The DIVERT-CARE (Collaboration Action Research & Evaluation) Trial: A Multi Provincial Pragmatic Cluster Randomized Trial of Cardio-Respiratory Management in Home Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 896
- 试验地点
- 6
- 主要终点
- The difference in days to first unplanned emergency department visit (hazard rate)
研究概览
简要总结
Rationale:
In Canada, home care clients are a large and expanding subgroup of medically complex older adults with relatively poor access to effective chronic disease management. They have double the emergency department utilization rate compared to nursing home residents or other older populations. The investigators previously published a case-finding tool (the Detection of Indicators and Vulnerabilities for Emergency Room Trips (DIVERT) Scale) that has been recommended for chronic disease management case-finding in home care. The investigators recently conducted a pilot trial in Niagara, Canada, of a targeted, person-centered model of supportive cardio-respiratory disease management.
Objectives:
The investigators will evaluate a cardio-respiratory disease management model in home care to manage symptoms and avoid emergency department use. A pan-Canadian, pragmatic cluster-randomized trial will be conducted by a collaboration of trial investigators and public home care providers (i.e., health regions).
The main objective is to evaluate the effectiveness and preliminary cost-effectiveness of a targeted, person-centered cardio-respiratory management model.
The main question is:
P: Among home care clients experiencing cardio-respiratory symptoms (objectively targeted using the DIVERT Scale), I: can a guideline-based, feasible, multi-component/complex, cardio-respiratory management model, C: compared to regular care, O: reduce cardio-respiratory symptoms, reduce/postpone unplanned emergency department (ED) visits, reduce unplanned hospital use, improve patient activation, or improve health-related quality of life for clients, T: over a 6-month follow-up period from baseline?
详细描述
BACKGROUND
Context:
Public home care services are delivered to at least 6% of Canadians age 65-74, 15% age 75-84 and 32% age 85 or older. These clients are medically complex, access care across settings, have very high emergency department utilization rates, and have relatively poor access to effective chronic disease management. Their frequent emergency department use is not aligned with chronic disease management or geriatric care principles.
Effective chronic disease management models employ multiple components delivered by a coordinated multidisciplinary team. According to the 'chronic disease management model', home care plays a complementary function to medical practitioners. Clinical and self-care support as well as case management are among the most effective components in chronic disease management. Self-care education and support has been shown to improve health outcomes across chronic diseases. Sustained follow-up by nurses or other non-medical staff is also effective.
Canadian home care providers, historically focused on the delivery of personal support services, have started to develop supportive chronic disease management capacity (e.g. specialist nurse monitoring). However, most trials exclude frail seniors and are not specific to home care, which leaves little evidence to inform chronic disease management practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Long-stay home care clients living in a noninstitutional setting (i.e. Admitted to home care and receive comprehensive clinical assessment (RAI-HC))
- •DIVERT score of 9, 10, 14, or 15 (i.e. at least one cardio-respiratory symptom (chest pain, dyspnea, dizziness, irregular pulse) and at least one cardiac condition (congestive heart failure or coronary artery disease))
排除标准
- •Clients receiving palliative care (i.e. Prognosis of less than six months to live at time of assessment (Q. K8e from RAI-HC))
- •Clients receiving dialysis (Q. P2g from RAI-HC)
结局指标
主要结局
The difference in days to first unplanned emergency department visit (hazard rate)
时间窗: Up to six months from baseline
As identified from NACRS data set
Changes in patient activation (patient activation questionnaire)
时间窗: Baseline, 2 months, 4 months, 6 months
As identified from PAM measure
The difference in total care costs controlling for length of stay
时间窗: Up to six months from baseline
As identified in administrative (service cost) data sets
The difference in the number of symptoms
时间窗: Baseline, 2 months, 4 months, 6 months
As identified from RAI-HC data set
次要结局
- Description of health-related quality of life (quality of life questionnaire)(Baseline, 4 months, 6 months)
- The difference in the number of unplanned emergency department visits(Up to six months from baseline)
研究者
Andrew Costa
Assistant Professor and Schlegel Chair in Clinical Epidemiology & Aging
McMaster University