Clinical trial NCT05753020: A Pilot Study of The CKM JumpStart Tool
Official title: A Pilot Study of The CKM JumpStart Tool
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Kidney supportive care
Communication
Shared decision-making
Conservative kidney management
Palliative care
End-of-life care
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 76
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Patient-provider discussion of CKM
timeFrame: 3 months
measure: Attrition
timeFrame: 3 months
Secondary outcomes:
measure: Treatment preference
timeFrame: 3 months
measure: Quality of Communication
timeFrame: 3 months
measure: Documentation of CKM Discussion
timeFrame: 3 months
measure: Patient Post-Intervention Interview
timeFrame: 2 weeks
measure: Provider Use of CKM Jumpstart Tool
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Susan P Wong, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: