Clinical trial NCT04998110: Integrated Palliative Care With Nephrology Care
Official title: Pilot Randomized Controlled Trial of Integrated Palliative Care With Nephrology Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CKD
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-08-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18
2. Documented diagnosis of Chronic Kidney Disease stage IV or V
3. Speaks Spanish or English fluently
4. Provision of signed and dated informed consent form
5. Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.

Exclusion Criteria:

1. Exposure to supportive/palliative care in the last six months either inpatient or outpatient.
2. 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.
3. Pregnant women.
4. Not fluent in either English or Spanish
5. Any urgent supportive/palliative care needs identified on screening interview.

Primary outcomes:
measure: Change in Integrated Palliative Outcome Score-Renal (IPOS-Renal) Score
timeFrame: Baseline, Month 6
measure: Recruitment Rate
timeFrame: Month 3
measure: Recruitment Rate
timeFrame: Month 6
measure: Recruitment Rate
timeFrame: Month 9
measure: Recruitment Rate
timeFrame: Month 12
measure: Recruitment Rate
timeFrame: Month 15
measure: Recruitment Rate
timeFrame: Month 18
measure: Recruitment Rate
timeFrame: Month 21
measure: Recruitment Rate
timeFrame: Month 24
measure: Number of Participants who Maintain Participation in the Study (Retention)
timeFrame: Month 3
measure: Number of Participants who Maintain Participation in the Study (Retention)
timeFrame: Month 6
measure: Number of Participants who Maintain Participation in the Study (Retention)
timeFrame: Month 9
measure: Number of Participants who Maintain Participation in the Study (Retention)
timeFrame: Month 12
measure: Number of Participants who Maintain Participation in the Study (Retention)
timeFrame: Month 15
measure: Number of Participants who Maintain Participation in the Study (Retention)
timeFrame: Month 18
measure: Number of Participants who Maintain Participation in the Study (Retention)
timeFrame: Month 21
measure: Number of Participants who Maintain Participation in the Study (Retention)
timeFrame: Month 24
measure: Number of participant dropouts (Retention)
timeFrame: Month 3
measure: Number of participant dropouts (Retention)
timeFrame: Month 6
measure: Number of participant dropouts (Retention)
timeFrame: Month 9
measure: Number of participant dropouts (Retention)
timeFrame: Month 12
measure: Number of participant dropouts (Retention)
timeFrame: Month 15
measure: Number of participant dropouts (Retention)
timeFrame: Month 18
measure: Number of participant dropouts (Retention)
timeFrame: Month 21
measure: Number of participant dropouts (Retention)
timeFrame: Month 24
measure: Average number of clinical visits attended per participant (Retention)
timeFrame: Month 3
measure: Average number of clinical visits attended per participant (Retention)
timeFrame: Month 6
measure: Average number of clinical visits attended per participant (Retention)
timeFrame: Month 9
measure: Average number of clinical visits attended per participant (Retention)
timeFrame: Month 12
measure: Average number of clinical visits attended per participant (Retention)
timeFrame: Month 15
measure: Average number of clinical visits attended per participant (Retention)
timeFrame: Month 18
measure: Average number of clinical visits attended per participant (Retention)
timeFrame: Month 21
measure: Average number of clinical visits attended per participant (Retention)
timeFrame: Month 24
measure: Ability to Collect Planned Data
timeFrame: Month 3
measure: Ability to Collect Planned Data
timeFrame: Month 6
measure: Ability to Collect Planned Data
timeFrame: Month 9
measure: Ability to Collect Planned Data
timeFrame: Month 12
measure: Ability to Collect Planned Data
timeFrame: Month 15
measure: Ability to Collect Planned Data
timeFrame: Month 18
measure: Ability to Collect Planned Data
timeFrame: Month 21
measure: Ability to Collect Planned Data
timeFrame: Month 24
Secondary outcomes:
measure: Change in Kidney Disease Quality of Life (KDQOL-36) Score
timeFrame: Baseline, Month 6
measure: Engagement in Advance Care Planning
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: NYC Health + Hospitals / Bellevue
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jennifer Scherer, MD
role: PRINCIPAL_INVESTIGATOR
References: