Explore the previous funded projects from the PATIENTS Program.

To read more about each project, click or tap on the link of the project(s) in which you are most interested to expand the selection.

Previous Funded Projects

The 10-Step Project

Principal Investigator: C. Daniel Mullins, PhD (University of Maryland School of Pharmacy)

In a PCORI-funded report titled "Patient Engagement in Research: A Systematic Review", the authors concluded that "research dedicated to identifying the best methods to achieve engagement is lacking and clearly needed." A subsequent study reiterated that fact, stating that "the most effective approaches to engagement have not been well defined." Principal investigator, C. Daniel Mullins, PhD, professor and chair of the Department of Pharmaceutical Health Services Research (PHSR) and director of the PATIENTS Program at the School of Pharmacy, along with the PATIENTS team and the project's stakeholder advisory board, conducted a research project funded by PCORI to examine different ways of engaging patients at each of the 10 steps of the research process.

The project, which began in September 2015 and was completed 2018, aimed to identify evidence-based engagement strategies, emerging methods, and develop methodological guidance for selecting the most appropriate, meaningful, and impactful engagement method for each step of PCOR and the relevant resources required. The project put considerable effort into advancing patient and stakeholder engagement methods that aim to expand rather than duplicate prior work.

Learn more about the 10-Step Project

Agency for Healthcare Research and Quality (AHRQ) R13 Initiative: Building Capacity for Patient-Centered Research

Thank you to everyone who registered, attended, and took part in the Building Capacity for Patient-Centered Research Conference. We had more than 200 people sign up to attend this virtual conference held on June 19.

Attendees nationwide learned from researchers and their community members about how to build partnerships in their communities that are meant to last. Guests had a chance to ask questions and win a chance at a raffle for The PATIENTS Program swag.

If you missed out, don’t worry. All sessions, questions, and answers were recorded and can be found on our website, Facebook, and YouTube pages.

Shila Mortazavi, a fourth-year student pharmacist who worked with us, wrote about the conference in a blog post published on the School of Pharmacy's Inside SOP blog.

The conference was also featured in the School of Pharmacy's News Center.

We thank The PATIENTS Program's community and funder, the Agency for Healthcare Research and Quality (AHRQ), for making this meeting possible.

Communities and Universities Engaged to Fight COVID-19 (CEAL CUE COVID-19)

PROJECT UPDATES:

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

Communicating about COVID-19 Testing to Underrepresented Populations

PROJECT OVERVIEW:

Background: There is a need to understand attitudes, beliefs, and values around testing for COVID-19 in underrepresented populations and willingness to share their data in national repositories. This information will allow CDRH to tailor messaging as well as inform outreach efforts for monitoring transmission and penetrance of the disease.

Proposed Solution: To achieve these aims, the University of Maryland School of Pharmacy PATIENTS Program and University of Maryland at College Park collaborators will conduct a qualitative study using virtual focus group discussions and key informant interviews to gather information from underrepresented participants in the greater Baltimore area.

Objectives: The research goals are to understand (1) attitudes around testing for COVID-19 in underrepresented populations and (2) willingness to share their data in national repositories.

PROJECT UPDATES:

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

COmmunity Based Development of CollaboRatIVE and Sustainable PartNerships in PCOR/CER – (CO-DRIVEN)

PROJECT OVERVIEW:

Background: Disparities in the social determinants of health and deep-rooted mistrust due to historical research atrocities are very prevalent in West Baltimore communities, particularly among African Americans. The PATIENTS Program at the University of Maryland, Baltimore (UMB) seeks to repair that broken trust by meeting people "where they are." We actively engage communities and encourage community members to partner to initiate and participate in patient-centered outcomes research (PCOR) and comparative effectiveness research (CER). In collaboration with The Southwest Partnership (SWP), The PATIENTS Program seeks to expand our PCOR/CER footprint to the Southwest Baltimore community.

