Home-based Conservative Care Model for Advanced Kidney Disease

NCT06411613 | Terminated Results

• 1 other identifier: IIR 21-061
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

CKD

Outcome Measures

Primary Outcomes (5)

• Patient Interviews

  At each study visit, patients will be invited to complete a 45- to 60-minute interview to ascertain their experiences with and perspectives on their kidney care. Interviews will follow a structured guide intended to elicit: 1) benefits; 2) challenges; 3) unanticipated issues; and, 4) opportunities to improve respective approaches to care. Non-specific probes will be used to prompt subjects to elaborate on their responses for greater depth and detail. Veterans will be interviewed separately, in private, and in-person or by phone according to each person's preference. All interviews will be audio-recorded then transcribed without personal identifiers.

  1 year

• Clinician Interviews

  Clinicians will be invited to participate in up to two 30-minute structured interviews about their perception of their experiences with and perspectives on patients' kidney care. Interviews will follow a structured guide similar to that for Veterans and caregivers.

  1 year

• Field Observations

  Patients will invite study staff to observe clinical encounters that they perceive as important to their kidney care. These clinical encounters can include face-to-face, telephone, and video encounters. During the encounter, study staff will either digitally audio-record and/or note-take conversations and interactions or only observe and note-take after the encounter per each subject's preference. After the encounter is complete, we will ask subjects clarifying questions about the encounter as needed

  1 year

• Document Review

  Clinical progress notes entered into each patient's electronic medical record during the study period and abstract passages documenting care considerations regarding CKD.

  1 year

• Caregiver Interviews

  At each study visit caregivers of patients will be invited to complete a 45- to 60-minute interview to ascertain their experiences with and perspectives on the patient's kidney care. Interviews will follow a structured guide intended to elicit: 1) benefits; 2) challenges; 3) unanticipated issues; and, 4) opportunities to improve respective approaches to care. Non-specific probes will be used to prompt subjects to elaborate on their responses for greater depth and detail. Caregivers will be interviewed separately, in private, and in-person or by phone according to each person's preference. All interviews will be audio-recorded then transcribed without personal identifiers.

  1 year

Secondary Outcomes (8)

• Health Outcomes Prioritization Scale

  1 year

• Zarit Burden Interview

  1 year

• Consultation Satisfaction Questionnaire

  1 year

• Edmonton Symptom Assessment Scale

  1 year

• EQ-5D-5L

  1 year

Study Arms (2)

CC Program Received Intervention

EXPERIMENTAL

The CC Program will be delivered through the existing HBPC infrastructure at VA Puget Sound Health Care System. Each HBPC team is comprised on a lead physician or nurse practitioner, nurse, pharmacist, nutritionist, social worker, psychologist, therapist, and chaplain. At a minimum, subsequent clinical encounters and assessments for each Veteran will be scheduled no less than on a quarterly basis and more often as needed based on the HBPC team's clinical judgment. On a monthly basis, the entire HBPC team will conduct MDC meetings to review each Veteran's medical plan. The Program aims to provide patient-centered, whole-person and team-based care, shared decision-making, active symptom management, advance care planning and end-of-life care.

Other: CC Program

Usual Care

NO INTERVENTION

Does not receive intervention.

Interventions

CC Program OTHER

The CC Program will be delivered through the existing HBPC infrastructure at VA Puget Sound Health Care System. Each HBPC team is comprised on a lead physician or nurse practitioner, nurse, pharmacist, nutritionist, social worker, psychologist, therapist, and chaplain. At a minimum, subsequent clinical encounters and assessments for each Veteran will be scheduled no less than on a quarterly basis and more often as needed based on the HBPC team's clinical judgment. On a monthly basis, the entire HBPC team will conduct MDC meetings to review each Veteran's medical plan. The Program aims to provide patient-centered, whole-person and team-based care, shared decision-making, active symptom management, advance care planning and end-of-life care.

CC Program Received Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dawn Bates
• Organization: VA Puget Sound Health Care System

dawn.bates@va.gov

206-277-3012

Study Officials

• Ann M. O'Hare, MD MA

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Test the feasibility and acceptability of a novel care program

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 13, 2024
• Study Start: July 31, 2024
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: October 14, 2025
• Results First Posted: October 14, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available immediately following publication, ending 5 years following article publication.
• Access Criteria: Available immediately following publication, ending 5 years following article publication.

Locations

US (1)