Explore the projects below to learn how The PATIENTS Program is helping to support research that will help answer real-world, patient-centered questions, and lead to lasting changes across the field of health care.

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.

Current Funded Projects

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

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.

Eugene Washington PCORI Engagement Award: DISRUPTS

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.

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.

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

The 2020 R13 Conference entitled ‘Building Capacity for Patient-Centered Research’ will be held Friday, June 19, 2020. As an encore from our first conference, we will be delving into topics that community partners, patient advisors, researchers, and students need to know. Topics will include strategies to build capacity and institutional support for patient-centered outcomes research (PCOR), implementing community engaged research/PCOR partnerships, sharing results and best practices and so much more. Speakers will include community partners and renowned researchers from seven different institutions across the country that have truly transformed the way PCOR is conducted at their institutions.

Come learn with us, share your own strategies, and network with other individuals that share the same passion for PCOR.

Follow The Patients Program for updates and details on how to register.

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 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.

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

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.

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

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.