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Wiser Choices in Acute Myocardial Infarction

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AMI Choice Decision Aid
Usual Care
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Decision aid, Heart attack, myocardial infarction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Do Not Intubate/Do Not Resuscitate (DNI/DNR) status
  • Will be discharged to a nursing home
  • AMI is not the presumptive diagnosis

Sites / Locations

  • Saint Marys Hospital, Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Decision Aid

Usual Care

Arm Description

Patients in this arm will discuss medications to help the heart heal after a heart attack with the clinician and the help of the acute myocardial infarction (AMI) Choice Decision Aid.

Patients and clinicians in this arm will discuss medications to help the heart heal after a heart attack in their usual manner.

Outcomes

Primary Outcome Measures

Increases adherence to cardiac medications with proven benefits
Reduces patients' decisional conflict (increase patient decisional quality)
Decreases rehospitalization rates and death
Increase patient knowledge of medication to help the heart heal

Secondary Outcome Measures

Full Information

First Posted
April 24, 2009
Last Updated
March 18, 2016
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00888537
Brief Title
Wiser Choices in Acute Myocardial Infarction
Official Title
Wiser Choices in Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Decision aid, Heart attack, myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decision Aid
Arm Type
Experimental
Arm Description
Patients in this arm will discuss medications to help the heart heal after a heart attack with the clinician and the help of the acute myocardial infarction (AMI) Choice Decision Aid.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Patients and clinicians in this arm will discuss medications to help the heart heal after a heart attack in their usual manner.
Intervention Type
Other
Intervention Name(s)
AMI Choice Decision Aid
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Patients and clinicians in this arm will discuss medications to help the heart heal after a heart attack in their usual manner.
Primary Outcome Measure Information:
Title
Increases adherence to cardiac medications with proven benefits
Time Frame
6 months
Title
Reduces patients' decisional conflict (increase patient decisional quality)
Time Frame
During hospital stay
Title
Decreases rehospitalization rates and death
Time Frame
5 weeks and 6 months
Title
Increase patient knowledge of medication to help the heart heal
Time Frame
During hospital stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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 Do Not Intubate/Do Not Resuscitate (DNI/DNR) status Will be discharged to a nursing home AMI is not the presumptive diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Ting, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Marys Hospital, Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35673524
Citation
Branda ME, Kunneman M, Meza-Contreras AI, Shah ND, Hess EP, LeBlanc A, Linderbaum JA, Nelson DM, Mc Donah MR, Sanvick C, Van Houten HK, Coylewright M, Dick SR, Ting HH, Montori VM. Shared Decision-Making for Patients Hospitalized with Acute Myocardial Infarction: A Randomized Trial. Patient Prefer Adherence. 2022 Jun 1;16:1395-1404. doi: 10.2147/PPA.S363528. eCollection 2022.
Results Reference
derived
PubMed Identifier
25179289
Citation
Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.
Results Reference
derived

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Wiser Choices in Acute Myocardial Infarction

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