Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support (V1SAGES)
|ClinicalTrials.gov Identifier: NCT01719991|
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : December 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Diseases||Other: Nurse case management and self-management support||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||247 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pragmatic Evaluation of Case Management and Self-management Support for Vulnerable People With Chronic Diseases in Primary Care|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Nurse case management and self-management support
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
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.
No Intervention: Control group
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).
- Change in patient perception of personal self-efficacy at 6 months [ Time Frame: 6 months ]The patient capacity to self-management measured by the Self-Efficacy for Managing Chronic Disease instrument.
- Change in patient perception of self-management practice at 6 months [ Time Frame: 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).
- Change in patient perception of health behaviours at 6 months [ Time Frame: 6 months ]Fruit and vegetable consumption, smoking status, alcohol consumption, healthy weight and physical activity.
- Change in patient perception of activation at 6 month [ Time Frame: 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 [ Time Frame: 6 months ]Measured by the Psychological Distress instrument.
- Change in patient perception of empowerment at 6 months. [ Time Frame: 6 months ]Health education impact measured by the Health Education Impact Questionnaire (HEIQ).
- Change in patient perception of quality of life at 6 months [ Time Frame: 6 months ]Measured by the 12-Item Short Form Health Survey
- Change in use of health services at 6 months [ Time Frame: 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.
- Socioeconomic status [ Time Frame: 2 weeks before the intervention ]
- Health literacy status [ Time Frame: 2 weeks before the intervention ]The degree to which individuals have the capacity to obtain, process and understand basic health information and services needed to make appropriate health decisions measured by the Newest Vital Sign.
- Mental health status [ Time Frame: 2 weeks before the intervention ]Measured by the Hospital Anxiety and Depression Scale.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719991
|Centre de santé et de services sociaux Lac-Saint-Jean-Est|
|Alma, Quebec, Canada, G8B 5W3|
|Centre de santé et de services sociaux de Chicoutimi|
|Chicoutim, Quebec, Canada, G7H 5H6|
|Principal Investigator:||Catherine Hudon, PhD||Université de Sherbrooke|
|Principal Investigator:||Maud-Christine Chouinard, PhD||Université du Québec à Chicoutimi|