Clinical trial NCT03595748: Peer Mentorship to Improve Outcomes in Patients on Maintenance Hemodialysis
Official title: Peer Mentorship to Improve Outcomes in Patients on Maintenance Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dialysis
Keywords: Hospitalizations
Dialysis patients
Peer mentorship
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-07-23
Enrollment: 199
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: ED Visits and Hospitalizations
timeFrame: During 3 months of intervention and up to 15 months of follow up (up to 18 months observation total)
Secondary outcomes:
measure: Change From Baseline to End of Follow-up in Average Number of Monthly Missed Dialysis Minutes
timeFrame: up to 18 months
measure: Change From Baseline to End of Follow-up in Average Monthly Interdialytic Weight Gain in Patient Participants.
timeFrame: up to 18 months
measure: Change From Baseline in Average Monthly Serum Albumin Levels
timeFrame: up to 18 months
measure: Efficacy of Intervention to Change Dialysis Knowledge in Mentees
timeFrame: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.
measure: Efficacy of Intervention to Change Curriculum Specific Dialysis Knowledge in Patient Participants
timeFrame: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.
measure: Change From Baseline in General Health (GH) Perceptions Domain of V 2.0 of the RAND SF-36 Quality of Life (QOL) in Patient Participants Assigned to Peer-mentor Intervention as Compared to Patient Participants Assigned to Usual Care
timeFrame: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.
measure: Change From Baseline in Physical Functioning (PF) Domain of V 2.0 of the RAND SF-36 Quality of Life (QOL) in Patient Participants Assigned to Peer-mentor Intervention as Compared to Patient Participants Assigned to Usual Care
timeFrame: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.
measure: Change From Baseline in Social Functioning (SF) Domain of V 2.0 of the RAND SF-36 Quality of Life (QOL) in Patient Participants Assigned to Peer-mentor Intervention as Compared to Patient Participants Assigned to Usual Care
timeFrame: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.
measure: Effectiveness of Intervention to Change From Baseline to End of Follow-up, Scores on the Perceived Knowledge/Dialysis Self-Management Scale
timeFrame: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.
measure: Efficacy of Intervention to Change From Baseline to End of Follow up, Scores on the CESD-R Scale in Participants Assigned to Peer Mentor Intervention as Compared to Participants Assigned to Usual Care
timeFrame: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.
measure: Efficacy of Intervention to Change From Baseline to End of Follow up, Perception of Social Support by Intervention Mentees as Compared to Usual Care Mentees
timeFrame: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.
measure: Efficacy of Intervention to Change From Baseline Kidney Disease Self-management Behaviors in Intervention Mentees as Compared to Usual Care Mentees
timeFrame: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time
measure: Efficacy of Intervention to Change From Baseline Kidney Disease Coping Ability in Intervention Mentees as Compared to Usual Care Mentees
timeFrame: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.
Other outcomes:
measure: Efficacy of Intervention to Change From Baseline to End of Follow up, Perception of Dialysis Specific Social Support by Intervention Mentees as Compared to Usual Care Mentees
timeFrame: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine/Montefiore Medical Center
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
citation: Golestaneh L, Melamed M, Kim RS, St Clair Russell J, Heisler M, Villalba L, Perry T, Cavanaugh KL. Peer mentorship to improve outcomes in patients on hemodialysis (PEER-HD): a randomized controlled trial protocol. BMC Nephrol. 2022 Mar 5;23(1):92. doi: 10.1186/s12882-022-02701-1.