Dialysis CHW Pilot

Study Overview
=================
Brief Summary
-----------------
To determine the acceptability and feasibility of a community health worker intervention that assists dialysis patients with low socioeconomic status navigate community resources to address health-related social needs. Findings will be used for a future randomized trial that determines the efficacy of the CHW intervention on mental health, quality of life, addressing social needs, and clinical outcomes. This study is intended to be generalizable in all dialysis centers.

Detailed Description
-----------------
The research team will conduct a single-arm 6-month pilot study testing the feasibility of implementing a tailored, health-related social needs intervention among dialysis patients. The research teamwill recruit 30 dialysis (all modalities) patients aged≥18 years with low socioeconomic status to participate in a CHW intervention. The CHW intervention will be modeled after IMPaCT (Individualized Management for Patient-Centered Targets), a 6-month CHW intervention that addresses upstream socioeconomic and behavioral barriers to treatment for individuals with chronic diseases, which has been adapted to numerous populations and shown to improve care and reduce hospitalizations. The CHW will identify health-related social needs and help participants navigate community resources to meet needs. All participants will receive the intervention. All participants will also participate in a CHW-led support group, that will occur monthly. The research team will compare outcomes during the 6-months before and during the intervention period. This pilot study aims to (1) assess the feasibility of recruiting dialysis patients experiencing health-related social needs to an intervention trial, and (2) assess the feasibility of implementing the intervention within this population, in a fashion deemed acceptable.

Official Title
-----------------
Community Health Worker Navigation of Community Resources for Dialysis Patients: A Pilot Intervention

Conditions
-----------------
Chronic Kidney Diseases, RENAL INSUFFICIENCY, CHRONIC

Intervention / Treatment
-----------------
* Behavioral: Community Health Worker Support with Resources


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have kidney failure and be receiving dialysis Exclusion Criteria: Live in a nursing facility or institution Physically or mentally unable or unwilling to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: IMPaCT (Individualized Management for Patient-Centered Targets)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHW Dialysis Implementation<br>A single-arm 6-month pilot study testing the feasibility of tailored implementation, by using IMPaCT model with a Community Health Worker to help low-income dialysis patient to navigate the health system and community resources to eliminate or minimize health-related social needs among dialysis patients so that they adhere to the treatment, improve their health and may be candidates for transplantation. | Behavioral: Community Health Worker Support with Resources<br>* 6-months of hands-on tailored support spanning the domains of social support, advocacy and navigation to achieve their action plans.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participant recruited and ended intervention | To measure Study Feasibility the research team will be assessing the number of participants enrolled and recruitment at the beginning of the intervention and the number of participants that engage by ending the intervention. These measurements will provide information on the feasibility of the intervention among low-income people receiving dialysis treatment. | 1-year | 
| Number of participants accepting the CWH intervention as helpful | Assess acceptability at follow-up with a focus group. All participants will complete a focus group that discusses: (1) whether the CHW's guidance/assistance was helpful in meeting needs; (2) the utility of having the CHW work with them outside of the dialysis unit; (3) the perceived knowledge of the CHW; (4) the perceived willingness and ability of community partners to participate in the intervention; (5) general satisfaction; and (6) input on the intervention design. This qualitative analysis on the acceptability of the intervention among the participants will provide us with data on which components of the intervention are feasible to improve the quality of life and health in the target population, and what type of components we should improve and/or change to increase the effectiveness of the intervention. acceptability. | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants changing levels of depression in pre-post test | This study will not be powered to detect differences in outcomes. However, in order to estimate the needed sample size for a future trial, the research team will collect information on the following outcomes pre-post changes in symptoms of depression by using the Beck depression inventory. The research team is expecting in the future that the levels of depression will get lower or none after the intervention. | 1-Year | 
| Number of participants changing levels of anxiety in pre-post | This study will not be powered to detect differences in outcomes. However, in order to estimate the needed sample size for a future trial, the research team will collect information on the following outcomes pre-post changes in symptoms of anxiety by using GAD-7 Anxiety inventory. The research team is expecting in the future that the levels of anxiety will get lower or none after the intervention. | 1-Year | 
| Number of participants changing levels of quality of life in pre-post | This study will not be powered to detect differences in outcomes. However, in order to estimate the needed sample size for a future trial, the research team will collect information on the following outcomes pre-post changes in the quality of life. The research team is expecting in the future that the levels of better quality of life will get higher after the intervention. | 1-Year | 
| Number of connection with community resources per participants in pre-post | The research team is expecting a greater amount of connection made with a community resource after the intervention. | 1-Year | 
| Number of dialysis session missed, ended early and amount of participants in transplanting listing. | The research team is expecting less number of missed dialysis sessions, an increase in the number of times the participant ended a dialysis session early, and an increase of participants in transplant listing. | 1-Year |