Home-based Conservative Care Model for Advanced Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

Home-based Conservative Care Model for Advanced Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06411613
• Other study ID #: IIR 21-061
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: Susan Wong, MD MS
• Phone: (206) 277-3012
• Email: susan.wong2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2030
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• CC Program
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.

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Health Outcomes Prioritization Scale	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.	1 year
Secondary	Zarit Burden Interview	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).	1 year
Secondary	Consultation Satisfaction Questionnaire	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.	1 year
Secondary	Edmonton Symptom Assessment Scale	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).	1 year
Secondary	EQ-5D-5L	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: 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.; 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).	1 year
Secondary	Non-Enrollment: Provider did not agree to recruitment of Veteran	The investigators will record reasons why eligible Veterans' primary care +/- nephrology provider did not agree to recruitment of Veterans to participate in the study.	1 year
Secondary	Non-Enrollment: Veteran refusal to participate	The investigators will record reasons for refusal to participate in the study by eligible Veterans.	1 year
Secondary	Attrition	The investigators will ask enrolled subjects who withdraw from the study their reasons for withdrawal.	1 year