Clinical trial NCT05400720: Peer Support In Dialysis
Official title: Peer Support In Dialysis: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: Satellite Healthcare
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We aim to conduct the study over 6 to 12 months to obtain enough experience to enable feasibility evaluation.

Mentor pool sample size: We anticipate having about 10 patients in the mentors' pool during the study period.

Mentee sample size: We anticipate approaching between 20 to 30 dialysis patients over the study period.

Supporting team: All members of the supporting staff will be invited to participate.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Peer mentoring is an approach used to support patients through their experience. In the End Stage Kidney Disease community many patients find out about their kidney failure without warning. This study is designed to test the feasibility of a structured peer support program, specifically, patient uptake, engagement and patient and staff perspectives.


Eligibility criteria: Mentor Patient Participants Inclusion criteria:

* Patients living with dialysis or kidney transplant, who volunteer to support other patients.
* Mentor participants agree to complete the CMS End Stage Renal Disease Network Peer Mentoring training program (https://www.kidneylearninghub.com/patients-peer-mentoring-program/ ) and follow the guidelines for participation in the program.

Mentor Patient Participants Exclusion criteria:

* Age \<18 years.
* Patient cannot communicate in English.
* Concerns raised by the clinical team that may expose the mentor, mentee, staff, or the program to risks, as identified by the clinical team and discussed with the principal investigator.

Mentee Patient Participants Inclusion criteria:

* All incident (new) dialysis patients or their care partners, within the first three months of dialysis.

OR

* Prevalent dialysis patients or their care partners identified by the clinical team to need peer support.

Mentee Patient Participants Exclusion criteria:

* Age \< 18 years.
* Significant physical or psychological health conditions (including cognitive impairment) that would limit the patient's ability to interact with the mentor, AND care partner not available or reachable to join the program.
* This criteria will be subjectively evaluated by the clinical team.

Clinical and administrative staff supporting the program inclusion criteria

* referring physicians, the medical director of the center, social workers, nurses, patient care technicians (PCT), certified clinical hemodialysis technicians (CCHT), and administrative staff.
* Support staff are those who interact with mentors or mentees as part of their routine work.
* Formally participate in supporting the program by identifying candidates, introducing them to the program, or providing them with support.

Primary outcomes:
measure: Mentor
timeFrame: 6 - 12 months
measure: Mentee
timeFrame: 1 month
Secondary outcomes:
measure: Mentor Perspectives
timeFrame: 6-12month
measure: Mentee Perspectives
timeFrame: 1-4 weeks
measure: Support Staff Perspectives
timeFrame: 3,6,9 and 12 months
measure: Mentor - Mentee Matching
timeFrame: 1 month
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Satellite Healthcare Mountain View
state: California
city: Mountain View
country: United States
facility: WellBound Mountain View
state: California
Study officials:
affiliation: Satellite Healthcare
name: Wael Hussein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bennett PN, St Clair Russell J, Atwal J, Brown L, Schiller B. Patient-to-patient peer mentor support in dialysis: Improving the patient experience. Semin Dial. 2018 Sep;31(5):455-461. doi: 10.1111/sdi.12703. Epub 2018 May 2.
citation: Collins, K. (2016). NKF Peers Mentoring Program. National Kidney Foundation Journal of Nephrology Social Work, 40(2), 25-33.
citation: Fida'Husain, H. K., & Johan, A. (2020). Effects of Peer Support Program on Self-Management in Patients with End-Stage Renal Disease Undergoing Hemodialysis.
citation: Flythe JE, Narendra JH, Yule C, Manivannan S, Murphy S, Lee SD, Strigo TS, Peskoe S, Pendergast JF, Boulware LE, Green JA. Targeting Patient and Health System Barriers To Improve Rates of Hemodialysis Initiation with an Arteriovenous Access. Kidney360. 2021 Feb 26;2(4):708-720. doi: 10.34067/KID.0007812020. eCollection 2021 Apr 29.
citation: Hussein WF, Bennett PN, Schiller B. Innovations to Increase Home Hemodialysis Utilization: The Transitional Care Unit. Adv Chronic Kidney Dis. 2021 Mar;28(2):178-183. doi: 10.1053/j.ackd.2021.02.009.
citation: Orsmond GI, Cohn ES. The Distinctive Features of a Feasibility Study: Objectives and Guiding Questions. OTJR (Thorofare N J). 2015 Jul;35(3):169-77. doi: 10.1177/1539449215578649.
citation: St Clair Russell J, Southerland S, Huff ED, Thomson M, Meyer KB, Lynch JR. A Peer-to-Peer Mentoring Program for In-Center Hemodialysis: A Patient-Centered Quality Improvement Program. Nephrol Nurs J. 2017 Nov-Dec;44(6):481-496.