STEMIRAPID-PCINCT01625104
Randomized Trial of a Quality Improvement Intervention to Decrease D2B Time in Primary PCI for AMI
A study testing Non Intervention and Agressive Intervention Process Improvement Strategies in people with STEMI, run by University of Michigan at 1 site in United States.
Trial summary
The primary objective of this study is to assess whether an aggressive quality improvement intervention strategy will decrease time from hospital presentation to first balloon inflation in non-transfer patients with acute ST segment elevation MI (STEMI) treated with primary percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- STEMI
- What is being tested?
- Non Intervention and Agressive Intervention Process Improvement Strategies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 882 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Dec 2006
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute ST segment myocardial infarction, non transfer patients, with symptom onset to balloon time less than or equal to 24 hours.
Who cannot join
- Patients transferred from one facility to another,
- non ST segment myocardial infarction patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Aggressive Process of Care Quality Improvement Intervention to Decrease Door to Balloon Time in Primary PCI for Acute Myocardial Infarction
The primary objective of this study is to assess whether an aggressive quality improvement intervention strategy will decrease time from hospital presentation to first balloon inflation in non-transfer patients with acute ST segment elevation MI (STEMI) treated with primary percutaneous coronary intervention (PCI). Twelve hospitals in Michigan were randomized to either aggressive intervention or control. The intervention consisted of Grand Rounds at each hospital, sharing of best practices, and coordinating center staff working closely with staff at each intervention hospital to discuss solutions to barriers to rapid treatment for STEMI patients.
Read the detailed description
The participating hospitals randomized to the aggressive intervention strategy actively worked to create teams to analyze processes of care for STEMI patients, identify areas needing improvement, and implemented strategies to streamline treatment.
Hospitals randomized to control were instructed to conduct "business as usual".
- Conditions
- STEMI
- Being tested
- Non Intervention, Agressive Intervention Process Improvement Strategies
- Keywords
- Myocardial Infarction, Time to Treatment, Door to Balloon Time
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non InterventionOther
Business as usual
Agressive Intervention Process Improvement StrategiesOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Aggressive Intervention Strategy | Experimental | Hospitals were randomized to an aggressive intervention strategy or to "business as usual". The hospitals randomized to the aggressive intervention strategy underwent the following:
1. Grand Rounds conducted by physician and nurse from the Coordinating Center. This included a formal presentation on the evidence supporting rapid time to treatment in STEMI patients and evidence based strategies for reducing treatment delays.
2. Discussion with staff regarding perceived barriers to treatment and suggestions/ideas for strategies to overcome these barriers
3. Follow-up monthly phone conferences to continue to discuss strategies and ideas sharing
4. Written plan from sites detailing plans to change processes of care. Receives: Other: Agressive Intervention Process Improvement Strategies |
| Group 2: Control Strategy | Placebo comparator | Hospitals randomized to the control group were instructed to conduct "business as usual". Receives: Other: Non Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Sites With Reduction in Door to Balloon Time
Arrival time in Emergency Department to first balloon inflation in the coronary artery.
Any reduction in median Door to Balloon Time from baseline to follow-up was counted as reduction in time
Measured: Arrival to balloon inflation, measured in minutes (generally less than 120 mins)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startSep 2003
- Primary completionFeb 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- None (open label)
- Enrolment
- 882 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Eva Kline-Rogers, University of Michigan
- Investigators
- Mauro Moscucci, M.D., Principal investigator, University of MichiganEva M Kline-Rogers, MS, RN, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625104
- Sponsor's protocol ID
- 1998-0080
- Acronym
- RAPID-PCI
- Status last verified
- May 2017
- First submitted
- 19 Jun 2012
- Last updated
- 15 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Aggressive Process of Care Quality Improvement Intervention to Decrease Door to Balloon Time in Primary PCI for Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01625104
- Acronym / sponsor ID
- RAPID-PCI / 1998-0080
- Conditions
- STEMI
- Keywords
- Myocardial Infarction, Time to Treatment, Door to Balloon Time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 882 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- Sep 2003
- Primary completion
- Feb 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Posted 15 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess whether an aggressive quality improvement intervention strategy will decrease time from hospital presentation to first balloon inflation in non-transfer patients with acute ST segment elevation MI (STEMI) treated with primary percutaneous coronary intervention (PCI). Twelve hospitals in Michigan were randomized to either aggressive intervention or control. The intervention consisted of Grand Rounds at each hospital, sharing of best practices, and coordinating center staff working closely with staff at each intervention hospital to discuss solutions to barriers to rapid treatment for STEMI patients.
Detailed description
The participating hospitals randomized to the aggressive intervention strategy actively worked to create teams to analyze processes of care for STEMI patients, identify areas needing improvement, and implemented strategies to streamline treatment.
Hospitals randomized to control were instructed to conduct "business as usual".
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Aggressive Intervention Strategy | Experimental | Other: Agressive Intervention Process Improvement StrategiesHospitals were randomized to an aggressive intervention strategy or to "business as usual". The hospitals randomized to the aggressive intervention strategy underwent the following: 1. Grand Rounds conducted by physician and nurse from the Coordinating Center. This included a formal presentation on the evidence supporting rapid time to treatment in STEMI patients and evidence based strategies for reducing treatment delays. 2. Discussion with staff regarding perceived barriers to treatment and suggestions/ideas for strategies to overcome these barriers 3. Follow-up monthly phone conferences to continue to discuss strategies and ideas sharing 4. Written plan from sites detailing plans to change processes of care. |
| Group 2: Control Strategy | Placebo comparator | Other: Non InterventionHospitals randomized to the control group were instructed to conduct "business as usual". |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Acute ST segment myocardial infarction, non transfer patients, with symptom onset to balloon time less than or equal to 24 hours.
Key exclusion criteria (2 listed)
- Patients transferred from one facility to another,
- non ST segment myocardial infarction patients.
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 |
|---|---|---|
| Non InterventionBusiness as usual | Other | Group 2: Control Strategy |
| Agressive Intervention Process Improvement Strategies | Other | Group 1: Aggressive Intervention Strategy |
Primary outcome
Percentage of Sites With Reduction in Door to Balloon Time
Time frame: Arrival to balloon inflation, measured in minutes (generally less than 120 mins)
Arrival time in Emergency Department to first balloon inflation in the coronary artery. Any reduction in median Door to Balloon Time from baseline to follow-up was counted as reduction in time
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for STEMI
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Integrated Assessment of Immune-Inflammatory and Metabolic Biomarkers for Prediction of Coronary No-Reflow Following Primary PCI in STEMI Patients
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Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
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Metabolic Characteristics of Plasma OxPLs in STEMI Patients.
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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.
Mauro Moscucci, M.D. principal investigator
University of Michigan
Eva M Kline-Rogers, MS, RN study director
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Intervention and Agressive Intervention Process Improvement Strategies in people with STEMI, run by University of Michigan 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 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 15 Dec 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Sites With Reduction in Door to Balloon Time (time frame: Arrival to balloon inflation, measured in minutes (generally less than 120 mins)). 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 15 Dec 2017.