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PLATFORM to Maximize Patient Knowledge of Health Goals After Acute Myocardial Infarction

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Tool
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction, patient education, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Educational tool

Usual care

Arm Description

Patients randomized to the educational tool arm of the study will receive mailed educational materials at 1 week post hospital discharge and again at 3 months after discharge.

Patients in this arm of the study will receive usual care.

Outcomes

Primary Outcome Measures

Change in the effect of patient health goal and reminder tool on health outcomes
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
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

Secondary Outcome Measures

Age-associated changes that modulate antiplatelet response
Describe the physical and functional changes (inflammation, functional decline, nutrition and depression) that modulate platelet inhibitory response to anti-platelet medications
Association between antiplatelet response and subsequent bleeding events
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
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)

Full Information

First Posted
February 28, 2013
Last Updated
May 24, 2017
Sponsor
Duke University
Collaborators
Gilead Sciences, Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT01807208
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Gilead Sciences, Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute myocardial infarction, patient education, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational tool
Arm Type
Experimental
Arm Description
Patients randomized to the educational tool arm of the study will receive mailed educational materials at 1 week post hospital discharge and again at 3 months after discharge.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients in this arm of the study will receive usual care.
Intervention Type
Other
Intervention Name(s)
Educational Tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the effect of patient health goal and reminder tool on health outcomes
Description
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)
Time Frame
baseline, 6 months
Title
Satisfaction and usefulness of education tools
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Age-associated changes that modulate antiplatelet response
Description
Describe the physical and functional changes (inflammation, functional decline, nutrition and depression) that modulate platelet inhibitory response to anti-platelet medications
Time Frame
index hospitalization (average 3-5 days), 6 months post discharge
Title
Association between antiplatelet response and subsequent bleeding events
Description
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
Time Frame
6 months
Title
Age-associated variation in platelet inhibitory response
Description
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)
Time Frame
index hospitalization (average 3-5 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with either ST-elevation MI (STEMI) or non-ST-elevation MI (NSTEMI) who are on antiplatelet therapy at the time of enrollment. English language literacy and Able to provide written informed consent. Exclusion Criteria: Patients less than 18 years of age. Patients who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements Life expectancy less than 6 months or discharged on hospice care. Patients without at least 1 scheduled outpatient follow-up visit inside the Duke University Affiliated Physicians network. Patients who receive a coronary artery bypass grafting (CABG) during the eligible enrollment hospitalization. Active chronic inflammatory conditions (e.g., inflammatory bowel disease, lupus, rheumatoid arthritis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Peterson, MD, MPH
Organizational Affiliation
Duke University
Official's Role
Study Chair
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27715
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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PLATFORM to Maximize Patient Knowledge of Health Goals After Acute Myocardial Infarction

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