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Clinical Trials/NCT00449852
NCT00449852
Completed
Phase 2

An Interactive, Voice Response-Mediated, Follow-up and Triage System for Smoking Cessation in Smokers With Coronary Heart Disease

Ottawa Heart Institute Research Corporation1 site in 1 country442 target enrollmentJuly 2006

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Ottawa Heart Institute Research Corporation
Enrollment
442
Locations
1
Primary Endpoint
Biochemically confirmed 7-day point prevalent smoking abstinence
Status
Completed
Last Updated
15 years ago

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
July 2006
End Date
February 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patient is currently a smoker (greater than 5 cigarettes per day in the month preceding admission);
  • Patient is 18 years of age and older;
  • 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;
  • Patient has received automatic referral for smoking cessation counseling;
  • Patient is willing to provide informed consent

Exclusion Criteria

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

Outcomes

Primary Outcomes

Biochemically confirmed 7-day point prevalent smoking abstinence

Time Frame: 52 weeks

Secondary Outcomes

  • Use of smoking cessation resources(26 & 52 weeks)
  • Self-efficacy in regards to smoking cessation(26 & 52 weeks)
  • Patient Satisfaction of the IVR system(26 weeks)
  • Continuous Abstinence since hospitalization(52 weeks)

Study Sites (1)

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