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

Ladan Golestaneh, Michal Melamed, Ryung S Kim, Jennifer St Clair Russell, Michele Heisler, Lisandra Villalba, Taylor Perry, Kerri L Cavanaugh, Ladan Golestaneh, Michal Melamed, Ryung S Kim, Jennifer St Clair Russell, Michele Heisler, Lisandra Villalba, Taylor Perry, Kerri L Cavanaugh

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.

Keywords: Clinical trial; Hemodialysis patients; Hospitalization; Peer mentorship; Self-efficacy; Self-management.

Conflict of interest statement

Dr. Golestaneh receives salary support from the Montefiore Care Management Organization and DaVita for her roles as consultant and medical director of Williamsbridge Home dialysis center, respectively.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Trial Design-Phase 2 with Patient Participants
Fig. 2
Fig. 2
Training Program for Mentor Participants

References

    1. United States Renal Data System-Annual Report. 2018:. accessed 20 29 May 2019.
    1. Plantinga LC, Fink NE, Harrington-Levey R, et al. Association of social support with outcomes in incident dialysis patients. Clin J Am Soc Nephrol. 2010;5(8):1480–1488.
    1. Erickson KF, Winkelmayer WC, Chertow GM, Bhattacharya J. Hemodialysis hospitalizations and readmissions: the effects of payment reform. Am J Kidney Dis. 2017;69(2):237–246.
    1. Saran R, Robinson B, Abbott KC, et al. US renal data system 2017 annual data report: epidemiology of kidney disease in the United States. Am J Kidney Dis. 2018;71(3S1):A7.
    1. Saran R, Bragg-Gresham JL, Rayner HC, et al. Nonadherence in hemodialysis: associations with mortality, hospitalization, and practice patterns in the DOPPS. Kidney Int. 2003;64(1):254–262.
    1. Kimmel PL, Peterson RA, Weihs KL, et al. Behavioral compliance with dialysis prescription in hemodialysis patients. J Am Soc Nephrol. 1995;5(10):1826–1834.
    1. Kimmel PL, Peterson RA, Weihs KL, et al. Psychosocial factors, behavioral compliance and survival in urban hemodialysis patients. Kidney Int. 1998;54(1):245–254.
    1. Golestaneh L. Decreasing hospitalizations in patients on hemodialysis: time for a paradigm shift. Semin Dial. 2018;31(3):278–288.
    1. Golestaneh L, Bellin E, Neugarten J, Lo Y. Avoidable visits to the emergency department(ED) and their association with sex, age and race in a cohort of low socio-economic status patients on hemodialysis in the Bronx. PLoS One. 2018;13(8):e0202697.
    1. Arora P, Kausz AT, Obrador GT, et al. Hospital utilization among chronic dialysis patients. J Am Soc Nephrol. 2000;11(4):740–746.
    1. Ronksley PE, Hemmelgarn BR, Manns BJ, et al. Potentially preventable hospitalization among patients with CKD and high inpatient use. Clin J Am Soc Nephrol. 2016;11(11):2022–2031.
    1. Tuot DS, Cavanaugh KL. Evaluating the merits of CKD patient educational materials: readability is necessary but not sufficient. Am J Kidney Dis. 2015;65(6):814–816.
    1. Tuot DS, Davis E, Velasquez A, Banerjee T, Powe NR. Assessment of printed patient-educational materials for chronic kidney disease. Am J Nephrol. 2013;38(3):184–194.
    1. Heisler M, Vijan S, Makki F, Piette JD. Diabetes control with reciprocal peer support versus nurse care management: a randomized trial. Ann Intern Med. 2010;153(8):507–515.
    1. St Clair Russell, Jennifer, Shiree Southerland, Edwin D. Huff, Maria Thomson, Klemens B. Meyer, Janet R. Lynch. “A Peer-to-Peer Mentoring Program for In-Center Hemodialysis: A Patient-Centered Quality Improvement Program.” Nephrol Nurs J. 2017;44(6):481–96.
    1. Pennsylvania TKFoC. Patient and Family Partner Program. ; downloaded August 11 2020.
    1. (NPFE-LAN) NPaFELaAN. ; downloaded August 11, 2020.
    1. Foundation NK. PEERs. ; Downloaded August 11, 2020.
    1. Perry E, Swartz J, Brown S, Smith D, Kelly G, Swartz R. Peer mentoring: a culturally sensitive approach to end-of-life planning for long-term dialysis patients. Am J Kidney Dis. 2005;46(1):111–119.
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207.
