Integrated Palliative Care With Nephrology Care

CKD Clinical Trial

Official title:

Pilot Randomized Controlled Trial of Integrated Palliative Care With Nephrology Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04998110
• Other study ID #: 21-00507
• Secondary ID: K23DK125840-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: October 15, 2024

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: October 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CKD

Intervention

Other:
• Ambulatory Supportive Care
Ambulatory supportive care visits monthly for six months - a monthly visit with an ambulatory palliative care provider educated in kidney disease

Locations

Country	Name	City	State
United States	NYC Health + Hospitals / Bellevue	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Integrated Palliative Outcome Score-Renal (IPOS-Renal) Score	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.	Baseline, Month 6
Primary	Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 3
Primary	Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 6
Primary	Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 9
Primary	Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 12
Primary	Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 15
Primary	Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 18
Primary	Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 21
Primary	Recruitment Rate	This will be reported as the percentage of participants who provide informed consent.	Month 24
Primary	Number of Participants who Maintain Participation in the Study (Retention)		Month 3
Primary	Number of Participants who Maintain Participation in the Study (Retention)		Month 6
Primary	Number of Participants who Maintain Participation in the Study (Retention)		Month 9
Primary	Number of Participants who Maintain Participation in the Study (Retention)		Month 12
Primary	Number of Participants who Maintain Participation in the Study (Retention)		Month 15
Primary	Number of Participants who Maintain Participation in the Study (Retention)		Month 18
Primary	Number of Participants who Maintain Participation in the Study (Retention)		Month 21
Primary	Number of Participants who Maintain Participation in the Study (Retention)		Month 24
Primary	Number of participant dropouts (Retention)		Month 3
Primary	Number of participant dropouts (Retention)		Month 6
Primary	Number of participant dropouts (Retention)		Month 9
Primary	Number of participant dropouts (Retention)		Month 12
Primary	Number of participant dropouts (Retention)		Month 15
Primary	Number of participant dropouts (Retention)		Month 18
Primary	Number of participant dropouts (Retention)		Month 21
Primary	Number of participant dropouts (Retention)		Month 24
Primary	Average number of clinical visits attended per participant (Retention)		Month 3
Primary	Average number of clinical visits attended per participant (Retention)		Month 6
Primary	Average number of clinical visits attended per participant (Retention)		Month 9
Primary	Average number of clinical visits attended per participant (Retention)		Month 12
Primary	Average number of clinical visits attended per participant (Retention)		Month 15
Primary	Average number of clinical visits attended per participant (Retention)		Month 18
Primary	Average number of clinical visits attended per participant (Retention)		Month 21
Primary	Average number of clinical visits attended per participant (Retention)		Month 24
Primary	Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 3
Primary	Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 6
Primary	Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 9
Primary	Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 12
Primary	Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 15
Primary	Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 18
Primary	Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 21
Primary	Ability to Collect Planned Data	This will be reported as the percent of completed data surveys	Month 24
Secondary	Change in Kidney Disease Quality of Life (KDQOL-36) Score	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.	Baseline, Month 6
Secondary	Engagement in Advance Care Planning	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.	Baseline, Month 6