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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Diseases
• Intervention / Treatment: Other: Nurse case management and self-management support

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 Type: Interventional
• Enrollment (Actual): 247
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Alma, Quebec, Canada, G8B 5W3
      • Centre de santé et de services sociaux Lac-Saint-Jean-Est
    • Chicoutim, Quebec, Canada, G7H 5H6
      • Centre De Sante Et De Services Sociaux De Chicoutimi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant 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).

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socioeconomic status		2 weeks before the intervention
Health literacy status	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.	2 weeks before the intervention
Mental health status	Measured by the Hospital Anxiety and Depression Scale.	2 weeks before the intervention

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Fonds de la Recherche en Santé du Québec; Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean; Centre de santé et de services sociaux de Chicoutimi
• Investigators: Principal Investigator: Catherine Hudon, PhD, Universite de Sherbrooke; Principal Investigator: Maud-Christine Chouinard, PhD, Université du Québec à Chicoutimi

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: October 25, 2012
• First Submitted That Met QC Criteria: October 31, 2012
• First Posted (Estimate): November 1, 2012

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Primary care; Self-management; Self-support; Nurse case management
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: FRSQ-26758

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No