Clinical trial NCT06411613: Home-based Conservative Care Model for Advanced Kidney Disease
Official title: Home-based Conservative Care Model for Advanced Kidney Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: CKD
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-05-13
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Test the feasibility and acceptability of a novel care program
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a randomized pilot study to test the feasibility and acceptability of a novel conservative care (CC) pathway among patients with advanced chronic kidney disease (CKD) who have chosen to forgo initiation of maintenance dialysis, their caregivers and providers.

Detailed description: This study is a randomized pilot study to test the acceptability and feasibility of a CC pathway, called the Kidney Care at Home Program, with patients with advanced CKD who have chosen to forgo dialysis, their caregivers and providers. The novel CC program will be developed upon an existing home-based multidisciplinary care (MDC) program in the Veterans Affairs (VA) called the Home-Based Primary Care (HBPC) program. HBPC provides for Veterans with multimorbidity and functional limitation with the goal of supporting Veterans' quality of life and mitigating the complications of illness through to the end of life.

The investigators hypothesize that HBPC serves as the ideal starting ground to build the VA's first CC program for Veterans with advanced CKD. The investigators will use implementation science and ethnographic research methods, including field observations, interviews, medical record review, and serial structured surveys on quality of life, symptom burden, care satisfaction and goal concordant care to assess the feasibility and acceptability of the Kidney Care at Home Program (intervention) vs. usual care (control).

Eligibility criteria: Inclusion Criteria:

Patients:

* Receives primary +/- nephrology care from VAPS as defined as having at least 1 outpatient primary or nephrology visit in the prior year
* Advanced CKD as defined as defined as having 2 or more outpatient measures of an eGFR 20 ml/min/1.73m2 separated by 90 or more days
* Unsure or do not wish to undergo maintenance dialysis
* Agreement by their VA primary +/- nephrology care provider that patients can participate in the study

Caregivers:

* Nominated by enrolled patient as a caregiver whom patient agrees to participate in the study

Clinicians:

* Employed at VAPS
* Identified by enrolled Veterans as important to their CKD and nominated by the Veteran to be interviewed for the study

Exclusion Criteria:

Patients:

* Unable to complete "teach-back" method of informed consent
* Currently receiving maintenance dialysis
* Currently enrolled in HBPC Program

Caregivers:

* Unable to complete "teach-back" method of informed consent
* If a Veteran withdraws from the study, their caregivers' participation in the study is also terminated at that time

Clinicians:

* If a Veteran withdraws from the study, their clinicians will no longer be eligible to participate in interviews

Primary outcomes:
measure: Patient interviews
timeFrame: 1 year
measure: Clinician interviews
timeFrame: 1 year
measure: Field Observations
timeFrame: 1 year
measure: Document Review
timeFrame: 1 year
measure: Caregiver interviews
timeFrame: 1 year
Secondary outcomes:
measure: Health Outcomes Prioritization Scale
timeFrame: 1 year
measure: Zarit Burden Interview
timeFrame: 1 year
measure: Consultation Satisfaction Questionnaire
timeFrame: 1 year
measure: Edmonton Symptom Assessment Scale
timeFrame: 1 year
measure: EQ-5D-5L
timeFrame: 1 year
measure: Non-Enrollment: Provider did not agree to recruitment of Veteran
timeFrame: 1 year
measure: Non-Enrollment: Veteran refusal to participate
timeFrame: 1 year
measure: Attrition
timeFrame: 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Ann M. O'Hare, MD MA
role: PRINCIPAL_INVESTIGATOR
References: