Overview

This trial has been completed.

Condition acute myocardial infarction
Treatments quality improvement strategies and tools, process optimization
Sponsor China National Center for Cardiovascular Diseases
Start date December 2014
End date June 2016
Trial size 8000 participants
Trial identifier NCT02322944, MOST-2013BAI09B01

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
The intervention group will take the treatment quality improvement strategies and tools into implementation.
quality improvement strategies and tools
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.
(No Intervention)
The control group will maintain the routine practice pattern.
(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.
quality improvement strategies and tools
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.
process optimization
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)

Primary Outcomes

Measure
Reperfusion therapy rate
time frame: 24 hours after admission

Secondary Outcomes

Measure
Timeliness of primary PCI
time frame: 24 hours after admission
Timeliness of thrombolytic therapy
time frame: 24 hours after admission
Timeliness of primary PCI
time frame: 24 hours after admission
Timeliness of thrombolytic therapy
time frame: 24 hours after admission

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients with STEMI who arrive at the hospital within 12 hours from the symptoms onset. Exclusion Criteria: - Received reperfusionthrombolytic therapy before the index hospitalization; - AMI occurring during hospitalization; - Chest trauma resulting in secondary acute myocardial infarction.

Additional Information

Official title China Patient-centered Evaluative Assessment of Cardiac Events II: Quality Improvement for Acute Myocardial Infarction
Principal investigator Lixin Jiang, MD, PhD
Description 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. The primary outcome measure is reperfusion rate among eligible patients with STEMI, and secondary ones include timeliness of primary PCI (D2B) and fibrinolytic therapy (D2N). the assessment is based on consecutively recruiting all eligible inpatients, as well as collecting relevant medical information via a case report form finished by local doctors and central medical record abstraction. During the first study period, the baseline performance of all 100 participating hospitals before the implementation of the intervention will be assessed. During the following period, 3-5 PCI-capable and 3-5 non-PCI capable 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, including examining local hospitals' workflow to determine the key link affecting the rate of reperfusion therapy and its timeliness (such as pre-paid policy for fibrinolytic or PPCI, thrombolytic drug preparation, cardiac catheterization laboratory preparation, transferring from the ER to the Cath lab, interventional medical team gathering, etc.). Also, QI strategies and tools developed in the current study will be provided to these hospital, including training in standardized treatment pattern; building quality management team and determining improvement goals; periodical quality feedback report and regular quality meeting; tools like 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, study website serving as the communication platform. Meanwhile, other participating hospitals will be divided into intervention and control groups in a 1:1 ratio using minimization allocation, in which the intervention group will take the QI strategies and tools developed in the current study as mentioned above, while the control group will maintain the routine practice pattern. Then the outcome measures and other performance indicators will be compared among different groups (process optimization, intervention and control).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by China National Center for Cardiovascular Diseases.