V1SAGES: Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support

Sponsor

Université de Sherbrooke (Other)

Overall Status

Completed

CT.gov ID

NCT01719991

Collaborator

Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean (Other), Centre de santé et de services sociaux de Chicoutimi (Other), Fonds de la Recherche en Santé du Québec (Other)

247

Enrollment

Locations

Arms

Duration (Months)

123.5

Patients Per Site

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Diseases	Other: Nurse case management and self-management support	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

247 participants

Allocation:

Randomized

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 :

Nov 1, 2012

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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).

Arm

Intervention/Treatment

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).

Outcome Measures

Primary Outcome Measures

Change in patient perception of personal self-efficacy at 6 months [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 [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 [6 months]
Fruit and vegetable consumption, smoking status, alcohol consumption, healthy weight and physical activity.
Change in patient perception of activation at 6 month [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 [6 months]
Measured by the Psychological Distress instrument.

Secondary Outcome Measures

Change in patient perception of empowerment at 6 months. [6 months]
Health education impact measured by the Health Education Impact Questionnaire (HEIQ).
Change in patient perception of quality of life at 6 months [6 months]
Measured by the 12-Item Short Form Health Survey
Change in use of health services at 6 months [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.

Other Outcome Measures

Socioeconomic status [2 weeks before the intervention]
Health literacy status [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 [2 weeks before the intervention]
Measured by the Hospital Anxiety and Depression Scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de santé et de services sociaux Lac-Saint-Jean-Est	Alma	Quebec	Canada	G8B 5W3
2	Centre de santé et de services sociaux de Chicoutimi	Chicoutim	Quebec	Canada	G7H 5H6

Sponsors and Collaborators

Université de Sherbrooke
Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean
Centre de santé et de services sociaux de Chicoutimi
Fonds de la Recherche en Santé du Québec

Investigators

Principal Investigator: Catherine Hudon, PhD, Université de Sherbrooke
Principal Investigator: Maud-Christine Chouinard, PhD, Université du Québec à Chicoutimi