Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pragmatic Evaluation of Case Management and Self-management Support for Vulnerable People With Chronic Diseases in Primary Care

Conditions
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Chronic Diseases

Intervention / Treatment
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* Other: Nurse case management and self-management support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Patient unable to provide consent With cognitive impairment With uncontrolled psychiatric illness Patient with a prognostic of less than one years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse case management and self-management support<br>The first component of the intervention is the monitoring offered under the case management process. The second component of the intervention consists of group meetings (10-12 people) for self-management support in accordance with the stanford model. A sample of patients in each of the four FMGs (n = 126) will be recruited. These patients will receive the intervention for six months. | Other: Nurse case management and self-management support<br>* Case management: The intervention will focus on four main components: (1) A thorough evaluation of the patient's needs and resources; (2) Establishing and maintaining a patient-centered, individualized service plan (ISP); (3) Coordination of services among partners; and (4) Self-management support for patients and their families. Self-management support: A standardized six-week program with interactive weekly group meetings led by two volunteer peer helpers (appointed trainers), who themselves have a chronic disease.<br>|
| No Intervention: Control group<br>Patients in the control group (n = 121) will receive the usual care for six months and then the same intervention as the experimental group for the next five months (waiting list control group). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient perception of personal self-efficacy at 6 months | The patient capacity to self-management measured by the Self-Efficacy for Managing Chronic Disease instrument. | 6 months | 
| Change in patient perception of self-management practice at 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). | 6 months | 
| Change in patient perception of health behaviours at 6 months | Fruit and vegetable consumption, smoking status, alcohol consumption, healthy weight and physical activity. | 6 months | 
| Change in patient perception of activation at 6 month | Patient knowledge, skills and self-confidence in self-management measured by the Patient Activation instrument. | 6 months | 
| Change in patient perception of psychological distress at 6 months | Measured by the Psychological Distress instrument. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient perception of empowerment at 6 months. | Health education impact measured by the Health Education Impact Questionnaire (HEIQ). | 6 months | 
| Change in patient perception of quality of life at 6 months | Measured by the 12-Item Short Form Health Survey | 6 months | 
| Change in use of health services at 6 months | Measured by hospitalizations, emergency room visits and health services use(e.g., psychosocial services or specialized services related to the specific chronic disease. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary care, Self-management, Self-support, Nurse case management