Acute Coronary Syndrome KCMC

NCT04563546 | Completed Results

• 1 other identifier: Pro00090902
• Study Type: interventional
• Target: 641
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants Presenting With Chest Pain or Shortness of Breath Who Undergo ECG and Cardiac Biomarker Testing During Their ED Stay

  Initial ED visit (baseline)

• Survival of Participants With Acute Coronary Syndrome (ACS) at 30 Days After Enrollment

  30 days after enrollment

• Number of Participants With Acute Coronary Syndrome (ACS) Taking Aspirin at Baseline

  Initial ED visit (baseline)

• Number of Participants With Acute Coronary Syndrome (ACS) Taking Aspirin 30 Days After Enrollment

  30 days after enrollment

Study Arms (1)

MI Patients in northern Tanzania

OTHER

Patients presenting to KCMC emergency department with acute MI

Other: Quality Improvement

Interventions

Quality Improvement OTHER

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

MI Patients in northern Tanzania

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• symptoms related to acute coronary syndrome
• myocardial infarction
• clinically sober
• able to communicate in Swahili or English

You may not qualify if:

• medically unstable
• have a deteriorating condiction
• too critically ill to participate

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

• Hertz JT, Nworie JE, Shayo F, Galson SW, Coaxum LA, Daniel I, Makambay PS, Akrabi AM, Manyangu GJ, Thielman NM, Bloomfield G, Sakita FM. Acute myocardial infarction diagnosis and treatment following implementation of a multicomponent intervention in Tanzania: the MIMIC pilot trial. BMJ Open. 2025 Nov 11;15(11):e107857. doi: 10.1136/bmjopen-2025-107857.

  PMID: 41218933 DERIVED

• Hertz JT, Sakita FM, Haukila KF, Shayo PS, Shayo FM, Willy J, Lameck G, Kisanga E, Bosworth HB, Bettger JP, Rahim FO. Acceptability and Feasibility of a Multicomponent Intervention to Improve Acute Myocardial Infarction Care in Northern Tanzania: the MIMIC Pilot Trial. medRxiv [Preprint]. 2024 Dec 16:2024.12.13.24319026. doi: 10.1101/2024.12.13.24319026.

  PMID: 39763513 DERIVED

• Hertz JT, Sakita FM, Rahim FO, Mmbaga BT, Shayo F, Kaboigora V, Mtui J, Bloomfield GS, Bosworth HB, Bettger JP, Thielman NM. Multicomponent Intervention to Improve Acute Myocardial Infarction Care in Tanzania: Protocol for a Pilot Implementation Trial. JMIR Res Protoc. 2024 Sep 24;13:e59917. doi: 10.2196/59917.

  PMID: 39316783 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Quality Improvement

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Engineering; Technology, Industry, and Agriculture; Quality of Health Care; Health Services Administration

Results Point of Contact

• Title: Julian T. Hertz, MD
• Organization: Duke University

julian.hertz@duke.edu

919-681-0196

Study Officials

• Julian Hertz, MD

  Duke University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 24, 2020
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)