MedDataX Logo

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

NCT ID: NCT01625104

Last Updated: 2017-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

882 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

STEMI

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Myocardial Infarction Time to Treatment Door to Balloon Time

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1: Aggressive Intervention 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:

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 Type EXPERIMENTAL

Agressive Intervention Process Improvement Strategies

Intervention Type OTHER

Group 2: Control Strategy

Hospitals randomized to the control group were instructed to conduct "business as usual".

Group Type PLACEBO_COMPARATOR

Non Intervention

Intervention Type OTHER

Business as usual

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non Intervention

Business as usual

Intervention Type OTHER

Agressive Intervention Process Improvement Strategies

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Patients transferred from one facility to another,
* non ST segment myocardial infarction patients.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Blue Cross Blue Shield of Michigan Foundation

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eva Kline-Rogers

Study Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mauro Moscucci, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Eva M Kline-Rogers, MS, RN

Role: STUDY_DIRECTOR

University of Michigan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1998-0080

Identifier Type: -

Identifier Source: org_study_id