Acute Coronary Syndrome Sri Lanka Audit Project (ACSSLAP)

September 15, 2016 updated by: Vipula R Bataduwaarachchi, University of Colombo

Improving Care for Patients With Acute Coronary Syndrome: Acute Coronary Syndrome Sri Lanka Audit Project (ACSSLAP)

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sri Lanka
    • Western Province
      • Colombo, Western Province, Sri Lanka, 80200
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discharge, recovery or death after diagnosed acute coronary syndrome
Time Frame: From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay
Recovery, discharge or death after acute coronary syndrome management following admission to a hospital
From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient management
Time Frame: From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay
To assess acute coronary sysndrome (ACS) patient management clinical practices island wide
From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay
Health care resources utilization
Time Frame: From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay
To assess health care resources utilization for acute coronary syndrome patients island wide
From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colombo

Collaborators

Ministry of Health, Sri Lanka

Investigators

  • Principal Investigator: Priyadarshani Galappatthy, MD, Department of Pharmacology, Faculty of Medicine, University of Colombo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Estimate)

September 16, 2016

Last Update Submitted That Met QC Criteria

September 15, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC00101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be documented on September 17th, 2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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