Clinical trial NCT02851732: Brazilian inteRvention to Increase eviDence usaGe in practicE - Cardiovascular Prevention
Official title: A Cluster Randomized Trial Evaluating the Effect of a Multifaceted Intervention to Increase Evidence Based Strategies Usage for Cardiovascular Prevention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Quality Improvement
Cluster Analysis
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2016-08-02
Enrollment: 1623
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients over 40 years old, with manifested atherothrombotic diseases ( coronary artery disease, stroke or transient ischemic attack, or peripheral artery disease)

Exclusion Criteria:

* Patients from institutions that don't provide the Institutional Authorization Term, as well as patients that withdraw Inform Consent for Data Collection.
* Patients with a history of atrial fibrillation or that at the discretion of the physician needs anticoagulation, will be excluded.

Primary outcomes:
measure: Adherence to evidence based therapies
timeFrame: 12 months
Secondary outcomes:
measure: Adherence to evidence based therapies
timeFrame: six and twelve months
measure: LDL < 100mg/dL in 12 months
timeFrame: 12 months
measure: LDL < 70mg/dL in 12 months
timeFrame: 12 months
measure: Adherence to Lipid Lowering Agents (Statins)
timeFrame: 12 months
measure: Adherence to Antiplatelets
timeFrame: 12 months
measure: Adherence to ACE inhibitors or ARBs
timeFrame: 12 Months
measure: Composite Outcome of Major Cardiovascular Events
timeFrame: 12 months
measure: Adherence to Beta Blockers
timeFrame: 12 months
measure: Smoke Cessation Education
timeFrame: 12 Months
measure: Blood Pressure < 140 x 90 mmHg
timeFrame: 12 months
measure: Blood Pressure < 120 mmHg
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Machline-Carrion MJ, Soares RM, Damiani LP, Campos VB, Sampaio B, Fonseca FH, Izar MC, Amodeo C, Pontes-Neto OM, Santos JY, Gomes SPDC, Saraiva JFK, Ramacciotti E, Barros E Silva PGM, Lopes RD, Brandao da Silva N, Guimaraes HP, Piegas L, Stein AT, Berwanger O; BRIDGE Cardiovascular Prevention Investigators. Effect of a Multifaceted Quality Improvement Intervention on the Prescription of Evidence-Based Treatment in Patients at High Cardiovascular Risk in Brazil: The BRIDGE Cardiovascular Prevention Cluster Randomized Clinical Trial. JAMA Cardiol. 2019 May 1;4(5):408-417. doi: 10.1001/jamacardio.2019.0649.