Expanding rural access to chronic pain care through nurse care management: A hybrid type I effectiveness-implementation trial protocol

STUDY PROTOCOL Expanding rural access to chronic pain care through nurse care management: A hybrid type I effectiveness-implementation trial protocol Brennan Keiser 1*, Karina Cortez1, Elise Hoffman2, Jin Wang2, Kelly Reeves 3, Andrew Humbert4, Robert W. Bailey1, Stacy Shaw Welch1,5, Sophia Jawort2, Laura-Mae Baldwin1, Caleb Holtzer 6, Hazel Tapp3, Thomas Ludden3, Basia Belza7, Kushang V. Patel 2, Sebastian T. Tong 1 1 Department of Family Medicine, University of Washington, Seattle, Washington, United States of America, 2 Department of Anesthesiology & Pain Medicine, University of Washington, Seattle, Washington, United States of America, 3 Department of Family Medicine, Atrium Health Wake Forest Baptist, Charlotte, North Carolina, United States of America, 4 Department of Rehabilitation Medicine, University of Washington, Seattle, Washington, United States of America, 5 Department of Psychology, University of Washington, Seattle, Washington, United States of America, 6 Providence Northeast Washington Medical Group, Colville, Washington, United States of America, 7 Department of Biobehavioral Nursing and Health Informatics, University of Washington, Seattle, Washington, United States of America * OPEN ACCESS Citation: Keiser B, Cortez K, Hoffman E, Wang J, Reeves K, Humbert A, et al. (2026) Expanding rural access to chronic pain care through nurse care management: A hybrid type I effectiveness-implementation trial protocol. PLoS One 21(5): e0349526. https://doi. org/10.1371/journal.pone.0349526 Editor: Annesha Sil, PLOS: Public Library of Science, UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND Received: April 15, 2026 Accepted: April 28, 2026 Published: May 27, 2026 Peer Review History: PLOS recognizes the benefits of transparency in the peer review process; therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. The editorial history of this article is available here: https://doi.org/10.1371/journal. pone.0349526 Copyright: © 2026 Keiser et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, Abstract Background Chronic pain affects more than 20% of U.S. adults, with prevalence approaching 30% in rural communities. It can substantially impair physical functioning, mental health, and quality of life, and rural residents experience poorer pain-related outcomes. Effective care requires a comprehensive, multidisciplinary approach; however, rural primary care clinicians often rely on medications—particularly prescription opioids— as the predominant treatment despite limited evidence and substantial risks. Innovative strategies are needed to expand access to evidence-based, non-pharmacologic pain management in rural settings. Objective To determine the effectiveness of a nurse care management (NCM) model for chronic pain compared with usual care and to evaluate its implementation. Methods A pragmatic, hybrid type I effectiveness–implementation randomized controlled trial will be conducted from April 2026 to July 2028. A total of 450 adults with chronic pain and a Pain, Enjoyment of Life, and General Activity (PEG) scale total score ≥12 will be recruited from rural health systems. Rural eligibility will be verified using the PLOS One | https://doi.org/10.1371/journal.pone.0349526 May 27, 2026 1 / 12 which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data availability statement: No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion. Funding: This work was supported within (NIH) Pragmatic Trials Collaboratory by cooperative agreement UH3 NR020930 from the National Institute of Nursing Research (NINR). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This work also received logistical and technical support from the NIH Pragmatic Trials Collaboratory Coordinating Center under award number U24 AT009676 from the National Center for Complementary and Integrative Health (NCCIH), the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Minority Health and Health Disparities (NIMHD), the National Institute of Neurological Disorders and Stroke (NINDS), NINR, the National Institute on Aging (NIA), the NIH Office of Behavioral and Social Sciences Research (OBSSR), and the NIH Office of Disease Prevention (ODP). The content is solely the responsibility of the authors and does not necessarily represent the official views of NINR or the NCCIH, NCI, NIA, NIAMS, NHLBI, NIAID, NIMHD, NINDS, OBSSR, or ODP, or the NIH. Infrastructural support for our research network was provided by the Institute of Translational Health Sciences, which is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health through Grant Number UL1 TR002319. The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the views of the NIH. Competing interests: The authors have declared that no competing interests exist. Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer. Participants will be randomly assigned to the NCM intervention or to usual care using permuted block randomization with variable block sizes (4 or 6). The 6-month virtually delivered NCM intervention includes (1) cognitive behavioral therapy, (2) care coordination, and (3) referral to Tele-Enhance®Fitness, an instructor-led virtual group exercise program. The primary outcome is pain interference and intensity measured by the PEG scale. Secondary outcomes include pain catastrophizing, depression, anxiety, physical functioning, sleep disturbance, satisfaction with health, and opioid use. Implementation outcomes—reach, fidelity, feasibility, and sustainment—will be evaluated with the Practical, Robust Implementation and Sustainability Model (PRISM) framework. Discussion This pragmatic trial will assess the effectiveness of the NCM model for chronic pain care and collect implementation data to guide potential scale-up in rural primary care. Trial registration ClinicalTrials.gov identifier: NCT06407115. Introduction Chronic pain affects more than 20% of U.S. adults, with prevalence approaching 30% in rural regions [1,2]. The annual economic burden of chronic pain in the United States is estimated at $722.8 billion [3], encompassing both medical care costs and lost work productivity [2]. Chronic pain exerts profound effects on physical functioning, mental health, and overall quality of life [4]—outcomes that are consistently (...truncated)