What We Do

• Project Lead: Michelle Medeiros
• Project Budget Amount: $250,000
• Award Date: 5/17/2023
• Project Period: 18 months
• Award Category: Engagement Award Project

We propose a platform to engage local and national community members to build mental health PCOR capacity called COmmunity-Based Collaboration to Address the Pillar of Mental Health in PCOR/CER Research (CO-PILLAR). CO-PILLAR will offer training for patients, caregivers, and community representatives to talk about community mental health concerns, share promising practices in creating mental health PCOR, and how they can build the capacity to co-create mental health PCOR that addresses the 4 pillars of health (mental, physical, financial, and spiritual). We will assemble a Council of Community Partners (CCP) who will co-develop our Training Continuum and guide the recruitment of our participants. The CCP will be comprised of mental health experts such as advocates with lived mental health experience, community practitioners, and researchers. These experts will be supported by experts of the physical, financial, and spiritual pillars of health. 

Objective. Create virtual, interactive capacity-building programming with community partners, especially those that are underserved, focused on the conduct of PCOR/CER projects aimed at addressing mental health and its intersection with the three other pillars of health (physical, spiritual, financial) to improve holistic health(4PH) outcomes. 

Aim 1. Form a Council of Community Partners of individuals with lived experience and subject matter experts on the four pillars of health. The majority of the CCP will be mental health experts including, patient and community representatives, academic or community-based researchers, clinicians, caregivers, and others who have become mental health advocates. This core will be complemented by community representatives who are subject matter experts on the other pillars of health (physical, spiritual, financial). The role of the CCP will be to guide the work and co-develop all trainings. 

Aim 2. Co-develop and deliver a virtual, tiered Training Continuum focused on established or promising, community-based capacity building practices in mental health PCOR/CER research. We aim to include over 100 individuals in the introductory tier of training and expect 50% will go on to additional training tiers, with 20% reaching the community studio tier. 

Specific Aims

Health equity is when all individuals or populations have optimal opportunities to attain the best health possible. Our community-academic partnership has been working with and in communities to achieve health equity for decades. Advancing health equity through diversity in clinical trials and other regulatory science research can be achieved with diverse community-based recruitment sites when amplified with innovative application of the science of engagement and appropriate community infrastructure.

Prior attempts to enhance diversity in research document success when researchers work collaboratively with underrepresented populations, such as Black, Latino, Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality; however, lessons learned from prior attempts underscore the need to address infrastructures in non-research intensive community sites and the need to redesign studies to be patient-centered and meaningful to patients.

This proposal builds on the PATIENTS Program’s decade of advancing health equity research and the science of engagement in collaboration with established community-based organization (CBO) partnerships with (1) Walgreens, the nation’s second largest network of community pharmacies and (2) Mt. Lebanon Baptist Church, an African American church that has been a longstanding partner of the PATIENTS Program. 

NIH has promoted the science of team science (SciTS) as a methodologic approach to enhance the structure, process, and outcomes of large-scale collaborative research and training programs. Most SciTS has not included community partners in their SciTS activities and programs; the PATIENTS Program at The University of Maryland Baltimore (UMB) includes their partners in shared governance and views community partners as part of the research team. Dr. Mullins and the PATIENTS Program have advanced the science of engagement, which builds upon fundamental concepts of SciTS but expands the “team” to include non-traditional researchers, such as patients, community-based providers, community health advocates, learning health system administrators, and other stakeholders in scientific investigations. Including and engaging a more diverse team of stakeholders is proposed as a means to incorporate multistakeholder perspectives that collaboratively and synergistically can advance health equity. Despite the vast array of research and discussions on the topic, the hypothesized feasibility and impact of achieving health equity through alternative approaches to enhancing diversity in clinical trial participation have not been fully tested. Therefore, before full scale implementation of diversity initiatives using CBOs, it is important to produce a “proof of concept” to demonstrate the feasibility of CBOs to effectively identify, recruit, refer, retain, and continuously engage patients and relevant stakeholders throughout the clinical trial. Our proof of concept is achieved through simulation exercises of clinical trial and other health equity regulatory science studies in CBO locations. 

