Clinical trial NCT01309217: Dissemination of Tobacco Tactics for Hospitalized Smokers
Official title: Dissemination of Tobacco Tactics Versus 1-800-QUIT-NOW for Hospitalized Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2011-03-07
Enrollment: 1528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Nurse-administered smoking cessation interventions have been shown to be efficacious, but are seldom implemented due to lack of training and time. This project aims to disseminate and test the nurse-administered Tobacco Tactics intervention in 6 hospitals.

Detailed description: Background: Dr. Duffy has developed, tested, and refined the efficacious, nurse-administered Tobacco Tactics intervention and has packaged it into a Toolkit for dissemination in two Veterans Affairs (VA) hospitals. However, rigorous testing of dissemination outside of the VA is needed.

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.

Eligibility criteria: Inclusion Criteria:

1. are at least 18 years of age;
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:

1. are too ill to participate;
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.

Primary outcomes:
measure: Biochemically confirmed 7-day point-prevalence abstinence at 6-month
timeFrame: 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Saint Mary's Healthcare
state: Michigan
city: Livonia
country: United States
facility: St. Mary Mercy
state: Michigan
city: Muskegon
country: United States
facility: Mercy Health Partners - Hackley Campus
state: Michigan
city: Muskegon
country: United States
facility: Mercy Health Partners - Mercy Campus
state: Michigan
city: Oakland
country: United States
facility: St. Joseph Mercy
state: Michigan
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sonia A Duffy, PhD, RN
role: PRINCIPAL_INVESTIGATOR
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