Proposed Solution: The proposed solution is to develop a community-academic partnership for building PCOR/CER capacity. SWP and UMB will serve as foundational partners on this project to open a bridge between this community and researchers, health care providers, and more.

Objectives: The overall objective is to foster a multistakeholder collaboration focused on PCOR/CER by leveraging SWP's standing in the community to develop a sustainable partnership with the community to engage in the research process from topic selection through dissemination of results.

PROJECT UPDATES:

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

COmmunity Mistrust and Measures of Institutional Trustworthiness (COMMIT)

PROJECT UPDATES:

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

COmmunity Mistrust and Measures of Institutional Trustworthiness to Advance Health Equity Research (COMMIT-EQ)

PROJECT UPDATES:

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

Eugene Washington PCORI Engagement Award: Capacity Building for a Learning PCOR System

PROJECT OVERVIEW:

The PATIENTS Program kicked off its new project, titled "Capacity Building for a Learning PCOR System," on Thursday, Oct. 3, 2019, at the University of Maryland Baltimore. A Learning PCOR System strives to have authentic shared learning across many patient-centered outcomes research (PCOR) studies.

  • Goal 1: Co-develop and create a system for how to do PCOR better.

  • Goal 2: Obtain input from the following stakeholders to create new ways to share information ("give backs") and new ways to deliver solutions back to health care system and stakeholders:
    • Health care providers
    • PCOR researchers
    • Payers
    • Policymakers
  • Goal 3: Deliver a plan: document activities, deliberations, and feedback.

PROJECT UPDATES:

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

Eugene Washington PCORI Engagement Award: DISRUPTS

PROJECT OVERVIEW:

Led by Carly Lovelett, CCRP, clinical research manager at St. Lawrence Health System (SLHS), this project is titled "Developing InfraStructure for Research to Utilize Patient- centered Techniques at SLHS" (DISRUPTS).

The PATIENTS Program will:

  • help create engagement plan strategies
  • manage daily operations of the engagement plan and
  • create media content to reach diverse audiences.

The project team created a Stakeholder Advisory Committee to give guidance and oversight during the course of the initiative.

This is a two-year project.

PROJECT UPDATES:

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

#IDatHome: Engaging Multiple Stakeholders While Quarantined — A Virtual Conference for Infectious Disease-Focused Patient-Centered Outcomes Research and Comparative Effectiveness Research

Background: Coronavirus disease 2019 (COVID-19) hospitalizations and the demand for testing forced public health officials to accelerate the development of recommendations to mitigate the disease’s impact. With a frequently changing and incredibly unstable body of evidence regarding prevention, treatment, and general best practices, the need for more engagement is apparent. The design, development, and dissemination of patient-centered outcomes research (PCOR) on COVID-19 and other infectious diseases (ID) will be critical to address the current crisis and prepare for future pandemics. Government restrictions aimed at reducing travel and quarantining individuals impose a major barrier to in-person, continuous engagement of patients and stakeholders.

Proposed Solution: The project team’s proposed solution, a virtual conference (#IDatHome), will address ID-specific comparative effectiveness research (CER)/PCOR design and facilitate the exchange of evidence-based methods of engagement among ID providers, researchers, and patient advocates. The team aims to build from a foundational collaboration between The PATIENTS Program and the Institute of Human Virology (IHV) at the University of Maryland, Baltimore (UMB), previously formed thanks to a 2018 PCORI Pipeline to Proposal Award.

Objectives: The objectives for the conference are: to engage a variety of stakeholders remotely by leveraging technology; to explore COVID-19-specific challenges patients are facing to identify and prioritize future CER/PCOR for infectious diseases.

PROJECT UPDATES:

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

Learning Health Care Community

Principal Investigator: C. Daniel Mullins, PhD (University of Maryland School of Pharmacy)

Minorities comprise more than a third of all Americans and more than half of American children under age five, according to Census figures. However, their prominence in the U.S. population also comes with greater health disparities. In Baltimore, where minorities make up 72 percent of the city, a similar picture exists. Traditionally, poor communication by health care providers and lack of trust in the medical system have resulted in negative health care experiences in medically underserved communities. In particular, within African American communities, such experiences are aggravated by years of distrust of medical research.

