NCT02851732

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,623

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Aug 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

August 26, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 2, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

July 28, 2016

Last Update Submit

October 1, 2018

Conditions

Cardiovascular Diseases

Keywords

Quality ImprovementCluster Analysis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Adherence to evidence based therapies

    six and twelve months

  • LDL < 100mg/dL in 12 months

    12 months

  • LDL < 70mg/dL in 12 months

    12 months

  • Adherence to Lipid Lowering Agents (Statins)

    12 months

  • Adherence to Antiplatelets

    12 months

  • +6 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

Quality Improvement InterventionBEHAVIORAL

The quality improvement intervention includes case management, reminders, check lists, educational materials, and audit and feedback reports

Intervention

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30942842DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Otavio Berwanger

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 2, 2016

Study Start

August 26, 2016

Primary Completion

August 31, 2018

Study Completion

September 1, 2018

Last Updated

October 2, 2018

Record last verified: 2018-10