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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL077597 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| American Society of Health-System Pharmacists Research and Education Foundation | OTHER |
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Coronary heart disease (CHD) is the leading cause of death in the United States. Most people who die from CHD die of a heart attack. Acute coronary syndrome (ACS) is a term that includes mild heart attacks, as well as other episodes of chest pain that may serve as a warning sign for an upcoming heart attack.
There are many medicines that can help prevent and treat ACS. However, at least 25% of patients don't take their medications as prescribed. When patients don't take their medications, we say they are noncompliant or nonadherent with the treatment.
The period following hospital discharge is a vulnerable time for many patients. Patients are often confused about what to do when they return home from the hospital. Many patients don't take their medications correctly, or they don't take them at all. Patients with poor literacy skills have more trouble than others, because it is harder for them to follow written instructions. Overall, about half of the adults in the U.S. have poor literacy skills. It is important to develop ways to help these adults manage their health better.
The purposes of this research project are 1) to learn more about the relationship between low literacy and medication adherence after hospital discharge, and 2) to test a strategy designed to help patients take their medicines more regularly. We will recruit consenting patients hospitalized with ACS. We will measure their literacy skills, ask questions about how they take their medicines, and measure other related factors like social support and self-efficacy. Patients will then be assigned to 1 of 2 groups. One group will receive only usual care at hospital discharge, which usually includes the nurse and physician briefly reviewing the medication prescriptions. The other group will receive an illustrated daily medication schedule and special, tailored counseling from a pharmacist at their time of discharge. About 1 week after patients leave the hospital we will contact them by phone to ask them questions about how they have been taking their medicines. We will get data from patients records for 6 months to see if the intervention had an impact on their medication compliance, blood pressure, cholesterol, and diabetes measurements.
If this study is successful, this simple strategy could be implemented by hospitals to improve medication compliance after discharge. This study will also provide more information about how patients' literacy skills affect their medication compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health literacy intervention | Experimental | Illustrated medication schedules, pill boxes, pharmacist counseling |
|
| Usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health literacy intervention | Behavioral | Illustrated medication schedules, pill boxes, pharmacist counseling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Refills and Medications Scale (ARMS) | Validated self-report measure of medication adherence. Possible range 12-48, with lower values indicating better adherence. | Approximately 2 weeks after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Efficacy for Appropriate Medication Use Scale (SEAMS) | Validated measure of confidence in taking medications correctly. Possible range 13-39, with higher values indicating greater confidence. | Approximately 2 weeks after hospital discharge |
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Inclusion Criteria:
- Present with acute chest pain or angina equivalent, lasting ≥ 10 minutes of suspected ischemic origin, within the previous 24 hours of presentation to the hospital.
PLUS
Patient must have documented objective evidence of myocardial ischemia based on a or b:
EKG changes in ≥ 2 contiguous leads shown by:
* Transient (< 30 min) ST-segment elevation of ≥ 1.0mm
OR
* Transient or persistent ST-segment depression of ≥ 0.5mm (flat or downsloping at the J-point and at 80ms after the J-point)
OR
* Persistent T-wave inversion of ≥ 2.0mm
Abnormal elevation of cardiac enzymes
* Elevation of creating kinase (CK) and creatine kinase-myocardial band (CK-MB)
OR
* Elevation of troponin
Exclusion Criteria:
Previously enrolled in the study
Police custody
Corrected visual acuity worse than 20/60
Lack of cooperation
Severe hearing impairment
Too ill to participate
Unintelligible speech
Age younger than 18 years
Native language other than English
Psychotic illness
Caregiver administers all medications
Delirium/severe dementia
Does not fill prescriptions at Grady
No regular telephone/address
Not taking chronic medications prior to admission
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| Name | Affiliation | Role |
|---|---|---|
| Sunil Kripalani, MD, MSc | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Health Literacy Intervention | Illustrated medication schedules, pill boxes, pharmacist counseling Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling |
| FG001 | Usual Care | Usual care arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Literacy Intervention | Illustrated medication schedules, pill boxes, pharmacist counseling Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling |
| BG001 | Usual Care |
| 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 | Adherence to Refills and Medications Scale (ARMS) | Validated self-report measure of medication adherence. Possible range 12-48, with lower values indicating better adherence. | Participants who were able to be contacted and provided outcome data. | Posted | Mean | Standard Deviation | units on a scale | Approximately 2 weeks after hospital discharge |
|
2 weeks
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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 | Health Literacy Intervention | Illustrated medication schedules, pill boxes, pharmacist counseling Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Goggins, Research Coordinator | Vanderbilt University Medical Center | 6159364819 | Kathryn.m.goggins@vanderbilt.edu |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D001519 | Behavior |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
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Usual care arm
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Income | Count of Participants | Participants |
|
| Employment status | Count of Participants | Participants |
|
| Education | Mean | Standard Deviation | years |
|
| Rapid Estimate of Adult Literacy in Medicine (REALM) | Validated measure of health literacy involving participants' ability to read medical terms from a list. Possible range of scores 0-66, with higher values indicating better literacy. | Mean | Standard Deviation | units on a scale |
|
| Smoking status | Count of Participants | Participants |
|
|
|
| Secondary | Self-Efficacy for Appropriate Medication Use Scale (SEAMS) | Validated measure of confidence in taking medications correctly. Possible range 13-39, with higher values indicating greater confidence. | Participants who were able to be contacted and provided outcome data. | Posted | Mean | Standard Deviation | units on a scale | Approximately 2 weeks after hospital discharge |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
| EG001 | Usual Care | Usual care (Standard) | 0 | 65 | 0 | 65 | 0 | 65 |
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