Readiness for Behavior Change After a Heart Attack (ENROLL)

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Coronary Artery Disease; Stable Angina
• Intervention / Treatment: Behavioral: Early appointment (within 10 days); Other: Routine referral (at 5 weeks)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Appointment; Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge	Behavioral: Early appointment (within 10 days); Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.
Placebo Comparator: Standard Referral; 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); Standard Referral to Cardiac Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Quinn R Pack, MD, Henry Ford Hospital; Study Director: Steven J Keteyian, PhD, Henry Ford Hospital

Publications and helpful links

General Publications

• Balady GJ, Ades PA, Bittner VA, Franklin BA, Gordon NF, Thomas RJ, Tomaselli GF, Yancy CW; American Heart Association Science Advisory and Coordinating Committee. Referral, enrollment, and delivery of cardiac rehabilitation/secondary prevention programs at clinical centers and beyond: a presidential advisory from the American Heart Association. Circulation. 2011 Dec 20;124(25):2951-60. doi: 10.1161/CIR.0b013e31823b21e2. Epub 2011 Nov 14. No abstract available.
• Russell KL, Holloway TM, Brum M, Caruso V, Chessex C, Grace SL. Cardiac rehabilitation wait times: effect on enrollment. J Cardiopulm Rehabil Prev. 2011 Nov-Dec;31(6):373-7. doi: 10.1097/HCR.0b013e318228a32f.
• Pack QR, Mansour M, Barboza JS, Hibner BA, Mahan MG, Ehrman JK, Vanzant MA, Schairer JR, Keteyian SJ. An early appointment to outpatient cardiac rehabilitation at hospital discharge improves attendance at orientation: a randomized, single-blind, controlled trial. Circulation. 2013 Jan 22;127(3):349-55. doi: 10.1161/CIRCULATIONAHA.112.121996. Epub 2012 Dec 18.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 10, 2012

Study Record Updates

• Last Update Posted (Estimate): November 14, 2012
• Last Update Submitted That Met QC Criteria: November 13, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: cardiac rehabilitation; timing; referral; enrollment
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Angina Pectoris; Myocardial Infarction; Infarction; Coronary Artery Disease; Angina, Stable
• Other Study ID Numbers: HFHS 6649