Back to resultsAcute Coronary Syndrome KCMC
Primary Purpose
Acute Coronary Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality Improvement
Sponsored by
About this trial
This is an interventional health services research trial for Acute Coronary Syndrome
Eligibility Criteria
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
Sites / Locations
- Duke University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MI Patients in northern Tanzania
Arm Description
Patients presenting to KCMC emergency department with acute MI
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Patients with ACS taking aspirin 30 days after enrollment
Percentage of patients taking aspiring at 30 days
Survival of ACS patients at 30 days after enrollment
Percentage of patients who have survived at 30 days
Aspirin administration
Percent of ED patients diagnosed with acute coronary syndrome receiving aspirin.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04563546
Brief Title
Acute Coronary Syndrome KCMC
Official Title
Community and Physician Perceptions of Chest Pain and Prevalence of Acute Coronary Syndrome Among HIV-infected and -Uninfected Patients in Moshi, Tanzania
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MI Patients in northern Tanzania
Arm Type
Other
Arm Description
Patients presenting to KCMC emergency department with acute MI
Intervention Type
Other
Intervention Name(s)
Quality Improvement
Intervention Description
A quality improvement intervention including reminders, care protocols, and text messages to improve care of myocardial infarction in the KCMC ED
Primary Outcome Measure Information:
Title
Acceptability as measured by the Acceptability of Intervention Measure (AIM)
Description
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.
Time Frame
Initial ED visit (baseline)
Secondary Outcome Measure Information:
Title
Patients presenting with chest pain or shortness of breath who undergo ECG and cardiac biomarker testing during their ED stay
Description
Percentage of patients with these symptoms who undergo ECG and cardiac biomarker testing
Time Frame
Initial ED visit (baseline)
Title
Patients with ACS taking aspirin 30 days after enrollment
Description
Percentage of patients taking aspiring at 30 days
Time Frame
30 days after enrollment
Title
Survival of ACS patients at 30 days after enrollment
Description
Percentage of patients who have survived at 30 days
Time Frame
30 days after enrollment
Title
Aspirin administration
Description
Percent of ED patients diagnosed with acute coronary syndrome receiving aspirin.
Time Frame
Initial ED visit (baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julian Hertz, MD
Phone
919-681-0196
Email
julian.hertz@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian Hertz, MD
Organizational Affiliation
Duke University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We are bound by local Tanzanian guidelines regarding patient privacy and data security and are not allowed to share individual participant data without express permission of the Tanzanian National Institute for Medical Research.
Learn more about this trial
Acute Coronary Syndrome KCMC
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