Expanding Access to Home-Based Palliative Care Through Primary Care Medical Groups
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Edmonton Symptom Assessment Survey for Patients
研究概览
简要总结
This study will test the effectiveness of integrating an evidence-based model of home-based palliative (HBPC) within primary care clinics on patient and caregiver outcomes. The investigators will conduct a randomized controlled trial, randomizing 1,155 seriously ill patients (and approximately 884 family caregivers) who receive primary care from 30-40 regional accountable care organizations (ACOs) in California to one of two study groups: HBPC or enhanced usual care (EUC). Follow-up data will be collected via telephone surveys with patients at 1- and 2-months and with caregivers at 1- and 2-months, and, as appropriate, following the death of the patient.
详细描述
Background and Significance
Patients with serious illness from cancer, heart failure (HF), and chronic obstructive pulmonary disease (COPD) often receive poor quality of care, resulting in unmitigated pain and related symptoms, unmet psychosocial needs, and significant caregiver burden. Palliative care, a patient-centered approach that provides pain and symptom management and psychosocial and spiritual support, has strong evidence for improved outcomes for these seriously ill patients. Palliative care differs from hospice in that it is offered early in the illness course and in conjunction with other therapies intended to prolong life. Most palliative care programs are hospital-based; few offer care at home, where patients spend the most time and require the most support.
Study Aims
This study will test the effectiveness of integrating an evidence-based model of home-based palliative (HBPC) within primary care clinics on patient and caregiver outcomes. The investigators will conduct a randomized controlled trial, randomizing 1,155 seriously ill patients (and approximately 884 family caregivers) who receive primary care from 30-40 regional accountable care organizations (ACOs) in California to one of two study groups: HBPC or enhanced usual care (EUC). Follow-up data will be collected via telephone surveys with patients at 1- and 2-months and with caregivers at 1- and 2-months, and, as appropriate, following the death of the patient.
The study's specific aims are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older;
- •diagnosis of HF, COPD, or advanced cancer;
- •one or more hospitalizations or ED visits in the previous year;
- •an Australia-Modified Karnofsky Performance Scale score of 70% or less; and
- •English- or Spanish-speaking.
排除标准
- •is receiving hospice care;
- •has end-stage renal disease; and/or
- •lives in a nursing home.
结局指标
主要结局
Edmonton Symptom Assessment Survey for Patients
时间窗: 1-month following baseline
The Edmonton Symptom Assessment Survey for patients is a brief and reliable self-report assessment that measures the frequency and intensity of a variety of physical and psychological symptoms. Response scores range from 0 (no pain/symptoms) to 90 (highest pain symptoms) based on responses scored from 0 (no pain/symptoms) to 10 (highest pain/symptoms) on 9 items. Note: our data represents the composite score of the 9 items.
Hospital Anxiety and Depression Scale (HADS) for Patients
时间窗: 1-month following baseline
The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that measures anxiety and depression using a 4-point Likert scale. The assessment consists of 14 patient-reported items, with seven questions reflecting anxiety (HADS-A) and seven reflecting depression (HADS-D). The total score for each subscale ranges from 0 to 21, and the total score is the sum of the two subscale scores. Low scores indicate normal responses while high scores are abnormal (0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal).
次要结局
- Patient Health Questionnaire-9 (PHQ-9) for Patients(1-months following baseline)
- Rating of Being at Peace Among Patients(1-month following baseline)
- Hearth Hope Index for Patients(1-month following baseline)
- Consultation Care Measure (CCM) for Patients(At 1 months following baseline)
- Zarit Burden: Short (ZBI) Interview Among Caregivers(At 1 month following baseline)
- Caregiver's Experience of Death Rating on Family Assessment of Treatment at End of Life- Short Form (FATE-S), When Applicable.(Two months following the death of a patient)
- Hospital Anxiety and Depression Scale (HADS) for Caregivers(At 1 month following baseline)
- Consultation Care Measure (CCM) for Caregivers(At 1- month following baseline)
研究者
Susan Enguidanos
Associate Professor of Gerontology
University of Southern California