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| Name | Class |
|---|---|
| Blue Cross Blue Shield of Michigan Foundation | OTHER |
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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.
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
|
| Group 2: Control Strategy | Placebo Comparator | Hospitals randomized to the control group were instructed to conduct "business as usual". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Intervention | Other | Business as usual |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Arrival to balloon inflation, measured in minutes (generally less than 120 mins) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauro Moscucci, M.D. | University of Michigan | Principal Investigator |
| Eva M Kline-Rogers, MS, RN | University of Michigan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Site were randomized according to baseline Door to Balloon times.
6 sites were randomized to the aggressive strategy and 6 sites were randomized to control.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Agressive Strategy | Hospitals were randomized to an aggressive intervention strategy or to "business as usual". The hospitals randomized to the aggressive intervention strategy underwent the following:
|
| FG001 | Group 2: Control | Hospitals randomized to the control group were instructed to conduct "business as usual". |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Agressive Intervention | Hospitals were randomized to an aggressive intervention strategy or to "business as usual". The hospitals randomized to the aggressive intervention strategy underwent the following:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | percentage of sites with improved D2B | Arrival to balloon inflation, measured in minutes (generally less than 120 mins) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Agressive Intervention | Hospitals were randomized to an aggressive intervention strategy or to "business as usual". The hospitals randomized to the aggressive intervention strategy underwent the following:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Kline-Rogers MS, RN | University of Michigan | 734 9985909 | evakline@med.umich.edu |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Agressive Intervention Process Improvement Strategies |
| Other |
|
| BG001 | Group 2: Control Strategy | Hospitals randomized to the control group were instructed to conduct "business as usual". Business as usual was described as site specific protocol for treatment of STEMI patient +/- any ongoing quality improvement efforts. No specific recommendations were given to sites from the coordinating center. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 448 |
| 0 |
| 448 |
| EG001 | Group 2: Control Strategy | Hospitals randomized to the control group were instructed to conduct "business as usual". Business as usual was defined as normal protocol for treatment of STEMI patients at each individual site +/- quality improvement efforts. No contact or advice was given to the sites from the coordinating center. | 0 | 434 | 0 | 434 |
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |