Clinical trial NCT01277250: Web-based Smoking Cessation Intervention: Transition From Inpatient to Outpatient
Official title: Web-based Smoking Cessation Intervention: Transition From Inpatient to Outpatient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cigarette Smoking
Home Access to Internet and Email
Cognitively and Physically Able to Participate
English Speaking and Reading
Keywords: Hospitalized adults
Tobacco users
Smokers
Smoking cessation
Web-based
Transition coach
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-01-14
Enrollment: 1548
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project, "Web-based Smoking Cessation Intervention: transition from inpatient to outpatient," addresses smoking among hospitalized patients, whose rates are higher than among the general population. Hospitalization offers a unique opportunity to intervene, as it requires temporary abstinence and patients are focused on health concerns. Hypotheses: A tailored web-based and e-message smoking cessation program for current smokers that, upon hospital discharge, transitions the patient to continue a quit attempt when home will be effective. Further, the investigators hypothesize that this approach will be cost-effective. Specific Aims: 1. To test the effectiveness of a web-based smoking cessation intervention. 2. To determine the cost-effectiveness of this approach. Research Design - Methods: A randomized two-arm follow-up design will be used to test the effectiveness of an evidence- and theoretically-based smoking cessation program designed for post-hospitalization. Patients randomized to this arm will be contacted by hospital staff, trained as 'transition coaches,' to engage in Decide2Quit, an interactive web-based program that offers personalized and tailored messages, e-group support, and text messages promoting tobacco abstinence. All hospitalized patients will receive standardized smoking cessation materials. As well, physicians can order nicotine replacement therapy via the hospital's electronic order system. The investigators primary outcome is biologically confirmed and self-reported tobacco abstinence at 6 months follow-up; the investigators will also assess self-reported quit rates at 3 and 12 months and variables hypothesized to predict quit success. We will measure health care utilization and quality of life to allow testing the cost-effectiveness of this program conducted from the perspective of a hospital, health care payers, patients and society. Significance of results: At study completion the investigators will know whether imbedding smoking cessation into usual hospital care, with minimal hospital-staff burden, and an interactive web-based tailored intervention program is an effective way to reduce smoking rates among hospitalized patients, and if it is cost-effective. This program will be an "off the shelf approach that could be disseminated easily.


Eligibility criteria: Inclusion Criteria:

* 19 years of age or older
* Current smoker (at least one puff in the last 30 days)
* Regular (at least weekly) email/internet access
* Can read and speak English
* Can communicate well enough to provide meaningful responses to the screening questions and informed consent
* Well enough to participate (provide meaningful responses to the screening questions and informed consent)
* On standard or contact isolation only
* Cognitively able to participate (to provide meaningful responses to the screening questions and informed consent)
* Does not have another household member participating in this study

Exclusion Criteria:

* Under age 19
* Non-smoker
* Cannot read and speak English
* No email/internet access
* Cannot communicate well enough to provide meaningful responses to the screening questions and informed consent
* Too ill to participate (provide meaningful responses to the screening questions and informed consent)
* On isolation precautions other than standard or contact
* Cognitively unable to participate (to provide meaningful responses to the screening questions and informed consent)
* Has another household member participating in this study

