Integration of Geriatric Care Into Dialysis Clinics
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Kidney Diseases
- Sponsor
- Duke University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change in geriatric problem management as measured by survey
- Status
- Enrolling By Invitation
- Last Updated
- 4 months ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •community-dwelling dialysis patients 55 and older
- •may have cognitive impairment
Exclusion Criteria
- •advanced dementia
- •non-English or Spanish speaking
- •nursing home residents
- •hospice enrollees
Outcomes
Primary Outcomes
Change in geriatric problem management as measured by survey
Time Frame: Baseline, 4, 8, 12 months
Problems include depression, anxiety, 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 Outcomes
- 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)