Year: 2024
Type: article
Abstract: BACKGROUND: The NIH Pragmatic Trials Collaboratory supports the design and conduct of 31 embedded pragmatic clinical trials, and many of these trials use patient-reported outcome measures (PROMs) to provide valuable information about the patients' health and wellness. Often these trials enroll medically underserved patients, including people with incomes below the federal poverty threshold, racial or ethnic minority groups, or rural or frontier communities. OBJECTIVES: In this series of trial case reports, we provide lessons learned about collecting PROMs in these populations. Unbiased collection of PROM data is critical to increase the generalizability of trial outcomes and to address health inequities. Use of electronic health records (EHRs) and other digital modes of PROM administration has gained traction. However, engagement with these modes is often low among populations prone to disparity due to lower digital proficiency, device access, and uptake of EHR portals and web interfaces. METHODS: To maximize the completeness and representativeness of their trial outcome data, study teams tested a range of strategies to improve PROM response rates with emphasis on disparities prone and underserved patient groups. This manuscript describes the approaches, their implementation, and the targeted populations. CONCLUSION: Optimized PROM collection required hybrid approaches with multiple outreach modes, high-touch methods, creativity in promoting digital uptake, multimodal participant engagement, and text messaging.
Source: Applied Clinical Informatics
DOI: 10.1055/a-2462-8699
Authors: Andrea Cheville, Crystal L. Patil, Andrew D. Boyd, Leslie J. Crofford, Dana Dailey, Victoria de Martelly, Guilherme Del Fiol, Miriam O. Ezenwa, Keturah R. Faurot, Mitch Knisely, Kaitlyn R. McLeod, Natalia E. Morone, Emily O'Brien, Rosa M. Gonzalez-Guarda, Kathleen A. Sluka, Karen Staman, Anne Thackeray, Christina K. Zigler, Judith M. Schlaeger
Institutions: Mayo Clinic, Mayo Clinic Comprehensive Cancer Center (Minnesota), University of Michigan, University of Illinois Chicago, Vanderbilt University Medical Center, University of Iowa, Saint Ambrose University, University of Utah, University of Florida, University of North Carolina at Chapel Hill, Duke University, University of Colorado Denver, Boston University, Boston Medical Center
Language: English
Subfield: Sociology and Political Science
Field: Social Sciences
Domain: Social Sciences
Open Access status: hybrid
Funders: National Institutes of Health, National Institute on Aging, National Heart, Lung, and Blood Institute, National Cancer Institute, National Institute of Nursing Research, National Institute of Allergy and Infectious Diseases, National Institute of Neurological Disorders and Stroke, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Office of Behavioral and Social Sciences Research, Office of Disease Prevention, National Institute on Minority Health and Health Disparities, National Center for Complementary and Integrative Health
Awards: G1118800860, Nonpharmacologic Pain Management in FQHC primary care clinics, G1566821804, G2009607857, G204676442, Nonpharmacologic Pain Management in FQHC primary care clinics, Non-pharmacological Options in postoperative Hospital-based And Rehabilitation pain Management (NOHARM) pragmatic clinical trial, G2855724243, G3111920434, G3906315918, HEAL Collaboratory Resource Coordinating Center (PRISM) (U24), Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain, G6698185126, Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain, G7561302851, G7864057360, Group-Based Mindfulness for Patients with Chronic Low Back Pain in the Primary Care, G8132398235, G9000031849, Interdisciplinary Training Program in Pain Research, G936337638
OpenAlex ID: W4404129315