Home-based Conservative Care Model for Advanced Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Field Observations
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Field Observations
时间窗: 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
时间窗: 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.
Patient Interviews
时间窗: 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.
Caregiver Interviews
时间窗: 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.
Clinician Interviews
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Edmonton Symptom Assessment Scale(1 year)
- Health Outcomes Prioritization Scale(1 year)
- EQ-5D-5L(1 year)
- Attrition(1 year)
- Zarit Burden Interview(1 year)
- Consultation Satisfaction Questionnaire(1 year)
- Zarit Burden Interview(1 year)
- Health Outcomes Prioritization Scale(1 year)
- Consultation Satisfaction Questionnaire(1 year)
- Edmonton Symptom Assessment Scale(1 year)
- EQ-5D-5L(1 year)
- Non-Enrollment: Provider Did Not Agree to Recruitment of Veteran(1 year)
- Non-Enrollment: Veteran Refusal to Participate(1 year)
- Attrition(1 year)