Dialysis Geriatric Care Model

Duke University

Status: Invitation-only

Conditions: Geriatric; Chronic Kidney Diseases; Dialysis

Treatments: Behavioral: Geriatric Care Model; Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05793138

Pro00112850

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient Inclusion Criteria:

• community-dwelling dialysis patients 55 and older
• may have cognitive impairment

Patient Exclusion Criteria:

• advanced dementia
• non-English or Spanish speaking
• nursing home residents
• hospice enrollees

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

Usual Care

Placebo Comparator group

Description:

Participants will receive usual dialysis care for 12 months, then they will receive the geriatric care model.

Treatment:

Behavioral: Usual Care

Geriatric Care Model

Active Comparator group

Description:

Participants will complete the GOLD, along with a few additional short surveys and a Short Physical Performance Battery. 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. Participants will be seen every 4 months for follow-up for roughly 12 months.

Treatment:

Behavioral: Geriatric Care Model