    1. Fisher W, Fisher J, Harman J. The Information-Motivation-Behavioral Skills Model: A General Social Psychological Approach to Understanding and Promoting Health Behavior. 2009. pp. 82–106.
    1. Tang TS, Funnell M, Sinco B, et al. Comparative effectiveness of peer leaders and community health workers in diabetes self-management support: results of a randomized controlled trial. Diabetes Care. 2014;37(6):1525–1534.
    1. Heisler M. Different models to mobilize peer support to improve diabetes self-management and clinical outcomes: evidence, logistics, evaluation considerations and needs for future research. Fam Pract. 2010;27(Suppl 1):i23–i32.
    1. Piette JD, Resnicow K, Choi H, Heisler M. A diabetes peer support intervention that improved glycemic control: mediators and moderators of intervention effectiveness. Chronic Illn. 2013;9(4):258–267.
    1. Mathews P. Sample Size Calculations: Practical Methods for Engineers and Scientists. 2010.
    1. Cavanaugh KL, Wingard RL, Hakim RM, Elasy TA, Ikizler TA. Patient dialysis knowledge is associated with permanent arteriovenous access use in chronic hemodialysis. Clin J Am Soc Nephrol. 2009;4(5):950–956.
    1. Wild MG, Wallston KA, Green JA, et al. The perceived medical condition self-management scale can be applied to patients with chronic kidney disease. Kidney Int. 2017;92(4):972–978.
    1. Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92–100.
    1. Zimet GD, Dahlem NW, Zimet SG, Farley GK. The multidimensional scale of perceived social support. J Pers Assess. 1988;52(1):30–41.
    1. Revised TCfESDS . CESD-R English. 2004.
    1. Makoul G. Communication Assessment Tool. 2004.
    1. Corporation R. 36-item short form survey (SF-36). RAND healthcare. RAND MEDICAL OUTCOMES STUDY Web site. . Accessed 15 Dec 2021.
    1. Theory CfS-D. The Health Care Climate Questionnaire (HCCQ). PAS-Health Care Climate Web site. . Accessed 15th Dec 2021.
    1. Pinheiro JCaB, D.M. Mixed-effects models in S and S-Plus. In: Springer; 2000.
    1. Schoonover KL, Hickson LJ, Norby SM, et al. Risk factors for hospitalization among older, incident haemodialysis patients. Nephrology (Carlton) 2013;18(11):712–717.
    1. Collins AJ, Foley RN, Chavers B, et al. US Renal Data System 2013 Annual Data Report. Am J Kidney Dis. 2014;63(1 Suppl):A7.
    1. United States Renal Data System. 2020 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. Bethesda: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2020.
    1. Flythe JE, Katsanos SL, Hu Y, Kshirsagar AV, Falk RJ, Moore CR. Predictors of 30-day hospital readmission among maintenance hemodialysis patients: a Hospital’s perspective. Clin J Am Soc Nephrol. 2016;11(6):1005–1014.
    1. USRDS. Chapter 9: Cardiovascular Disease in Patients With ESRD. 2016;2(9).
    1. Hecking M, Rayner H, Wabel P. What are the consequences of volume expansion in chronic Dialysis patients?: defining and measuring fluid overload in hemodialysis patients. Semin Dial. 2015;28(3):242–247.
    1. Assimon MM, Nguyen T, Katsanos SL, Brunelli SM, Flythe JE. Identification of volume overload hospitalizations among hemodialysis patients using administrative claims: a validation study. BMC Nephrol. 2016;17(1):173.
    1. Flythe JE, Curhan GC, Brunelli SM. Shorter length dialysis sessions are associated with increased mortality, independent of body weight. Kidney Int. 2013;83(1):104–113.
    1. Leggat JE., Jr Adherence with dialysis: a focus on mortality risk. Semin Dial. 2005;18(2):137–141.
    1. Leggat JE, Jr, Orzol SM, Hulbert-Shearon TE, et al. Noncompliance in hemodialysis: predictors and survival analysis. Am J Kidney Dis. 1998;32(1):139–145.
    1. Held PJ, Port FK, Wolfe RA, et al. The dose of hemodialysis and patient mortality. Kidney Int. 1996;50(2):550–556.
    1. Qureshi AR, Alvestrand A, Danielsson A, et al. Factors predicting malnutrition in hemodialysis patients: a cross-sectional study. Kidney Int. 1998;53(3):773–782.
