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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Ontario | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interactive Voice Response Group | Experimental |
| |
| Usual Care Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive Voice Response | Behavioral | The IVR group will receive a telephone call from the IVR system three, 14, 30, 90, 120 and 150 days after hospital discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Abstinence Rate | Self-reported abstinence from any tobacco product during the time period. | Baseline to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Abstinence Rate | Self-reported abstinence from any tobacco product during the time period. | 27 to 52 weeks |
| 7-day Point-prevalence Abstinence Rates | no smoking (not even a puff) in the preceding 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert D Reid, PhD. | University of Ottawa Heart Institute, Minto Prevention and Rehabilitation Centre | Study Chair |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y4W | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29800420 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interactive Voice Response Group | Participants received automated telephone calls at Days 3, 14, 30, 30, 90, 120, 150, and 180 after hospitalization in addition to the in-hospital counseling with a trained nurse counsellor with a standardized flowsheet and written smoking cessation information. |
| FG001 | Usual Care Group | Participants received in-hospital counseling from a trained nurse-coordinator, guided by a standardized flowsheet and were provided written information about smoking cessation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interactive Voice Response Group | Participants received automated telephone calls at Days 3, 14, 30, 30, 90, 120, 150, and 180 after hospitalization in addition to the in-hospital counseling with a trained nurse counsellor with a standardized flowsheet and written smoking cessation information. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participants who died or moved to an untraceable address during treatment were removed from analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Continuous Abstinence Rate | Self-reported abstinence from any tobacco product during the time period. | Posted | Number | Percentage | Baseline to 26 weeks |
|
Baseline to 52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interactive Voice Response Group | Participants received automated telephone calls at Days 3, 14, 30, 30, 90, 120, 150, and 180 after hospitalization in addition to the in-hospital counseling with a trained nurse counsellor with a standardized flowsheet and written smoking cessation information. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Reid | University of Ottawa Heart Institute | 6136967000 | EQuirouette@ottawaheart.ca |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Research Assistants completing follow up for outcome data at weeks 26 and 52 were blinded to the treatment allocation.
| At weeks 26 and 52. |
| Usual Care Group |
Participants received in-hospital counseling from a trained nurse-coordinator, guided by a standardized flowsheet and were provided written information about smoking cessation. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Participants who died or moved to an untraceable address during treatment were removed from analysis. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Highest level of education completed | Participants who died or moved to an untraceable address during treatment were removed from analysis. | Count of Participants | Participants |
|
| Reason for hospital admission | Participants who died or moved to an untraceable address during treatment were removed from analysis. | Count of Participants | Participants |
|
| Cigarettes per day | Participants who died or moved to an untraceable address during treatment were removed from analysis. | Count of Participants | Participants |
|
| Fagerstrom score for nicotine dependence | Scored 0-10, higher scores indicate higher dependence | Participants who died or moved to an untraceable address during treatment were removed from analysis. | Mean | Standard Deviation | score |
|
| Ready to quit within next 30 days | Participants who died or moved to an untraceable address during treatment were removed from analysis. | Count of Participants | Participants |
|
| Received cost-free NRT | Participants who died or moved to an untraceable address during treatment were removed from analysis. | Count of Participants | Participants |
|
|
|
| Secondary | Continuous Abstinence Rate | Self-reported abstinence from any tobacco product during the time period. | Posted | Number | Percentage | 27 to 52 weeks |
|
|
|
| Secondary | 7-day Point-prevalence Abstinence Rates | no smoking (not even a puff) in the preceding 7 days | Posted | Number | Precentage | At weeks 26 and 52. |
|
|
|
| 6 |
| 216 |
| 0 |
| 216 |
| 0 |
| 216 |
| EG001 | Usual Care Group | Participants received in-hospital counseling from a trained nurse-coordinator, guided by a standardized flowsheet and were provided written information about smoking cessation. | 5 | 224 | 0 | 224 | 0 | 224 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |