Clinical trial NCT01807208: PLATFORM to Maximize Patient Knowledge of Health Goals After Acute Myocardial Infarction
Official title: PLATFORM to Maximize Patient Knowledge of Health Goals After Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
patient education
prevention
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2013-03-08
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goals of this study are two fold: 1) To learn whether a personalized patient health goal and reminder tool helps patients to learn more about their condition and to make changes in behavior and medication taking to reduce the risk of another heart attack. 2) To examine a blood sample to learn how patients are responding to their medications. The study team will enroll approximately 220 patients in the hospital recovering from a heart attack. Half of the patients will receive the educational tools and a copy will be sent to their outpatient provider.

Detailed description: The goals of this study are two fold: 1) To evaluate the impact of a personalized patient health goal education and reminder tool on patient adherence to evidence based therapies and subsequent cardiovascular risk factor modification after acute myocardial infarction (AMI); 2) To assess age-related heterogeneity in antiplatelet response among AMI patients. This is a prospective study of \~220 AMI patients, with at least half over age 65 years. Patients will be surveyed with questionnaires (at baseline and 6 months post discharge) and biomarkers (baseline only) to assess the status of their physical function, depression, nutrition, inflammation, and response to antiplatelet therapies. Patients will also be administered a walking test and a grip strength test at baseline. About 1 week after hospital discharge, and again about 3 months after hospital discharge, about half of the patients and their outpatient providers will receive the personalized post-AMI health goal education and reminder tool on patient adherence to evidence-based secondary prevention therapies. Data will be analyzed in aggregate using descriptive statistics. The primary endpoint of interest is a composite measure of adherence at six months to secondary prevention therapies described as the sum of measures received divided by the sum of available opportunities. The secondary endpoint will be analyzed to describe platelet response profiles as a function of age. The study team anticipates the risks for this study to be minimal, since the patient does not receive any investigational therapies.

Eligibility criteria: Inclusion Criteria:

1. Patients with either ST-elevation MI (STEMI) or non-ST-elevation MI (NSTEMI) who are on antiplatelet therapy at the time of enrollment.
2. English language literacy and
3. Able to provide written informed consent.

Exclusion Criteria:

1. Patients less than 18 years of age.
2. Patients who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements
3. Life expectancy less than 6 months or discharged on hospice care.
4. Patients without at least 1 scheduled outpatient follow-up visit inside the Duke University Affiliated Physicians network.
5. Patients who receive a coronary artery bypass grafting (CABG) during the eligible enrollment hospitalization.
6. Active chronic inflammatory conditions (e.g., inflammatory bowel disease, lupus, rheumatoid arthritis)

Primary outcomes:
measure: Change in the effect of patient health goal and reminder tool on health outcomes
timeFrame: baseline, 6 months
measure: Satisfaction and usefulness of education tools
timeFrame: 6 months
Secondary outcomes:
measure: Age-associated changes that modulate antiplatelet response
timeFrame: index hospitalization (average 3-5 days), 6 months post discharge
measure: Association between antiplatelet response and subsequent bleeding events
timeFrame: 6 months
measure: Age-associated variation in platelet inhibitory response
timeFrame: index hospitalization (average 3-5 days)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Eric Peterson, MD, MPH
role: STUDY_CHAIR
References: