Interactive Voice Response Telephone Technology for the Treatment of Smoking in Patients With Heart Disease (IVR)

Study Description

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Brief Summary:

A randomized control trial is planned to evaluate an interactive voice response (IVR) mediated follow-up and triage system, against usual care, to help smokers hospitalized with Coronary Heart Disease (CHD) to quit smoking. The investigators hypothesize that compared to usual care, participants in the IVR group will; a) have a significantly higher 7-day point prevalence abstinence rate at 26 and 52 weeks after hospital discharge, b) will have a higher rate of continuous abstinence at 26 and 52 weeks after hospital discharge, c) will use a greater number of proven effective interventions over time, and d) will develop greater self-efficacy with respect to smoking cessation, over time.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Behavioral: Interactive Voice Response	Phase 2

Detailed Description:

Quitting smoking appears to be the single most effective intervention or treatment to reduce mortality in patients with Coronary Heart Disease (CHD). However, despite interventions, almost two-thirds of smokers resumed smoking in the year after hospitalization for CHD related illnesses; one-third resumed smoking within one month. A critical challenge for institution-level programs is how to provide consistent patient follow-up and linkage to community-based smoking cessation resources. Interactive voice response (IVR) technology has the potential to improve follow-up with smokers after hospitalization and to enhance triage to clinical support for smoking cessation. IVR uses natural language to place automated out-going calls that can pose questions regarding smoking status and progress with smoking cessation, that is then dropped into a database. A counselor is then able to link with the database and obtain information about the patient's smoking cessation needs and provide support as appropriate. A randomized control trial (RCT) is planned to evaluate whether an IVR system for follow-up and triage helps smokers hospitalized for CHD, quit smoking over 26- and 52-week follow-up periods. Participants are randomized into either a Usual Care or IVR group. Both groups will receive in-patient counseling and offer of nicotine replacement therapy. The IVR group will additionally receive a telephone call from the IVR system three, 14, 30, 60, 90, 120, and 150 days after hospital discharge. Variables that will be assessed at 26 and 52 weeks include: smoking status, both 7-day point-prevalent and continuous abstinence, as well as self-efficacy for smoking cessation, use of effective cessation resources and patient satisfaction (at 26 weeks).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	442 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	None (Open Label)
Official Title:	An Interactive, Voice Response-Mediated, Follow-up and Triage System for Smoking Cessation in Smokers With Coronary Heart Disease
Study Start Date :	July 2006
Actual Primary Completion Date :	February 2011
Actual Study Completion Date :	February 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Interactive Voice Response Group	Behavioral: Interactive Voice Response; The IVR group will receive a telephone call from the IVR system three, 14, 30, 90, 120 and 150 days after hospital discharge.
No Intervention: Usual Care Group

Outcome Measures

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Primary Outcome Measures :

1. Biochemically confirmed 7-day point prevalent smoking abstinence [ Time Frame: 52 weeks ]

Secondary Outcome Measures :

1. Use of smoking cessation resources [ Time Frame: 26 & 52 weeks ]
2. Self-efficacy in regards to smoking cessation [ Time Frame: 26 & 52 weeks ]
3. Patient Satisfaction of the IVR system [ Time Frame: 26 weeks ]
4. Continuous Abstinence since hospitalization [ Time Frame: 52 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Patient is currently a smoker (greater than 5 cigarettes per day in the month preceding admission);
2. Patient is 18 years of age and older;
3. Patient is admitted to the in-patient cardiology service at the University of Ottawa Heart Institute (UOHI) for: a) Acute Coronary Syndrome (includes patients admitted for unstable angina or acute myocardial infarction), b) Elective Percutaneous Coronary Intervention (PCI), c) Coronary Artery Bypass Graft (CABG) or d) diagnostic catheterization procedures related to CHD;
4. Patient has received automatic referral for smoking cessation counseling;
5. Patient is willing to provide informed consent

Exclusion Criteria:

1. Patient is unable to read and understand English;
2. Patient lives more than 1.5 hours from UOHI;
3. Patient is returning to referring institution/hospital

Contacts and Locations

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Locations

Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W

Sponsors and Collaborators

Ottawa Heart Institute Research Corporation

Heart and Stroke Foundation of Ontario

Investigators

Study Chair:	Robert D Reid, PhD.	University of Ottawa Heart Institute, Minto Prevention and Rehabilitation Centre
Principal Investigator:	Andrew Pipe, C.M, MD	University of Ottawa Heart Institute, Minto Prevention and Rehabilitation Centre
Principal Investigator:	Bonnie Quinlan, BSCN	University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
Principal Investigator:	Heather Sherrard, BSCN, MHA	Ottawa Heart Institute Research Corporation

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Robert Reid PhD MBA, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:	NCT00449852 History of Changes
Other Study ID Numbers:	NA 5845
First Posted:	March 21, 2007
Last Update Posted:	April 29, 2011
Last Verified:	April 2011

Keywords provided by Ottawa Heart Institute Research Corporation:

Randomized Control Trial; Smoking Cessation; Secondary Prevention; Rehabilitation; Counseling

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases	Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases