Wiser Choices in Acute Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Henry H. Ting, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00888537
First received: April 24, 2009
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

Patients who are hospitalized because of a heart attack are prescribed a number of medicines to help the heart heal. The investigators will examine different ways in which clinicians share information about those treatment options with patients and the impact that this can have on patients' choices and health.


Condition Intervention
Acute Myocardial Infarction
Other: AMI Choice Decision aid
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Wiser Choices in Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Increases adherence to cardiac medications with proven benefits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reduces patients' decisional conflict (increase patient decisional quality) [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]
  • Decreases rehospitalization rates and death [ Time Frame: 5 weeks and 6 months ] [ Designated as safety issue: No ]
  • Increase patient knowledge of medication to help the heart heal [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: March 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Decision Aid
Patients in this arm will discuss medications to help the heart heal after a heart attack with the clinician and the help of a decision aid.
Other: AMI Choice Decision aid
The decision aid describes the risk of dying in the first six months following a heart attack without and with taking a bundle of medications to help the heart heal.
Active Comparator: Usual Care
Patients and clinicians in this arm will discuss medications to help the heart heal after a heart attack in their usual manner.
Other: Usual Care
Patients and clinicians in this arm will discuss medications to help the heart heal after a heart attack in their usual manner.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between the ages of 18 and 90
  • Hospitalized at Saint Marys Hospital
  • A primary diagnosis of AMI,
  • Have heart rate, blood pressure, troponin and creatinine measurements,
  • There is an intention to offer treatment medications
  • Are able and willing to provide informed consent

Exclusion Criteria:

  • Have not had a myocardial infarction
  • Have significant cognitive, visual impairment,
  • Non-English speaker
  • Have a DNI/DNR status
  • Will be discharged to a nursing home
  • AMI is not the presumptive diagnosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888537

Locations
United States, Minnesota
Saint Marys Hospital, Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Henry Ting, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Henry H. Ting, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00888537     History of Changes
Other Study ID Numbers: 09-000748
Study First Received: April 24, 2009
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Decision aid
Heart attack
myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014