Supported by a two-year, $250,000 grant from Merck, the University of Maryland School of Pharmacy is developing a new approach -- a Learning Health Care Community -- focused on continuous patient engagement and establishing partnerships with churches, organizations, providers, caregivers, health care facilities, and other area stakeholders. The project involves community leaders in facilitating patient engagement and collecting information with the community itself from the outset, in an environment centered on comfort and trust.

The framework of the Learning Health Care Community was developed over 18 months, utilizing the PATIENTS Program's resources, partners, and stakeholders. Team members collected a full range of community perspectives to guide best practices and incorporate lessons learned from patient engagement. "The community can help us address disparities and create health equity," says C. Daniel Mullins, PhD, professor and chair of the Department of Pharmaceutical Health Services Research (PHSR) and principal investigator for the study.

To learn more about this project, please visit the Learning Health Care Community project webpage.

National Institute on Aging Alzheimer’s Disease and Related Dementias (NIA ADRD)

PROJECT UPDATES:

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

NIA Bioethics Supplement

PROJECT UPDATES:

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

National Institute on Aging (NIA) R24 Initiative: Building Trust to Enhance Diversity in Aging Research

The overarching objective for the NIA R24 Initiative: Building Trust to Enhance Diversity in Aging Research (R24 AG063728-01) is that, through work with community allies, we can reduce health disparities of diverse groups of older adults. In doing this, we can address barriers to elderly residents taking part in health research.

  1. First Aim: Create a partnership between the community and research team that builds trust, invites older residents to engage in research and maintain relationships with them, and increase diversity in studies of aging.

  2. Second Aim: Help older people, their doctors, and researchers learn from each other.
    • Help older people be comfortable being in research
    • Help researchers earn the trust of older people they study
  3. Third Aim: Encourage older adults to join research studies using ethical methods. Focus our efforts on the following groups:
    • Older African Americans
    • Older adults with impairments (hearing, vision, mobility)
    • Those who cannot leave their homes

Future Objectives: Create a database that includes older and underrepresented community members by inviting older residents to engage in research and maintain relationships with them. Have researchers and older residents learn from each other to reduce current health disparities and prioritize the most important healthcare topics for the community.

To learn more about this project, please visit the NIA R24 Initiative: Building Trust to Enhance Diversity in Aging Research webpage.

PROJECT UPDATES:

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

Pharmacy Student and New Practitioner Educational Debt and Burnout Rx - Debt

PROJECT UPDATES:

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

The PREP-IT Trial

Principal Investigator: Gerard P. Slobogean, MD, MPH (University of Maryland, Baltimore)

Research Objective: PREP-IT (A Program of Randomized trials to Evaluate Pre-operative antiseptic skin solutions In orthopaedic Trauma), consists of two sister trials which will compare the effectiveness of antiseptic cleaning solutions, iodine povacrylex and chlorhexidine gluconate, on reducing surgical site infections (SSI) after surgery to repair broken bones.

Study Design: These two multi-center pragmatic cluster randomized crossover trials study four antiseptic solutions in three independent populations of surgically treated fracture participants. The research program was co-developed by research personnel and stakeholders, which include patient advisors, representatives from professional associations, a multidisciplinary team of healthcare professionals, and a media representative.

Population Studied: Patients who have an acute fracture requiring surgery receive an antiseptic solution prior to surgery. These trials seek to enroll approximately 10,000 patients over a 3 year phase.

