Peer Mentorship to Improve Outcomes in Patients on Maintenance Hemodialysis

Dialysis Clinical Trial

Official title:

Peer Mentorship to Improve Outcomes in Patients on Maintenance Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595748
• Other study ID #: 2017-8531
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: September 2, 2022

Study information

• Verified date: October 2022
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project tests a peer mentor intervention to improve outcomes in patients with end-stage renal disease (ESRD). The investigators will train peer mentors to deliver social support and to provide information and motivation in order to improve adherence behaviors and self management practices in assigned mentees who are also patients on maintenance hemodialysis. The intervention will consist of a weekly telephone call between mentor and mentee, over a period of 3 months. The study will recruit patients at 7 dialysis facilities (5 in the Bronx, NY and 2 in Nashville, TN) and randomize the patients to the peer mentorship intervention versus usual care. The primary outcome will be the sum of number of emergency department visits and hospitalizations during 3 months of intervention and 9 or 15 months of follow-up observation.

Description:

The overarching goal of this research is to improve End Stage Renal Disease (ESRD) related morbidity and mortality. The medical care of patients with ESRD is highly complex and enormously expensive. Hospitalizations drive up to 40% of the cost for ESRD care. Cardiovascular disease and infections account for over 50% of ESRD-related hospitalizations and contribute to disproportionate mortality in this patient population. This study tests the implementation and impact on hospitalization outcomes of a peer mentor led intervention designed to increase effective self-management in patients receiving hemodialysis, in a real-world setting with high potential for widespread dissemination.

Patients receiving hemodialysis who can self-manage their fluid status effectively, are adherent to their dialysis schedule and to their dietary plan are hospitalized less frequently and have lower morbidity and mortality than patients who are less adherent. However, numerous impediments to dialysis self-management exist including facility, physician and patient-level barriers. The following are patient-level barriers to optimal self-management: 1) poor knowledge about the rationale and metrics of estimated dry weight (EDW), 2) poor knowledge about the metrics of urea clearance and nutritional parameters, 3) under-utilization of available hours for unscheduled dialysis, and 4) low self-efficacy leading to non-adherent schedule and dietary behaviors. Dialysis self-management education is often not successful in improving patients' skills. Educational tools from dialysis facilities and providers are didactic, have medical jargon and lack concrete steps to mitigate patient visits to emergency departments (ED) and subsequent hospitalizations. A culturally sensitive, easy to understand educational program that can increase hemodialysis self-management is critically needed.

Peer mentorship has been used effectively to enhance self-efficacy and self-management behaviors in patients with chronic disease. A single study of peer mentorship for ESRD patients found that peer mentors improved adherence and satisfaction with care among mentees. This strategy has high potential to improve the factors that drive hospitalizations among this high-risk patient group. The goal of this research is to implement a peer mentor training program to increase patients' knowledge about the metrics of hemodialysis, enhance self-management to meet EDW, nutritional and adherence goals, and to enhance self-efficacy in mentees. The peer-mentor intervention is based on the information, motivation, behavior (IMB) model of health behavior and the Chronic Disease Self-Management Program. There will be a didactic component to increase knowledge, and a semi-structured component to increase perception of social support. The investigators will test the feasibility of implementation of this program and the efficacy of it to reduce hospitalizations in a pragmatic trial comparing the peer mentor intervention on mentees to a control group assigned to usual care. The study will also test the intervention at two geographically diverse locations (Bronx, NY and Nashville, TN) to provide evidence of its scalability and acceptability in different patient populations. The study hypothesis states: a structured peer mentor telephone intervention will be more effective than usual care in increasing hemodialysis related knowledge, self-management adherent behaviors and in decreasing ED visits and hospitalizations in ESRD.

Specific Aim 1: To evaluate the effects of a 3-month semi-structured and telephone delivered peer mentor intervention on a composite of ED visits and hospitalizations in 100 high risk patients on hemodialysis randomized to peer mentor intervention as compared to 100 high risk patients on hemodialysis assigned to usual care.

• Secondary outcomes include: 1) dialysis adherence (mean weekly minutes of dialysis), 2) mean monthly inter-dialytic weight gain (IDWG), and 3) mean monthly albumin levels, in the intervention mentees as compared to the controls.

• To compare by group patient dialysis knowledge, self-efficacy and social support.

