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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


NCT number NCT01309217
Study type Interventional
Source University of Michigan
Contact
Status Completed
Phase Phase 4
Start date July 2011
Completion date March 2014

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