The proposed simulation exercises align with Dr. Mullins’ evidence based 10-Step Framework for Continuous Patient and Stakeholder Engagement. Our work with Mt. Lebanon Baptist Church spans methodologic research on the science of engagement, sustainable community-academic partnerships, and patient-centered community-engaged research (CEnR) funded by AHRQ, FDA, NHLBI, NIA, NIMHD and PCORI. Walgreens provided funding to The University of Maryland School of Pharmacy for our Objective Structured Clinical Exams (OSCEs) suite, which provides a systematic simulated approach to student assessment. Aspects of the OSCE assessment will be incorporated into our research simulation exercises. Our simulation exercises are designed to assess whether and how to partner with CBOs to achieve health equity through partnerships with CBOs to enhance diversity in clinical trials and other regulatory science research. To achieve that overarching goal, we propose three Aims as follows: 

Aim 1: Collaboratively prioritize health equity simulation scenarios to address health equity-related barriers and facilitators for underrepresented populations’ enrollment in clinical trials and other regulatory science research in partnership with 2 CBOs: community pharmacies and faith-based organizations 

Aim 2: Conduct and evaluate health equity simulation of enrollment in clinical trials and other health equity regulatory science research to test feasibility of workflow in CBO settings as enrollment, retention, and dissemination sites for clinical trials and other regulatory science research 

Aim 3: Evaluate and prioritize action-oriented health equity activities to enhance CBO capacity to address health equity-related barriers and facilitators and increase enrollment in clinical trials and other regulatory science research by underrepresented populations 

PROJECT UPDATES:

For the latest updates about this research initiative, please explore the following links:

• June 2022: The FDA One Health Initiative Project Update
• February 2022: The FDA One Health Initiative Project Update (English) (Spanish)

The Inflation Reduction Act (IRA) gives the Centers for Medicare and Medicaid Services (CMS) new authority to negotiate drug prices based on multiple factors, including a drug’s clinical benefit based on comparative effectiveness research. While CMS has suggested they are interested in considering the outcomes and experiences of patients during their decision-making process, they do not yet seem to have a formal plan in place to engage patients in a systematic way.

Patient perspectives can only be valued and considered if engagement occurs early and meaningfully throughout the process to identify and assess data and determine how the data are weighted and used in CMS decision making.

The PATIENTS Professors, who are trained patient experts in continuous patient engagement in research, undertook a series of discussions for the CMS Patient Engagement Town Hall Initiative centered on the question, “Are there touchpoints you would like to see built into CMS’ process to engage the patient community?”. The goal of this initiative was to provide insights and recommendations to CMS to ensure patient perspectives can be sought and are represented in CMS’ decision making.

Resources

• Patient-driven Recommendations for the Medicare Drug Price Negotiation Program
• Recommendations for the CMS Drug Price Negotiation Program - Final Report

PROJECT OVERVIEW:

Background: Lack of dissemination experience and lack of incentives inhibit patient-centered outcomes research (PCOR) and comparative clinical effectiveness research (CER) investigators from prioritizing dissemination throughout their projects. Evidence-based tools for dissemination exist, yet investigators may still struggle with how to conduct continuous dissemination during the intermediate stages of an award.

Proposed Solution to the Problem: Shining the SpOtlight Wide (SHOW) proposes a half-day virtual conference to engage patient and stakeholder partners, dissemination scientists, and PCOR investigators on how to systematically address common barriers to continuous dissemination in research. It will provide participants with the tools necessary to subsequently embed continuous dissemination within their respective studies. Three months after the SHOW conference, the stakeholder advisory board (SAB) will host a Dissemination Think Tank (DTT) to further support future dissemination efforts of conference participants.

Read more about the project funded by the Patient-Centered Outcomes Research Institute (PCORI).