A Pilot Study of The CKM JumpStart Tool

Not Applicable

Recruiting

• Conditions: Chronic Kidney Diseases
• Interventions: Behavioral: CKM Jumpstart Tool

• Registration Number: NCT05753020
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

This study is a randomized pilot study to test the acceptability and feasibility of a novel communication tool, called the CKM Jumpstart Tool, to promote discussion of CKM between patients with advanced CKM and their healthcare providers, the investigators hypothesize that the Guide will be feasible and acceptable to patients and their healthcare providers as reflected in greater discussion of CKM between them following use of the Tool as compared with usual care. The investigators will enroll 76 patients aged 75 years and older with advanced CKD and their healthcare providers from University of Washington Medicine and Veterans Affairs Puget Sound Health Care System. Patients will be randomized together in a 1:1 fashion to receive the intervention or usual care. Data from participants will be collected at the time of enrollment (T1), within 2-weeks of their following clinic visit with their healthcare provider (T2), and approximately 3-month after this clinic visit (T3). The primary outcome measure and measure of feasibility is difference in patient-reported rates of discussion of CKM with a healthcare provider at T2 and T3. The investigators will also evaluate whether provider document in the medical chart of patients whether they had a discussion about CKM with the patient at T2 and T3. The investigators will also collect attrition rates at T2 and T3 as a measure of acceptability. The investigators will further assess user experience of the CKM JumpStart by performing a qualitative analysis of post-intervention interviews with patients and nephrologists, coding for themes elucidating pros, cons and other considerations with using the CKM JumpStart Tool and discussion about CKM.

Study Timeline

• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-03-03
• Study Start: 2023-04-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CKM Jumpstart Tool	CKM Jumpstart Tool	Receives intervention

Primary Outcome Measures

Name	Time	Method
Patient-provider discussion of CKM	3 months	We will ask patients whether they had discussed CKM with their healthcare provider at T2 and T3.
Attrition	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Treatment preference	3 months	At each study visit, we will record each patient's preference for dialysis or CKM using the Decision Conflict Scale at each study visit.
Quality of Communication	3 months	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.
Documentation of CKM Discussion	3 months	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.
Patient Post-Intervention Interview	2 weeks	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.
Provider Use of CKM Jumpstart Tool	2 weeks	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.

Trial Locations

Locations (2)

VA Puget Sound Health Care System; 🇺🇸 Seattle, Washington, United States

University of Washington; 🇺🇸 Seattle, Washington, United States