Latinos with End-Stage Renal Disease (ESRD) represent 17% of the US adult ESRD community and suffer a disproportionate burden of social challenges that impacts their well-being. With support from the Amos award from the Robert Wood Johnson Foundation (RWJF), the investigators assessed the feasibility of a 1-arm intervention of a 5-visit lay Peer Navigator intervention to support Latino ESRD patients with social challenges and adherence (using motivational interviewing \& patient activation). This trial will build on the Amos work as a small Randomized Controlled Trial (RCT). The overall aims of this proposal are to: 1) engage key operational and clinical stakeholders early-on to develop a Peer Navigator-intervention; 2) conduct a pilot RCT of the peer navigator intervention versus standard care to test feasibility and acceptability; and 3) assess the efficacy of the intervention on interdialytic weight gain (primary outcome) as well as health-related quality of life, patient activation, and hemodialysis adherence (secondary outcomes).
The goal of this project is to assess the feasibility and acceptability of a pilot RCT of a culturally tailored peer-navigator (PN) intervention to improve patient-centered and clinical outcomes for Latino patients with end-stage kidney disease (ESKD). We will compare a culturally tailored intervention that includes a PN to control (standard care). In the culturally tailored intervention, the bilingual PN will provide support with social challenges during 5 visits. We will assess the feasibility of (1) referral, (2) recruitment, (3) retention, (4) intervention implementation, and (5) data collection. We will also assess various outcomes including inter-dialytic weight gain and other adherence and patient-centered outcomes. Specific Aim 1: Conduct a pilot RCT of the peer navigator intervention to assess feasibility, acceptability, as well as outcomes of the proposed peer navigator intervention. Hypothesis 1: A culturally tailored intervention that consists of a bilingual/culture-concordant peer navigator that provides support with social challenges and support with adherence using motivational interviewing for Latino end-stage kidney disease (ESKD) patients, is feasible and acceptable.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
139
The intervention is aimed to provide support with social challenges and adherence. The peer navigator will meet with patients to provide support with social challenges and use motivational interviewing to provide support with adherence.
Control patients will have met the same inclusion and exclusion criteria as intervention patients.
Fresenius Medical Care Rocky Mountain Dialysis
Denver, Colorado, United States
Interdialytic weight gain
Inter-dialytic weight gain will be calculated as the monthly average of the difference between the pre-dialysis weight and the weight at the end of the previous dialysis session, divided by determined dry weight, expressed as a percentage of change in weight per day (%Δkg per day).
Time frame: Data collection 3 months prior to consent (collected retrospectively) and 6 months following study completion
Kidney Dialysis Quality of Life Short Form - 36 questions
KDQOL(Kidney Disease Quality Of Life) - Short Form 36 (SF-36). The KDQOL Short Form-36 (KDQOL-SF-36), a 36 item survey with five subscales (Physical Component Summary, Mental Component Summary, Burden of Kidney Disease subscale, Symptoms and Problems subscale, and Effects of Kidney Disease on Daily Life). The KDQOL-SF-36 are scored linearly (with higher score indicating better quality of life) on a range of 0-100 using the developer-recommended scoring (available at https://www.rand.org/health-care/surveys\_tools/kdqol.html).
Time frame: Change from baseline health-related quality of life up to 24 months
Hemodialysis shortening
Hemodialysis shortening: Defined as shortening the hemodialysis session by greater than or equal to 10 minutes.
Time frame: This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion.
Hemodialysis adherence
Hemodialysis adherence defined defined as the proportion of monthly scheduled sessions missed (other than for vacation or hospitalization)
Time frame: This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion.
Albumin
Albumin
Time frame: This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion.
Potassium
Potassium
Time frame: This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion.
Phosphorus
Phosphorus
Time frame: Assessed 3 months prior to enrollment, monitored monthly during intervention, and followed for 3 months after intervention
Social determinants of health composite survey
Several questions from various previously validated surveys that assess social determinants of health.
Time frame: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
Self-Efficacy
Patient-Reported Outcomes Measurement Information System (PROMIS) measure to assess self-efficacy
Time frame: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
Patient Activation Measure
Patient Activation Measure has 13 questions, each item is rated on a four-point scale (1 strong disagree to 4 strong agree, with additional 'non-applicable.' Level 1 (less than 47) indicates 'not believing activation is important.' Level 2 (47 to 55.1) indicates 'a lack of knowledge and confidence to take action.' Level 3 (55.2 to 67) indicates 'beginning to take action.' Level 4 (greater than 67) indicates 'taking action.'
Time frame: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
Emergency Department visits and hospitalizations
Number of Emergency Department (ED) visits and hospitalizations, length of stay
Time frame: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
Social Isolation
PROMIS measure
Time frame: Assessed twice: At time of enrollment and at time of study completion (up to 1 year)
Qualitative interviews to assess acceptability
10 participants will be interviewed using semi-structured approach. The results will be a thematic analysis (that ties in the themes and subthemes with illustrative quotes).
Time frame: Assessed twice: At time of enrollment and at time of study completion (up to 1 year)
Kidney transplantation Questions derived/tailored from two previously published questionnaires.
Kidney transplantation interest in pursuing, placement on list, receipt of transplantation. Questions were derived and tailored from two studies: Ayanian NEJM 1999;341:1661-9 \& Bouleware American J of Transplantation 2005;5:1503-1512. Some are yes/no questions and others are on a Likert Scale.
Time frame: Assessed twice: At time of enrollment and at time of study completion (up to 1 year)
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