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

NCT ID: NCT00449852

Last Updated: 2011-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 442 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2011-02-28

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).

Conditions

Coronary Artery Disease

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Blinding Strategy: NONE

Study Groups

Interactive Voice Response Group

Group Type: EXPERIMENTAL

Interactive Voice Response

Intervention Type: BEHAVIORAL

The IVR group will receive a telephone call from the IVR system three, 14, 30, 90, 120 and 150 days after hospital discharge.

Usual Care Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role: collaborator

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

University of Ottawa Heart Institute

Principal Investigators

Robert D Reid, PhD.

Role: STUDY_CHAIR

University of Ottawa Heart Institute, Minto Prevention and Rehabilitation Centre

Andrew Pipe, C.M, MD

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa Heart Institute, Minto Prevention and Rehabilitation Centre

Bonnie Quinlan, BSCN

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa Heart Institute, Prevention and Rehabilitation Centre

Heather Sherrard, BSCN, MHA

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 29800420 (View on PubMed)

Other Identifiers

NA 5845

Identifier Type: -

Identifier Source: org_study_id