Chronic Kidney Diseases
Conditions
Keywords
CKD
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).
Interventions
OTHERCC 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Test the feasibility and acceptability of a novel care program
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Interviews | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Non-Enrollment: Provider Did Not Agree to Recruitment of Veteran | 1 year | The investigators will record reasons why eligible Veterans' primary care +/- nephrology provider did not agree to recruitment of Veterans to participate in the study. |
| Health Outcomes Prioritization Scale | 1 year | 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. |
| Attrition | 1 year | The investigators will ask enrolled subjects who withdraw from the study their reasons for withdrawal. |
| Non-Enrollment: Veteran Refusal to Participate | 1 year | The investigators will record reasons for refusal to participate in the study by eligible Veterans. |
| Zarit Burden Interview | 1 year | 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). |
| Consultation Satisfaction Questionnaire | 1 year | 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. |
| Edmonton Symptom Assessment Scale | 1 year | 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). |
| EQ-5D-5L | 1 year | 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). |
Countries
United States
Participant flow
Pre-assignment details
Only patients with advanced CKD were enrolled in the study. Caregivers and clinicians were not enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Usual Care Does not receive intervention. | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | CC Program Received Intervention | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
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.
Time frame: 1 year
Population: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
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.
Time frame: 1 year
Population: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
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.
Time frame: 1 year
Population: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
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
Time frame: 1 year
Population: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
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.
Time frame: 1 year
Population: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
Secondary
Attrition
The investigators will ask enrolled subjects who withdraw from the study their reasons for withdrawal.
Time frame: 1 year
Population: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
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.
Time frame: 1 year
Population: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
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).
Time frame: 1 year
Population: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
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: 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).
Time frame: 1 year
Population: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
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.
Time frame: 1 year
Population: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
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.
Time frame: 1 year
Population: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
Secondary
Non-Enrollment: Veteran Refusal to Participate
The investigators will record reasons for refusal to participate in the study by eligible Veterans.
Time frame: 1 year
Population: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.
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).
Time frame: 1 year
Population: Due to a budget deficit and hiring freeze, the intervention could not be implemented and will not be collected in the future.