    1. Colman S, Bross R, Benner D, et al. The nutritional and inflammatory evaluation in Dialysis patients (NIED) study: overview of the NIED study and the role of dietitians. J Ren Nutr. 2005;15(2):231–243.
    1. Pupim LB, Evanson JA, Hakim RM, Ikizler TA. The extent of uremic malnutrition at the time of initiation of maintenance hemodialysis is associated with subsequent hospitalization. J Ren Nutr. 2003;13(4):259–266.
    1. Steiber AL, Handu DJ, Cataline DR, Deighton TR, Weatherspoon LJ. The impact of nutrition intervention on a reliable morbidity and mortality indicator: the hemodialysis-prognostic nutrition index. J Ren Nutr. 2003;13(3):186–190.
    1. Kimmel PL. Psychosocial factors in adult end-stage renal disease patients treated with hemodialysis: correlates and outcomes. Am J Kidney Dis. 2000;35(4 Suppl 1):S132–S140.
    1. Flythe JE, Mangione TW, Brunelli SM, Curhan GC. Patient-stated preferences regarding volume-related risk mitigation strategies for hemodialysis. Clin J Am Soc Nephrol. 2014;9(8):1418–1425.
    1. Denhaerynck K, Manhaeve D, Dobbels F, Garzoni D, Nolte C, De Geest S. Prevalence and consequences of nonadherence to hemodialysis regimens. Am J Crit Care. 2007;16(3):222–235.
    1. Curtin RB, Mapes D, Schatell D, Burrows-Hudson S. Self-management in patients with end stage renal disease: exploring domains and dimensions. Nephrol Nurs J. 2005;32(4):389–395.
    1. Chenitz KB, Fernando M, Shea JA. In-center hemodialysis attendance: patient perceptions of risks, barriers, and recommendations. Hemodial Int. 2014;18(2):364–373.
    1. Latham CE. Is there data to support the concept that educated, empowered patients have better outcomes? J Am Soc Nephrol. 1998;9(12 Suppl):S141–S144.
    1. Li H, Jiang YF, Lin CC. Factors associated with self-management by people undergoing hemodialysis: a descriptive study. Int J Nurs Stud. 2014;51(2):208–216.
    1. Cabrera VJ, Hansson J, Kliger AS, Finkelstein FO. Symptom Management of the Patient with CKD: the role of Dialysis. Clin J Am Soc Nephrol. 2017;12(4):687–693.
    1. Cabrera C, Brunelli SM, Rosenbaum D, et al. A retrospective, longitudinal study estimating the association between interdialytic weight gain and cardiovascular events and death in hemodialysis patients. BMC Nephrol. 2015;16:113.
    1. Sharp J, Wild MR, Gumley AI. A systematic review of psychological interventions for the treatment of nonadherence to fluid-intake restrictions in people receiving hemodialysis. Am J Kidney Dis. 2005;45(1):15–27.
    1. Russell J. Peer mentoring reduces missed Dialysis treatments. NN&I Staff.
    1. National Kidney F . Benefits of Peer Support. 2017.
    1. Scheel A, Beaton A, Okello E, Longenecker CT, Otim IO, Lwabi P, Sable C, Webel AR, Aliku T. The impact of a peer support group for children with rheumatic heart disease in Uganda. Patient Educ Couns. 2018;101(1):119–123. 10.1016/j.pec.2017.07.006.
    1. Webel AR, Okonsky J, Trompeta J, Holzemer WL. A systematic review of the effectiveness of peer-based interventions on health-related behaviors in adults. Am J Public Health. 2010;100(2):247–253.
    1. Dennis CL, Hodnett E, Kenton L, et al. Effect of peer support on prevention of postnatal depression among high risk women: multisite randomised controlled trial. BMJ. 2009;338:a3064.
    1. Batchelder AW, Cockerham-Colas L, Peyser D, Reynoso SP, Soloway I, Litwin AH. Perceived benefits of the hepatitis C peer educators: a qualitative investigation. Harm Reduct J. 2017;14(1):67.
    1. Brownson CA, Heisler M. The role of peer support in diabetes care and self-management. Patient. 2009;2(1):5–17.
    1. Fisher EB, Ayala GX, Ibarra L, et al. Contributions of peer support to health, health care, and prevention: papers from Peers for Progress. Ann Fam Med. 2015;13(Suppl 1):S2–S8.
    1. Newman BM, Lohman BJ, Newman PR. Peer group membership and a sense of belonging: their relationship to adolescent behavior problems. Adolescence. 2007;42(166):241–263.

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