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      COMMunity of Practice And Safety Support for Navigating Pain (COMPASS-NP): study protocol for a randomized controlled trial with home care workers

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          Abstract

          Background

          Chronic pain is a prevalent and costly problem that often has occupational origins. Home care workers (HCWs) are at high risk for work-related injuries, pain, and disability. Current treatments for chronic pain emphasize medications, which are an inadequate stand-alone treatment and can produce significant adverse effects.

          Methods

          In this translational study, we will adapt an established work-based injury prevention and health promotion program (COMmunity of Practice And Safety Support: COMPASS) to address the needs of HCWs experiencing chronic pain. COMPASS employs peer-led, scripted group meetings that include educational content, activities, goal setting, and structured social support. The translated intervention, named COMPASS for Navigating Pain (COMPASS-NP), will be delivered in an online group format. Safety protections will be strengthened through an ergonomic self-assessment and vouchers for purchasing ergonomic tools. Educational content will integrate a self-management approach to chronic pain using proven cognitive-behavioral therapy (CBT) principles. We will use a mixed-methods hybrid type 2 evaluation approach to assess effectiveness and implementation. A cluster-randomized waitlist control design will involve 14 groups of 10 HCWs ( n = 140) recruited from Washington, Oregon, and Idaho. Half of the groups will be randomly selected to complete the intervention during the first 10 weeks, while the waitlist groups serve as controls. During weeks 10–20, the waitlist groups will complete the intervention while the original intervention groups complete a follow-up period without further intervention. Our primary hypothesis is that COMPASS-NP will reduce pain interference with work and life. Secondary outcomes include injury and pain prevention behaviors, pain severity, changes in medication use, risk for opioid misuse, well-being, physical activity, and sleep. Qualitative data, including phone interviews with group facilitators and organizational partners, will evaluate the implementation and guide dissemination.

          Discussion

          The results will advance the use and knowledge of secondary prevention interventions such as ergonomic tools and cognitive behavior therapy, to reduce injury, pain, and disability and to encourage appropriate uses of analgesic medications among HCWs.

          Trial registration

          ClinicalTrials.gov NCT05492903. Registered on 08 August 2022

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s13063-023-07149-8.

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              SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

              High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
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                Author and article information

                Contributors
                jhess@uoregon.edu
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                10 April 2023
                10 April 2023
                2023
                : 24
                : 264
                Affiliations
                [1 ]GRID grid.5288.7, ISNI 0000 0000 9758 5690, Oregon Institute of Occupational Health Sciences, Oregon Health & Science University, ; 3222 SW Research Drive, Portland, OR 97239-3098 USA
                [2 ]GRID grid.5288.7, ISNI 0000 0000 9758 5690, Oregon Health & Science University-Portland State University School of Public Health, VPT, ; 3181 SW Sam Jackson Park Road, Portland, OR 97239 USA
                [3 ]GRID grid.262075.4, ISNI 0000 0001 1087 1481, Department of Psychology, , Portland State University, ; P.O. Box 751, Portland, OR 97207-0751 USA
                [4 ]GRID grid.170202.6, ISNI 0000 0004 1936 8008, Labor Education & Research Center, , University of Oregon, ; 1675 Agate Street, Eugene, OR 97403-1289 USA
                [5 ]GRID grid.34477.33, ISNI 0000000122986657, Department of Anesthesiology & Pain Medicine, , University of Washington, BB 1425 HSC, ; Box 356540, 1949 NE Pacific Street, Seattle, WA 98195-6540 USA
                [6 ]GRID grid.5288.7, ISNI 0000 0000 9758 5690, Family Medicine, School of Medicine, , Oregon Health & Science University, FM, ; 3181 SW Sam Jackson Park, Portland, OR 97239 USA
                Author information
                http://orcid.org/0000-0002-3114-5478
                Article
                7149
                10.1186/s13063-023-07149-8
                10088173
                37038235
                0d2a1179-bed0-460b-a5b9-9d4b57f457da
                © The Author(s) 2023

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 5 January 2023
                : 8 February 2023
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000125, National Institute for Occupational Safety and Health;
                Award ID: U19OH010154
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2023

                Medicine
                home care workers,total worker health,pain management,ergonomics,cognitive-behavioral therapy,injury prevention,self-management

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