Specific Aim 2: To test the feasibility of a peer training program focused on teaching self-management skills focused on adherence, dietary and fluid management, in dialysis facilities.

• To test the feasibility of a training program conducted in 7 dialysis facilities the investigators will conduct peer training of 20 recruited mentors (10 in New York and 10 in Nashville), using a semi-structured curriculum taught in 4 sets of 2-hour sessions, over 4 weeks per facility.

• To test the fidelity of the curriculum training the investigators will use attendance records, content analysis, pre- and post-knowledge assessments and course evaluations.

This pragmatic trial will test the effects and implementation of a low cost, educational, telephone-based, peer-mentor intervention to increase self-management behaviors of patients receiving hemodialysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2, 2022
• Est. primary completion date: July 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Age >21 years

One of the following:

• One or more hospitalizations or ED visits in the previous month

• >1 missed treatment or 2 shortened dialysis treatments in the last month

• use of catheter as only access

• >4% intradialytic weight gain

• serum albumin less than 3.5 in the last month

• Incident dialysis patient

• Willing to give informed consent and to be randomized and to allow a telephone intervention with mentors

• Speaks Spanish or English

Exclusion Criteria:

• Intellectual disability/ active mental illness or active substance abuse

• less than a 6- month life expectancy

• not a patient at one of the participating dialysis facilities

Related Conditions & MeSH terms

• Dialysis

Intervention

Behavioral:
• Peer mentorship
Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine/Montefiore Medical Center	Bronx	New York
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To test the attendance of mentor subjects at planned training programs	To test the feasibility of a training program conducted in a central location by the investigators over 4, 2 hours sessions, attendance records will be checked and reported a ratio of those who showed up on time over the total number expected.; The investigators will review attendance records, number of make-up training sessions needed and they will do a qualitative review of formative and summative assessments completed by trainee mentors. The authors will also gather data on trainee participants utilization of snacks, any late arrivals, and impression by trainers of participation.	once at 4 weeks from beginning of training
Other	Acceptability of training program	To test the acceptability of the curriculum training the investigators will record the number of make-up training sessions required in order to complete all training for all mentors.	once at 4 weeks from beginning of training
Other	Efficacy of training program to change the amount of knowledge exhibited by mentors.	To test the efficacy of the training the investigators will do a pre- and post- comparison of scores on the CHeKS mentors at time 0 (during initial assessment) and post-mentor training (at the end of the last training module).	once at 4 weeks from beginning of training
Other	Feasibility of the intervention	The investigators will track the sum of duration of telephone contact made between mentors and their assigned mentees during the 3-month intervention period.	every 3 months (at the end of the mentee intervention interval)
Other	Efficacy of training program to support mentoring skills by the trained mentors	The investigators will track the self-assessment of performance by mentors after each intervention period using the "Self-Assessment by Mentors at Quarterly Intervals" tool developed by the study staff.; The "Self-Assessment by Mentors at Quarterly Intervals" survey is a "free text" questionnaire which will under qualitative review by the investigators.	3 months
Other	Efficacy of training program to change the amount of curriculum-focused knowledge exhibited by mentors	To test the efficacy of the training the investigators will do a pre- and post- score comparison of on the curriculum focused: "CHeKS PLus" at time 0 (during initial assessment) and post-training (at the end of the last training module)	3 months
Other	Acceptability of the intervention	The investigators will also do a qualitative analysis of monthly recorded conversations (recorded by mentors) on a monthly basis for each mentee/mentor conversation.	3 months
Other	Efficacy of training program to help mentors assist intervention mentees with coping skills	Investigators will the Health Care Climate Questionnaire (HCCQ)(https://selfdeterminationtheory.org/questionnaires) to measure the performance of mentors from the perspective of their assigned mentees.; The HCCQ long form scale is from 1-7 with 1 indicating "strongly disagree" and 7 indicating "strongly agree".	3 months
