A Pilot Study of The CKM JumpStart Tool

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-10

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CKM Jumpstart Tool

Receives intervention

Group Type EXPERIMENTAL

CKM Jumpstart Tool

Intervention Type BEHAVIORAL

The CKM JumpStart Tool is a 1-page handout that describes the values of a patient and words that a providers can try with the patient to explore the patient' values more and to provide a values-based introduction to CKM. The values described in the CKM JumpStart Tool is based on a patient's response to a single validated question that we will ask the patient at T1, if they had to choose, do they value care directed at longevity or comfort. Using the patient's answer to the values question, study staff will generate a CKM JumpStart Tool prior to their upcoming clinic visit with their nephrologist. Study staff will inform the patient that their response to the values question will be shared with their provider prior to their next clinic visit and that their providers might bring up their values and treatment options for kidney disease, if the situation permits. We will share the CKM Jumpstart Tool with their provider and provide instruction on how to use the Tool.

Control

Does not receive intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CKM Jumpstart Tool

The CKM JumpStart Tool is a 1-page handout that describes the values of a patient and words that a providers can try with the patient to explore the patient' values more and to provide a values-based introduction to CKM. The values described in the CKM JumpStart Tool is based on a patient's response to a single validated question that we will ask the patient at T1, if they had to choose, do they value care directed at longevity or comfort. Using the patient's answer to the values question, study staff will generate a CKM JumpStart Tool prior to their upcoming clinic visit with their nephrologist. Study staff will inform the patient that their response to the values question will be shared with their provider prior to their next clinic visit and that their providers might bring up their values and treatment options for kidney disease, if the situation permits. We will share the CKM Jumpstart Tool with their provider and provide instruction on how to use the Tool.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes