- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02478853
Impact of a Regional Program Agir Sur Sa SantE
Agir Sur Sa SantE- Impact of a Regional Integrated Prevention and Management of Cardio-metabolic Chronic Diseases Program in Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
- 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).
- 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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1H 5N4
- Centre de recherché du CHUS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Marie-France Langlois, MD, Université de Sherbrooke
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCER 14-15 -15
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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