Other	Efficacy of training program to help mentors perform well in their tasks	"Checklist for mentee assessment of mentors"(developed by study staff after adaptation from "Peer Up" program) to measure the performance of mentors from the perspective of their assigned mentees.; "Checklist for mentee assessment of mentors" scale of 1-7 with 1 indicating "strongly disagree" and 7 indicating "strongly agree"	3 months
Primary	Rate of ED visits and Hospitalizations	Composite outcome	12 or 18 months
Secondary	Rate of missed or cut dialysis treatments	Mean weekly missed minutes of dialysis treatments by intervention mentees as compared to control mentees during the intervention and follow-up periods	12 or 18 months
Secondary	Mean monthly interdialytic weight gain in intervention mentees as compared to control mentees during the intervention and follow-up periods	Mean monthly amount of changed fluid weight in-between dialysis treatments by intervention mentees as compared to control mentees during intervention and follow-up periods.	12 or 18 months
Secondary	Mean monthly albumin levels	The monthly albumin levels in intervention mentees as compared to control mentees during intervention and follow-up periods.	12 or 18 months
Secondary	Efficacy of intervention to change dialysis knowledge in mentees	The scores on Chronic Hemodialysis Knowledge Survey (CHeKS) and knowledge assessments in mentees assigned to intervention as compared mentees assigned to control.; CHeKS: percent correct out of a total of 23 questions	3 months (immediately post intervention) and 12 or 18 months
Secondary	Efficacy of intervention to change curriculum specific dialysis knowledge in mentees	The scores on Chronic Hemodialysis Knowledge Survey (CHeKS) plus knowledge assessments in mentees assigned to intervention as compared mentees assigned to control.; CHeKS Plus: percent correct out of a total of 8 questions	3 months (immediately post intervention) and 12 or 18 months
Secondary	Efficacy of intervention to change quality of life in intervention mentees as compared to control mentees	The scores on SF36 Health Survey(36 item short form health survey by RAND) in mentees assigned to intervention as compared to control mentees.; For the SF-36 Health Survey, the scoring varies depending on question with some questions having a scale from 1-6 and others having a scale from 1-3. All items are scored so a high score defines a more favorable health state.(https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/scoring.html)	At 3 months (immeditely post intervention) and 12 or 18 months.
Secondary	Efficacy of intervention to change self-efficacy by intervention mentees as compared to usual care mentees	Scores on "Perceived Dialysis Self Management Scale(PKDSMS)" and Kidney "Disease Self Management Behavioral Index(KDBI)" in mentees assigned to intervention as compared to mentees assigned to control.; PKDSMS: scores on a scale from 1 to 5 for each of 8 items, with 1 representing "strongly agree" to 5 representing "strongly disagree.; KDBI: scores on a scale of 1 to 4 with 1 representing "not at all" to 4 representing "all the time"	At 3 months and 12 or 18 months.
Secondary	Efficacy of intervention to change curriculum taught dialysis knowledge in intervention mentees as compared to usual care mentees	The scores on the Chronic Hemodialysis Knowledge Survey-Plus (CHeKS Plus) (developed by investigators) assessment in mentees assigned to intervention as compared mentees assigned to control.; CHeKS Plus: percent correct out of a total of 8 questions	3 months (immediately post intervention) and 12 or 18 months
Secondary	Efficacy of intervention to change coping ability in intervention mentees as compared to usual care mentees	The score on Brief KCOPE in mentees assigned to intervention as compared to control mentees. For the brief KCOPE (developed by C.S. Carver (1997)): Scale 1-4 with 1 indication not at all and 4 indicating " doing it a lot".	At 3 months and 12 or 18 months.
Secondary	Efficacy of intervention to change depression scores in intervention mentees as compared to usual care mentees	The scores on CESD-10 (Center for Epidemiologic Studies Depression Scale Revised)in mentees assigned to intervention as compared to control mentees. For the CESD-R10 questions have a scale of 1-4 with 1 indicating rarely or none of the time and 4 indicating all of the time. (https://cesd-r.com/)	At 3 months and 12 or 18 months.
Secondary	Efficacy of intervention to change perception of social support by intervention mentees as compared to usual care mentees	Scores on the "Multi-dimensional Scare of Perceived Social Support(MSPSS)" and "Dialysis Specific Social Support Survey"(developed by PI's) in mentees assigned to intervention as compared to mentees assigned to control. MSPSS: scores on a scale of 1-7 with 1 representing "very strongly disagree" and 7 representing "very strongly agree".; Dialysis specific social support survey: scores on a scale from 1-5 with 1 indicating "none of the time" and 5 indication " all of the time".	At 3 months and 12 or 18 months.