Outcomes of a Palliative Care Intervention to Improve Kidney Therapy Decision-Making for Older People With Advanced Chronic Kidney Disease (CKD)

Chronic Kidney Diseases Clinical Trial

— CKD-EDU  

Official title:

Outcomes of a Palliative Care Intervention to Improve Kidney Therapy Decision-Making for Older People With Advanced Chronic Kidney Disease (CKD)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06410144
• Other study ID #: STUDY00009330
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: May 2029

Study information

• Verified date: June 2024
• Source: University of Rochester
• Contact: Brooke Daigneault
• Phone: 585-275-7033
• Email: brooke_daigneault[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators are conducting a study to see if an educational program called Chronic Kidney Disease-Education (CKD-EDU) can help make better kidney therapy decisions and improve the well-being of older adults. Investigators are also investigating if this program can reduce the number of hospital or emergency room visits in the first 6 months of the study, as well as potentially improve end-of-life care for older adults.

Half of the participants will receive the CKD-EDU intervention, while the other half will continue with their usual nephrology care. Investigators will compare the two groups to see if participants who received the intervention feel better prepared about their kidney therapy decisions, experience improved end-of-life care, and have fewer emergency room visits, hospital admissions,

Participants in the intervention group will get information about kidney disease treatment and meet with a palliative care specialist who's an expert in decision-making.

Description:

Older adults ≥75 years represent the fastest-growing population to initiate dialysis in the US; despite the life-altering effects of dialysis on quality of life, dialysis is often presented as a default without considering patient preferences, prognosis, and alternative options such as conservative kidney management. This study will test the first palliative care intervention for older patients with advanced chronic kidney disease to improve the kidney therapy decision-making process. This research not only has the potential to help thousands of older patients with advanced chronic kidney disease who often have unanswered questions, unmet information needs, and restricted opportunities to share personal treatment preferences with their nephrologists but also has the possibility of creating new models of collaborative care by integrating palliative care into routine nephrology care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 326
• Est. completion date: May 2029
• Est. primary completion date: May 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Age = 75 years old

• Estimated glomerular filtration rate (eGFR) = 30 ml/min/1.73 m2 as measured by non-race-based eGFR assays

• Speaks English

• Has not yet made a dialysis decision

Exclusion Criteria:

• Has already decided on dialysis or active medical care without dialysis.

• Has already been seen by a Palliative Care (PC) clinician or is enrolled in hospice

• Currently on dialysis

• Unable to provide informed consent or complete orally administered surveys due to health, sensory, or cognitive impairment.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• CKD-EDU
Subjects in the intervention group will receive 1) a video and paper decision aid , and 2) coaching from a palliative care clinician. The visits will be aimed to support patients with kidney therapy decision making.
• Usual Care
Subjects in the Control Group will receive the usual care from their nephrologist and a dialysis educator.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 4-6 weeks	Determine whether the intervention improves kidney therapy decision-making at 4-6 weeks by using the Decisional Conflict Scale. Score ranges from 0-100. Lower scores indicate better outcomes.	Baseline, 4-6 weeks
Secondary	Changes in patients' well-being at 6 months using the Burden of Kidney Disease Subscale	Determine whether the intervention improves patient well-being at 6 months using the Burden of Kidney Disease Subscale, a 4-question scale with response options ranging from 'definitely true (0)' to 'definitely false (3)'. Higher scores indicate better outcomes.	Base line 6 months
Secondary	Changes in number of hospital admissions, intensive care admissions, and emergency room visits	Review electronic health records to determine whether the intervention reduces the number of hospital admissions, intensive care admissions, and emergency room visits between study entry and 6 months.	Baseline, 6 months
Secondary	Differences in end-of-life care between intervention and control arm	Review patients' medical charts to determine whether the intervention improves end-of-life care treatment during the last 30 days of life, as measured by the rates of aggressive procedures such as cardiopulmonary resuscitation (CPR), dialysis, intubation, gastrostomy (G-tube), etc.	Baseline to 6 months