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

Chronic Diseases Clinical Trial

— V1SAGES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719991
• Other study ID #: FRSQ-26758
• Status: Completed
• Phase: N/A
• First received: October 25, 2012
• Last updated: December 1, 2014
• Start date: November 2012
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre de santé et de services sociaux Lac-Saint-Jean-Est	Alma	Quebec
Canada	Centre de santé et de services sociaux de Chicoutimi	Chicoutim	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Socioeconomic status		2 weeks before the intervention	No
Other	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	No
Other	Mental health status	Measured by the Hospital Anxiety and Depression Scale.	2 weeks before the intervention	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Change in patient perception of psychological distress at 6 months	Measured by the Psychological Distress instrument.	6 months	No
Secondary	Change in patient perception of empowerment at 6 months.	Health education impact measured by the Health Education Impact Questionnaire (HEIQ).	6 months	No
Secondary	Change in patient perception of quality of life at 6 months	Measured by the 12-Item Short Form Health Survey	6 months	No
Secondary	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	No