ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000491268

Ethics application status

Approved

Date submitted

5/06/2009

Date registered

19/06/2009

Date last updated

6/07/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

Clinical Pathways for Acute Coronary Syndromes in China - phase 2: implementation and evaluation

Scientific title

In patients with acute coronary syndromes admitted to urban hospitals in China, are clinical pathways effective for improving the quality of care.

Universal Trial Number (UTN)

Trial acronym

CPACS-2

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute Coronary Syndromes

Condition category

Condition code

Cardiovascular

Coronary heart disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Clinical pathways in this study are standardized algorithms for the treatment of acute coronary syndromes that aim to optimize and streamline patient care. They are established according to American Heart Association (AHA) and American College of Cardiology (ACC) guidelines to promote the use of evidence-based treatments for high risk patients and ultimately, improve clinical outcomes. The clinical pathways are designed to accompany the patient’s medical record and available in printed copy. In this study after baseline data collection, the printed clinical pathways as a reminder of guideline adherence will be added in front of patient’s medical record in relevant departments in the participating hospitals. The clinical pathways will be used for at least 24 month in participating hospitals. Its impact will be evaluated periodically (every 6 months) by comparing a series of key performance indicators, e.g. average door-to needle time and average door-to-balloon time for patients with ST elevated myocardial infarction.

Intervention code [1]

Behaviour

Comparator / control treatment

1. Randomized comparison: hospitals will be selected to implement the clinical pathways “early” and to implement “12 month later”. Approximately one-half of the 75 participating hospitals will be allocated (at random, stratified by hospital size and level) to commence the study in the first year of the full program (Group A), while the remaining one-half (Group B) will commence during the second year. This staggered commencement will be necessary from a logistic viewpoint, but will also provide the opportunity to make a randomized evaluation of the intervention program on the key performance indicators (12 month data for Group A vs. baseline data for Group B).
2. Non-randomized comparison: a “before-after” comparison in key performance indicators among all 75 hospitals will be conducted from up to 3750 patients (50 patients from each of the 75 hospitals) at each 6-month interval with baseline and the previous 6-month time periods. After 24 months, summary data will be available for over 15000 patients to examine overall trends in key performance indicators.

Control group

Active

Outcomes

Primary outcome [1]

Proportion of ST elevated myocardial infarction patients arriving at hospital within 12 hours of symptom onset who receive thrombolysis or primary percutaneous coronary intervention

Timepoint [1]