Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02478853 |
| Other study ID # |
CCER 14-15 -15 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2015 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
May 2023 |
| Source |
Université de Sherbrooke |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
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.
