Cardiovascular DiseasesBRIDGE-CVNCT02851732
Brazilian inteRvention to Increase eviDence usaGe in practicE - Cardiovascular Prevention
A study testing Quality Improvement Intervention in people with Cardiovascular Diseases, run by Hospital do Coracao.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Quality Improvement Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,623 participants
- Where
- No sites listed yet
- Study dates
- 26 Aug 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 40 years old, with manifested atherothrombotic diseases ( coronary artery disease, stroke or transient ischemic attack, or peripheral artery disease)
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Quality Improvement Intervention
- Keywords
- Quality Improvement, Cluster Analysis
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Improvement InterventionBehavioural
The quality improvement intervention includes case management, reminders, check lists, educational materials, and audit and feedback reports
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Quality Improvement Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (11)
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).
Measured: six and twelve months
LDL < 100mg/dL in 12 months
Percentage of eligible patients with LDL < 100mg/dL
Measured: 12 months
LDL < 70mg/dL in 12 months
Percentage of eligible patients with LDL < 70mg/dL
Measured: 12 months
Adherence to Lipid Lowering Agents (Statins)
Adherence to Lipid Lowering Agents (Statins) in patients without contraindications
Measured: 12 months
Adherence to Antiplatelets
Adherence to Antiplatelets in Patients without contra-indications
Measured: 12 months
Adherence to ACE inhibitors or ARBs
Adherence to ACE inhibitors or ARBs in patients without contra-indications
Measured: 12 Months
Composite Outcome of Major Cardiovascular Events
Composite Outcome (death, non fatal myocardial infarction and non fatal stroke)
Measured: 12 months
Adherence to Beta Blockers
Adherence to Beta Blockers in patients with a history of myocardial infarction and without contra-indications
Measured: 12 months
Smoke Cessation Education
Smoke Cessation Education delivered to smokers
Measured: 12 Months
Blood Pressure < 140 x 90 mmHg
Percentage of patients with blood pressure < 140 x 90 mmHg
Measured: 12 months
Blood Pressure < 120 mmHg
Percentage of patients with blood pressure < 140 x 90 mmHg
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study start26 Aug 2016
- Primary completion31 Aug 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Instituto de Pesquisa, Hospital do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851732
- Sponsor's protocol ID
- BRIDGE0003
- Acronym
- BRIDGE-CV
- Status last verified
- Oct 2018
- First submitted
- 28 Jul 2016
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30942842
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Trial Evaluating the Effect of a Multifaceted Intervention to Increase Evidence Based Strategies Usage for Cardiovascular Prevention.
- ClinicalTrials.gov ID
- NCT02851732
- Acronym / sponsor ID
- BRIDGE-CV / BRIDGE0003
- Conditions
- Cardiovascular Diseases
- Keywords
- Quality Improvement, Cluster Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,623 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 26 Aug 2016 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Quality Improvement InterventionEducational 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 40 years old, with manifested atherothrombotic diseases ( coronary artery disease, stroke or transient ischemic attack, or peripheral artery disease)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality Improvement InterventionThe quality improvement intervention includes case management, reminders, check lists, educational materials, and audit and feedback reports | Behavioural | Intervention |
Primary outcome
Adherence to evidence based therapies
Time frame: 12 months
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.
11 secondary outcomes
Adherence to evidence based therapies
Time frame: six and twelve months
LDL < 100mg/dL in 12 months
Time frame: 12 months
LDL < 70mg/dL in 12 months
Time frame: 12 months
Adherence to Lipid Lowering Agents (Statins)
Time frame: 12 months
Adherence to Antiplatelets
Time frame: 12 months
Adherence to ACE inhibitors or ARBs
Time frame: 12 Months
Composite Outcome of Major Cardiovascular Events
Time frame: 12 months
Adherence to Beta Blockers
Time frame: 12 months
Smoke Cessation Education
Time frame: 12 Months
Blood Pressure < 140 x 90 mmHg
Time frame: 12 months
Blood Pressure < 120 mmHg
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Derived from this study: PubMed 30942842Machline-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Quality Improvement Intervention in people with Cardiovascular Diseases, run by Hospital do Coracao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to evidence based therapies (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02851732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.