Pilot Randomized Controlled Trial of Integrated Palliative Care With Nephrology Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Recruitment Rate
Study Overview
Brief Summary
This study is a pilot randomized controlled trial testing the effectiveness of integrated ambulatory supportive care visits with standard nephrology outpatient visits for six months in patients with advanced CKD. The study team hypothesizes that patients in the integrated care arm will trend towards improved symptom burden, improved quality of life scores and more engagement in advance care planning.
Primary objectives: To test the impact of integrated ambulatory supportive care in nephrology care on symptom burden. Secondary: To test the impact of integrated ambulatory supportive care on quality of life and engagement in advance care planning and to demonstrate study feasibility.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
The statistician will be blinded.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Documented diagnosis of Chronic Kidney Disease stage IV or V
- •Speaks Spanish or English fluently
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.
Exclusion Criteria
- •Exposure to supportive/palliative care in the last six months either inpatient or outpatient.
- •Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation, for example not being able to cognitively understand the questions or to provide informed consent.
- •Pregnant women.
- •Not fluent in either English or Spanish
- •Any urgent supportive/palliative care needs identified on screening interview.
Outcomes
Primary Outcomes
Recruitment Rate
Time Frame: Month 12
This will be reported as the percentage of participants who provide informed consent.
Number of Participants who Maintain Participation in the Study (Retention)
Time Frame: Month 12
Reported as percentage of participants who signed informed consent, who completed the study.
Average number of clinical visits attended per participant (Retention)
Time Frame: Month 12
Ability to Collect Planned Data
Time Frame: Month 12
This will be reported as the percent of completed data surveys
Secondary Outcomes
- Change in Kidney Disease Quality of Life (KDQOL-36) Score(Baseline, Month 6)
- Engagement in Advance Care Planning(Baseline, Month 6)
- Change in Integrated Palliative Outcome Score-Renal (IPOS-Renal) Score(Baseline, Month 6)
- Change in Kidney Disease Quality of Life (KDQOL-36) Score(Baseline, Month 6)
- Engagement in Advance Care Planning(Baseline, Month 6)