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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04563546
Other study ID # Pro00090902
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date October 1, 2024

Study information

Verified date September 2023
Source Duke University
Contact Julian Hertz, MD
Phone 919-681-0196
Email julian.hertz@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to develop a quality improvement intervention to address barriers to evidence-based acute coronary syndrome (ACS) care in northern Tanzania. Patients who presented to Kilimanjaro Christian Medical Center (KCMC) will be asked to complete a survey about barriers and facilitators of health care. In addition the survey will be administered to all providers, policymakers, and administrators participating in in-depth interviews. Data from this survey will be used to develop a quality improvement intervention that will be piloted by KCMC staff. Six months after the pilot program is implemented providers, patients, and administrators will be interviewed for their perspectives on the program.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date October 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years or older - symptoms related to acute coronary syndrome - myocardial infarction - clinically sober - able to communicate in Swahili or English Exclusion Criteria: - medically unstable - have a deteriorating condiction - too critically ill to participate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Quality Improvement
A quality improvement intervention including reminders, care protocols, and text messages to improve care of myocardial infarction in the KCMC ED

Locations

Country Name City State
United States Duke University Hospital Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability as measured by the Acceptability of Intervention Measure (AIM) The AIM tool is a 4-question survey that evaluates the acceptability of an intervention. Responses to each question are on a 5-point Likert Scale (Strongly Agree=5, Agree=4, Neutral=3, Disagree=2, Strongly Disagree=1). Responses of "Strongly Agree" (5) and "Agree" (4) are considered to indicate a more acceptable intervention. The responses to each question will be averaged together to give an acceptability score between 1 and 5 for each respondent. The primary outcome will be the overall mean acceptability score among respondents. A mean acceptability score >= 4 will be considered to indicate acceptability. Initial ED visit (baseline)
Secondary Patients presenting with chest pain or shortness of breath who undergo ECG and cardiac biomarker testing during their ED stay Percentage of patients with these symptoms who undergo ECG and cardiac biomarker testing Initial ED visit (baseline)
Secondary Patients with ACS taking aspirin 30 days after enrollment Percentage of patients taking aspiring at 30 days 30 days after enrollment
Secondary Survival of ACS patients at 30 days after enrollment Percentage of patients who have survived at 30 days 30 days after enrollment
Secondary Aspirin administration Percent of ED patients diagnosed with acute coronary syndrome receiving aspirin. Initial ED visit (baseline)
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