--- title: Home-based Conservative Care Model for Advanced Kidney Disease nct_id: NCT06411613 overall_status: TERMINATED phase: NA sponsor: VA Office of Research and Development study_type: INTERVENTIONAL primary_condition: Chronic Kidney Diseases countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06411613.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06411613" ct_last_update_post_date: 2025-10-14 last_seen_at: "2026-05-12T06:54:56.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Home-based Conservative Care Model for Advanced Kidney Disease **NCT ID:** [NCT06411613](https://clinicaltrials.gov/study/NCT06411613) ## Key Facts - **Status:** TERMINATED - **Why Stopped:** Due to a budget deficit and hiring freeze, the intervention could not be implemented. Consequently, the study was modified from a pilot trial to an observational study. - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 2 - **Lead Sponsor:** VA Office of Research and Development - **Conditions:** Chronic Kidney Diseases - **Start Date:** 2024-07-31 - **Completion Date:** 2024-08-06 - **CT.gov Last Update:** 2025-10-14 ## 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 - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** Yes ``` 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 ``` ## Arms - **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. - **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. ## Primary Outcomes - **Patient Interviews** _(time frame: 1 year)_ — 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. - **Clinician Interviews** _(time frame: 1 year)_ — 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. - **Field Observations** _(time frame: 1 year)_ — 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 - **Document Review** _(time frame: 1 year)_ — Clinical progress notes entered into each patient's electronic medical record during the study period and abstract passages documenting care considerations regarding CKD. - **Caregiver Interviews** _(time frame: 1 year)_ — 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. ## Secondary Outcomes - **Health Outcomes Prioritization Scale** _(time frame: 1 year)_ - **Zarit Burden Interview** _(time frame: 1 year)_ - **Consultation Satisfaction Questionnaire** _(time frame: 1 year)_ - **Edmonton Symptom Assessment Scale** _(time frame: 1 year)_ - **EQ-5D-5L** _(time frame: 1 year)_ - **Non-Enrollment: Provider Did Not Agree to Recruitment of Veteran** _(time frame: 1 year)_ - **Non-Enrollment: Veteran Refusal to Participate** _(time frame: 1 year)_ - **Attrition** _(time frame: 1 year)_ ## Locations (1) - VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle, Washington, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.whyStopped` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.va puget sound health care system seattle division, seattle, wa|seattle|washington|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06411613.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06411613* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*