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      Peer mentorship to improve outcomes in patients on hemodialysis (PEER-HD): a randomized controlled trial protocol

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          Abstract

          Background

          Patients receiving in-center hemodialysis experience disproportionate morbidity and incur high healthcare-related costs. Much of this cost stems from potentially avoidable hospitalizations. Peer mentorship has been used effectively to improve outcomes for patients with complex chronic diseases. We propose testing the efficacy of peer mentorship on hospitalization rates among patients receiving hemodialysis.

          Methods

          This is a multicenter parallel group randomized controlled pragmatic trial of patients treated at hemodialysis facilities in Bronx, NY and Nashville, TN. The study has two phases. Phase 1 will enroll and train 16 hemodialysis patients (10 in Bronx, NY and 6 in Nashville TN) to be mentors using a program focused on enhancing self-efficacy, dialysis self-management and autonomy-supportive communication skills. Phase 2 will enroll 200 high risk adults receiving hemodialysis (140 in Bronx, NY and 60 in Nashville, TN), half of whom will be randomized to intervention and half to usual care. Intervention participants are assigned to weekly telephone calls with trained mentors (see Phase 1) for a 3-month period.

          The primary outcome of Phase 1 will be engagement of mentors with training and change in knowledge scores and autonomy skills from pre- to post-training. The primary outcome of Phase 2 will be the composite count of ED visits and hospitalizations at the end of study follow-up in patient participants assigned to intervention as compared to those assigned to usual care. Secondary outcomes for Phase 2 include the change over the trial period in validated survey scores measuring perception of social support and self-efficacy, and dialysis adherence metrics, among intervention participants as compared to usual care participants.

          Discussion

          The PEER-HD study will test the feasibility and efficacy of a pragmatic peer-mentorship program designed for patients receiving hemodialysis on ED visit and hospitalization rates. If effective, peer-mentorship holds promise as a scalable patient-centered intervention to decrease hospital resource utilization, and by extension morbidity and cost, for patients receiving maintenance in-center hemodialysis.

          Trial registration

          Clinicaltrials.gov identifier: NCT03595748; 7/23/2018.

          Trial sponsor

          National Institutes of Diabetes, Digestive and Kidney Disease (NIDDK) 5R18DK118471.

          Funding

          Funding for this study was provided by the National Institutes of Diabetes, Digestive and Kidney Disease: R18DK118471.

          Study status

          This is an ongoing study and not complete. We are still collecting data for observational follow-up on participants.

          Related articles

          No related articles for this study have been submitted to any journal.

          The study sponsor and funders had no role in the design, analysis or interpretation of this data. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12882-022-02701-1.

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          Most cited references56

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          SPIRIT 2013 statement: defining standard protocol items for clinical trials.

          The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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            The Multidimensional Scale of Perceived Social Support

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              You want to measure coping but your protocol's too long: consider the brief COPE.

              Studies of coping in applied settings often confront the need to minimize time demands on participants. The problem of participant response burden is exacerbated further by the fact that these studies typically are designed to test multiple hypotheses with the same sample, a strategy that entails the use of many time-consuming measures. Such research would benefit from a brief measure of coping assessing several responses known to be relevant to effective and ineffective coping. This article presents such a brief form of a previously published measure called the COPE inventory (Carver, Scheier, & Weintraub, 1989), which has proven to be useful in health-related research. The Brief COPE omits two scales of the full COPE, reduces others to two items per scale, and adds one scale. Psychometric properties of the Brief COPE are reported, derived from a sample of adults participating in a study of the process of recovery after Hurricane Andrew.
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                Author and article information

                Contributors
                lgolesta@montefiore.org
                Journal
                BMC Nephrol
                BMC Nephrol
                BMC Nephrology
                BioMed Central (London )
                1471-2369
                5 March 2022
                5 March 2022
                2022
                : 23
                : 92
                Affiliations
                [1 ]GRID grid.251993.5, ISNI 0000000121791997, Department of Medicine, Division of Nephrology, , Albert Einstein College of Medicine/ Montefiore Medical Center, ; Bronx, NY 10467 USA
                [2 ]GRID grid.251993.5, ISNI 0000000121791997, Department of Epidemiology and Population Health, , Albert Einstein College of Medicine, ; Bronx, NY 10461 USA
                [3 ]GRID grid.26009.3d, ISNI 0000 0004 1936 7961, Department of Medicine, Division of General Internal Medicine, , Duke University, ; Durham, NC 27701 USA
                [4 ]GRID grid.214458.e, ISNI 0000000086837370, Department of Medicine, Institute for Healthcare Policy and Innovation, , University of Michigan, ; Ann Arbor, MI 48109 USA
                [5 ]GRID grid.412807.8, ISNI 0000 0004 1936 9916, Department of Nephrology and Hypertension, , Vanderbilt University Medical Center, ; Nashville, TN 37232 USA
                [6 ]GRID grid.412807.8, ISNI 0000 0004 1936 9916, Vanderbilt Center for Effective Health Communication, , Vanderbilt University Medical Center, ; Nashville, TN 37232 USA
                Author information
                http://orcid.org/0000-0003-1848-582X
                Article
                2701
                10.1186/s12882-022-02701-1
                8897762
                35247960
                1f18f24a-fc52-42d0-b8d8-f3a3ec69d74c
                © The Author(s) 2022

                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
                : 20 January 2022
                : 12 February 2022
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000062, National Institute of Diabetes and Digestive and Kidney Diseases;
                Award ID: 5R18DK118471
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2022

                Nephrology
                hemodialysis patients,peer mentorship,hospitalization,self-management,self-efficacy,clinical trial

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