Pragmatic Evaluation of Case Management and Self-management Support for Vulnerable People With Chronic Diseases in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 4
- 主要终点
- Change in patient perception of personal self-efficacy at 6 months
研究概览
简要总结
The purpose of this study is to implement a pragmatic intervention in four (4) family medicine groups(FMGs) in the region of Saguenay-Lac-Saint-Jean (Quebec, Canada)for patients with chronic diseases.
详细描述
Chronic diseases represent a major health burden worldwide. Some people with chronic diseases require a higher level of care due to personal characteristics that increase their vulnerability. For these patients, nurse effective case management in primary care are associated with positive outcomes. Moreover, self-management programs, such as the standford program developed by the School of Medicine at the University of Standford in California (USA), are also recognized for their benefits on patients with chronic diseases.
The aim of our project is to implement, within four (4) FMGs of the region of Saguenay-Lac-Saint-Jean , a practical intervention involving case management by a nurse to promote interdisciplinary person-centered monitoring and self-management support for highly vulnerable individuals with chronic diseases (diabetes, cardiovascular diseases, respiratory diseases, musculoskeletal diseases and/or chronic pain).
The objectives of our study : 1) To analyze the implementation of the intervention in the participating FMGs in order to determine how the various contexts have influenced the implementation and the observed effects; 2) To evaluate the proximal and intermediate effects of the intervention on patients; 3) To conduct an economic analysis of the effectiveness and cost-benefit of the intervention.
The analysis of the implementation will be conducted using realistic evaluation approaches and participatory practice within four categories of key players (FMG stakeholders, FMG/health center managers, patients and their families, health center partners or communities). The data will be obtained through individual or group interviews, literature reviews and documentation from the intervention undertaken. The evaluation of the effects in patients will be based on a pragmatic randomized experimental design before and after (six months) with delayed intervention in the control group. Economic analysis will include a cost-effectiveness analysis and a cost-benefit analysis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of the participating FMGs
- •Aged between 25 and 80 years
- •Affected by chronic disease (diabetes, cardiovascular diseases, respiratory diseases, musculoskeletal diseases and/or chronic pain)
- •Identified as a frequent user of health services (by a health care provider or/and a software)
排除标准
- •Patient unable to provide consent
- •With cognitive impairment
- •With uncontrolled psychiatric illness
- •Patient with a prognostic of less than one years
结局指标
主要结局
Change in patient perception of personal self-efficacy at 6 months
时间窗: 6 months
The patient capacity to self-management measured by the Self-Efficacy for Managing Chronic Disease instrument.
Change in patient perception of health behaviours at 6 months
时间窗: 6 months
Fruit and vegetable consumption, smoking status, alcohol consumption, healthy weight and physical activity.
Change in patient perception of activation at 6 month
时间窗: 6 months
Patient knowledge, skills and self-confidence in self-management measured by the Patient Activation instrument.
Change in patient perception of psychological distress at 6 months
时间窗: 6 months
Measured by the Psychological Distress instrument.
Change in patient perception of self-management practice at 6 months
时间窗: 6 months
The patient capacity to manage their condition and their physical and psychological reaction measured by a subscale of the Health Education Impact Questionnaire (HEIQ).
次要结局
- Change in patient perception of quality of life at 6 months(6 months)
- Change in use of health services at 6 months(6 months)
- Change in patient perception of empowerment at 6 months.(6 months)
研究者
Catherine Hudon
MD, Pr
Université de Sherbrooke