China PEACE II: Quality Improvement for Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— PEACE-QI-AMI  

Official title:

China Patient-centered Evaluative Assessment of Cardiac Events II: Quality Improvement for Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02322944
• Other study ID #: MOST-2013BAI09B01
• Status: Completed
• Phase: N/A
• First received: December 15, 2014
• Last updated: October 21, 2016
• Start date: December 2014
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8000
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• 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)

Locations

Country	Name	City	State
China	Qinyang People's Hospital	Jiaozuo	Henan

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	In-hospital mortality	Proportion of in-hospital mortality or withdraw treatment due to a terminal status at discharge.	10 days on average (during hospitalization)	No
Other	Aspirin use within 24 hours	Proportion of aspirin use within 24 hours of admission among eligible patients	24 hours after admission	No
Other	Heparin use within 24 hours	Proportion of heparin use within 24 hours of admission among eligible patients	24 hours after admission	No
Other	Evaluation of left ventricular function	Proportion of left ventricular function evaluation within 24 hours of admission among all patients.	24 hours after admission	No
Other	ß-blockers use during hospitalization	Proportion of ß-blockers use during hospitalization among eligible patients.	10 days on average (during hospitalization)	No
Other	Statins use during hospitalization	Proportion of statins use during hospitalization among eligible patients.	10 days on average (during hospitalization)	No
Other	ACEI/ARB use during hospitalization	Proportion of ACEI/ARB use during hospitalization among eligible patients.	10 days on average (during hospitalization)	No
Other	Aspirin use at discharge	Proportion of aspirin use at discharge among eligible patients.	10 days on average (during hospitalization)	No
Other	Clopidogrel (or ticagrelor) use at discharge	Proportion of Clopidogrel (or ticagrelor) use at discharge among eligible patients.	10 days on average (during hospitalization)	No
Other	ß-blockers use at discharge	Proportion of ß-blockers use at discharge among eligible patients.	10 days on average (during hospitalization)	No
Other	ACEI/ARB use at discharge	Proportion of ACEI/ARB use at discharge among eligible patients.	10 days on average (during hospitalization)	No
Other	Statins use at discharge	Proportion of statins use at discharge among eligible patients.	10 days on average (during hospitalization)	No
Primary	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	No
Secondary	Timeliness of primary PCI	The proportion of door to balloon (D2B) within 90 minutes among all patients receiving PPCI.	24 hours after admission	No
Secondary	Timeliness of thrombolytic therapy	The proportion of door to needle time (D2N) within 30 minutes among all patients receiving fibrinolytic therapy.	24 hours after admission	No
Secondary	Timeliness of primary PCI	Door to balloon (D2B) time	24 hours after admission	No
Secondary	Timeliness of thrombolytic therapy	Door to needle (D2N) time	24 hours after admission	No