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Trial Outcomes & Findings for Acute Coronary Syndrome KCMC (NCT NCT04563546)

NCT ID: NCT04563546

Last Updated: 2025-01-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

641 participants

Primary outcome timeframe

Initial ED visit (baseline)

Results posted on

2025-01-31

Participant Flow

Participant milestones

Participant milestones
Measure
Myocardial Infarction (MI) Patients in Northern Tanzania
Patients presenting to KCMC (Kilimanjaro Christian Medical Center) emergency department with acute MI Quality Improvement: A quality improvement intervention including reminders, care protocols, and text messages to improve care of myocardial infarction in the KCMC ED
Providers in the KCMC Emergency Department
Providers in the KCMC (Kilimanjaro Christian Medical Center) Emergency Department
Overall Study
STARTED
577
64
Overall Study
COMPLETED
577
64
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acute Coronary Syndrome KCMC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Myocardial Infarction (MI) Patients in Northern Tanzania
n=577 Participants
Patients presenting to KCMC (Kilimanjaro Christian Medical Center) emergency department with acute MI Quality Improvement: A quality improvement intervention including reminders, care protocols, and text messages to improve care of myocardial infarction in the KCMC ED
Providers in the KCMC Emergency Department
n=64 Participants
Providers in the KCMC (Kilimanjaro Christian Medical Center) Emergency Department
Total
n=641 Participants
Total of all reporting groups
Age, Continuous
62.4 years
STANDARD_DEVIATION 18.0 • n=5 Participants
29.6 years
STANDARD_DEVIATION 5.7 • n=7 Participants
59.1 years
STANDARD_DEVIATION 16.8 • n=5 Participants
Sex: Female, Male
Female
304 Participants
n=5 Participants
23 Participants
n=7 Participants
327 Participants
n=5 Participants
Sex: Female, Male
Male
273 Participants
n=5 Participants
41 Participants
n=7 Participants
314 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
577 Participants
n=5 Participants
64 Participants
n=7 Participants
641 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
577 Participants
n=5 Participants
64 Participants
n=7 Participants
641 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
Tanzania
577 Participants
n=5 Participants
64 Participants
n=7 Participants
641 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Initial ED visit (baseline)

Population: The AIM was assessed among KCMC ED providers.

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.

Outcome measures

Outcome measures
Measure
Providers in the KCMC Emergency Department
n=64 Participants
Providers in the KCMC (Kilimanjaro Christian Medical Center) Emergency Department
Acceptability as Measured by the Acceptability of Intervention Measure (AIM)
4.82 score on a scale
Standard Deviation 0.31

SECONDARY outcome

Timeframe: Initial ED visit (baseline)

Outcome measures

Outcome measures
Measure
Providers in the KCMC Emergency Department
n=577 Participants
Providers in the KCMC (Kilimanjaro Christian Medical Center) Emergency Department
Number of Participants Presenting With Chest Pain or Shortness of Breath Who Undergo ECG and Cardiac Biomarker Testing During Their ED Stay
431 Participants

SECONDARY outcome

Timeframe: 30 days after enrollment

Population: Participants who met criteria for ACS.

Number of participants with ACS who have survived at 30 days

Outcome measures

Outcome measures
Measure
Providers in the KCMC Emergency Department
n=141 Participants
Providers in the KCMC (Kilimanjaro Christian Medical Center) Emergency Department
Survival of Participants With Acute Coronary Syndrome (ACS) at 30 Days After Enrollment
90 Participants

SECONDARY outcome

Timeframe: Initial ED visit (baseline)

Population: Participants who met criteria for ACS.

Outcome measures

Outcome measures
Measure
Providers in the KCMC Emergency Department
n=141 Participants
Providers in the KCMC (Kilimanjaro Christian Medical Center) Emergency Department
Number of Participants With Acute Coronary Syndrome (ACS) Taking Aspirin at Baseline
101 Participants

SECONDARY outcome

Timeframe: 30 days after enrollment

Population: Participants who met criteria for ACS and survived to 30 days.

Outcome measures

Outcome measures
Measure
Providers in the KCMC Emergency Department
n=90 Participants
Providers in the KCMC (Kilimanjaro Christian Medical Center) Emergency Department
Number of Participants With Acute Coronary Syndrome (ACS) Taking Aspirin 30 Days After Enrollment
42 Participants

Adverse Events

Myocardial Infarction (MI) Patients in Northern Tanzania

Serious events: 0 serious events
Other events: 0 other events
Deaths: 163 deaths

Providers in the KCMC Emergency Department

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julian T. Hertz, MD

Duke University

Phone: 919-681-0196

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place