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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Behavioral: Interactive Voice Response

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 Type: Interventional
• Enrollment (Actual): 442
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Biochemically confirmed 7-day point prevalent smoking abstinence	52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Collaborators: 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

Publications and helpful links

General Publications

• Reid RD, Aitken DA, Mullen KA, McDonnell L, Armstrong A, LeBlanc AG, Slovinec-D'Angelo M, Pipe AL. Automated Telephone Follow-up for Smoking Cessation in Smokers With Coronary Heart Disease: A Randomized Controlled Trial. Nicotine Tob Res. 2019 Jul 17;21(8):1051-1057. doi: 10.1093/ntr/nty108.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: March 19, 2007
• First Submitted That Met QC Criteria: March 20, 2007
• First Posted (Estimate): March 21, 2007

Study Record Updates

• Last Update Posted (Estimate): April 29, 2011
• Last Update Submitted That Met QC Criteria: April 27, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Rehabilitation; Counseling; Smoking Cessation; Randomized Control Trial; Secondary Prevention
• Additional Relevant MeSH Terms: Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease
• Other Study ID Numbers: NA 5845