Myocardial InfarctionPhase 3NCT01590290
Randomized Controlled Cluster Trial of Resident Pay for Performance and Cardiovascular Outcomes
A Phase 3 study testing financial compensation in people with Myocardial Infarction and Heart Failure, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to determine if a pay for performance model in contrast to the traditional "fee for service" model may improve the number of patients discharged being treated in accordance with Joint Commission on Health Care JCAHO (a non-for profit organization that accredits health care organizations)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Heart Failure
- What is being tested?
- financial compensation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Apr 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician inclusion: Resident physician on the Acute Cardiology Service, the Coronary Care Unit, or the General Medicine Service at the University of Virginia
- Patient inclusion: discharge diagnosis of heart failure or myocardial infarction.
Who cannot join
- Residents that are part of the study team
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22902
Robert C Schutt, MD, 434-924-0000 ext. 4234, rob.schutt@virginia.edu
Robert C Schutt, MD
About this study
The purpose of this study is to determine if a pay for performance model in contrast to the traditional "fee for service" model may improve the number of patients discharged being treated in accordance with Joint Commission on Health Care JCAHO (a non-for profit organization that accredits health care organizations) standards and standard of care for management of hyperlipidemia
In this study the investigators will evaluate these two models by training resident physicians (doctors in training) on JCAHO core measures and specific criteria related to accepted standard of care for acute myocardial infarction and heart failure. The physicians will be randomized to a pay for performance or a fee for service model. Then a medical record review will be performed on patient records that received a discharge diagnosis of myocardial infarction or heart failure and were cared for by the physician subjects
- Conditions
- Myocardial Infarction, Heart Failure
- Being tested
- financial compensation
- Medical subject headings
- Myocardial Infarction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
financial compensationOther
financial monetary reimbursement
| Study group | Role | What they receive |
|---|---|---|
| pay for performance | Active comparator | Not described Receives: Other: financial compensation |
| no pay for performance | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance with composite pay for performance measure
In patients discharged from the Coronary Care Unit, Acute Coronary Care Service, or General Medical Service with the discharge diagnosis of either heart failure or myocardial infarction, there is no difference in the rate of compliance with the composite score (see below; Heart Failure Score or Myocardial Infarction Score) between physicians reimbursed in a pay for performance scheme and those who receive no additional reimbursement.
Measured: 1 month
Secondary outcomes (3)
heart failure composite score
In patients discharged from the Coronary Care Unit, Acute Coronary Care Service, or General Medical Service with the discharge diagnosis of heart failure there is no difference between rate of compliance with Heart Failure Score between physicians reimbursed in a pay for performance scheme and those who receive no additional reimbursement.
Measured: 1 month
myocardial infarction score
In patients discharged from the Coronary Care Unit, Acute Coronary Care Service, or General Medical Service with the discharge diagnosis of myocardial infarction there is no difference between the rate of compliance with Myocardial Infarction Score between physicians reimbursed in a pay for performance scheme and those who receive no additional reimbursement.
Measured: 1 month
readmission rate
In patients discharged from the Coronary Care Unit, Acute Coronary Care Service, or General Medical Service with the discharge diagnosis heart failure there is no difference between 30-day readmission rate between patients that had an appointment less than 7 days and those that did not.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Schutt, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590290
- Sponsor's protocol ID
- 16033
- Status last verified
- Apr 2012
- First submitted
- 30 Apr 2012
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Cluster Trial of Resident Pay for Performance and Cardiovascular Outcomes
- ClinicalTrials.gov ID
- NCT01590290
- Acronym / sponsor ID
- 16033
- Conditions
- Myocardial Infarction, Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (estimated)
- First posted
- 2 May 2012 (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 this study is to determine if a pay for performance model in contrast to the traditional "fee for service" model may improve the number of patients discharged being treated in accordance with Joint Commission on Health Care JCAHO (a non-for profit organization that accredits health care organizations) standards and standard of care for management of hyperlipidemia
In this study the investigators will evaluate these two models by training resident physicians (doctors in training) on JCAHO core measures and specific criteria related to accepted standard of care for acute myocardial infarction and heart failure. The physicians will be randomized to a pay for performance or a fee for service model. Then a medical record review will be performed on patient records that received a discharge diagnosis of myocardial infarction or heart failure and were cared for by the physician subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pay for performance | Active comparator | Other: financial compensation |
| no pay for performance | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physician inclusion: Resident physician on the Acute Cardiology Service, the Coronary Care Unit, or the General Medicine Service at the University of Virginia
- Patient inclusion: discharge diagnosis of heart failure or myocardial infarction.
Key exclusion criteria (1 listed)
- Residents that are part of the study team
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 |
|---|---|---|
| financial compensationfinancial monetary reimbursement | Other | pay for performance |
Primary outcome
compliance with composite pay for performance measure
Time frame: 1 month
In patients discharged from the Coronary Care Unit, Acute Coronary Care Service, or General Medical Service with the discharge diagnosis of either heart failure or myocardial infarction, there is no difference in the rate of compliance with the composite score (see below; Heart Failure Score or Myocardial Infarction Score) between physicians reimbursed in a pay for performance scheme and those who receive no additional reimbursement.
3 secondary outcomes
heart failure composite score
Time frame: 1 month
myocardial infarction score
Time frame: 1 month
readmission rate
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing financial compensation in people with Myocardial Infarction and Heart Failure, run by University of Virginia at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compliance with composite pay for performance measure (time frame: 1 month). 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 2 May 2012.