Chest PainPhase 3NCT00674375
Risk Score Alerts for Chest Pain Care
A Phase 3 study testing Electronic risk alerts in people with Chest Pain and Acute Myocardial Infarction, run by Harvard Vanguard Medical Associates at 2 sites in United States.
Trial summary
The evaluation of chest pain in the primary care office is a challenging problem, with many patients suffering from missed diagnoses of acute myocardial infarction and many other low risk patients receiving unnecessary evaluations. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chest Pain, Acute Myocardial Infarction
- What is being tested?
- Electronic risk alerts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Jan 2010
- Phase
- Phase 3
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 30 years and older presenting to one of 14 ambulatory health centers and their evaluating primary care clinician will be eligible for this study.
Who cannot join
- Prior history of coronary heart disease
- Age <30 years
- Presentation for an annual physical examination
- Prior hospital admission or emergency department visit for evaluation of chest pain within 30 days of their presentation to primary care clinician
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Harvard Vanguard Medical Associates
Newton, Massachusetts, 02466
About this study
Official title: Can Risk Score Alerts Improve Office Care for Chest Pain?
The evaluation of chest pain in the primary care office is a challenging problem, with many patients suffering from missed diagnoses of acute myocardial infarction and many other low risk patients receiving unnecessary evaluations. This project will provide primary care physicians evaluating patients complaining of chest pain with computerized alerts that differentiate high-risk patients from low risk patients, and provide individualized evaluation and treatment recommendations.
Read the detailed description
The evaluation of ambulatory patients with chest pain is a challenging and serious problem, accounting for a significant proportion of all outpatient visits. High risk patients may go undetected, resulting in missed diagnoses of acute myocardial ischemia, while low risk patients may be subject to unnecessary evaluations. To substantially improve the evaluation and treatment of outpatients with acute chest pain syndromes, new strategies need to be developed in the primary care setting to risk stratify symptomatic patients and direct appropriate care. Our prior work demonstrates that an elevated Framingham Risk Score (at least 10%) reliably identifies patients with chest pain in the primary care setting who are at high risk for acute myocardial infarction.
This study will implement and evaluate electronic risk alerts to risk stratify outpatients with chest pain and present this information to primary care clinicians within the context of an electronic health record. The intervention will take place within Harvard Vanguard Medical Associates, a multispecialty integrated group practice with 140 primary care physicians caring for approximately 300,000 patients at 14 centers in eastern Massachusetts. With a randomized, controlled study design, the study has three specific aims:
- To identify predictors of risk-appropriate evaluation and treatment of patients presenting to primary care offices with acute chest pain, including race and sex.
- To determine whether rates of appropriate evaluation and treatment of patients with acute chest pain can be improved through the use of point-of-care electronic risk alerts that provide individual patient cardiac risk profiles and tailored evaluation and treatment recommendations to primary care clinicians.
- To perform a cost analysis for the provision of electronic decision support for patients with acute chest pain.
This study has important implications for determining how the treatment of outpatients with chest pain syndromes can be optimized through the innovative use of electronic decision support, while documenting the cost implications of such a strategy. This work will also provide a model for how ambulatory practices across the country can use electronic health records to present real-time patient risk information to clinicians with the goal of improving patient safety and quality, which has important implications for both acute and chronic care.
- Conditions
- Chest Pain, Acute Myocardial Infarction
- Being tested
- Electronic risk alerts
- Keywords
- Chest Pain, Acute Myocardial Infarction, Patient Safety, Misdiagnosis
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic risk alertsOther
Electronic risk alerts within the electronic medical record system will automatically calculate a patient's Framingham Risk Score during office visits for chest pain. These alerts will recommend electrocardiogram performance and aspirin therapy for patients with Framingham Risk Score at least 10%, and will recommend against exercise stress testing for patients with a Framingham Risk Score less than 10%.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Primary care clinicians (physicians, nurse practitioners, and physician assistants) randomized to the intervention arm will receive electronic alerts within the electronic medical record system during office visits with patients complaining of chest pain. Receives: Other: Electronic risk alerts |
| 2 | No intervention | Primary care clinicians randomized to the 'no intervention' arm will evaluate and treat patients complaining of chest pain without the aid of electronic risk alerts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of electrocardiogram for patients with Framingham Risk Score greater than or equal to 10%.
