Integrated Palliative Care With Nephrology Care
- Conditions
- CKD
- Interventions
- Other: Ambulatory Supportive Care
- Registration Number
- NCT04998110
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- Age ≥ 18
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supportive Care Intervention Ambulatory Supportive Care The supportive care intervention arm will receive their usual ambulatory longitudinal nephrology care integrated with ambulatory supportive care through monthly supportive care visits over six months.
- Primary Outcome Measures
Name Time Method Average number of clinical visits attended per participant (Retention) Month 24 Ability to Collect Planned Data Month 24 This will be reported as the percent of completed data surveys
Recruitment Rate Month 24 This will be reported as the percentage of participants who provide informed consent.
Number of participant dropouts (Retention) Month 24 Change in Integrated Palliative Outcome Score-Renal (IPOS-Renal) Score Baseline, Month 6 The scoring will include 11 questions on the degree of impact kidney-specific symptoms have had on patients over the past week, plus additional items on concerns beyond symptoms, such as information needs, practical issues, and family anxiety. This includes one question that has 15 sub-questions asking about specific physical symptoms. All scores are on a scale of 0-90, with lower scores representing less problems.
Number of Participants who Maintain Participation in the Study (Retention) Month 24
- Secondary Outcome Measures
Name Time Method Engagement in Advance Care Planning Baseline, Month 6 Advance care planning will be measured by total number of advance care planning conversations held + number of documents such as surrogate decision makers, health care proxies, or treatment limiting directives.
Change in Kidney Disease Quality of Life (KDQOL-36) Score Baseline, Month 6 The KDQOL is a 36-item quality of life survey that includes five domains: Physical Component Summary (PCS), a Mental Component Summary (MCS), Burden of Kidney Disease Score, Symptoms and Problems of Kidney Disease Score, and Effect of Kidney Disease Score. All scores are on a scale of 0-100, with higher scores representing better quality of life.
Trial Locations
- Locations (1)
NYC Health + Hospitals / Bellevue
🇺🇸New York, New York, United States