, the SAC meets quarterly by telephone and annually in-person. The SAC monitors research progress and provides feedback on all study processes. The stakeholder engagement survey reveals improved engagement over time as well as continued challenges. CONCLUSIONS: Stakeholder engagement in the research process has meaningfully contributed to the study design, patient recruitment, and preliminary analysis of findings.

Engaging Community and Academic Partners to Explore Adolescent Emotional Well-Being.

In an under-resourced area of the South Bay of Los Angeles, partnerships were formed between community advocates with extensive research experience, less experienced academic investigators, and an urban public high school without partnered research experience. This article outlines the process of developing these partnerships through a community-academic research conference addressing a priority area identified by the local community to define and understand the importance and relevance of adolescent emotional well-being. Teen participants from the high school identified support from the community as the most crucial ingredient for achieving adolescent emotional well-being.

Engaging LGBTQ Communities in Community-Partnered Participatory Research: Lessons from the Resilience Against Depression Disparities Study.

BACKGROUND: The Resilience Against Depression Disparities (RADD), a community partnered, randomized comparative effectiveness study, aimed to address mental health in Lesbian, Gay, Bisexual, Transgender, and Queer/Questioning (LGBTQ) racial/ethnic populations in New Orleans and Los Angeles. OBJECTIVES: To describe engagement methods, lessons learned, and recommendations in engaging LGBTQ individuals and agencies throughout the RADD study. METHODS: RADD used a community partnered participatory research framework to engage LGBTQ community members and agencies. Observational and quantitative data were collected to describe engagement activities and study adaptations from October 2016 to May 2019. RESULTS: Our partnered approach resulted in multiple study adaptations. The principles of cultural humility, coleadership, and addressing health determinants were important to successful engagement with LGBTQ community members and study participants. We recommend maintaining cultural humility as the tenant of all research activities. CONCLUSIONS: This project's engagement plan demonstrates that community-academic partnerships can be forged to create and modify existing study models for LGBTQ communities.

Engaging Community Networks to Improve Depression Services: A Cluster-Randomized Trial of a Community Engagement and Planning Intervention.

This paper explores the effects of a group-randomized controlled trial, Community Partners in Care (CPIC), on the development of interagency networks for collaborative depression care improvement between a community engagement and planning (CEP) intervention and a resources for services (RS) intervention that provided the same content solely via technical assistance to individual programs. Both interventions consisted of a diverse set of service agencies, including health, mental health, substance abuse treatment, social services, and community-trusted organizations such as churches and parks and recreation centers. Participants in the community councils for the CEP intervention reflected a range of agency leaders, staff, and other stakeholders. Network analysis of partnerships among agencies in the CEP versus RS condition, and qualitative analysis of perspectives on interagency network changes from multiple sources, suggested that agencies in the CEP intervention exhibited greater growth in partnership capacity among themselves than did RS agencies. CEP participants also viewed the coalition development intervention both as promoting collaboration in depression services and as a meaningful community capacity building activity. These descriptive results help to identify plausible mechanisms of action for the CPIC interventions and can be used to guide development of future community engagement interventions and evaluations in under-resourced communities.

Resilience Against Depression Disparities (RADD): a protocol for a randomised comparative effectiveness trial for depression among predominantly low-income, racial/ethnic, sexual and gender minorities.

INTRODUCTION: Depression is the leading cause of adult disability and common among sexual and gender minority (SGM) adults. The current study builds on findings showing the effectiveness of depression quality improvement (QI) and delivery of cognitive behavioural therapy (CBT) skills provided by community health workers in reducing depression. Depression QI approaches across healthcare and social/community services in safety-net settings have shown improvements in mental wellness, mental health quality of life and depression over 12 months. Further, a randomised study showed improved depression among low-income racial/ethnic minorities enrolled in a CBT-informed resiliency class (Building Resilience and Increasing Community Hope (B-RICH)). The current protocol describes a comparativeness effectiveness study to evaluate whether predominantly low-income, SGM racial/ethnic minority adults randomised to a CBT-informed resiliency class have improvements in depressive symptoms over and above community-engaged QI resources and training only. METHODS AND ANALYSIS: The study approached three clusters of four to five programs serving predominantly SGM and racial/ethnic minority communities in the USA: two clusters in Los Angeles, California, and one in New Orleans, Louisiana. Clusters are comprised of one primary care, one mental health and two to three community agencies (eg, faith-based, social services/support, advocacy). All programs received depression QI training. The current study employed a community-partnered participatory research model to adapt the CBT-informed resiliency class, B-RICH+, to SGM communities. Study participants were screened and recruited in person from participating programs, and will complete baseline, 6- and 12-month survey follow-ups. Participants were depressed adults (8-item Patient Health Questionnaire ≥10; ≥18 years of age) who provided contact information. Enrolled participants were individually randomised to B-RICH+ or depression QI alone. Primary outcomes are depressive symptoms; secondary outcomes are mental health quality of life, mental wellness and physical health quality of life. Data collection for this study is ongoing. ETHICS AND DISSEMINATION: The current study was approved by the UCLA Institutional Review Board. Study findings will be disseminated through scientific publications and community conferences. TRIAL REGISTRATION NUMBER: https://clinicaltrials.gov/ct2/show/NCT02986126.