Measured: During office visit
Administration of aspirin therapy for patients with Framingham Risk Score greater than or equal to 10%
Measured: During office visit
Performance of exercise stress testing for patients with Framingham Risk Score less than 10%
Measured: Within 2 months of office visit
Secondary outcomes (2)
EKG and aspirin therapy for patients with Framingham Risk Score at least 10% among intervention and control clinicians according to clinician risk tolerance. Hypothesis: Intervention effect will be greatest among clinicians with a high risk tolerance.
Measured: During office visit
Exercise stress testing for patients with Framingham Risk Score less than 10% among intervention and control clinicians according to clinician risk tolerance. Hypothesis: Intervention effect will be greatest among clinicians with lowest risk tolerance.
Measured: Within 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Vanguard Medical Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Thomas Dean Sequist, Harvard Vanguard Medical Associates
- Investigators
- Thomas D Sequist, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674375
- Sponsor's protocol ID
- 1R18HS017075-01
- Status last verified
- Mar 2015
- First submitted
- 6 May 2008
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sequist TD, Marshall R, Lampert S, Buechler EJ, Lee TH. Missed opportunities in the primary care management of early acute ischemic heart disease. Arch Intern Med. 2006 Nov 13;166(20):2237-43. doi: 10.1001/archinte.166.20.2237.
PubMed 17101942Sequist TD, Morong SM, Marston A, Keohane CA, Cook EF, Orav EJ, Lee TH. Electronic risk alerts to improve primary care management of chest pain: a randomized, controlled trial. J Gen Intern Med. 2012 Apr;27(4):438-44. doi: 10.1007/s11606-011-1911-6. Epub 2011 Oct 13.
PubMed 21993999
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Risk Score Alerts Improve Office Care for Chest Pain?
- ClinicalTrials.gov ID
- NCT00674375
- Acronym / sponsor ID
- 1R18HS017075-01
- Conditions
- Chest Pain, Acute Myocardial Infarction
- Keywords
- Chest Pain, Acute Myocardial Infarction, Patient Safety, Misdiagnosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Harvard Vanguard Medical AssociatesUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Nov 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 May 2008 (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 evaluation of chest pain in the primary care office is a challenging problem, with many patients suffering from missed diagnoses of acute myocardial infarction and many other low risk patients receiving unnecessary evaluations. This project will provide primary care physicians evaluating patients complaining of chest pain with computerized alerts that differentiate high-risk patients from low risk patients, and provide individualized evaluation and treatment recommendations.
Detailed description
The evaluation of ambulatory patients with chest pain is a challenging and serious problem, accounting for a significant proportion of all outpatient visits. High risk patients may go undetected, resulting in missed diagnoses of acute myocardial ischemia, while low risk patients may be subject to unnecessary evaluations. To substantially improve the evaluation and treatment of outpatients with acute chest pain syndromes, new strategies need to be developed in the primary care setting to risk stratify symptomatic patients and direct appropriate care. Our prior work demonstrates that an elevated Framingham Risk Score (at least 10%) reliably identifies patients with chest pain in the primary care setting who are at high risk for acute myocardial infarction.
This study will implement and evaluate electronic risk alerts to risk stratify outpatients with chest pain and present this information to primary care clinicians within the context of an electronic health record. The intervention will take place within Harvard Vanguard Medical Associates, a multispecialty integrated group practice with 140 primary care physicians caring for approximately 300,000 patients at 14 centers in eastern Massachusetts. With a randomized, controlled study design, the study has three specific aims:
- To identify predictors of risk-appropriate evaluation and treatment of patients presenting to primary care offices with acute chest pain, including race and sex.
