Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-01-04 @ 9:35 AM
Study NCT ID:
NCT02851732
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2016-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brazilian inteRvention to Increase eviDence usaGe in practicE - Cardiovascular Prevention
Sponsor:
Hospital do Coracao
Organization:
Study Overview
Official Title:
A Cluster Randomized Trial Evaluating the Effect of a Multifaceted Intervention to Increase Evidence Based Strategies Usage for Cardiovascular Prevention.
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRIDGE-CV
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: