Geriatric Care Model for Dialysis

Overseen By Rasheeda K Hall, MD, MBA, MHS, FASN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Advanced dementia, Non-English, Nursing home, Hospice

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is the Geriatric Care Model for Dialysis safe for humans?

The research highlights that older adults, especially those with multiple health issues, are at higher risk for adverse drug reactions and events. However, careful management and consultation with specialists can help reduce these risks, suggesting that with proper care, the Geriatric Care Model can be safe for use in humans. ^{1 2 3 4 5}

How is the Geriatric Care Model treatment for dialysis unique?

The Geriatric Care Model for dialysis is unique because it focuses on addressing the specific needs of older adults with kidney failure, incorporating a comprehensive geriatric assessment to manage not just kidney issues but also other age-related health problems. This approach aims to improve overall health and quality of life by considering the complex health challenges faced by elderly patients on dialysis. ^{6 7 8 9 10}

What data supports the effectiveness of the Geriatric Care Model treatment for dialysis patients?

Research suggests that tailoring dialysis treatment plans to address geriatric impairments (age-related health issues) can improve outcomes for older patients. By being aware of these impairments, healthcare providers can make better decisions that may enhance the care and quality of life for elderly patients on dialysis. ^{6 7 11 12 13}

Who Is on the Research Team?

Rasheeda K Hall, MD, MBA, MHS, FASN

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for community-dwelling dialysis patients aged 55 and older, who may have some cognitive impairment. Those with severe cognitive issues can join if they have a caregiver present to assist them during the study.

Inclusion Criteria

I am 55 or older and receive dialysis while living at home.

I have cognitive issues but can join if I have a caregiver, unless my impairment is severe.

Exclusion Criteria

Hospice enrollees

Non-English speaking

I have advanced dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Refinement Aim 1

Participants complete the care model and undergo geriatric evaluation

4 months

Refinement Aim 2

Assessment of acceptability and feasibility of the care model through surveys and interviews

4 months

Pilot RCT

Conduct pilot RCT comparing geriatric care model vs. usual care and assess outcomes

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Geriatric Care Model
• Usual Care

Trial Overview The study is testing a new Geriatric Care Model against the usual care given to older adults on dialysis. It's set up as a pilot randomized controlled trial, meaning participants are randomly assigned to one of the two approaches.

How Is the Trial Designed?

Group I: Geriatric Care Model Active Control 1 Intervention

While specifics of the intervention will be finalized after aim 2, the investigators anticipate participants will complete the GOLD and telehealth prioritization visit. Information gathered will guide the research geriatric team's recommendation report to the participants' dialysis care team. The dialysis teams will receive training on how to use the recommendation report and local resources to initiate geriatric problem management.

Group II: Usual Care Placebo Group 2 Interventions

Participants will receive usual dialysis care for 12 months, then they will receive the geriatric care model.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

Geriatric patients are at a higher risk for adverse drug events due to changes in how their bodies process medications (pharmacokinetics) and how medications affect their bodies (pharmacodynamics).

Careful selection of medications and appropriate dosage adjustments can significantly reduce the risk of medication-related adverse events in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacology for the geriatric surgical patient. Then, J., Tisherman, SA.[2015]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Nephrology-tailored geriatric assessment as decision-making tool in kidney failure. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Dialysis in nursing homes. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The Factors Affecting Survival in Geriatric Hemodialysis Patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Unmet Needs of Older Adults Receiving In-Center Hemodialysis: A Qualitative Needs Assessment. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Geriatric assessment for the nephrologist. [2012]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Identification of adverse drug reactions in geriatric inpatients using a computerised drug database. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Reporting adverse events at geriatric facilities: categorization by type of adverse event and function of reporting personnel. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Pharmacology for the geriatric surgical patient. [2015]

9. England pubmed.ncbi.nlm.nih.gov

GeriMedRisk, a telemedicine geriatric pharmacology consultation service to address adverse drug events in long-term care: a stepped-wedge cluster randomized feasibility trial protocol (ISRCTN17219647). [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Medical adverse events in elderly hospitalized patients: a prospective study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Geriatric Issues in Older Dialysis Patients. [2017]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Geriatric Assessment in Elderly Patients with End-Stage Kidney Disease. [2023]

13. France pubmed.ncbi.nlm.nih.gov

[Contributions of a geriatric outpatient consultation in a dialysis facility]. [2021]