Primary outcomes:
measure: Smoking abstinence
timeFrame: 6 months
Secondary outcomes:
measure: Smoking abstinence
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham - Lung Health Center
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Kathleen F Harrington, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Centers for Disease Control and Prevention (CDC). Cigarette smoking among adults--United States, 2007. MMWR Morb Mortal Wkly Rep. 2008 Nov 14;57(45):1221-6.
citation: Centers for Disease Control and Prevention (CDC). State-specific prevalence and trends in adult cigarette smoking--United States, 1998-2007. MMWR Morb Mortal Wkly Rep. 2009 Mar 13;58(9):221-6.
citation: Boyle RG, Solberg LI, Asche SE, Maciosek MV, Boucher JL, Pronk NP. Proactive recruitment of health plan smokers into telephone counseling. Nicotine Tob Res. 2007 May;9(5):581-9. doi: 10.1080/14622200701243201.
citation: 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.
citation: Mohiuddin SM, Mooss AN, Hunter CB, Grollmes TL, Cloutier DA, Hilleman DE. Intensive smoking cessation intervention reduces mortality in high-risk smokers with cardiovascular disease. Chest. 2007 Feb;131(2):446-52. doi: 10.1378/chest.06-1587.
citation: Katz A, Goldberg D, Smith J, Trick WE. Tobacco, alcohol, and drug use among hospital patients: concurrent use and willingness to change. J Hosp Med. 2008 Sep;3(5):369-75. doi: 10.1002/jhm.358.
citation: Division of Chronic Disease Prevention and Control. Illinois Department of Public Health Tobacco Burden in Illinois 2005. Springfield, IL: Illinois Department of Public Health; 2005.
citation: Reid RD, Mullen KA, Slovinec D'Angelo ME, Aitken DA, Papadakis S, Haley PM, McLaughlin CA, Pipe AL. Smoking cessation for hospitalized smokers: an evaluation of the "Ottawa Model". Nicotine Tob Res. 2010 Jan;12(1):11-8. doi: 10.1093/ntr/ntp165. Epub 2009 Nov 10.
citation: Shields M. Smoking-prevalence, bans and exposure to second-hand smoke. Health Rep. 2007 Aug;18(3):67-85. No abstract available.
citation: Benowitz NL, Schultz KE, Haller CA, Wu AH, Dains KM, Jacob P 3rd. Prevalence of smoking assessed biochemically in an urban public hospital: a rationale for routine cotinine screening. Am J Epidemiol. 2009 Oct 1;170(7):885-91. doi: 10.1093/aje/kwp215. Epub 2009 Aug 27.
citation: California Department of Health Services, Section TC. Adult Smoking Prevalence. http.//www.dhs.ca.gov/tobacco. Accessed January 6, 2010.
citation: The Joint Commission. Comprehensive Accreditation Manual for Hospitals. http://www.jcrinc.com/Joint-Commission-Requirements/Hospitals/. Accessed January 13, 2010.
citation: Freund M, Campbell E, Paul C, Sakrouge R, Lecathelinais C, Knight J, Wiggers J, Walsh RA, Jones T, Girgis A, Nagle A. Increasing hospital-wide delivery of smoking cessation care for nicotine-dependent in-patients: a multi-strategic intervention trial. Addiction. 2009 May;104(5):839-49. doi: 10.1111/j.1360-0443.2009.02520.x. Epub 2009 Mar 13.
citation: Center for Medicare and Medicaid Services. Electronic Medical Records. http://search.cms.hhs.gov/search?q=electronic+medical+record&site=cms_collection&output=xml_no_dtd&client=cms_frontend&proxystylesheet=cms_frontend&oe=UTF-8&ie=UTF-8&ip=10.10.4.252&access=p&sort=date%3AD%3AL%3Ad1&entqr=0&ud=1&start=10. Accessed January 12, 2010.
citation: CDC. Tobacco-Related Costs and Expenditure in the United States. http://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/index.htm. Accessed January 13, 2010.
citation: Glantz SA. Meta-analysis of the effects of smokefree laws on acute myocardial infarction: an update. Prev Med. 2008 Oct;47(4):452-3. doi: 10.1016/j.ypmed.2008.06.007. Epub 2008 Jun 18. No abstract available.
citation: Centers for Disease Control and Prevention (CDC). Reduced hospitalizations for acute myocardial infarction after implementation of a smoke-free ordinance--City of Pueblo, Colorado, 2002-2006. MMWR Morb Mortal Wkly Rep. 2009 Jan 2;57(51):1373-7.
