Dissemination of Tobacco Tactics for Hospitalized Smokers

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sonia Duffy, University of Michigan
ClinicalTrials.gov Identifier:
NCT01309217
First received: March 4, 2011
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Behavioral: Tobacco Tactics Intervention
Other: Usual Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Dissemination of Tobacco Tactics Versus 1-800-QUIT-NOW for Hospitalized Smokers

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Biochemically confirmed 7-day point-prevalence abstinence at 6-month [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2350
Study Start Date: July 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Experimental: 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.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309217

Locations
United States, Michigan
Saint Mary's Healthcare
Grand Rapids, Michigan, United States, 49503
St. Mary Mercy
Livonia, Michigan, United States, 48154
Mercy Health Partners - Hackley Campus
Muskegon, Michigan, United States, 49442
Mercy Health Partners - Mercy Campus
Muskegon, Michigan, United States, 49444
St. Joseph Mercy
Oakland, Michigan, United States, 48341
St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States, 48197
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Sonia A Duffy, PhD, RN University of Michigan
  More Information

Publications:

Responsible Party: Sonia Duffy, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01309217     History of Changes
Other Study ID Numbers: 1 U01 HL105218-01
Study First Received: March 4, 2011
Last Updated: November 26, 2013
Health Authority: United States: National Heart, Lung, and Blood Institute (NHLBI)
United States: Institutional Review Board

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on July 29, 2014