Dialysis Geriatric Care Model

Chronic Kidney Diseases Clinical Trial

Official title:

Integration of Geriatric Care Into Dialysis Clinics

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05793138
• Other study ID #: Pro00112850
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 16, 2024
• Est. completion date: August 31, 2028

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 194
• Est. completion date: August 31, 2028
• Est. primary completion date: August 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Patient Inclusion Criteria:

• community-dwelling dialysis patients 55 and older

• may have cognitive impairment; however, patients with severe cognitive impairment will require a caregiver present to participate in the study (mini MoCA <6)

Patient Exclusion Criteria:

• advanced dementia

• non-English speaking

• nursing home residents

• hospice enrollees

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Dialysis
• Geriatric
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.
• 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-directed, individualized recommendations for geriatric problem management.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in geriatric problem management as measured by survey	Problems include depression, 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.	Baseline, 4, 8, 12 months
Secondary	Practicality as measured by amount of time utilized by study personnel to conduct RCT (randomized controlled trial)		up to 12 months
Secondary	Practicality as measured by number of resources utilized by study personnel to conduct RCT (randomized controlled trial)		up to 12 months
Secondary	Fidelity as measured by number of completed study visits		up to 12 months
Secondary	Retention as measured by number of participants who complete the study		up to 12 months
Secondary	Recruitment as measured by number of participants enrolled		up to 12 months