PMID- 36927459 OWN - NLM STAT- MEDLINE DCOM- 20230320 LR - 20230520 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 24 IP - 1 DP - 2023 Mar 16 TI - Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. PG - 196 LID - 10.1186/s13063-023-07165-8 [doi] LID - 196 AB - BACKGROUND: Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use. METHODS: As part of the National Institutes of Health Helping to End Addiction Long-term(R) (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; >/= 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment. DISCUSSION: This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services. TRIAL REGISTRATION: ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020. CI - (c) 2023. The Author(s). FAU - Mayhew, Meghan AU - Mayhew M AUID- ORCID: 0000-0002-9469-2188 AD - Kaiser Permanente Center for Health Research, Portland, USA. meghan.h.mayhew@kpchr.org. FAU - Balderson, Benjamin H AU - Balderson BH AD - Kaiser Permanente Washington Health Research Institute, Seattle, USA. FAU - Cook, Andrea J AU - Cook AJ AD - Kaiser Permanente Washington Health Research Institute, Seattle, USA. FAU - Dickerson, John F AU - Dickerson JF AD - Kaiser Permanente Center for Health Research, Portland, USA. FAU - Elder, Charles R AU - Elder CR AD - Kaiser Permanente Center for Health Research, Portland, USA. FAU - Firemark, Alison J AU - Firemark AJ AD - Kaiser Permanente Center for Health Research, Portland, USA. FAU - Haller, Irina V AU - Haller IV AD - Essentia Institute of Rural Health, Duluth, USA. FAU - Justice, Morgan AU - Justice M AD - Kaiser Permanente Washington Health Research Institute, Seattle, USA. FAU - Keefe, Francis J AU - Keefe FJ AD - Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, USA. FAU - McMullen, Carmit K AU - McMullen CK AD - Kaiser Permanente Center for Health Research, Portland, USA. FAU - O'Keeffe-Rosetti, Maureen C AU - O'Keeffe-Rosetti MC AD - Kaiser Permanente Center for Health Research, Portland, USA. FAU - Owen-Smith, Ashli A AU - Owen-Smith AA AD - Georgia State University and Center for Health Research and Evaluation Kaiser Permanente Georgia, Atlanta, USA. FAU - Rini, Christine AU - Rini C AD - Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine and Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, USA. FAU - Schneider, Jennifer L AU - Schneider JL AD - Kaiser Permanente Center for Health Research, Portland, USA. FAU - Von Korff, Michael AU - Von Korff M AD - Kaiser Permanente Washington Health Research Institute, Seattle, USA. FAU - Wandner, Laura D AU - Wandner LD AD - National Institute of Neurological Disorders and Stroke, Bethesda, USA. FAU - DeBar, Lynn L AU - DeBar LL AD - Kaiser Permanente Center for Health Research, Portland, USA. LA - eng SI - ClinicalTrials.gov/NCT04523714 GR - UG3 AG067493/AG/NIA NIH HHS/United States GR - UH3 AG067493/AG/NIA NIH HHS/United States GR - UH3AG067493/AG/NIA NIH HHS/United States PT - Clinical Trial Protocol PT - Journal Article DEP - 20230316 PL - England TA - Trials JT - Trials JID - 101263253 SB - IM MH - Humans MH - Cost-Benefit Analysis MH - *Chronic Pain/diagnosis/therapy MH - Quality of Life MH - *Cognitive Behavioral Therapy/methods MH - *Telemedicine MH - Randomized Controlled Trials as Topic PMC - PMC10018633 OTO - NOTNLM OT - Chronic pain OT - Cognitive behavioral therapy OT - Nonpharmacologic treatment OT - Pragmatic trial OT - Telehealth COIS- The authors declare that they have no competing interests. EDAT- 2023/03/18 06:00 MHDA- 2023/03/21 06:00 PMCR- 2023/03/16 CRDT- 2023/03/17 08:22 PHST- 2023/01/18 00:00 [received] PHST- 2023/02/13 00:00 [accepted] PHST- 2023/03/17 08:22 [entrez] PHST- 2023/03/18 06:00 [pubmed] PHST- 2023/03/21 06:00 [medline] PHST- 2023/03/16 00:00 [pmc-release] AID - 10.1186/s13063-023-07165-8 [pii] AID - 7165 [pii] AID - 10.1186/s13063-023-07165-8 [doi] PST - epublish SO - Trials. 2023 Mar 16;24(1):196. doi: 10.1186/s13063-023-07165-8.