PLATFORM to Maximize Patient Knowledge of Health Goals After Acute Myocardial Infarction
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||PLATFORM to Maximize Patient Knowledge of Health Goals After Acute Myocardial Infarction|
- Change in the effect of patient health goal and reminder tool on health outcomes [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]The study team plans to evaluate the impact of a personalized patient health goal education and reminder tool on 6-month clinical and other health outcomes. The measure will be a composite of lab measures (such as blood pressure at goal; BMI at goal), behavior change (physical activity, smoking cessation) and medication use (beta blockers, angiotensin-converting enzyme inhibitors (ACEI)/ angiotensin receptor blockers (ARBs), statins if not contraindicated)
- Satisfaction and usefulness of education tools [ Time Frame: 6 months ] [ Designated as safety issue: No ]The study team will ask patients whether they used the education tools in their follow-up physician visits post-AMI; how helpful the tools were; whether they were easy to read and understand; and whether the amount of material presented was appropriate
- Age-associated changes that modulate antiplatelet response [ Time Frame: index hospitalization (average 3-5 days), 6 months post discharge ] [ Designated as safety issue: No ]Describe the physical and functional changes (inflammation, functional decline, nutrition and depression) that modulate platelet inhibitory response to clopidogrel
- Association between antiplatelet response and subsequent bleeding events [ Time Frame: 6 months ] [ Designated as safety issue: No ]Explore the association between antiplatelet response and subsequent bleeding events (number and location of bleeds) among AMI patients to optimize risk stratification and individualize treatment using clinical, physical function and laboratory data
- Age-associated variation in platelet inhibitory response [ Time Frame: index hospitalization (average 3-5 days) ] [ Designated as safety issue: No ]To examine blood biomarkers of platelet inhibitory response and variability in these biomarkers between younger (less than or equal to 70 years of age) and older patients (over 70 years)
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Educational tool
Patients randomized to the educational tool arm of the study will receive mailed educational materials at 2 weeks post hospital discharge and again at 4 months after discharge.
Other: Educational Tool
A personalized health goal education and reminder tool, with 3 parts: "report card" showing the status of secondary prevention domains during hospitalization; questions to help prepare the patient for the follow-up visit; and potential questions for the physician.
No Intervention: Usual care
Patients in this arm of the study will receive usual care.
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 200 AMI patients, with at least half over age 65 years, treated with antiplatelet therapy at the time of enrollment. 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. Four - six weeks after hospital discharge: 100 randomized patients and their outpatient providers will receive a evaluate the impact of a personalized post-AMI health goal education and reminder tool on patient adherence to evidence-based secondary prevention therapies and long-term clinical outcomes. Data will be analyzed in aggregate using descriptive statistics. The primary endpoint of interest is a composite measure of at six months adherence 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01807208
|Contact: Rob Mathews, MDfirstname.lastname@example.org|
|Contact: Laura Webb, BSemail@example.com|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27715|
|Contact: Laura Webb 919-668-8977 firstname.lastname@example.org|
|Principal Investigator: Tracy Wang, MD|
|Study Chair:||Eric Peterson, MD, MPH||Duke University|