Funded Projects

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.

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, is conducting 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 is slated to end late 2018, aims 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 puts 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

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.

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.

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 will be developed over 18 months, utilizing the PATIENTS Program's resources, partners, and stakeholders. Team members will collect 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 and see if you might be eligible to get involved, please visit the Learning Health Care Community project webpage.

The PREPARE Trial

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

Surgical site infection (SSI) after surgery to mend a broken bone is an avoidable adverse patient-centered outcome with significant patient and health care system burden. More than one million Americans suffer an extremity fracture (broken bone in the arm, leg, or pelvis) that requires surgery each year. Approximately five percent (or 50,000) of surgical fracture patients develop an SSI, which is twice the rate among most surgical patients, and nearly five times the rate among patients undergoing elective orthopaedic surgeries (e.g., joint replacement).

In collaboration with the PATIENTS Program and other stakeholders, the PREPARE trial will enroll 8,680 fracture patients to determine the most effective preoperative skin cleansing (antiseptic) solution to reduce the risk of SSI. To ensure a diverse patient population, a systematic process was used to carefully select 10 hospitals from the trial team's network of over 100 trauma centers across the U.S. and Canada to participate in the PREPARE trial.

The PREPARE trial will compare two antiseptic solutions (Iodine- versus CHG-containing antiseptic surgical prep solutions) that are ubiquitously used in US hospitals, inexpensive, and universally considered effective. Since the interventions are similar in appearance, application, and cost, the results of our trial are poised for immediate implementation to reduce SSIs for one million fracture surgery patients a year. This potential for overnight practice changing results reflects our goal to find simple, inexpensive means to reduce SSI. This approach aligns with one of PCORI's strategic goals to speed the implementation and use of patient-centered outcomes research evidence.

The PREPARE team held its kick-off meeting on November 29, and is slated to run for a five-year period.