NCT01309217

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,528

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2011

Typical duration for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

2.7 years

First QC Date

March 4, 2011

Last Update Submit

November 17, 2014

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

Tobacco Tactics Intervention

EXPERIMENTAL

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

Interventions

Tobacco Tactics InterventionBEHAVIORAL

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.

Tobacco Tactics Intervention
Usual CareOTHER

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.

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Saint Mary's Healthcare

Grand Rapids, Michigan, 49503, United States

Location

St. Mary Mercy

Livonia, Michigan, 48154, United States

Location

Mercy Health Partners - Hackley Campus

Muskegon, Michigan, 49442, United States

Location

Mercy Health Partners - Mercy Campus

Muskegon, Michigan, 49444, United States

Location

St. Joseph Mercy

Oakland, Michigan, 48341, United States

Location

St. Joseph Mercy Hospital

Ypsilanti, Michigan, 48197, United States

Location

Related Publications (37)

  • 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.

    PMID: 18995161BACKGROUND

  • 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.

    PMID: 18569750BACKGROUND

  • Rice VH, Stead LF. Nursing interventions for smoking cessation. Cochrane Database Syst Rev. 2004;(1):CD001188. doi: 10.1002/14651858.CD001188.pub2.

    PMID: 14973964BACKGROUND

  • 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.

    PMID: 17119047BACKGROUND

  • 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.

    PMID: 20077145BACKGROUND

  • 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.

    PMID: 18852395BACKGROUND

  • Rice VH, Stead LF. Nursing interventions for smoking cessation. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD001188. doi: 10.1002/14651858.CD001188.pub3.

    PMID: 18253987BACKGROUND

  • 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.

    PMID: 10580218BACKGROUND

  • 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.

    PMID: 15096421BACKGROUND

  • 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.

    PMID: 17329608BACKGROUND

  • 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.

    PMID: 10946439BACKGROUND

  • 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.

    PMID: 2365893BACKGROUND

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND

  • 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.

    PMID: 17636688BACKGROUND

  • 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.

    PMID: 8329970BACKGROUND

  • 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.

    PMID: 9215357BACKGROUND

  • 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.

    PMID: 9201012BACKGROUND

  • 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.

    PMID: 7503354BACKGROUND

  • Fagerstrom KO, Heatherton TF, Kozlowski LT. Nicotine addiction and its assessment. Ear Nose Throat J. 1990 Nov;69(11):763-5. No abstract available.

    PMID: 2276350BACKGROUND

  • 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.

    PMID: 15095547BACKGROUND

  • 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.

    PMID: 3369382BACKGROUND

  • 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.

    PMID: 8805870BACKGROUND

  • 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.

    PMID: 17878473BACKGROUND

  • 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.

    PMID: 17760793BACKGROUND

  • 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.

    PMID: 3367456BACKGROUND

  • Lancaster T, Stead L. Physician advice for smoking cessation. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD000165. doi: 10.1002/14651858.CD000165.pub2.

    PMID: 15494989BACKGROUND

  • 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.

    PMID: 16534040BACKGROUND

  • 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.

    PMID: 10163409BACKGROUND

  • 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.

    PMID: 15152882BACKGROUND

  • 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.

    PMID: 3565666BACKGROUND

  • 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.

    PMID: 11406063BACKGROUND

  • 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.

    PMID: 14985603BACKGROUND

  • 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.

    PMID: 15032259BACKGROUND

  • 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.

    PMID: 27814722DERIVED

  • 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.

    PMID: 27647056DERIVED

  • 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.

    PMID: 26336372DERIVED

  • 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.

    PMID: 22852834DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Sonia A Duffy, PhD, RN

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 4, 2011

First Posted

March 7, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

US(6)