Dissemination of Tobacco Tactics for Hospitalized Smokers

Smoking Cessation Clinical Trial

Official title:

Dissemination of Tobacco Tactics Versus 1-800-QUIT-NOW for Hospitalized Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309217
• Other study ID #: 1U01HL105218-01
• Status: Completed
• Phase: Phase 4
• First received: March 4, 2011
• Last updated: November 17, 2014
• Start date: July 2011
• Est. completion date: March 2014

Study information

• Verified date: November 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: National Heart, Lung, and Blood Institute (NHLBI)United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1528
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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

• Smoking Cessation

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically confirmed 7-day point-prevalence abstinence at 6-month	The question used to evaluate smoking is: "Have you smoked any cigarette products, even a puff, in the last seven days?" Along with the 6-month survey, patients will be sent a sample for NicAlert urinary test.	6-month follow-up	No