The Community and Patient Partnered Research Network (CPPRN): Application of Patient-Centered Outcomes Research to Promote Behavioral Health Equity.

Objective: We describe the rationale, development, and progress on the Community and Patient Partnered Research Network (CPPRN). The CPPRN builds on more than a decade of partnered work and is designed to promote health equity by developing partnered research on behavioral health and social risk factors in Los Angeles and New Orleans. Setting: A community-academic partnership across Los Angeles County and New Orleans. Methods: Review of rationale, history, structure, activities and progress in applying community partnered participatory research (CPPR) to CPPRN. Findings: Patient and community stakeholders participated in all phases of development, including local and national activities. Key developments include partnered planning efforts, progress on aggregating a large, de-identified dataset across county agencies, and development of an information technology-supported screening approach for behavioral and social determinants in health care, social, and community-based settings. Conclusion: The CPPRN represents a promising approach for research data networks, balancing the potential benefit of information technology and data analytic approaches while addressing potential risks and priorities of relevant stakeholders.

Commentary: Community Partner Experiences in CPPR: What Participation in Partnered Research Can Mean to Community and Patient Stakeholders.

Community partners and stakeholders currently engaged in community partnered participatory research (CPPR) can provide personal and professional insight into the processes and outcomes surrounding the CPPR model. This insight may indicate alternative solutions or methods of care delivery that can improve the model and existing interventions. We conducted in-person and phone interviews with five community partners who are currently involved in CPPR. The interviews were audio- and video-recorded, transcribed, and major themes identified. Interviewees recounted their experiences with CPPR and reported various levels of personal (ie, behavioral) and professional growth as a result of their involvement. Interviewees also indicated that CPPR can highlight various aspects of existing interventions (eg, leadership structure, stakeholder representation, methods of provider-to-patient communication, and provision of resources) that may benefit from re-evaluation. Engagement in CPPR may offer various personal and professional benefits for individuals (ie, community partners) involved in stages of development, implementation, and dissemination. The benefits affect these individuals in several ways, from personal growth (eg, emotional maturity, behavioral progress, increased familial resiliency) to professional growth (eg, progression of one's career/role/responsibilities, organizational growth, learned skills). These maturations have secondary effects (eg, increased community resilience, strengthened relationships, community-based mentorships) impacting the communities in which these community partners serve.

Comparative Effectiveness of Coalitions Versus Technical Assistance for Depression Quality Improvement in Persons with Multiple Chronic Conditions.

Significance: Prior research suggests that Community Engagement and Planning (CEP) for coalition support compared with Resources for Services (RS) for program technical assistance to implement depression quality improvement programs improves 6- and 12-month client mental-health related quality of life (MHRQL); however, effects for clients with multiple chronic medical conditions (MCC) are unknown. Objective: To explore effectiveness of CEP vs RS in MCC and non-MCC subgroups. Design: Secondary analyses of a cluster-randomized trial. Setting: 93 health care and community-based programs in two neighborhoods. Participants: Of 4,440 clients screened, 1,322 depressed (Patient Health Questionnaire, PHQ8) provided contact information, 1,246 enrolled and 1,018 (548 with ≥3 MCC) completed baseline, 6- or 12-month surveys. Intervention: CEP or RS for implementing depression quality improvement programs. Outcomes and Analyses: Primary: depression (PHQ9 <10), poor MHRQL (Short Form Health Survey, SF-12<40); Secondary: mental wellness, good physical health, behavioral health hospitalization, chronic homelessness risk, work/workloss days, services use at 6 and 12 months. End-point regressions were used to estimate intervention effects on outcomes for subgroups with ≥3 MCC, non-MCC, and intervention-by-MCC interactions (exploratory). Results: Among MCC clients at 6 months, CEP vs RS lowered likelihoods of depression and poor MHRQL; increased likelihood of mental wellness; reduced work-loss days among employed and likelihoods of ≥4 behavioral-health hospitalization nights and chronic homelessness risk, while increasing faith-based and park community center depression services; and at 12 months, likelihood of good physical health and park community center depression services use (each P<.05). There were no significant interactions or primary outcome effects for non-MCC. Conclusions: CEP was more effective than RS in improving 6-month primary outcomes among depressed MCC clients, without significant interactions.

