Readiness for Behavior Change After a Heart Attack

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Stages of Change Through the Cardiac Rehabilitation Experience After a Recent Hospitalization

Conditions
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Myocardial Infarction, Stable Angina, Coronary Artery Disease

Intervention / Treatment
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* Behavioral: Early appointment (within 10 days)
* Other: Routine referral (at 5 weeks)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Appointment<br>Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge | Behavioral: Early appointment (within 10 days)<br>* Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.<br>|
| Placebo Comparator: Standard Referral<br>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. | Other: Routine referral (at 5 weeks)<br>* Standard Referral to Cardiac Rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance at the free orientation session for Cardiac Rehabilitation |  | within 5 weeks of randomized apointment date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of at least one exercise session in Cardiac Rehabilitation |  | within 1 month of orientation date | 
| Total number of cardiac rehabilitation exercise sessions attended |  | within 6 months of actual orientation date | 
| Completion of the cardiac rehabilitation program | Completion is defined at attending the number of sessions agreed to at the onset of cardiac rehabilitation (e.g. agreeing to 3 session and attending 3) or attending 12 or more sessions. | within 6 months | 
| Change in exercise capacity from the beginning to end of cardiac rehabilitation | exercise capacity will be calculated from treadmill workloads using standardized formulas published in the 8th edition of ACSM's Guidelines for exercise testing and prescription | within 6 months | 
| Readiness to make positive behavior changes | Based on a 10 question survey, each patient will have a summary score to collapse across these questions. This summary score will be compared at 0, 5, and 13 weeks. | within 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac rehabilitation, referral, enrollment, timing