Dialysis Geriatric Care Model

Not Applicable

• Conditions: Chronic Kidney Diseases; Dialysis; Geriatric
• Interventions: Behavioral: Geriatric Care Model; Behavioral: Usual Care

• Registration Number: NCT05793138
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-03-31
• Status Verified: 2024-05
• Study Start: 2024-05-16
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-20
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 194

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Geriatric Care Model	Geriatric Care Model	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.
Usual Care	Usual Care	Participants will receive usual dialysis care for 12 months, then they will receive the geriatric care model.

Primary Outcome Measures

Name	Time	Method
Change in geriatric problem management as measured by survey	Baseline, 4, 8, 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Practicality as measured by amount of time utilized by study personnel to conduct RCT (randomized controlled trial)	up to 12 months
Retention as measured by number of participants who complete the study	up to 12 months
Fidelity as measured by number of completed study visits	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
Recruitment as measured by number of participants enrolled	up to 12 months

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States