PROJECT UPDATES:

Publications:

Promoting Understanding in Social Needs Research Projects by Listening and Engaging (PURPLE)

PROJECT UPDATES:

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

Prioritization of Comparative Effectiveness Research (CER)/Patient-Centered Outcomes Research (PCOR) on Prostate Cancer Active Surveillance (AS): Community Consensus Initiative

PROJECT OVERVIEW:

Background: Men newly diagnosed with localized prostate cancer (PCa) who have a low-risk disease profile are candidates for active surveillance (AS) — the process of close monitoring in deferral of treatment if cancer progresses. AS avoids overtreatment and complications associated with prostate cancer therapy. Despite overwhelming support in national and international clinical guidelines, less than half of all eligible men initially opt for AS. Additionally, some men who do pursue AS eventually discontinue it in favor of treatment, despite no evidence of disease progression. The PATIENTS Program at the University of Maryland, Baltimore (UMB) seeks to begin addressing these unanswered CER/PCOR questions by bringing communities together, discussing AS challenges, and identifying areas of future research impactful to patients and physicians alike.

Proposed Solution: The proposed solution is convening a day-long stakeholder meeting. The conference will bring together members of key stakeholder communities, patients, spouses, caregivers, urologists, etc., to initiate a collaborative process to ensure appropriate focus (nationally and internationally) on immediate, shorter-term research initiatives. The conference will generate a prioritized list of unanswered questions in the PICOT (Population, Intervention, Comparison, Outcome, and Time) format that will facilitate meaningful future CER/PCOR centered on men with low-risk PCa.

Objectives: The overall objective is to develop and prioritize a list of research questions addressing men considering treatment options for low-risk PCa that will steer future PCOR/CER. To do so, we will:

  1. Form a diverse multi-stakeholder advisory board (MAB)
  2. Develop a comprehensive list of PCa decisional dilemmas for AS candidates for wide distribution and stakeholder ranking
  3. Convene a day-long meeting of relevant stakeholders to discuss and prioritize recommendations addressing the decisional dilemmas
  4. Develop and disseminate conference results for stakeholder ranking
  5. Publish prioritized decisional dilemmas and recommendations to guide future CER/PCOR

PROJECT UPDATES:

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

Project HEAL

Principal Investigator: Cheryl L. Holt, PhD (University of Maryland, College Park)

The Health through Early Awareness and Learning (HEAL) Project works with community partners, largely in faith-based communities, to increase early detection of breast, prostate, and colorectal screening. With the support of agencies such as the National Cancer Institute and the American Cancer Society, the project team employs a community-based participatory research approach to engage African American churches and health ministries to educate, empower, and connect people with resources they need to get screened. The PATIENTS Program's outreach and community engagement team members worked closely with the Project HEAL leadership and stakeholders to train church leadership in health ministry development, including training manuals and other resources.

Visit the Project HEAL website to hear testimonials from program participants and to download resource guides and community health advisor training modules.

PROJECT UPDATES:

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

Qualitative Investigation of Telemedicine and Sleep Disorder Treatments

PROJECT OVERVIEW:

Background: Insufficient and disturbed sleep are endemic in the modern military culture and are costly, incurring significant adverse impact on Warfighter health and operational readiness. For many sleep disorders, behavioral sleep interventions are recommended first-line treatments but a lack of behavioral sleep clinicians within the military and servicemembers’ mandatory and monitored schedules restricting ability participate in traditional behavioral sleep interventions present major barriers to treatment, negatively influencing servicemembers’ welfare. The University of Maryland Baltimore (UMB) seeks to improve physiological and psychological health and resilience among military servicemembers with sleep disorders.

Proposed Solution: To increase access to care, we propose a scalable, military-relevant Tele-Sleep Decision Assist (T-SDA) Tool that integrates evidence-based behavioral sleep interventions and validated objective monitoring technologies (i.e., an “app” and wearable sensors) that passively collects relevant sleep data. Following implementation, we will conduct a mixedmethods qualitative and quantitative Tool evaluation to facilitate dissemination and adoption among military servicemembers and all beneficiaries treated within the joint service DHA/military health system.

