HypertensionNCT02436421
Impact of Best Practice Alerts in Cardiology Outpatient Clinics
A study testing Best Practice Alert based in the Electronic Medical Record in people with Hypertension and Atrial Fibrillation, run by Duke University.
Trial summary
This quality improvement intervention seeks to implement two Best Practice Alerts (BPAs) for use in cardiology clinics while simultaneously evaluating the impact of each BPA- one for patients with uncontrolled blood pressure and one for patients with atrial fibrillation not on anticoagulation. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Atrial Fibrillation
- What is being tested?
- Best Practice Alert based in the Electronic Medical Record
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Aug 2016
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients seen routinely by cardiologists at Duke
Who cannot join
- none
About this study
This quality improvement intervention seeks to implement two Best Practice Alerts (BPAs) for use in cardiology clinics while simultaneously evaluating the impact of each BPA- one for patients with uncontrolled blood pressure and one for patients with atrial fibrillation not on anticoagulation.
Read the detailed description
Best Practice Alerts based will be created for hypertension and atrial fibrillation. Outpatient cardiology providers will be randomly allocated into one of three groups. The first group will receive the BPA for hypertension alone. The second group will receive the BPA for atrial fibrillation alone. The final group will receive both BPAs. The rate of blood pressure control for all patients and anticoagulation in patients with atrial fibrillation in each group will be evaluated prior to and after the implementation of the BPAs to determine the effect of the BPA.
- Conditions
- Hypertension, Atrial Fibrillation
- Being tested
- Best Practice Alert based in the Electronic Medical Record
- Medical subject headings
- Hypertension, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Practice Alert based in the Electronic Medical RecordOther
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation BPA | Other | The alert will notify providers when patients with atrial fibrillation are not on anticoagulation Receives: Other: Best Practice Alert based in the Electronic Medical Record |
| Hypertension BPA | Other | The alert will notify providers when patients have elevated blood pressure Receives: Other: Best Practice Alert based in the Electronic Medical Record |
| Atrial Fibrillation and Hypertension BPA | Other | Providers in this arm will receive both alerts Receives: Other: Best Practice Alert based in the Electronic Medical Record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of anticoagulation among patients with atrial fibrillation
Measured: 1 year
Rates of hypertension control among patients seen by cardiology
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436421
- Sponsor's protocol ID
- Pro00045379
- Status last verified
- Nov 2016
- First submitted
- 4 May 2015
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Best Practice Alerts in Cardiology Outpatient Clinics
- ClinicalTrials.gov ID
- NCT02436421
- Acronym / sponsor ID
- Pro00045379
- Conditions
- Hypertension, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 May 2015 (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.
This quality improvement intervention seeks to implement two Best Practice Alerts (BPAs) for use in cardiology clinics while simultaneously evaluating the impact of each BPA- one for patients with uncontrolled blood pressure and one for patients with atrial fibrillation not on anticoagulation.
Detailed description
Best Practice Alerts based will be created for hypertension and atrial fibrillation. Outpatient cardiology providers will be randomly allocated into one of three groups. The first group will receive the BPA for hypertension alone. The second group will receive the BPA for atrial fibrillation alone. The final group will receive both BPAs. The rate of blood pressure control for all patients and anticoagulation in patients with atrial fibrillation in each group will be evaluated prior to and after the implementation of the BPAs to determine the effect of the BPA.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation BPA | Other | Other: Best Practice Alert based in the Electronic Medical RecordThe alert will notify providers when patients with atrial fibrillation are not on anticoagulation |
| Hypertension BPA | Other | Other: Best Practice Alert based in the Electronic Medical RecordThe alert will notify providers when patients have elevated blood pressure |
| Atrial Fibrillation and Hypertension BPA | Other | Other: Best Practice Alert based in the Electronic Medical RecordProviders in this arm will receive both alerts |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients seen routinely by cardiologists at Duke
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Best Practice Alert based in the Electronic Medical Record | Other | Atrial Fibrillation BPA, Atrial Fibrillation and Hypertension BPA, Hypertension BPA |
Primary outcome
Rates of anticoagulation among patients with atrial fibrillation
Time frame: 1 year
Rates of hypertension control among patients seen by cardiology
Time frame: 1 year
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 30 Nov 2016.
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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 Best Practice Alert based in the Electronic Medical Record in people with Hypertension and Atrial Fibrillation, run by Duke University.
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 1 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 30 Nov 2016. 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?
Rates of anticoagulation among patients with atrial fibrillation (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2016.