Trial Outcomes & Findings for Home-based Conservative Care Model for Advanced Kidney Disease (NCT NCT06411613)
NCT ID: NCT06411613
Last Updated: 2025-10-14
Results Overview
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.
TERMINATED
NA
2 participants
1 year
2025-10-14
Participant Flow
Only patients with advanced CKD were enrolled in the study. Caregivers and clinicians were not enrolled.
Participant milestones
| Measure |
CC Program Received Intervention
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
Does not receive intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Home-based Conservative Care Model for Advanced Kidney Disease
Baseline characteristics by cohort
| Measure |
CC Program Received Intervention
n=1 Participants
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
n=1 Participants
Does not receive intervention.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 yearPopulation: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 yearPopulation: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
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
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 yearPopulation: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
Clinical progress notes entered into each patient's electronic medical record during the study period and abstract passages documenting care considerations regarding CKD.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 yearPopulation: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
At each study visit, patients will be asked to rank their health priorities and whether they receive care that is aligned with their top priority using the Health Outcomes Prioritization Scale: priority score 0-100 of four universal health outcomes: keeping you alive, maintaining independence, reducing or eliminating pain, and reducing or eliminating other symptoms, with higher scores indicating that the outcome was more important.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
At each study visit, caregivers will be asked about caregiver strain: a 12 item survey asking caregivers to rate the frequency with which they experience different forms of caregiver strain using the Zarit Burden Interview (4-point scale which describes degree of burden experienced from 0=never to 4=almost always).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
At each study visit patients will be ask to rate their level of satisfaction with the care they receive using the Consultation Satisfaction Questionnaire. The Consultation Satisfaction Questionnaire is a 17-item survey utilizing Likert Scale responses: strongly disagree, somewhat disagree, neutral, somewhat agree, strongly agree, to assess overall care, professionalism, communication, time spent, and depth of the relationship with clinicians involved in their kidney care based on their last clinical visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
At each study visit, patients will be asked about the presence and severity of common symptoms of advanced CKD using the Edmonton Symptom Assessment Scale (numeric rating scale 0=no symptoms to 10=worst possible).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
At each study visit, patients will be asked to rate different domains of their quality of life and overall health using the EuroQol 5D Questionnaire (EQ-5D-5L) to assess health-related quality of life. The EQ-5D-5L consists of two parts: 1. EQ-5D Descriptive System: Includes Five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has five levels of severity ranging from no problems to extreme problems. The respondent indicates their health state by selecting the most appropriate level for each dimension. 2. EQ Visual Analogue Scale (EQ-VAS): a scale where respondents rate their overall health from The worst health you can imagine (0) to the best health you can imagine (100).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
The investigators will record reasons why eligible Veterans' primary care +/- nephrology provider did not agree to recruitment of Veterans to participate in the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
The investigators will record reasons for refusal to participate in the study by eligible Veterans.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
The investigators will ask enrolled subjects who withdraw from the study their reasons for withdrawal.
Outcome measures
Outcome data not reported
Adverse Events
CC Program Received Intervention
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place