Cardiovascular Diseases Clinical Trial
Official title:
A Cluster Randomized Trial Evaluating the Effect of a Multifaceted Intervention to Increase Evidence Based Strategies Usage for Cardiovascular Prevention.
The purpose of the study is assess the impact of a multifaceted quality improvement intervention in adherence to evidence based therapies prescription (according to local guidelines) for cardiovascular prevention in high risk patients in 12 months.
The quality improvement strategy being assessed in this study will be applied to the
healthcare team, thus any intervention that is not well established in the literature will
not be prescribed to the patients. Thus, this trial does not imply any additional risk for
patients.
Furthermore, if this strategy is proved to be effective, it may be offered as a new clinical
practice that might benefit brazilian patients.
BRIDGE-CV consists of a quality improvement project by the incorporation of evidence based
interventions in public and private hospitals in Brazil. The chosen setting is cardiovascular
prevention in high risk patients since cardiovascular diseases represent the major cause of
death in Brazil.
It will be developed a cluster randomized trial, where hospitals will be allocated to receive
or not the multifaceted intervention.
The patients will be followed for 12 months in order to assess if the multifaceted
intervention can increase the evidence based prescriptions. If this is the case, this tool
package may be offered as a quality improvement intervention for all hospitals.
Sites will be selected through the HCor investigators network. Invited sites must complete a
screening form in order to verify eligibility and feasibility of application of the BRIDGE CV
tools.Clusters will be randomized and allocated 1:1 to the Multifaceted Intervention Group or
to the Control Group. Once the hospital/center is allocated to one of the groups every
patient at that institution must be assisted following the same procedures.
The randomization list will be created considering a random function with equal probability
of being allocated to each of the groups. Each site will receive a code number and just this
numbers will be used during randomization. This procedure will be performed by the HCor
statistician ensuring allocation concealment. The study coordinator will inform the site what
procedures must be taken, without revealing to the statistician which hospitals are allocated
to the intervention group.
The sample will be stratified considering primary care centers and secondary/tertiary
outpatients' clinics.
Considering the open nature of the study, treatment allocation will not be blinded to the
investigators, health care providers and patients.
However, clinical outcomes will be assessed and validated by a blinded committee.
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