- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01309217
Dissemination of Tobacco Tactics for Hospitalized Smokers
Dissemination of Tobacco Tactics Versus 1-800-QUIT-NOW for Hospitalized Smokers
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
- 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.
- 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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Michigan
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Grand Rapids, Michigan, United States, 49503
- Saint Mary's Healthcare
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Livonia, Michigan, United States, 48154
- St. Mary Mercy
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Muskegon, Michigan, United States, 49442
- Mercy Health Partners - Hackley Campus
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Muskegon, Michigan, United States, 49444
- Mercy Health Partners - Mercy Campus
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Oakland, Michigan, United States, 48341
- St. Joseph Mercy
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Ypsilanti, Michigan, United States, 48197
- St. Joseph Mercy Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- are at least 18 years of age;
- have smoked within one month prior to hospitalization;
- have a projected hospital stay of at least 24 hours; and
- are willing to complete the interview surveys.
Exclusion Criteria:
- are too ill to participate;
- are terminal;
- are involved in a concurrent trial that includes intervention on smoking; and
- are non-English speaking (the intervention is currently only in English);
- have significant cognitive impairment; and
- have significant communication barriers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6-month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sonia A Duffy, PhD, RN, University of Michigan
Publications and helpful links
General Publications
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- 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. doi: 10.1046/j.1360-0443.2000.9569017.x.
- 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. doi: 10.1111/j.1360-0443.1993.tb02093.x.
- Duffy SA, Cummins SE, Fellows JL, Harrington KF, Kirby C, Rogers E, Scheuermann TS, Tindle HA, Waltje AH; Consortium of Hospitals Advancing Research on Tobacco (CHART). Fidelity monitoring across the seven studies in the Consortium of Hospitals Advancing Research on Tobacco (CHART). Tob Induc Dis. 2015 Sep 3;13(1):29. doi: 10.1186/s12971-015-0056-5. eCollection 2015.
- 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. doi: 10.1001/archinte.166.5.536.
- 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.
- Rice VH, Stead LF. Nursing interventions for smoking cessation. Cochrane Database Syst Rev. 2004;(1):CD001188. doi: 10.1002/14651858.CD001188.pub2.
- 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. doi: 10.1158/1055-9965.EPI-05-0880.
- 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(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.
- Rice VH, Stead LF. Nursing interventions for smoking cessation. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD001188. doi: 10.1002/14651858.CD001188.pub3.
- Rice VH. Nursing intervention and smoking cessation: A meta-analysis. Heart Lung. 1999 Nov-Dec;28(6):438-54. doi: 10.1016/s0147-9563(99)70033-6.
- 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. doi: 10.1001/archotol.130.4.401.
- 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. doi: 10.1176/appi.psy.48.2.142.
- Cohen S, Lichtenstein E. Partner behaviors that support quitting smoking. J Consult Clin Psychol. 1990 Jun;58(3):304-9. doi: 10.1037//0022-006x.58.3.304.
- Rigotti NA, Munafo MR, Stead LF. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001837. doi: 10.1002/14651858.CD001837.pub2.
- 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. doi: 10.1093/geronb/52b.special_issue.49.
- 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. doi: 10.2105/ajph.85.12.1711. No abstract available.
- Fagerstrom KO, Heatherton TF, Kozlowski LT. Nicotine addiction and its assessment. Ear Nose Throat J. 1990 Nov;69(11):763-5. No abstract available.
- Smith MW, Barnett PG. Direct measurement of health care costs. Med Care Res Rev. 2003 Sep;60(3 Suppl):74S-91S. doi: 10.1177/1077558703257001.
- Golding JM, Gongla P, Brownell A. Feasibility of validating survey self-reports of mental health service use. Am J Community Psychol. 1988 Feb;16(1):39-51. doi: 10.1007/BF00906071.
- Weissman JS, Levin K, Chasan-Taber S, Massagli MP, Seage GR 3rd, Scampini L. The validity of self-reported health-care utilization by AIDS patients. AIDS. 1996 Jun;10(7):775-83. doi: 10.1097/00002030-199606001-00013.
- 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. doi: 10.1513/pats.200706-072JK.
- 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. doi: 10.1111/j.1547-5069.2007.00171.x.
- 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. doi: 10.1001/jama.259.19.2883.
- Lancaster T, Stead L. Physician advice for smoking cessation. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD000165. doi: 10.1002/14651858.CD000165.pub2.
- 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. doi: 10.1093/her/11.2.243.
- 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. doi: 10.5993/ajhb.28.3.4.
- 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. doi: 10.2105/ajph.77.5.634.
- Thomson O'Brien MA, Freemantle N, Oxman AD, Wolf F, Davis DA, Herrin J. Continuing education meetings and workshops: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2001;(2):CD003030. doi: 10.1002/14651858.CD003030.
- 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. doi: 10.1136/tc.2003.004515.
- 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.
- Duffy SA, Ronis DL, Ewing LA, Waltje AH, Hall SV, Thomas PL, Olree CM, Maguire KA, Friedman L, Klotz S, Jordan N, Landstrom GL. Implementation of the Tobacco Tactics intervention versus usual care in Trinity Health community hospitals. Implement Sci. 2016 Nov 4;11(1):147. doi: 10.1186/s13012-016-0511-6.
- Duffy SA, Ronis DL, Karvonen-Gutierrez CA, Ewing LA, Hall SV, Yang JJ, Thomas PL, Olree CM, Maguire KA, Friedman L, Gray D, Jordan N. Effectiveness of the Tobacco Tactics Program in the Trinity Health System. Am J Prev Med. 2016 Oct;51(4):551-65. doi: 10.1016/j.amepre.2016.03.012.
- Duffy SA, Ronis DL, Titler MG, Blow FC, Jordan N, Thomas PL, Landstrom GL, Ewing LA, Waltje AH. Dissemination of the nurse-administered Tobacco Tactics intervention versus usual care in six Trinity community hospitals: study protocol for a comparative effectiveness trial. Trials. 2012 Aug 1;13:125. doi: 10.1186/1745-6215-13-125.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1U01HL105218-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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