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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve dialysis care for older adults by testing a new geriatric care model. Researchers seek to determine if this approach can provide better support and management for patients on dialysis. The trial includes two groups: one will continue with usual care (also known as standard or conventional care), while the other will receive the geriatric care model, which includes personalized recommendations and support via telehealth. This trial suits dialysis patients aged 55 and older who live at home and may have mild memory issues. As an unphased trial, it offers patients the opportunity to contribute to innovative care improvements tailored to their needs.

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.

What prior data suggests that the Geriatric Care Model is safe for dialysis patients?

Research shows that the Geriatric Care Model aims to improve the health and well-being of older adults, including those on dialysis. This model employs a specialized team that addresses the needs of elderly patients to enhance their quality of life and overall health.

The GRACE model, which forms the basis of the Geriatric Care Model, has successfully helped older patients avoid health problems and remain active. Studies have shown that similar methods are well-received by older adults, with few negative effects reported.

Although specific safety data for this exact Geriatric Care Model in dialysis patients is lacking, geriatric-focused care in other settings has generally yielded positive results. The focus on personalized care usually leads to fewer problems. Participants can expect an emphasis on safety and comfort with this approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Geriatric Care Model for dialysis because it aims to enhance the standard of care by integrating geriatric-specific strategies. Unlike traditional dialysis treatments that primarily focus on the kidney function itself, this model looks at the bigger picture, addressing the broader health needs of elderly patients. It combines tools like the GOLD assessment and telehealth prioritization to tailor care recommendations for each patient. By training dialysis teams to use these personalized reports and local resources, the model hopes to improve overall patient well-being, potentially leading to better management of age-related issues and improved quality of life for older adults on dialysis.

What evidence suggests that the Geriatric Care Model is effective for dialysis?

Research has shown that adding a special care plan for older adults to dialysis treatment can be helpful. In this trial, participants will receive either the Geriatric Care Model or Usual Care. One study found that this type of care integrates well into managing chronic kidney disease (CKD). Health care professionals find it useful to assess the needs of older patients on dialysis. These assessments help customize care to improve their quality of life. While data collection continues on the effectiveness of this care model for dialysis patients, it appears promising for addressing the unique challenges older adults face. ^{6 7 8 9 10}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7825220/

DIALysis or not: Outcomes in older kidney patients with ... The aim of this prospective study is to compare HRQoL, clinical outcomes, and costs between conservative care and dialysis in older patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4189680/

The impact of dialysis therapy on older patients with advanced ... During a median follow-up period of 2.7 years, 6,292 (75.4%) older patients chose dialysis therapy and 2,049 (24.6%) received conservative care.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2590059524000207

Geriatric Assessment in CKD Care: An Implementation Study Geriatric assessment could successfully be integrated in CKD care and was perceived relevant to health care professionals.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2790040

Long-term Outcomes Among Patients With Advanced ... Younger cohorts aged 70 to 79 years (9 studies; 607 patients) had a median survival of 7 to 41 months, and cohorts 80 years or older (25 studies ...

5. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-025-04389-5

Predicting mortality in elderly chronic kidney disease patients ... This study aimed to develop ML models to predict six-month mortality in elderly patients initiating haemodialysis. We used data from a single- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05793138

Study Details | NCT05793138 | Dialysis Geriatric Care Model The investigators designed a new dialysis care model that includes a centralized geriatric team that uses information from the Geriatric screen for OLder ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7568080/

Applying a Geriatrics Framework to Older Dialysis Patients ... The GRACE model of care was developed to optimize the functional status and health of the elderly population, improve the geriatric care provided, and prevent ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2468024925005510

Pilot Randomized Trial of Dialysis Less Frequently in the ... There was no residual kidney function (RKF) trigger for HD prescription escalation. The primary outcomes were those of feasibility and safety.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11900943/

Geriatric Assessment in Older Patients with Advanced ... Some studies report that dialysis treatment offers a survival advantage in older adults, particularly for patients with fewer comorbidities or ...

10. agsjournals.onlinelibrary.wiley.com agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.17665

The Program of All‐Inclusive Care for the Elderly: A potential ... In this paper, we describe the special care needs of patients with ESRD and discuss the potential for the Program of All-Inclusive Care of the Elderly (PACE) ...