A pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety-net hospital: Protocol for a pilot study of feasibility of a randomized controlled trial
Background: Chronic kidney disease (CKD) impacts more than 800 million people. It causes significant suffering and disproportionately impacts marginalized populations in the United States. Kidney palliative care has the potential to alleviate this distress, but has not been tested. This pilot study...
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| Language: | English |
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Elsevier
2025-04-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865425000134 |
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| author | Jennifer S. Scherer Wenbo Wu Chen Lyu Keith S. Goldfeld Abraham A. Brody Joshua Chodosh David Charytan |
| author_facet | Jennifer S. Scherer Wenbo Wu Chen Lyu Keith S. Goldfeld Abraham A. Brody Joshua Chodosh David Charytan |
| author_sort | Jennifer S. Scherer |
| collection | DOAJ |
| description | Background: Chronic kidney disease (CKD) impacts more than 800 million people. It causes significant suffering and disproportionately impacts marginalized populations in the United States. Kidney palliative care has the potential to alleviate this distress, but has not been tested. This pilot study evaluates the feasibility of a randomized clinical trial (RCT) testing the efficacy of integrated kidney palliative and CKD care in an urban safety-net hospital. Methods: This is a single-site pilot RCT designed to enroll 85 participants, with a goal of at least 60 completing the study. The inclusion criteria are adults 18 or older, who are either Spanish or English speakers, have an estimated Glomerular Filtration Rate (eGFR) of ≤30 mL/min/1.73 m2, and are receiving care at our safety net hospital. Participants will be randomized in permuted blocks of two or four to either the intervention group, who will receive monthly ambulatory care visits for six months with a palliative care provider trained in kidney palliative care, or to usual nephrology care. Primary outcomes are feasibility of recruitment, retention, fidelity to the study visit protocol, and the ability to collect outcome data. These outcomes include symptom burden, quality of life, and engagement in advance care planning. Discussion: This pilot RCT will provide essential data on the feasibility of testing integrated palliative care in CKD care in an underserved setting. These outcomes will inform a larger, fully powered trial that tests the efficacy of our kidney palliative care approach. Clinical trial registration: NCT04998110. |
| format | Article |
| id | doaj-art-ceee7205f86d49fda664d43a7fdf9996 |
| institution | Kabale University |
| issn | 2451-8654 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-ceee7205f86d49fda664d43a7fdf99962025-02-08T05:00:45ZengElsevierContemporary Clinical Trials Communications2451-86542025-04-0144101439A pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety-net hospital: Protocol for a pilot study of feasibility of a randomized controlled trialJennifer S. Scherer0Wenbo Wu1Chen Lyu2Keith S. Goldfeld3Abraham A. Brody4Joshua Chodosh5David Charytan6Department of Medicine, NYU Grossman School of Medicine, USA; Corresponding author.Department of Medicine, NYU Grossman School of Medicine, USA; Department of Population Health, NYU Grossman School of Medicine, USADepartment of Population Health, NYU Grossman School of Medicine, USADepartment of Population Health, NYU Grossman School of Medicine, USADepartment of Medicine, NYU Grossman School of Medicine, USA; HIGN, NYU Rory Meyers College of Nursing, USADepartment of Medicine, NYU Grossman School of Medicine, USADepartment of Medicine, NYU Grossman School of Medicine, USABackground: Chronic kidney disease (CKD) impacts more than 800 million people. It causes significant suffering and disproportionately impacts marginalized populations in the United States. Kidney palliative care has the potential to alleviate this distress, but has not been tested. This pilot study evaluates the feasibility of a randomized clinical trial (RCT) testing the efficacy of integrated kidney palliative and CKD care in an urban safety-net hospital. Methods: This is a single-site pilot RCT designed to enroll 85 participants, with a goal of at least 60 completing the study. The inclusion criteria are adults 18 or older, who are either Spanish or English speakers, have an estimated Glomerular Filtration Rate (eGFR) of ≤30 mL/min/1.73 m2, and are receiving care at our safety net hospital. Participants will be randomized in permuted blocks of two or four to either the intervention group, who will receive monthly ambulatory care visits for six months with a palliative care provider trained in kidney palliative care, or to usual nephrology care. Primary outcomes are feasibility of recruitment, retention, fidelity to the study visit protocol, and the ability to collect outcome data. These outcomes include symptom burden, quality of life, and engagement in advance care planning. Discussion: This pilot RCT will provide essential data on the feasibility of testing integrated palliative care in CKD care in an underserved setting. These outcomes will inform a larger, fully powered trial that tests the efficacy of our kidney palliative care approach. Clinical trial registration: NCT04998110.http://www.sciencedirect.com/science/article/pii/S2451865425000134PilotFeasibilityPalliative careChronic kidney diseaseSafety net |
| spellingShingle | Jennifer S. Scherer Wenbo Wu Chen Lyu Keith S. Goldfeld Abraham A. Brody Joshua Chodosh David Charytan A pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety-net hospital: Protocol for a pilot study of feasibility of a randomized controlled trial Contemporary Clinical Trials Communications Pilot Feasibility Palliative care Chronic kidney disease Safety net |
| title | A pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety-net hospital: Protocol for a pilot study of feasibility of a randomized controlled trial |
| title_full | A pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety-net hospital: Protocol for a pilot study of feasibility of a randomized controlled trial |
| title_fullStr | A pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety-net hospital: Protocol for a pilot study of feasibility of a randomized controlled trial |
| title_full_unstemmed | A pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety-net hospital: Protocol for a pilot study of feasibility of a randomized controlled trial |
| title_short | A pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety-net hospital: Protocol for a pilot study of feasibility of a randomized controlled trial |
| title_sort | pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety net hospital protocol for a pilot study of feasibility of a randomized controlled trial |
| topic | Pilot Feasibility Palliative care Chronic kidney disease Safety net |
| url | http://www.sciencedirect.com/science/article/pii/S2451865425000134 |
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