Chronic Kidney Diseases, Dialysis, Geriatric
Conditions
Keywords
Dialysis, Quality of life, Care Model
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.
Interventions
BEHAVIORALGeriatric Care Model
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.
BEHAVIORALUsual Care
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.
Sponsors
Duke University
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in geriatric problem management as measured by survey | Baseline, 4 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
| Measure | Time frame | Description |
|---|---|---|
| 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 participants who needed study personnel assistance to complete the GOLD electronically | up to 12 months | — |
| Fidelity as measured by the Care model recommendation checklist | Baseline, 4 months | Care model recommendation checklist includes a recommendation informed by the GOLD, recommendation align with patient priority, recommendation received by clinician, and recommendation decision |
| 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 | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRasheeda K Hall, MD, MBA, MHS, FASN
Duke University
Outcome results
None listed