Clinical trial NCT01719991: Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support
Official title: Pragmatic Evaluation of Case Management and Self-management Support for Vulnerable People With Chronic Diseases in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Diseases
Keywords: Primary care
Self-management
Self-support
Nurse case management
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean
name: Centre de santé et de services sociaux de Chicoutimi
name: Fonds de la Recherche en Santé du Québec
First posted: 2012-11-01
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in patient perception of personal self-efficacy at 6 months
timeFrame: 6 months
measure: Change in patient perception of self-management practice at 6 months
timeFrame: 6 months
measure: Change in patient perception of health behaviours at 6 months
timeFrame: 6 months
measure: Change in patient perception of activation at 6 month
timeFrame: 6 months
measure: Change in patient perception of psychological distress at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change in patient perception of empowerment at 6 months.
timeFrame: 6 months
measure: Change in patient perception of quality of life at 6 months
timeFrame: 6 months
measure: Change in use of health services at 6 months
timeFrame: 6 months
Other outcomes:
measure: Socioeconomic status
timeFrame: 2 weeks before the intervention
measure: Health literacy status
timeFrame: 2 weeks before the intervention
measure: Mental health status
timeFrame: 2 weeks before the intervention
Locations:
city: Alma
country: Canada
facility: Centre de santé et de services sociaux Lac-Saint-Jean-Est
state: Quebec
city: Chicoutim
country: Canada
facility: Centre de santé et de services sociaux de Chicoutimi
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Catherine Hudon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université du Québec à Chicoutimi
name: Maud-Christine Chouinard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hudon C, Chouinard MC, Dubois MF, Roberge P, Loignon C, Tchouaket E, Lambert M, Hudon E, Diadiou F, Bouliane D. Case Management in Primary Care for Frequent Users of Health Care Services: A Mixed Methods Study. Ann Fam Med. 2018 May;16(3):232-239. doi: 10.1370/afm.2233.
citation: Couture EM, Chouinard MC, Fortin M, Hudon C. The relationship between health literacy and patient activation among frequent users of healthcare services: a cross-sectional study. BMC Fam Pract. 2018 Mar 9;19(1):38. doi: 10.1186/s12875-018-0724-7.
citation: Couture EM, Chouinard MC, Fortin M, Hudon C. The relationship between health literacy and quality of life among frequent users of health care services: a cross-sectional study. Health Qual Life Outcomes. 2017 Jul 6;15(1):137. doi: 10.1186/s12955-017-0716-7.
citation: Chouinard MC, Hudon C, Dubois MF, Roberge P, Loignon C, Tchouaket E, Fortin M, Couture EM, Sasseville M. Case management and self-management support for frequent users with chronic disease in primary care: a pragmatic randomized controlled trial. BMC Health Serv Res. 2013 Feb 7;13:49. doi: 10.1186/1472-6963-13-49.