Chronic Kidney Diseases Clinical Trial
Official title:
A Pilot Study of The CKM JumpStart Tool
This is a randomized pilot study to test the feasibility and acceptability of a tool to promote discussion about conservative kidney management (CKM) among older patients with advanced CKD and their providers.
Status | Recruiting |
Enrollment | 76 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 75 Years and older |
Eligibility | Patients Inclusion: - Adults aged =75 years - Advanced CKD as defined as having at least 2 outpatient measures of eGFR <25 ml/min/1.73m2 separated by >90 days in the prior year and with at least 1 eGFR measure <20. - English-speaking - Receive care from a provider at UW Medicine or VA Puget Sound - Open to discussing their values and treatment options for kidney disease with their provider. Exclusion: - Unable to complete the informed consent process - Currently receiving maintenance dialysis Providers Inclusion - Their patient is a participant in the study. - Are a UW Medicine or VA Puget Sound provider or trainee. Exclusion • None |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
United States | VA Puget Sound Health Care System | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient-provider discussion of CKM | We will ask patients whether they had discussed CKM with their healthcare provider at T2 and T3. | 3 months | |
Primary | Attrition | We will record the proportion of participants in each study arm who withdraw from the study and the reasons why at T2 and T3. Study withdrawal would indicate that the Tool and/or study is unacceptable or burdensome to the participant. | 3 months | |
Secondary | Treatment preference | At each study visit, we will record each patient's preference for dialysis or CKM using the Decision Conflict Scale at each study visit. | 3 months | |
Secondary | Quality of Communication | At each study visit, patients will be asked to rate the quality of serious illness communication with their nephrologists using the Quality of Communication Questionnaire. | 3 months | |
Secondary | Documentation of CKM Discussion | At T2 and T3, we will review each patient's recent nephrology clinic notes to determine whether their providers documented a discussion with patients about CKM. | 3 months | |
Secondary | Patient Post-Intervention Interview | For patients randomized to receive the intervention, at T2, patients will be invited to answer 4 open-ended questions about their clinical encounter with their provider. Questions will pertain to topics discussed during the encounter with their provider, whether their provider asked them about their values, whether CKM was discussed, and their perception of CKM based on the conversation. | 2 weeks | |
Secondary | Provider Use of CKM Jumpstart Tool | For patients randomized to receive the intervention, at T2, their providers will be asked whether they had used the CKM Jumpstart Tool during their visit, and if not their reasons for not using the Tool. | 2 weeks |
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