Brazilian inteRvention to Increase eviDence usaGe in practicE - Cardiovascular Prevention

Cardiovascular Diseases Clinical Trial

— BRIDGE-CV  

Official title:

A Cluster Randomized Trial Evaluating the Effect of a Multifaceted Intervention to Increase Evidence Based Strategies Usage for Cardiovascular Prevention.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851732
• Other study ID #: BRIDGE0003
• Status: Completed
• Phase: N/A
• Start date: August 26, 2016
• Est. completion date: September 2018

Study information

• Verified date: October 2018
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1623
• Est. completion date: September 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Quality Improvement Intervention
The quality improvement intervention includes case management, reminders, check lists, educational materials, and audit and feedback reports

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital do Coracao	Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	LDL < 100mg/dL in 12 months	Percentage of eligible patients with LDL < 100mg/dL	12 months
Secondary	LDL < 70mg/dL in 12 months	Percentage of eligible patients with LDL < 70mg/dL	12 months
Secondary	Adherence to Lipid Lowering Agents (Statins)	Adherence to Lipid Lowering Agents (Statins) in patients without contraindications	12 months
Secondary	Adherence to Antiplatelets	Adherence to Antiplatelets in Patients without contra-indications	12 months
Secondary	Adherence to ACE inhibitors or ARBs	Adherence to ACE inhibitors or ARBs in patients without contra-indications	12 Months
Secondary	Composite Outcome of Major Cardiovascular Events	Composite Outcome (death, non fatal myocardial infarction and non fatal stroke)	12 months
Secondary	Adherence to Beta Blockers	Adherence to Beta Blockers in patients with a history of myocardial infarction and without contra-indications	12 months
Secondary	Smoke Cessation Education	Smoke Cessation Education delivered to smokers	12 Months
Secondary	Blood Pressure < 140 x 90 mmHg	Percentage of patients with blood pressure < 140 x 90 mmHg	12 months
Secondary	Blood Pressure < 120 mmHg	Percentage of patients with blood pressure < 140 x 90 mmHg	12 months