Brazilian inteRvention to Increase eviDence usaGe in practicE - Cardiovascular Prevention (BRIDGE-CV)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Quality Improvement Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 1623
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Clusters randomized to the control group will keep their usual practice standards. Patient screening will be performed at the outpatient clinics and primary care centers. Both groups must complete the following forms: "Admission", "06 months", and "12 months". Data collection will be performed from medical records by an independent professional not involved in patient care. Furthermore, study coordinator and data collectors from the sites, when asked, must provide appropriate documents for adjudication purposes.
Experimental: Intervention; Educational 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. Health care professionals from each institution one being a physician (acting as a local leader) and the other being a research nurse (acting as a case manager) must attend the training course for high cardiovascular risk patients that will take place at HCor.	Behavioral: Quality Improvement Intervention; The quality improvement intervention includes case management, reminders, check lists, educational materials, and audit and feedback reports

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to evidence based therapies	Adherence to evidence based therapies ( aspirin/antiplatelets , lipid lowering agents(statins) and ACE inhibitors/ARB) in an "all or none" model for patients without contra indication in a period of 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to evidence based therapies	Adherence to aspirin/antiplatelets, lipid lowering agents(statins) and ACE Inhibitors/ARB in patients without contra indications (All or None Model).	six and twelve months
LDL < 100mg/dL in 12 months	Percentage of eligible patients with LDL < 100mg/dL	12 months
LDL < 70mg/dL in 12 months	Percentage of eligible patients with LDL < 70mg/dL	12 months
Adherence to Lipid Lowering Agents (Statins)	Adherence to Lipid Lowering Agents (Statins) in patients without contraindications	12 months
Adherence to Antiplatelets	Adherence to Antiplatelets in Patients without contra-indications	12 months
Adherence to ACE inhibitors or ARBs	Adherence to ACE inhibitors or ARBs in patients without contra-indications	12 Months
Composite Outcome of Major Cardiovascular Events	Composite Outcome (death, non fatal myocardial infarction and non fatal stroke)	12 months
Adherence to Beta Blockers	Adherence to Beta Blockers in patients with a history of myocardial infarction and without contra-indications	12 months
Smoke Cessation Education	Smoke Cessation Education delivered to smokers	12 Months
Blood Pressure < 140 x 90 mmHg	Percentage of patients with blood pressure < 140 x 90 mmHg	12 months
Blood Pressure < 120 mmHg	Percentage of patients with blood pressure < 140 x 90 mmHg	12 months

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Collaborators: Amgen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2016
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Quality Improvement; Cluster Analysis
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: BRIDGE0003