CKD
Conditions
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.
Interventions
OTHERAmbulatory Supportive Care
Ambulatory supportive care visits monthly for six months - a monthly visit with an ambulatory palliative care provider educated in kidney disease
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The statistician will be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | 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) | Month 12 | Reported as percentage of participants who signed informed consent, who completed the study. |
| Average number of clinical visits attended per participant (Retention) | Month 12 | — |
| Ability to Collect Planned Data | Month 12 | This will be reported as the percent of completed data surveys |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Engagement in Advance Care Planning | Baseline, Month 6 | Advance care planning will be measured by total number of advance care planning conversations held. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed