Coronary Artery Disease
Conditions
Keywords
Randomized Control Trial, Smoking Cessation, Secondary Prevention, Rehabilitation, Counseling
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).
Interventions
The IVR group will receive a telephone call from the IVR system three, 14, 30, 90, 120 and 150 days after hospital discharge.
Sponsors
Study design
Masking description
Research Assistants completing follow up for outcome data at weeks 26 and 52 were blinded to the treatment allocation.
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Abstinence Rate | Baseline to 26 weeks | Self-reported abstinence from any tobacco product during the time period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Abstinence Rate | 27 to 52 weeks | Self-reported abstinence from any tobacco product during the time period. |
| 7-day Point-prevalence Abstinence Rates | At weeks 26 and 52. | no smoking (not even a puff) in the preceding 7 days |
Countries
Canada
Contacts
University of Ottawa Heart Institute, Minto Prevention and Rehabilitation Centre
University of Ottawa Heart Institute, Minto Prevention and Rehabilitation Centre
University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
Ottawa Heart Institute Research Corporation
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54.6 Years STANDARD_DEVIATION 9.4 |
| Cigarettes per day </= 10 | 31 Participants |
| Cigarettes per day 11-20 | 72 Participants |
| Cigarettes per day 21-30 | 162 Participants |
| Cigarettes per day 31+ | 19 Participants |
| Cigarettes per day Unknown | 1 Participants |
| Fagerstrom score for nicotine dependence | 5.2 score STANDARD_DEVIATION 2.2 |
| Highest level of education completed High school | 100 Participants |
| Highest level of education completed Postsecondary | 101 Participants |
| Highest level of education completed Primary school | 26 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Ready to quit within next 30 days | 188 Participants |
| Reason for hospital admission Acute coronary syndrome | 254 Participants |
| Reason for hospital admission Coronary artery bypass grafting | 12 Participants |
| Reason for hospital admission Diagnostic catheterization | 100 Participants |
| Reason for hospital admission Percutaneous coronary intervention | 14 Participants |
| Received cost-free NRT | 67 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 216 | 5 / 224 |
| other Total, other adverse events | 0 / 216 | 0 / 224 |
| serious Total, serious adverse events | 0 / 216 | 0 / 224 |