- To determine whether rates of appropriate evaluation and treatment of patients with acute chest pain can be improved through the use of point-of-care electronic risk alerts that provide individual patient cardiac risk profiles and tailored evaluation and treatment recommendations to primary care clinicians.
- To perform a cost analysis for the provision of electronic decision support for patients with acute chest pain.
This study has important implications for determining how the treatment of outpatients with chest pain syndromes can be optimized through the innovative use of electronic decision support, while documenting the cost implications of such a strategy. This work will also provide a model for how ambulatory practices across the country can use electronic health records to present real-time patient risk information to clinicians with the goal of improving patient safety and quality, which has important implications for both acute and chronic care.
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 |
|---|---|---|
| 1 | Experimental | Other: Electronic risk alertsPrimary care clinicians (physicians, nurse practitioners, and physician assistants) randomized to the intervention arm will receive electronic alerts within the electronic medical record system during office visits with patients complaining of chest pain. |
| 2 | No intervention | –Primary care clinicians randomized to the 'no intervention' arm will evaluate and treat patients complaining of chest pain without the aid of electronic risk alerts. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults 30 years and older presenting to one of 14 ambulatory health centers and their evaluating primary care clinician will be eligible for this study.
Key exclusion criteria (4 listed)
- Prior history of coronary heart disease
- Age <30 years
- Presentation for an annual physical examination
- Prior hospital admission or emergency department visit for evaluation of chest pain within 30 days of their presentation to primary care clinician
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 |
|---|---|---|
| Electronic risk alertsElectronic risk alerts within the electronic medical record system will automatically calculate a patient's Framingham Risk Score during office visits for chest pain. These alerts will recommend electrocardiogram performance and aspirin therapy for patients with Framingham Risk Score at least 10%, and will recommend against exercise stress testing for patients with a Framingham Risk Score less than 10%. | Other | 1 |
Primary outcome
Performance of electrocardiogram for patients with Framingham Risk Score greater than or equal to 10%.
Time frame: During office visit
Administration of aspirin therapy for patients with Framingham Risk Score greater than or equal to 10%
Time frame: During office visit
Performance of exercise stress testing for patients with Framingham Risk Score less than 10%
Time frame: Within 2 months of office visit
2 secondary outcomes
EKG and aspirin therapy for patients with Framingham Risk Score at least 10% among intervention and control clinicians according to clinician risk tolerance. Hypothesis: Intervention effect will be greatest among clinicians with a high risk tolerance.
Time frame: During office visit
Exercise stress testing for patients with Framingham Risk Score less than 10% among intervention and control clinicians according to clinician risk tolerance. Hypothesis: Intervention effect will be greatest among clinicians with lowest risk tolerance.
Time frame: Within 2 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 18 Mar 2015.
- Background: PubMed 17101942Sequist TD, Marshall R, Lampert S, Buechler EJ, Lee TH. Missed opportunities in the primary care management of early acute ischemic heart disease. Arch Intern Med. 2006 Nov 13;166(20):2237-43. doi: 10.1001/archinte.166.20.2237.
- Derived from this study: PubMed 21993999Sequist TD, Morong SM, Marston A, Keohane CA, Cook EF, Orav EJ, Lee TH. Electronic risk alerts to improve primary care management of chest pain: a randomized, controlled trial. J Gen Intern Med. 2012 Apr;27(4):438-44. doi: 10.1007/s11606-011-1911-6. Epub 2011 Oct 13.
- Harvard Vanguard Medical AssociatesLink provided by the sponsor.
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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.
Thomas D Sequist, MD, MPH principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Electronic risk alerts in people with Chest Pain and Acute Myocardial Infarction, run by Harvard Vanguard Medical Associates at 2 sites in United States.
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 4 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 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Performance of electrocardiogram for patients with Framingham Risk Score greater than or equal to 10%. (time frame: During office visit). The study lists 3 primary outcomes in all. 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 NCT00674375, which also lists 2 linked publications.
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 18 Mar 2015.