China PEACE II: Quality Improvement for Acute Myocardial Infarction

NCT02322944 | Completed DMC

• 1 other identifier: MOST-2013BAI09B01
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop quality improvement strategies and relevant tools focusing on reperfusion therapy in patients with STEMI, and to evaluate their effectiveness via a hospital-level cluster randomized clinical trial, based on the nationally representative collaborative network of over 100 hospitals established in China PEACE retrospective study. In a baseline survey period, through consecutively recruiting all eligible inpatients and collecting relevant medical information, the performance of all participating hospitals before the implementation of the intervention will be assessed. During the following intervention period, 6-10 hospitals that show the strong willingness and ability to collaborate will be selected as "process optimization group". Their clinical pathways and team building will be re-organized for the purpose of quality improvement, and develop individualized treatment strategies and process. Meanwhile, other participating hospitals will be divided into intervention and control groups in a 1:1 ratio, in which the intervention group will take the treatment improvement strategy into implementation, while the control group will maintain the routine practice pattern. All hospitals will consecutively recruit qualified patients in the same method adopted in baseline period. Then the reperfusion rates and other performance measures will be compared among different groups (process optimization, intervention and control).

Conditions

Acute Myocardial Infarction

Keywords

acute myocardial infarction; quality improvement; reperfusion therapy

Outcome Measures

Primary Outcomes (1)

• Reperfusion therapy rate

  Reperfusion therapy rate is defined as utilization rate of thrombolytic therapy or primary PCI treatment among patients indicated with the reperfusion therapy.

  24 hours after admission

Secondary Outcomes (4)

• Timeliness of primary PCI

  24 hours after admission

• Timeliness of thrombolytic therapy

  24 hours after admission

• Timeliness of primary PCI

  24 hours after admission

• Timeliness of thrombolytic therapy

  24 hours after admission

Other Outcomes (12)

• In-hospital mortality

  10 days on average (during hospitalization)

• Aspirin use within 24 hours

  24 hours after admission

• Heparin use within 24 hours

  24 hours after admission

Study Arms (3)

Intervention group

EXPERIMENTAL

The intervention group will take the treatment quality improvement strategies and tools into implementation.

Behavioral: Quality improvement strategies and tools

Control group

NO INTERVENTION

The control group will maintain the routine practice pattern.

Process optimization group

EXPERIMENTAL

The process optimization group's clinical pathways and team building will be re-organized for the purpose of quality improvement, and develop individualized treatment strategies and process.

Behavioral: Quality improvement strategies and tools; Behavioral: Process optimization

Interventions

Quality improvement strategies and tools BEHAVIORAL

Training in standardized treatment pattern; building quality management team and determining improvement goals; tools (a wristband in order to remind all medical staff involved in the treatment process; workflow posters and cards; a CRF including a flowchart to inform the management steps); periodical quality feedback report and regular quality meeting; study website serving as the communication platform.

Intervention group; Process optimization group

Process optimization BEHAVIORAL

Examining local hospitals' workflow to determine the key link affecting the rate of reperfusion therapy and its timeliness (such as thrombolytic drug preparation, cardiac catheterization laboratory preparation, transferring from the ER to the cath lab, interventional medical team gathering, etc.) and systems (such as pre-paid policy for thrombolysis or PPCI)

Process optimization group

Eligibility Criteria

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

You may qualify if:

• Patients with STEMI who arrive at the hospital within 12 hours from the symptoms onset.

You may not qualify if:

• Received reperfusionthrombolytic therapy before the index hospitalization;
• AMI occurring during hospitalization;
• Chest trauma resulting in secondary acute myocardial infarction.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Qinyang People's Hospital

Jiaozuo, Henan, China

Location

Study Officials

• Lixin Jiang, MD, PhD

  Fuwai Hospital, National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 23, 2014
• Study Start: December 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 24, 2016

Record last verified: 2016-10

Locations

CN (1)