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OpenTrials
Completed

NCT Number: NCT04563546

Acute Coronary Syndrome KCMC

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality Improvement

Other

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

Primary outcomes

  1. Acceptability as Measured by the Acceptability of Intervention Measure (AIM)

    Time frame: Initial ED visit (baseline)

    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 outcomes

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

    Time frame: Initial ED visit (baseline)

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

    Time frame: 30 days after enrollment

    Number of participants with ACS who have survived at 30 days

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

    Time frame: Initial ED visit (baseline)

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

    Time frame: 30 days after enrollment

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Community and Physician Perceptions of Chest Pain and Prevalence of Acute Coronary Syndrome Among HIV-infected and -Uninfected Patients in Moshi, Tanzania

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 24, 2020
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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