NCT00888537

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

April 24, 2009

Last Update Submit

March 18, 2016

Conditions

Acute Myocardial Infarction

Keywords

Decision aidHeart attackmyocardial infarction

Outcome Measures

Primary Outcomes (4)

  • Increases adherence to cardiac medications with proven benefits

    6 months

  • Reduces patients' decisional conflict (increase patient decisional quality)

    During hospital stay

  • Decreases rehospitalization rates and death

    5 weeks and 6 months

  • Increase patient knowledge of medication to help the heart heal

    During hospital stay

Study Arms (2)

Decision Aid

EXPERIMENTAL

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.

Other: AMI Choice Decision Aid

Usual Care

ACTIVE COMPARATOR

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

Interventions

AMI Choice Decision AidOTHER

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.

Decision Aid
Usual CareOTHER

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

Usual Care

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Marys Hospital, Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

  • 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.

    PMID: 35673524DERIVED

  • 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.

    PMID: 25179289DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Henry Ting, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 27, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 21, 2016

Record last verified: 2016-03

Locations

US(1)