Clinical trial NCT02893280: Acute Coronary Syndrome Sri Lanka Audit Project
Official title: Improving Care for Patients With Acute Coronary Syndrome: Acute Coronary Syndrome Sri Lanka Audit Project (ACSSLAP)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Coronary Syndrome
Unstable Angina
Non ST Elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Lead sponsor: University of Colombo
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Sri Lanka
First posted: 2016-09-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This audit will be conducted representing the hierarchy of health care delivery system representing tertiary units, teaching hospitals, district general hospitals up to base hospital level where at least a physician is available. Sample size will be considered based on the number of admissions to each hospital. Minimum number from each hospital will be 30. This number was selected as according to International Network on Rational Use of Drugs (INRUD) guidelines of the World Health Organization, a minimum of 30 prescriptions are recommended from each unit and a minimum of 20 units when auditing prescription data to give a minimum of 600 prescription encounters.

Brief summary: ACSSLAP is the first island wide audit project in Sri Lanka on ACS.

Detailed description: Acute coronary syndrome is a leading cause of morbidity and mortality in the world. Even though up-to-date epidemiological data are not available, as per the institutional level experiences this is not differ much in the local settings. Having a free health care system, government of Sri Lanka has to allocate billions of funds and resources from the annual budget for the maintenance of health care system. Being a developing nation this is a considerable burden to the economy of the country. However, prioritization during resource allocation will prevent mal-distribution of limited resources.

Health care system in Sri Lanka should deliver free as well as quality care to the nation. However, lack of updated guidelines in Sri Lanka for the management for acute coronary syndrome (ACS) is a drawback. American College of Cardiology (ACC) and the European Heart Association (EHA) have developed evidence based and most up to date guidelines to standardize clinical practices in the management of ACS. It is recommended to adhere to local or International guidelines to deliver optimal and quality care to ACS patients.

In Sri Lanka, no audits have been conducted in the health sector in relation to patient management practices in the past. Even though institutional level audits have been carried out time to time for the purpose of allocating medicines and other diagnostic resources, island wide large scale audits have not been carried out. Therefore, conducting an audit on health recourse allocation and patient management clinical practices has become a high priority.

Investigators selected ACS as the most important clinical discipline to conduct an audit based on the institutional level data. This audit is included as a well-designed set of clinical criteria derived from the Myocardial Ischemia National Audit Project (MINAP) in UK, SNAPSHOT ACS study in Australia and New Zealand, American College of Cardiology and European Health Association guidelines. These criteria have been extensively reviewed by a panel of cardiologists and physicians to customize it according to the local requirements.

This project will be Coordinated by the Department of Pharmacology, Faculty of Medicine, University of Colombo in collaboration with the Sri Lanka Heart Association, Ceylon College of Physicians and will be carried out through the Quality and safety Unit of the Ministry of Health, Sri Lanka. Funding is sought from the Ministry of Health

Eligibility criteria: Inclusion Criteria:

-Patients who are diagnosed with acute coronary syndrome before/after admission to the hospital.

Exclusion Criteria:

* Patient who refuse to give consent
* Patients who are less than 18 years of age
* Patients whose diagnosis later changed to another diagnosis
* Patient who are enrolled in any other study.

Primary outcomes:
measure: Discharge, recovery or death after diagnosed acute coronary syndrome
timeFrame: From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay
Secondary outcomes:
Other outcomes:
measure: Patient management
timeFrame: From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay
measure: Health care resources utilization
timeFrame: From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay
Locations:
city: Colombo
country: Sri Lanka
facility: Faculty of Medicine
state: Western Province
Study officials:
affiliation: Department of Pharmacology, Faculty of Medicine, University of Colombo
name: Priyadarshani Galappatthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):e344-426. doi: 10.1161/CIR.0000000000000134. Epub 2014 Sep 23. No abstract available.