Impact of a Regional Program Agir Sur Sa SantE

May 15, 2023 updated by: Université de Sherbrooke

Agir Sur Sa SantE- Impact of a Regional Integrated Prevention and Management of Cardio-metabolic Chronic Diseases Program in Primary Care

The prevention and control of lifestyle-related non-communicable chronic diseases, including diabetes, obesity and cardiovascular disorders, that share common risk factors, has now become a major focus of the World Health Organization. Lifestyle modification, like improvement of diet, physical activity and tobacco cessation, is the corner stone of diabetes and cardio-metabolic chronic diseases (CMCD) prevention and management. Under the leadership of decision-makers of our regional health Agency in order to improve accessibility and quality of care, our team has collaborated to the development and implementation of an integrated care framework for the prevention and management of cardio-metabolic chronic diseases in primary care. This new care framework is currently being implemented in the context of community health centers (fall 2014) and family medicine groups (spring 2015), with the support of a Quebec Ministry of Health grant. The current research proposal aims to evaluate the implementation of this new care framework and explore its impact in the primary care context. This project is very important as it will generate knowledge on new models of care integrating preventive and management interventions in primary care settings, in continuum with specialized health care services and their implementation in an entire region.

Study Overview

Detailed Description

BACKGROUND: In an era where cardio-metabolic chronic diseases (CMCD) take epidemic proportions, health systems have to react by providing care to manage but also to prevent them. Our region has demonstrated leadership in developing and implementing regional care frameworks and patient trajectories defining services throughout the continuum of care (from community to primary to specialized care). However, these diabetes, cardiac rehabilitation and 0-5-30 prevention programs have been implemented in silos. Under the leadership of decision-makers of our regional health Agency, in order to improve accessibility and quality of care, our team has worked on the development and implementation of an integrated care framework for the prevention and management of cardio-metabolic chronic diseases: Agir Sur Sa SantÉ (ASSSÉ). This new framework, based on individual/group motivational techniques, care protocols and collective orders, is currently being implemented in the context of community health centers (CSSS). The investigators recently received a Quebec Ministry of Health grant to continue supporting the implementation in CSSS, implement the care framework in family medicine groups (FMG; spring 2015) and initiate some baseline evaluations (satisfaction and perceptions questionnaires). The investigators hypothesize that successful implementation of ASSSÉ could improve accessibility indicators, for patients affected or at risk for CMCD, patient and primary care personnel satisfaction, fidelity, quality and continuity of care in the context of FMGs.

OBJECTIVES: The investigators aim to:

  1. Analyze the implementation process of the new ASSSÉ framework in the context of FMGs by: a) establishing its acceptability and perceived usefulness by patients and health professionals; b) identifying the determinants (barriers and facilitators) of its implementation; c) describing the strategies used to implement the ASSSÉ care framework in FMGs.
  2. Estimate the size of the effects of ASSSÉ (including main effects and variability of effects across FMGs to allow for informed sample size calculation in the planning of a future large-scale trial) on: a) patients (satisfaction, health outcomes); b) primary care professionals (practice, satisfaction, self-efficacy); c) health care system (organizational and technical quality of care indicators, accessibility and continuity of care indicators, fidelity of care to framework).
  3. Effectively share knowledge obtained through these activities to relevant stakeholders in the health care and public health sectors, including policy makers, decision makers, health care professionals and patients using innovative tools and approaches.

METHODS AND APPROACH: This participatory research project will use a mixed-method approach combining qualitative and quantitative assessments. The project will be conducted in three steps: 1-Pre-implementation evaluation: Services and patient trajectories currently provided in all 14 FMGs of the Eastern Townships will be assessed using chart reviews to evaluate technical quality of care indicators and health outcomes. The investigators will also use questionnaires evaluating the concordance with the Expended chronic care model, self-efficacy, satisfaction of personnel and patients, and potential areas to target for improvement to assess organizational quality of care. Questionnaires and semi-structured group interviews with health professionals, decision-makers and patients with, or at risk for, CMCD will also be performed; 2- Post-implementation evaluation and data analysis: 12, 24 and 36 months after initiation of implementation, the investigators will perform a similar evaluation as done in the initial phase. Semi-structured group interviews will only be repeated at 24 months. Pre- and post-implementation comparisons will be performed using paired t-tests for continuous variables and McNemar tests for dichotomous variables to identify areas of improvement and persistent gaps. 3-Knowledge translation(KT): Integrated KT is an important outcome of this research, has already begun and will occur throughout the project with the various actors involved. The investigators will also reach out to various target audiences (health professionals, decision-makers and policy-makers, patients and Canadian population) through classic end-of-grant KT and the production of a clear executive summary of research results.

IMPACT: Considering the epidemic of chronic diseases, this project is very important as it will generate knowledge on models of care integrating preventive and management interventions of multiple conditions in primary care, in continuum with specialized health care services. It also has high transferability potential in various provincial and disease contexts.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre de recherché du CHUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All healthcare professionals involved in CMCD management in the targeted clinics will be invited to participate (questionnaires and group interviews). All adult patients prospectively presenting at the targeted clinics will receive an invitation letter describing the project.

Description

Inclusion Criteria:

  • Healthcare professionals involved in CMCD management in the targeted clinics
  • Eligible patients should have at least one CMCD (diabetes, pre-diabetes, obesity, cardio- or cerebrovascular disease, hypertension, dyslipidemia) or be active smokers.

Exclusion Criteria:

  • Patients who are not able to fill out questionnaires with help

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation of the new care framework assessed with interviews, chart audit and questionnaires
Time Frame: 36 months
Investigators will assess implementation of the framework including barriers and facilitators, acceptability and perceived usefulness and the strategies used to implement
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patients' satisfaction measure with questionnaire
Time Frame: 36 months
36 months
Patients' health outcome measure with chart audit
Time Frame: 36 months
36 months
Primary care professionals' satisfaction measure with questionnaire
Time Frame: 36 months
36 months
Primary care professionals' practice measure with interviews
Time Frame: 36 months
36 months
Primary care professionals' self-efficacy measure with questionnaire
Time Frame: 36 months
36 months
Organizational quality of care indicators measure with questionnaire
Time Frame: 36 months
36 months
Technical quality of care indicators measure with chart audit
Time Frame: 36 months
36 months
Accessibility of care indicators measure with administrative data
Time Frame: 36 months
36 months
Continuity of care indicators measure with chart audit
Time Frame: 36 months
36 months
Fidelity of care to framework measure with chart audit
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marie-France Langlois, MD, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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