Readiness for Behavior Change After a Heart Attack (ENROLL)

Henry Ford Health

Status: Completed

Conditions: Coronary Artery Disease; Stable Angina; Myocardial Infarction

Treatments: Other: Routine referral (at 5 weeks); Behavioral: Early appointment (within 10 days)

Study type: Interventional

Funder types: Other

Identifiers

NCT01596036

HFHS 6649

Details and patient eligibility

About

The purpose of this study is to test if an early appointment (within 10 days) when compared to a standard appointment (5 weeks) will affect attendance at the Cardiac Rehabilitation orientation and subsequent enrollment into cardiac rehabilitation.

Full description

Cardiac Rehabilitation is central to full recovery after a myocardial infarction or a cardiac stenting procedure. Yet, this therapy is underutilized across the nation. Henry Ford currently enrolls about 42% of eligible patients. In addition, it currently takes, on average, 42 +/-26 days from hospital discharge to enrollment in rehabilitation. During this delay, there is strong tendency to return to prior habits (sedentary lifestyle, smoking, poor nutrition, etc.) that led to the myocardial infarction in the first place. This delay is both 1) unnecessary and 2) probably harmful to the patients' readiness to make changes.

The investigators seek to perform a randomized controlled trial of early (7-10 days) vs standard referral (5-6 weeks) to cardiac rehabilitation. In addition, the investigators will examine the patients' readiness to change through the first 3 months of the post-hospitalization period and correlate that to their behavior and enrollment in cardiac rehabilitation. Assessment of readiness to change will be accomplished by serial survey's, which will be administered at discharge, 2 weeks, 5 weeks, and 13 weeks after discharge.

Patients will consent to take the survey and be observed in a clinical study. However, in order to avoid the Hawthorne Effect, patients they will not initially be aware of the primary hypothesis, as the investigators strongly believe this will affect the main behavior they are trying to measure. Full patient disclosure will occur at the end of the trial.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable Angina
• Myocardial infarction
• Percutaneous coronary intervention
• willingness to participate and consent for medical record review
• willingness to complete survey's

Exclusion criteria

• Recent illicit drug use
• Unstable psychiatric condition
• Moderate or severe dementia
• Inability to follow-up
• Leaving system with plans to enroll in cardiac rehabilitation out-of-system
• Inability to exercise (amputee, severe claudication)
• Unstable medical condition that would prevent regular exercise training
• Uncorrected severe aortic stenosis or severe mitral stenosis
• Referring physician feels that exercise is contra-indicated due to safety or other patient specific factors
• CABG, LVAD, or Heart Transplant

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups, including a placebo group

Early Appointment

Experimental group

Description:

Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge

Treatment:

Behavioral: Early appointment (within 10 days)

Standard Referral

Placebo Comparator group

Description:

Patients will receive an appointment to cardiac rehabilitation at 5 weeks from the date of their anticipated hospital discharge. A routine referral to cardiac rehabilitation will also occur in parallel. Consequently, it is possible that some patients will attend cardiac rehabilitation earlier than their assigned 5 week appointment.

Treatment:

Other: Routine referral (at 5 weeks)