Dissemination of Tobacco Tactics for Hospitalized Smokers
NCT ID: NCT01309217
Last Updated: 2014-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1528 participants
INTERVENTIONAL
2011-07-31
2014-03-31
Brief Summary
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Detailed Description
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Objectives: Using 6 community hospitals in the Trinity Health System, the objectives of this study are to:
1. Determine provider and patient receptivity, barriers, and facilitators to implementing the nurse-administered, inpatient Tobacco Tactics intervention versus usual care using face-to-face feedback and surveys.
2. Compare the effectiveness of the nurse-administered, inpatient Tobacco Tactics intervention versus usual care across hospitals, units, and patient characteristics using biochemically confirmed 7-day point-prevalence abstinence at 6-month cessation as the primary outcome.
3. Determine the cost-effectiveness of the nurse-administered, inpatient Tobacco Tactics intervention versus usual care including the cost per quitter, cost per life-year saved, and cost per quality-adjusted life-year saved.
Methods: This effectiveness study will be a cluster randomized control trial in 6 Michigan community hospitals of which 3 will get the nurse-administered Tobacco Tactics intervention and the other 3 will provide their usual care in accordance to how the hospital responds to current Joint Commission on Accreditation of Healthcare Organization's (JC) standards. A research nurse will disseminate the intervention in the 3 out of 6 sites to Master Trainers who will teach staff nurses on all shifts on all units, until all staff nurses are trained. The interventions will become the standard of care within the intervention sites. Research nurses will also conduct rolling evaluation to identify barriers and facilitators to dissemination and implement measures to ensure sustainability of the intervention. It is expected that 7,868 inpatient smokers per year will be eligible to participate in the study of which the investigators expect to recruit 2,350 to have sufficient power to analyze the objectives. Descriptive statistics (means and frequency distributions) will be used to summarize the nurses' survey results, participation rates, smokers' receipt of specific cessation services, and satisfaction with services. Logistic regressions and t-tests will be used to determine differences between intervention groups on satisfaction and quit rates, respectively, with adjustment for the clustering of patients within units and hospitals. Regression analyses will test the moderation of the effects of the interventions by patient characteristics such as confidence in ability to quit, nicotine addiction, alcohol intake, depression, demographics and a smoking related diagnosis such as heart disease. Cost-effectiveness will be assessed by constructing 3 ratios including the cost per quitter, cost per life-year saved, and the cost per quality-adjusted life-year saved.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Usual Care
The comparison group will receive usual care in accordance to how the hospital responds to current Joint Commission on Accreditation of Healthcare Organization's (JC) standards. See below for a complete description.
Usual Care
The comparison group will receive usual care in accordance to how the hospital responds to current Joint Commission on Accreditation of Healthcare Organization's (JC) standards. JC standards require that a patient with a smoking history receives at least one of the following: advice to stop smoking, brochures or handouts on smoking cessation, a smoking cessation aid such as nicotine patch, gum, nasal spray, inhaler, lozenge, or bupropion SR, viewed a smoking cessation video.
Tobacco Tactics Intervention
At the intervention sites the research nurse will teach the Tobacco Tactics Intervention to nurses. For nurses, the Cessation Toolkit includes: 1) 1 CEU contact hour for training; 2) PowerPoint presentation on behavioral and pharmaceutical interventions; 3) pocket card "Helping Smokers Quit: A Guide for Clinicians" developed by U.S. Department of Health and Human Services, Public Health Service; 4) behavioral and pharmaceutical protocols; and 5) computerized template for nurse documentation. For patients, the Cessation Toolkit includes: 1) brochure; 2) videotape; 3); and 4) pharmaceuticals.
Tobacco Tactics Intervention
At the intervention sites the research nurse will teach the Tobacco Tactics Intervention to nurses. For nurses, the Cessation Toolkit includes: 1) 1 CEU contact hour for training; 2) PowerPoint presentation on behavioral and pharmaceutical interventions; 3) pocket card "Helping Smokers Quit: A Guide for Clinicians" developed by U.S. Department of Health and Human Services, Public Health Service; 4) behavioral and pharmaceutical protocols; and 5) computerized template for nurse documentation. For patients, the Cessation Toolkit includes: 1) brochure; 2) videotape; 3); and 4) pharmaceuticals.
Interventions
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Tobacco Tactics Intervention
At the intervention sites the research nurse will teach the Tobacco Tactics Intervention to nurses. For nurses, the Cessation Toolkit includes: 1) 1 CEU contact hour for training; 2) PowerPoint presentation on behavioral and pharmaceutical interventions; 3) pocket card "Helping Smokers Quit: A Guide for Clinicians" developed by U.S. Department of Health and Human Services, Public Health Service; 4) behavioral and pharmaceutical protocols; and 5) computerized template for nurse documentation. For patients, the Cessation Toolkit includes: 1) brochure; 2) videotape; 3); and 4) pharmaceuticals.
Usual Care
The comparison group will receive usual care in accordance to how the hospital responds to current Joint Commission on Accreditation of Healthcare Organization's (JC) standards. JC standards require that a patient with a smoking history receives at least one of the following: advice to stop smoking, brochures or handouts on smoking cessation, a smoking cessation aid such as nicotine patch, gum, nasal spray, inhaler, lozenge, or bupropion SR, viewed a smoking cessation video.
Eligibility Criteria
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Inclusion Criteria
2. have smoked within one month prior to hospitalization;
3. have a projected hospital stay of at least 24 hours; and
4. are willing to complete the interview surveys.
Exclusion Criteria
2. are terminal;
3. are involved in a concurrent trial that includes intervention on smoking; and
4. are non-English speaking (the intervention is currently only in English);
5. have significant cognitive impairment; and
6. have significant communication barriers.
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
University of Michigan
OTHER
Responsible Party
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Sonia Duffy
Associate Professor
Principal Investigators
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Sonia A Duffy, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Saint Mary's Healthcare
Grand Rapids, Michigan, United States
St. Mary Mercy
Livonia, Michigan, United States
Mercy Health Partners - Hackley Campus
Muskegon, Michigan, United States
Mercy Health Partners - Mercy Campus
Muskegon, Michigan, United States
St. Joseph Mercy
Oakland, Michigan, United States
St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States
Countries
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References
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Other Identifiers
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