Growing a Community-Academic Partnership: Lessons Learned in Forming a Qualitative Interview Team for the Community Partners in Care Study.

By engaging, partnering, and building trust with community members, research on vulnerable populations may offer opportunities to improve population health in communities that suffer from health disparities. While the literature on participatory and partnered approaches offers techniques and strategies for forming community-academic partnerships, less information is available about how partnerships can grow and evolve over time. In this article, we describe the expansion of a long-standing partnership that uses principles of community partnered participatory research (CPPR), a variant of community-based participatory research (CBPR). We outline the preparation and executive phases of conducting qualitative interviewing with highly vulnerable study participants who have already been participants in a longitudinal survey. We describe the challenges and concerns at each phase of the research and summarize some lessons learned. To grow and evolve, the partnership must constantly be reaffirmed in the experiences of new members.

Participatory Technology Development to Enhance Community Resilience.

Objective: To assess the feasibility of a novel, partnered technology development process to co-create mobile health applications (apps) addressing community health priorities, using psychoeducation of cognitive behavioral therapy (CBT) principles for enhancing resilience as an example. Design: Stakeholder engagement, workgroups, pilot feasibility study using mixed methods during October 2013 through January 2016 over three phases: 1) defining the vision of the project and increasing technical capacity, 2) co-development and pilot testing of the app, and 3) planning for sustainability. Setting: An academic-community partnership in South Los Angeles, California. Participants: Eight stakeholders; 30 pilot participants from the community. Main Outcome Measures: Qualitative analysis of audio-recordings of the app development process and stakeholder interviews, surveys of stakeholders' perception of the development process, app use data, and feedback from pilot participants. Results: The participatory technology development process resulted in creation and pilot-testing of a resiliency-focused text messaging app. Of the 1,107 messages sent, 23 out of 30 (77%) app users responded to explore interactive content. Stakeholders reported increased perceived competency in creating mobile apps and that the process fostered a culture of co-leadership. There was also sustained engagement in mobile app development by stakeholders beyond the initial project period. Conclusions: This is the first study, to our knowledge, to demonstrate the feasibility of participatory technology development, an approach involving direct participation in the development, tailoring and maintenance of a mobile app by a broad set of stakeholders with high representation from racial/ethnic minorities from an under-resourced community. Participatory technology development is a promising approach for creating sustainable, relevant and engaging health technologies across different technological, clinical and community settings.

Community Partnership in Precision Medicine: Themes from a Community Engagement Conference.

Background: Patient and community engagement in under-resourced communities is a key issue for precision medicine research. We report proceedings from a community-academic partnered conference in Los Angeles to promote community understanding of precision medicine and generate engagement recommendations. Methods: Planning group review of planning, presentations, and audience discussions from facilitator notes and participant survey data from a one-day conference. Findings: Community-academic planning broadened community participation and presentations. More than 80% of survey participants indicated they would participate in the national precision medicine initiative, and most were willing to share diverse sources of data. Discussions identified trust concerns related to historical research abuses, data privacy, potential effects of findings on health care, personal safety, research procedures, the time-frame for benefit, and confusion about different initiatives. Concerns were balanced by belief in science to improve health. Recommendations included a community partnered participatory approach with support for local community and academic teams to engage stakeholders with written/online resources and partnered workgroups addressing key concerns. Conclusion: Conference participants expressed high willingness to participate in precision medicine studies, but discussions highlighted trust and transparency issues and suggested community partnered research with local capacity building.

Comparative Effectiveness of Two Models of Depression Services Quality Improvement in Health and Community Sectors.

