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A Pilot Study of The CKM JumpStart Tool

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University of Washington

Status

Enrolling

Conditions

Chronic Kidney Diseases

Treatments

Behavioral: CKM Jumpstart Tool

Study type

Interventional

Funder types

Other

Identifiers

NCT05753020
STUDY00017195

Details and patient eligibility

About

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.

Full 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.

Enrollment

76 estimated patients

Sex

All

Ages

75+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

76 participants in 2 patient groups

CKM Jumpstart Tool
Experimental group
Description:
Receives intervention
Treatment:
Behavioral: CKM Jumpstart Tool
Control
No Intervention group
Description:
Does not receive intervention

Trial documents
1

Trial contacts and locations

2

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Central trial contact

Olivia Gaughran, MA

Data sourced from clinicaltrials.gov

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