Randomized Trial of a Quality Improvement Intervention to Decrease D2B Time in Primary PCI for AMI

NCT01625104 | Completed Results

• 1 other identifier: 1998-0080
• Study Type: interventional
• Target: 882
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

STEMI

Keywords

Myocardial Infarction; Time to Treatment; Door to Balloon Time

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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.

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".

Other: Non Intervention

Interventions

Non Intervention OTHER

Business as usual

Group 2: Control Strategy

Agressive Intervention Process Improvement Strategies OTHER

Group 1: Aggressive Intervention Strategy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ST segment myocardial infarction, non transfer patients, with symptom onset to balloon time less than or equal to 24 hours.

You may not qualify if:

• Patients transferred from one facility to another,
• non ST segment myocardial infarction patients.

Sponsors & Collaborators

• University of Michigan: lead
• Blue Cross Blue Shield of Michigan Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Eva Kline-Rogers MS, RN
• Organization: University of Michigan

evakline@med.umich.edu

734 9985909

Study Officials

• Mauro Moscucci, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Eva M Kline-Rogers, MS, RN

  University of Michigan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Coordinator

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: September 1, 2003
• Primary Completion: February 1, 2006
• Study Completion: December 1, 2006
• Last Updated: December 15, 2017
• Results First Posted: December 15, 2017

Record last verified: 2017-05

Locations

US (1)