Acute Coronary Syndrome
Conditions
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.
Interventions
OTHERQuality Improvement
A quality improvement intervention including reminders, care protocols, and text messages to improve care of myocardial infarction in the KCMC ED
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability as Measured by the Acceptability of Intervention Measure (AIM) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 ACS who have survived at 30 days |
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 577 |
| Providers in the KCMC Emergency Department Providers in the KCMC (Kilimanjaro Christian Medical Center) Emergency Department | 64 |
| Total | 641 |
Baseline characteristics
| Characteristic | Myocardial Infarction (MI) Patients in Northern Tanzania | Total | Providers in the KCMC Emergency Department |
|---|---|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 18 | 59.1 years STANDARD_DEVIATION 16.8 | 29.6 years STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 577 Participants | 641 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 577 Participants | 641 Participants | 64 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Tanzania | 577 Participants | 641 Participants | 64 Participants |
| Sex: Female, Male Female | 304 Participants | 327 Participants | 23 Participants |
| Sex: Female, Male Male | 273 Participants | 314 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 163 / 577 | 0 / 64 |
| other Total, other adverse events | 0 / 577 | 0 / 64 |
| serious Total, serious adverse events | 0 / 577 | 0 / 64 |
Outcome results
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.
Time frame: Initial ED visit (baseline)
Population: The AIM was assessed among KCMC ED providers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Providers in the KCMC Emergency Department | Acceptability as Measured by the Acceptability of Intervention Measure (AIM) | 4.82 score on a scale | Standard Deviation 0.31 |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Providers in the KCMC 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 |
p-value: <0.001Chi-squared
Secondary
Number of Participants With Acute Coronary Syndrome (ACS) Taking Aspirin 30 Days After Enrollment
Time frame: 30 days after enrollment
Population: Participants who met criteria for ACS and survived to 30 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Providers in the KCMC Emergency Department | Number of Participants With Acute Coronary Syndrome (ACS) Taking Aspirin 30 Days After Enrollment | 42 Participants |
Secondary
Number of Participants With Acute Coronary Syndrome (ACS) Taking Aspirin at Baseline
Time frame: Initial ED visit (baseline)
Population: Participants who met criteria for ACS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Providers in the KCMC Emergency Department | Number of Participants With Acute Coronary Syndrome (ACS) Taking Aspirin at Baseline | 101 Participants |
p-value: <0.001Chi-squared
Secondary
Survival of Participants With Acute Coronary Syndrome (ACS) at 30 Days After Enrollment
Number of participants with ACS who have survived at 30 days
Time frame: 30 days after enrollment
Population: Participants who met criteria for ACS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Providers in the KCMC Emergency Department | Survival of Participants With Acute Coronary Syndrome (ACS) at 30 Days After Enrollment | 90 Participants |
p-value: 0.739Chi-squared