Integrated Palliative Care With Nephrology Care

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Randomized Controlled Trial of Integrated Palliative Care With Nephrology Care

Conditions
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CKD

Intervention / Treatment
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* Other: Ambulatory Supportive Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care Intervention<br>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. | Other: Ambulatory Supportive Care<br>* Ambulatory supportive care visits monthly for six months - a monthly visit with an ambulatory palliative care provider educated in kidney disease<br>|
| No Intervention: Usual Care Control<br>The usual care control arm will be seen at the discretion of their nephrologist, or receive their usual dialysis if on dialysis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Recruitment Rate | This will be reported as the percentage of participants who provide informed consent. | Month 3 | 
| Recruitment Rate | This will be reported as the percentage of participants who provide informed consent. | Month 6 | 
| Recruitment Rate | This will be reported as the percentage of participants who provide informed consent. | Month 9 | 
| Recruitment Rate | This will be reported as the percentage of participants who provide informed consent. | Month 12 | 
| Recruitment Rate | This will be reported as the percentage of participants who provide informed consent. | Month 15 | 
| Recruitment Rate | This will be reported as the percentage of participants who provide informed consent. | Month 18 | 
| Recruitment Rate | This will be reported as the percentage of participants who provide informed consent. | Month 21 | 
| Recruitment Rate | This will be reported as the percentage of participants who provide informed consent. | Month 24 | 
| Number of Participants who Maintain Participation in the Study (Retention) |  | Month 3 | 
| Number of Participants who Maintain Participation in the Study (Retention) |  | Month 6 | 
| Number of Participants who Maintain Participation in the Study (Retention) |  | Month 9 | 
| Number of Participants who Maintain Participation in the Study (Retention) |  | Month 12 | 
| Number of Participants who Maintain Participation in the Study (Retention) |  | Month 15 | 
| Number of Participants who Maintain Participation in the Study (Retention) |  | Month 18 | 
| Number of Participants who Maintain Participation in the Study (Retention) |  | Month 21 | 
| Number of Participants who Maintain Participation in the Study (Retention) |  | Month 24 | 
| Number of participant dropouts (Retention) |  | Month 3 | 
| Number of participant dropouts (Retention) |  | Month 6 | 
| Number of participant dropouts (Retention) |  | Month 9 | 
| Number of participant dropouts (Retention) |  | Month 12 | 
| Number of participant dropouts (Retention) |  | Month 15 | 
| Number of participant dropouts (Retention) |  | Month 18 | 
| Number of participant dropouts (Retention) |  | Month 21 | 
| Number of participant dropouts (Retention) |  | Month 24 | 
| Average number of clinical visits attended per participant (Retention) |  | Month 3 | 
| Average number of clinical visits attended per participant (Retention) |  | Month 6 | 
| Average number of clinical visits attended per participant (Retention) |  | Month 9 | 
| Average number of clinical visits attended per participant (Retention) |  | Month 12 | 
| Average number of clinical visits attended per participant (Retention) |  | Month 15 | 
| Average number of clinical visits attended per participant (Retention) |  | Month 18 | 
| Average number of clinical visits attended per participant (Retention) |  | Month 21 | 
| Average number of clinical visits attended per participant (Retention) |  | Month 24 | 
| Ability to Collect Planned Data | This will be reported as the percent of completed data surveys | Month 3 | 
| Ability to Collect Planned Data | This will be reported as the percent of completed data surveys | Month 6 | 
| Ability to Collect Planned Data | This will be reported as the percent of completed data surveys | Month 9 | 
| Ability to Collect Planned Data | This will be reported as the percent of completed data surveys | Month 12 | 
| Ability to Collect Planned Data | This will be reported as the percent of completed data surveys | Month 15 | 
| Ability to Collect Planned Data | This will be reported as the percent of completed data surveys | Month 18 | 
| Ability to Collect Planned Data | This will be reported as the percent of completed data surveys | Month 21 | 
| Ability to Collect Planned Data | This will be reported as the percent of completed data surveys | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |