Clinical trial NCT05793138: Dialysis Geriatric Care Model
Official title: Integration of Geriatric Care Into Dialysis Clinics
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Kidney Diseases
Dialysis
Geriatric
Keywords: Dialysis
Quality of life
Care Model
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2023-03-31
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Change in geriatric problem management as measured by survey
timeFrame: Baseline, 4, 8, 12 months
Secondary outcomes:
measure: Practicality as measured by amount of time utilized by study personnel to conduct RCT (randomized controlled trial)
timeFrame: up to 12 months
measure: Practicality as measured by number of resources utilized by study personnel to conduct RCT (randomized controlled trial)
timeFrame: up to 12 months
measure: Fidelity as measured by number of completed study visits
timeFrame: up to 12 months
measure: Retention as measured by number of participants who complete the study
timeFrame: up to 12 months
measure: Recruitment as measured by number of participants enrolled
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Rasheeda K Hall, MD, MBA, MHS, FASN
role: PRINCIPAL_INVESTIGATOR
References: