Health Behavior Clinical Trial
Official title:
Feasibility and Effectiveness of Innovative Programs for Health Promotion in Primary Care: The 'Prescribe Healthy Life' Project (PVS)
The potential health gains from healthy lifestyles are very well-known, what is still not known is how to help people to adopt these lifestyles, by means of brief interventions feasible in routine general practice. This study was designed to explore the feasibility and efficacy of innovative implementation strategies for the promotion physical activity, diet and smoking abstinence in primary care. The investigators hypothesize that collegiate planning between practitioners, researchers and managers, with a socio-ecological perspective and taking into account the real context of collaborating centers, will guarantee the sustainability and effectiveness of these programs.
BACKGROUND: Primary health care (PHC) services have special opportunities for healthy
lifestyles promotion. Yet, despite its potential impact health promotion is not widespread
and the results obtained are limited.
OBJECTIVE: To explore the feasibility and efficacy of an implementation strategy for
optimizing the promotion of physical activity, diet and smoking abstinence in PHC. The
strategy is innovative for its collegiate planning between practitioners, researchers and
managers, with a socio-ecological perspective and taking into account the real context of
collaborating centers.
DESIGN AND LOCATION: quasi-experimental hybrid implementation-effectiveness trial, conducted
in 6 PHC centers (20 practices in 3 intervention centers and 21 in 3 control centers), with
the collaboration of the majority of primary care professionals within each center, and the
participation of 4017 attendees randomly selected from the target population. INTERVENTION
CENTRES: Each of the intervention centers will be exposed to the PVS multicomponent
implementation strategy, including training, information and communication electronic tools
integrated into the electronic clinical record (ECR), local leadership, creation of a
community of practice, practice facilitation, and audit and feed-back for the implementation
of an intervention program to promote multiple healthy lifestyles (physical activity,
healthy diet, and smoking cessation), based on the 5A's (Ask, Advise, Agree, Assist and
Arrange follow-up), and modeled by professionals in each intervention center, according to
their organizational context and available community resources and agents.
CONTROL CENTRES: will receive the same training and dissemination of clinical guidelines,
electronic support tools integrated into the ECR, audit and feed-back.
MEASUREMENTS: Programs' implementation will be evaluated in terms of reach, adoption,
implementation and acceptability by PHC staff, following the RE-AIM framework. PHC attendees
will be followed with 2 repeated measurements at baseline, and 6 months to estimate change
in patients' adoption of the minimum recommended level of healthy lifestyles.
ANALYSIS: the investigators will compare the implementation rate of health promotion
activities in intervention and control centers, the proportion of users exposed to the 5 A's
and the observed change in users' healthy lifestyles. Centers with different intensities of
actual implementation will be compared to explore characteristics associated with
implementation and the interaction between implementation strategies and clinical
effectiveness of the intervention programs.
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