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Dissemination of Tobacco Tactics for Hospitalized Smokers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01309217
First Posted: March 7, 2011
Last Update Posted: November 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Sonia Duffy, University of Michigan
  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
Intervention Model: Parallel Assignment
Masking: None (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 Sonia Duffy, University of Michigan:

Primary Outcome Measures:
  • Biochemically confirmed 7-day point-prevalence abstinence at 6-month [ Time Frame: 6-month follow-up ]
    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.


Enrollment: 1528
Study Start Date: July 2011
Study Completion Date: March 2014
Primary Completion Date: March 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institutes of Health (NIH)
Investigators
Principal Investigator: Sonia A Duffy, PhD, RN University of Michigan
  More Information

Publications:
Duffy SA, Reeves P, Hermann C, Karvonen C, Smith P. In-hospital smoking cessation programs: what do VA patients and staff want and need? Appl Nurs Res. 2008 Nov;21(4):199-206. doi: 10.1016/j.apnr.2006.11.002.
Freund M, Campbell E, Paul C, McElduff P, Walsh RA, Sakrouge R, Wiggers J, Knight J. Smoking care provision in hospitals: a review of prevalence. Nicotine Tob Res. 2008 May;10(5):757-74. doi: 10.1080/14622200802027131. Review.
Rice VH, Stead LF. Nursing interventions for smoking cessation. Cochrane Database Syst Rev. 2004;(1):CD001188. Review. Update in: Cochrane Database Syst Rev. 2008;(1):CD001188.
Duffy SA, Ronis DL, Valenstein M, Lambert MT, Fowler KE, Gregory L, Bishop C, Myers LL, Blow FC, Terrell JE. A tailored smoking, alcohol, and depression intervention for head and neck cancer patients. Cancer Epidemiol Biomarkers Prev. 2006 Nov;15(11):2203-8.
Duffy SA, Karvonen-Gutierrez CA, Ewing LA, Smith PM; Veterans Integrated Services Network 11 Tobacco Tactics Team. Implementation of the Tobacco Tactics program in the Department of Veterans Affairs. J Gen Intern Med. 2010 Jan;25 Suppl 1:3-10. doi: 10.1007/s11606-009-1075-9.
Rigotti NA, Munafo MR, Stead LF. Smoking cessation interventions for hospitalized smokers: a systematic review. Arch Intern Med. 2008 Oct 13;168(18):1950-60. doi: 10.1001/archinte.168.18.1950. Review.
Rice VH, Stead LF. Nursing interventions for smoking cessation. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD001188. doi: 10.1002/14651858.CD001188.pub3. Review. Update in: Cochrane Database Syst Rev. 2013;8:CD001188.
Rice VH. Nursing intervention and smoking cessation: A meta-analysis. Heart Lung. 1999 Nov-Dec;28(6):438-54.
Terrell JE, Ronis DL, Fowler KE, Bradford CR, Chepeha DB, Prince ME, Teknos TN, Wolf GT, Duffy SA. Clinical predictors of quality of life in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg. 2004 Apr;130(4):401-8.
Duffy SA, Ronis DL, Valenstein M, Fowler KE, Lambert MT, Bishop C, Terrell JE. Depressive symptoms, smoking, drinking, and quality of life among head and neck cancer patients. Psychosomatics. 2007 Mar-Apr;48(2):142-8.
Etter JF, Bergman MM, Humair JP, Perneger TV. Development and validation of a scale measuring self-efficacy of current and former smokers. Addiction. 2000 Jun;95(6):901-13.
Cohen S, Lichtenstein E. Partner behaviors that support quitting smoking. J Consult Clin Psychol. 1990 Jun;58(3):304-9.
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Rigotti NA, Munafo MR, Stead LF. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001837. Review. Update in: Cochrane Database Syst Rev. 2012;5:CD001837.
Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804.
Stump TE, Clark DO, Johnson RJ, Wolinsky FD. The structure of health status among Hispanic, African American, and white older adults. J Gerontol B Psychol Sci Soc Sci. 1997 May;52 Spec No:49-60.
Simon JA, Solkowitz SN, Carmody TP, Browner WS. Smoking cessation after surgery. A randomized trial. Arch Intern Med. 1997 Jun 23;157(12):1371-6.
Chen Y, Rennie DC, Dosman JA. The reliability of cigarette consumption reports by spousal proxies. Am J Public Health. 1995 Dec;85(12):1711-2.
Fagerstrom KO, Heatherton TF, Kozlowski LT. Nicotine addiction and its assessment. Ear Nose Throat J. 1990 Nov;69(11):763-5.
Smith MW, Barnett PG. Direct measurement of health care costs. Med Care Res Rev. 2003 Sep;60(3 Suppl):74S-91S. Review.
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Thompson BT, Schoenfeld D. Usual care as the control group in clinical trials of nonpharmacologic interventions. Proc Am Thorac Soc. 2007 Oct 1;4(7):577-82. Review.
Lindquist R, Wyman JF, Talley KM, Findorff MJ, Gross CR. Design of control-group conditions in clinical trials of behavioral interventions. J Nurs Scholarsh. 2007;39(3):214-21.
Kottke TE, Battista RN, DeFriese GH, Brekke ML. Attributes of successful smoking cessation interventions in medical practice. A meta-analysis of 39 controlled trials. JAMA. 1988 May 20;259(19):2883-9.
Lancaster T, Stead L. Physician advice for smoking cessation. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD000165. Review. Update in: Cochrane Database Syst Rev. 2008;(2):CD000165.
An LC, Zhu SH, Nelson DB, Arikian NJ, Nugent S, Partin MR, Joseph AM. Benefits of telephone care over primary care for smoking cessation: a randomized trial. Arch Intern Med. 2006 Mar 13;166(5):536-42.
Lichtenstein E, Glasgow RE, Lando HA, Ossip-Klein DJ, Boles SM. Telephone counseling for smoking cessation: rationales and meta-analytic review of evidence. Health Educ Res. 1996 Jun;11(2):243-57.
Smith PM, Cameron R, McDonald PW, Kawash B, Madill C, Brown KS. Telephone counseling for population-based smoking cessation. Am J Health Behav. 2004 May-Jun;28(3):231-41.
Wilson W, Pratt C. The impact of diabetes education and peer support upon weight and glycemic control of elderly persons with noninsulin dependent diabetes mellitus (NIDDM). Am J Public Health. 1987 May;77(5):634-5.
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McAlister AL, Rabius V, Geiger A, Glynn TJ, Huang P, Todd R. Telephone assistance for smoking cessation: one year cost effectiveness estimations. Tob Control. 2004 Mar;13(1):85-6.
Javitz HS, Swan GE, Zbikowski SM, Curry SJ, McAfee TA, Decker DL, Patterson R, Jack LM. Cost-effectiveness of different combinations of bupropion SR dose and behavioral treatment for smoking cessation: a societal perspective. Am J Manag Care. 2004 Mar;10(3):217-26.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sonia Duffy, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01309217     History of Changes
Other Study ID Numbers: 1U01HL105218-01 ( U.S. NIH Grant/Contract )
First Submitted: March 4, 2011
First Posted: March 7, 2011
Last Update Posted: November 18, 2014
Last Verified: November 2014


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