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

This study is currently recruiting participants.
Verified April 2014 by Université de Sherbrooke
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Catherine Hudon, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01719991
First received: October 25, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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 Intervention
Chronic Diseases
Other: Nurse case management and self-management support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Change in patient perception of personal self-efficacy at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The patient capacity to self-management mesured by the Self-Efficacy for Managing Chronic Disease instrument.

  • Change in patient perception of self-management practice at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured by the Psychological Distress instrument.


Secondary Outcome Measures:
  • Change in patient perception of empowerment at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured by the SF-12.

  • Change in use of health services at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by hospitalizations, emergency room visits and CSSS services use(e.g., psychosocial services or specialized services related to the specific chronic disease.


Other Outcome Measures:
  • Socio-economic status [ Time Frame: 2 weeks before the intervention ] [ Designated as safety issue: No ]
  • Health literacy status [ Time Frame: 2 weeks before the intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured by the Hospital Anxiety and Depression Scale.


Estimated Enrollment: 400
Study Start Date: November 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 50 patients in each of the four FMGs (n = 200) 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 = 200) 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).

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient of the participating FMGs
  • Aged between 25 and 75 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719991

Contacts
Contact: Mireille Lambert, MA 418-541-1000 ext 3233 mireille.lambert@usherbrooke.ca

Locations
Canada, Quebec
Centre de santé et de services sociaux Lac-Saint-Jean-Est Recruiting
Alma, Quebec, Canada, G8B 5W3
Contact: Mireille Lambert, MA         
Principal Investigator: Maud-Christine Chouinard, PhD         
Centre de santé et de services sociaux de Chicoutimi Recruiting
Chicoutim, Quebec, Canada, G7H 5H6
Contact: Mireille Lambert, MA    418-541-1000 ext 3233    mireille.lambert@usherbrooke.ca   
Principal Investigator: Maud-Christine Chouinard, PhD         
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 University of Sherbrooke
Principal Investigator: Maud-Christine Chouinard, PhD Université du Québec à Chicoutimi
  More Information

No publications provided by Université de Sherbrooke

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catherine Hudon, MD, Pr, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01719991     History of Changes
Other Study ID Numbers: FRSQ-26758
Study First Received: October 25, 2012
Last Updated: April 10, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Sherbrooke:
Primary care
Self-management
Self-support
Nurse case management

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014