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

NCT01807208 | Completed

• 2 other identifiers: Pro000346505U19HS021092
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarction; patient education; prevention

Outcome Measures

Primary Outcomes (2)

• 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)

  baseline, 6 months

• 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

  6 months

Secondary Outcomes (3)

• Age-associated changes that modulate antiplatelet response

  index hospitalization (average 3-5 days), 6 months post discharge

• Association between antiplatelet response and subsequent bleeding events

  6 months

• Age-associated variation in platelet inhibitory response

  index hospitalization (average 3-5 days)

Study Arms (2)

Educational tool

EXPERIMENTAL

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.

Other: Educational Tool

Usual care

NO INTERVENTION

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

Interventions

Educational Tool OTHER

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.

Educational tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• Gilead Sciences: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27715, United States

Location

Study Officials

• Eric Peterson, MD, MPH

  Duke University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 8, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 30, 2017

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)