Dialysis Geriatric Care Model

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to refine the dialysis care model with key stakeholder input and conduct a pilot randomized controlled trial (RCT) to obtain evidence critical to inform a definitive RCT.

Detailed Description
-----------------
The investigators designed a new dialysis care model that includes a centralized geriatric team that uses information from the Geriatric screen for OLder Dialysis patients (GOLD) to develop individualized recommendations for geriatric syndrome management based on the patient's priorities. The study population is older adults receiving hemodialysis and dialysis staff. The investigators will have patient participants complete the care model and undergo geriatric evaluation. This phase will be referred to as refinement aim 1. The investigators will then assess agreement of each GOLD instrument with its corresponding geriatric evaluation. The investigators will assess acceptability and feasibility of the care model through surveys and interviews with patients and dialysis staff to complete refinement aim 2. Once the new dialysis care model is redefined, the investigators will conduct the third phase, pilot RCT (geriatric care model vs. usual care) and assess geriatric problem management at 4 months, as well as, patient reported outcomes, physical function, and health care utilization at intervals up to 12 months. The analyses will include 1) measure of agreement using Cohen's kappa, 2) qualitative rapid analyses, 3) descriptive statistics from acceptability and feasibility surveys, 4) descriptive statistics from pilot RCT data, and 5) tests for difference in geriatric problem management between treatment and control groups. The study does not involve activity from participants that would exceed normal or routine care so there are negligible physical, financial, or legal risks.

Official Title
-----------------
Integration of Geriatric Care Into Dialysis Clinics

Conditions
-----------------
Chronic Kidney Diseases, Dialysis, Geriatric

Intervention / Treatment
-----------------
* Behavioral: Geriatric Care Model
* Behavioral: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Patient Inclusion Criteria: community-dwelling dialysis patients 55 and older may have cognitive impairment; however, patients with severe cognitive impairment will require a caregiver present to participate in the study (mini MoCA <6) Patient Exclusion Criteria: advanced dementia non-English speaking nursing home residents hospice enrollees

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Usual Care<br>Participants will receive usual dialysis care for 12 months, then they will receive the geriatric care model. | Behavioral: Usual Care<br>* Participants will continue to receive standard of care. Then after 12 months, they will follow the Geriatric Care Model. They will complete the Geriatric screen for OLder adults receiving Dialysis (GOLD), a battery of validated, self-administered geriatric screening instruments, used to identify Geriatric 5M-related problems. Then, a research team with geriatrics expertise leads patient prioritization of GOLD-identified problems in a telehealth visit and provides the dialysis team with guideline-directed, individualized recommendations for geriatric problem management.<br>|
| Active Comparator: Geriatric Care Model<br>While specifics of the intervention will be finalized after aim 2, the investigators anticipate participants will complete the GOLD and telehealth prioritization visit. Information gathered will guide the research geriatric team's recommendation report to the participants' dialysis care team. The dialysis teams will receive training on how to use the recommendation report and local resources to initiate geriatric problem management. | Behavioral: Geriatric Care Model<br>* First, older adults complete the Geriatric screen for OLder adults receiving Dialysis (GOLD), a battery of validated, self-administered geriatric screening instruments, used to identify Geriatric 5M-related problems. Then, a research team with geriatrics expertise leads patient prioritization of GOLD-identified problems in a telehealth visit and provides the dialysis team with guideline-directed, individualized recommendations for geriatric problem management.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in geriatric problem management as measured by survey | Problems include depression, difficulty with memory, difficulty with daily activities, falling or fear of falling, obtaining and following instructions for taking medications, having unwelcome side effects from medications, not having enough support from others, and not having access to or eating enough food. The score for each problem ranges from 0 to 4, where a higher score indicates better management of the problem. | Baseline, 4, 8, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Practicality as measured by amount of time utilized by study personnel to conduct RCT (randomized controlled trial) |  | up to 12 months | 
| Practicality as measured by number of resources utilized by study personnel to conduct RCT (randomized controlled trial) |  | up to 12 months | 
| Fidelity as measured by number of completed study visits |  | up to 12 months | 
| Retention as measured by number of participants who complete the study |  | up to 12 months | 
| Recruitment as measured by number of participants enrolled |  | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dialysis, Quality of life, Care Model