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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MI Patients in northern Tanzania | Other | Patients presenting to KCMC emergency department with acute MI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality Improvement | Other | A quality improvement intervention including reminders, care protocols, and text messages to improve care of myocardial infarction in the KCMC ED |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julian Hertz, MD | Duke University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41218933 | Derived | 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. | |
| 40778095 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Providers in the KCMC Emergency Department | Providers in the KCMC (Kilimanjaro Christian Medical Center) Emergency Department |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The AIM was assessed among KCMC ED providers. | Posted | Mean | Standard Deviation | score on a scale | Initial ED visit (baseline) |
|
30 days
Any Adverse Event plausibly due to the intervention was collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Myocardial Infarction (MI) Patients in Northern Tanzania | Patients presenting to KCMC 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julian T. Hertz, MD | Duke University | 919-681-0196 | julian.hertz@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2024 | Dec 23, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 1, 2023 | Oct 7, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D058996 | Quality Improvement |
| ID | Term |
|---|---|
| D004738 | Engineering |
| D013676 | Technology, Industry, and Agriculture |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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Number of participants with ACS who have survived at 30 days
| 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 |
| Hertz JT, Sakita FM, Munshi ZR, Rahim FO, Mganga D, Kachenje A, Munisi JJ, Pyne AS, Bashaka P, Kilungu A, Aboud AM, Bosworth HB, Bettger JP. Implementation Outcomes of an Intervention to Improve Myocardial Infarction Care in Tanzania. Ann Glob Health. 2025 Aug 5;91(1):43. doi: 10.5334/aogh.4651. eCollection 2025. |
| 39763513 | 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. |
| 39316783 | 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. |
| Providers in the KCMC Emergency Department |
Providers in the KCMC (Kilimanjaro Christian Medical Center) Emergency Department |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants Presenting With Chest Pain or Shortness of Breath Who Undergo ECG and Cardiac Biomarker Testing During Their ED Stay | Posted | Count of Participants | Participants | Initial ED visit (baseline) |
|
|
|
|
| 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 | Participants who met criteria for ACS. | Posted | Count of Participants | Participants | 30 days after enrollment |
|
|
|
|
| Secondary | Number of Participants With Acute Coronary Syndrome (ACS) Taking Aspirin at Baseline | Participants who met criteria for ACS. | Posted | Count of Participants | Participants | Initial ED visit (baseline) |
|
|
|
|
| Secondary | Number of Participants With Acute Coronary Syndrome (ACS) Taking Aspirin 30 Days After Enrollment | Participants who met criteria for ACS and survived to 30 days. | Posted | Count of Participants | Participants | 30 days after enrollment |
|
|
|
| 163 |
| 577 |
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| 577 |
| 0 |
| 577 |
| EG001 | Providers in the KCMC Emergency Department | Providers in the KCMC (Kilimanjaro Christian Medical Center) Emergency Department | 0 | 64 | 0 | 64 | 0 | 64 |
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