OBJECTIVE: The effectiveness of community coalition building and program technical assistance was compared in implementation of collaborative care for depression among health care and community sector clients. METHODS: In under-resourced communities, within 93 programs randomly assigned to coalition building (Community Engagement and Planning) or program technical assistance (Resources for Services) models, 1,018 clients completed surveys at baseline and at six, 12, or 36 months. Regression analysis was used to estimate intervention effects and intervention-by-sector interaction effects on depression, mental health-related quality of life, and community-prioritized outcomes and on services use. RESULTS: For outcomes, there were few significant intervention-by-sector interactions, and stratified findings suggested benefits of coalition building in both sectors. For services use, at 36 months, increases were found for coalition building in primary care visits, self-help visits, and appropriate treatment for community clients and in community-based services use for health care clients. CONCLUSIONS: Relative to program technical assistance, community coalition building benefited clients across sectors and shifted long-term utilization across sectors.

A Community-Partnered, Participatory, Cluster-Randomized Study of Depression Care Quality Improvement: Three-Year Outcomes.

OBJECTIVE: Community Partners in Care, a community-partnered, cluster-randomized trial with depressed clients from 93 Los Angeles health and community programs, examined the added value of a community coalition approach (Community Engagement and Planning [CEP]) versus individual program technical assistance (Resources for Services [RS]) for implementing depression quality improvement in underserved communities. CEP was more effective than RS in improving mental health-related quality of life, reducing behavioral health hospitalizations, and shifting services toward community-based programs at six months. At 12 months, continued evidence of improvement was found. This study examined three-year outcomes. METHODS: Among 1,004 participants with depression who were eligible for three-year follow-up, 600 participants from 89 programs completed surveys. Multiple regression analyses estimated intervention effects on poor mental health-related quality of life and depression, physical health-related quality of life, behavioral health hospital nights, and use of services. RESULTS: At three years, no differences were found in the effects of CEP versus RS on depression or mental health-related quality of life, but CEP had modest effects in improving physical health-related quality of life and reducing behavioral health hospital nights, and CEP participants had more social- and community-sector depression visits and greater use of mood stabilizers. Sensitivity analyses with longitudinal modeling reproduced these findings but found no significant differences between groups in change from baseline to three years. CONCLUSIONS: At three years, CEP and RS did not have differential effects on primary mental health outcomes, but CEP participants had modest improvements in physical health and fewer behavioral health hospital nights.

Using Stakeholder Input to Inform an Innovative Research and Policy Initiative to Improve Depression in Safety Net Communities.

THE PROBLEM: Depression quality improvement programs based on chronic disease management models have been shown to improve depression outcomes. Nonetheless, access to and the use of such programs is limited in minority, under-resourced communities. PURPOSE OF ARTICLE: We report on the outcomes of a Delphi-based consensus exercise conducted by our partnership at a community-wide conference in Los Angeles. Participants identified and prioritized the needs of depressed individuals that should be addressed in a county-wide Health Neighborhood Initiative designed to increase existing mental health, substance use, healthcare, and social services for individuals with low socioeconomic position. KEY POINTS: Participants agreed that housing is the number one priority. Delphi results also illustrate the importance of addressing social, spiritual, and healthcare access needs of depressed individuals. CONCLUSIONS: Our study shows how to systematically engage community-based organizations, patients, families, and community members in the process of improving the design of community-wide health policy initiatives.

Dissemination and Implementation of Shared Decision Making Into Clinical Practice: A Research Agenda.

Shared decision making (SDM) is essential to advancing patient-centered care in emergency medicine. Despite many documented benefits of SDM, prior research has demonstrated persistently low levels of patient engagement by clinicians across many disciplines, including emergency medicine. An effective dissemination and implementation (D&I) framework could be used to alter the process of delivering care and to facilitate SDM in routine clinical emergency medicine practice. Here we outline a research and policy agenda to support the D&I strategy needed to integrate SDM into emergency care.

Adapting Conceptual Frameworks for Patient Engagement in Emergency Department Research.

For many people the emergency department (ED) is the first point of access to healthcare for acute needs and a recurring location for many with chronic healthcare needs. While the ED is well placed to identify unmet needs it can also be a net that people slip through when faced with uncoordinated and expensive healthcare challenges. Thus the ED has a responsibility to set patients on a safe and meaningful care trajectory, which can only be done in consultation and partnership with the patients themselves. The purpose of this article is to present crucial aspects of patient engagement that are essential for future research to foster an environment of colearning and respect that encourages ongoing involvement by patients, families, and staff.