Dialysis Geriatric Care Model
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Geriatric Care Model, Usual Care.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Diseases, Dialysis, Geriatric. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Integration of Geriatric Care Into Dialysis Clinics
Overview
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
- Behavioral Geriatric 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. - Behavioral Usual 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
Primary outcome measures
- Change in geriatric problem management as measured by survey [Time frame: Baseline, 4 months]
Secondary outcome measures (5)
- Practicality as measured by amount of time utilized by study personnel to conduct RCT (randomized controlled trial) [Time frame: up to 12 months]
- Practicality as measured by number of participants who needed study personnel assistance to complete the GOLD electronically [Time frame: up to 12 months]
- Fidelity as measured by the Care model recommendation checklist [Time frame: Baseline, 4 months]
- Retention as measured by number of participants who complete the study [Time frame: up to 12 months]
- Recruitment as measured by number of participants enrolled [Time frame: up to 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Duke University — Durham
Identifiers
NCT: NCT05793138 · Pro00112850