Objectives: The overall objective is to test the usability and acceptability of a novel tele-sleep decision assist tool in a real-world military medicine environment in order to improve physiological and psychological health and resilience among military servicemembers with sleep disorders.

Specific Aims: (1) Tailor a military-relevant T-SDA Tool by integrating two existing military sleep technologies (WellTap® and Real-Time Sleep™); (2) Assess the T-SDA Tool by conducting a pragmatic clinical implementation study in two joint service military hospitals to evaluate usability, impact, and acceptability; and (3) Monitor and describe patient use of specific behavioral sleep intervention treatment modules and evaluate preliminary changes in sleep associated with these tele-sleep treatments.

PROJECT UPDATES:

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

RadComp: A Study at the Heart of Breast Cancer Treatment

Principal Investigator: Justin E. Bekelman, MD (University of Pennsylvania)

Nearly three million women are living with breast cancer in the United States, and radiotherapy plays a major role in the treatment of this disease. Because of incidental radiation to the heart, radiotherapy carries increased risks of cardiovascular morbidity and mortality; survivors who receive radiotherapy have at least a two-fold increased risk of cardiovascular death. Thus, success of cancer therapy has led to survivorship burden. Patients live longer, but suffer from toxic consequences of treatment.

RadComp (short for Radiotherapy Comparative Effectiveness) is a group of radiotherapy sites that have come together for this new study of radiation therapy for breast cancer. The consortium has engaged a collaborative stakeholder effort to partner with patients to design the studies, and to build support for proton therapy comparative effectiveness research responsive to the information needs of stakeholders, decision makers, and policy makers. To better understand the patient perspective and the outcomes most meaningful to patients, RadComp leveraged the patient engagement expertise of the PATIENTS Program, conducting interviews with more than a dozen patient advisors individually and in small groups. The study aims to answer four key questions:

  • Does proton therapy reduce major cardiovascular events compared to photon therapy?
  • Is proton therapy not-inferior to photon therapy in reducing breast cancer recurrence?
  • Does proton therapy improve patient-reported quality of life compared to photon therapy?
  • Based on radiation dose distributions in real-world practice, can we develop predictive models of cardiovascular toxicity and quality of life to help patients make informed radiation treatment decisions?

Visit the PATIENTS YouTube channel to learn more about the RadComp trial, or visit the study's website for more details.

U.S. Food and Drug Administration (FDA) Grant: Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products

PROJECT OVERVIEW:

On Monday August 12, 2019, The PATIENTS Program received the official Notice of Award (NOA) for the second year (Phase 1b) of the FDA funded project: "Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products". This project is supported by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) collaboration with FDA which assesses the safety, efficacy, quality and performance of FDA-regulated products. The goal of this project is to explore health information-seeking needs, intentions, and behaviors of older women -- identified as 38 years old or older -- as well as barriers they face in their attempts to access a range of FDA-regulated products modes of communication.

To achieve this goal, in the first year (Phase 1a), The PATIENTS team, in collaboration with Westat, conducted 13 focus group discussions in the Baltimore-Washington Metropolitan Area with older women in three generation groups: 38- 53, 54-72, and 73-90 years old. Participants engaged in discussions about the following FDA-regulated products: drugs, vaccines, medical devices, and food package labels.

The purpose of Phase 1b focus groups is to expand the focus group discussions and explore new topics with women in other locales and demographics across the United States. We want to enrich our understanding of women's health seeking intentions and behaviors focusing on health communications associated with drugs and vaccines. We will employ broader recruitment strategies and engage national level partners to cover the four regions of the nation, while covering urban and rural settings in each of these regions. We will also explore a wider array of factors that comprise socioeconomic status; and include more diverse racial and ethnic groups of women.

By the end of Phase 1b, important and relevant items identified from the focus groups conducted in first two years will be identified to inform the development of Phase 2 nation-wide survey of this project.

PROJECT UPDATES:

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