citation: Pell JP, Haw S, Cobbe S, Newby DE, Pell AC, Fischbacher C, McConnachie A, Pringle S, Murdoch D, Dunn F, Oldroyd K, Macintyre P, O'Rourke B, Borland W. Smoke-free legislation and hospitalizations for acute coronary syndrome. N Engl J Med. 2008 Jul 31;359(5):482-91. doi: 10.1056/NEJMsa0706740.
citation: Rigotti NA, Munafo MR, Murphy MF, Stead LF. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2003;(1):CD001837. doi: 10.1002/14651858.CD001837.
citation: Tanni SE, Iritsu NI, Tani M, de Camargo PA, Sampaio MG, Godoy I, Godoy I. Risk perceptions and behavior among hospitalized patients with smoking-related diseases. Prev Chronic Dis. 2009 Oct;6(4):A138. Epub 2009 Sep 15. No abstract available.
citation: Prochazka AV, Palisoc A. What is the best intervention to help hospitalized patients quit smoking? The Hospitalist. 2008(June 2008).
citation: Committee on Quality of Health Care in America IoM. Crossing the Quality Chasm. Washington, DC: National Academy Press; 2001.
citation: Personal Health Working Group. Connecting for Health. New York, NY: Markle Foundation, (www.connectingforhealth.org); 2006.
citation: Pagliari C, Detmer D, Singleton P. Potential of electronic personal health records. BMJ. 2007 Aug 18;335(7615):330-3. doi: 10.1136/bmj.39279.482963.AD.
citation: National Research Council (US) Committee on Enhancing the Internet for Health Applications: Technical Requirements and Implementation Strategies. Networking Health: Prescriptions for the Internet. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK44718/
citation: American Health Information Management Association; American Medical Informatics Association. The value of personal health records. A joint position statement for consumers of healthcare by the American Health Information Management Association and the American Medical Informatics Association. J AHIMA. 2007 Apr;78(4):22, 24. No abstract available.
citation: Tang PC, Ash JS, Bates DW, Overhage JM, Sands DZ. Personal health records: definitions, benefits, and strategies for overcoming barriers to adoption. J Am Med Inform Assoc. 2006 Mar-Apr;13(2):121-6. doi: 10.1197/jamia.M2025. Epub 2005 Dec 15.
citation: Anderson JG, Rainey MR, Eysenbach G. The impact of CyberHealthcare on the physician-patient relationship. J Med Syst. 2003 Feb;27(1):67-84. doi: 10.1023/a:1021061229743.
citation: Liederman EM, Lee JC, Baquero VH, Seites PG. The impact of patient-physician Web messaging on provider productivity. J Healthc Inf Manag. 2005 Spring;19(2):81-6.
citation: Liederman EM, Lee JC, Baquero VH, Seites PG. Patient-physician web messaging. The impact on message volume and satisfaction. J Gen Intern Med. 2005 Jan;20(1):52-7. doi: 10.1111/j.1525-1497.2005.40009.x.
citation: Liederman EM, Morefield CS. Web messaging: a new tool for patient-physician communication. J Am Med Inform Assoc. 2003 May-Jun;10(3):260-70. doi: 10.1197/jamia.M1259. Epub 2003 Jan 28.
citation: eRisk Guidelines: ERisk Working Group for Healthcare http://www.medem.com/phy/phy_eriskguidelines.cfm. 2005.
citation: Hobbs J, Wald J, Jagannath YS, Kittler A, Pizziferri L, Volk LA, Middleton B, Bates DW. Opportunities to enhance patient and physician e-mail contact. Int J Med Inform. 2003 Apr;70(1):1-9. doi: 10.1016/s1386-5056(03)00007-8.
citation: Japuntich SJ, Zehner ME, Smith SS, Jorenby DE, Valdez JA, Fiore MC, Baker TB, Gustafson DH. Smoking cessation via the internet: a randomized clinical trial of an internet intervention as adjuvant treatment in a smoking cessation intervention. Nicotine Tob Res. 2006 Dec;8 Suppl 1:S59-67. doi: 10.1080/14622200601047900.
citation: Myung SK, McDonnell DD, Kazinets G, Seo HG, Moskowitz JM. Effects of Web- and computer-based smoking cessation programs: meta-analysis of randomized controlled trials. Arch Intern Med. 2009 May 25;169(10):929-37. doi: 10.1001/archinternmed.2009.109.
citation: Shahab L, McEwen A. Online support for smoking cessation: a systematic review of the literature. Addiction. 2009 Nov;104(11):1792-804. doi: 10.1111/j.1360-0443.2009.02710.x.
citation: Bock BC, Graham AL, Whiteley JA, Stoddard JL. A review of web-assisted tobacco interventions (WATIs). J Med Internet Res. 2008 Nov 6;10(5):e39. doi: 10.2196/jmir.989.
citation: Kushniruk A, Patel V, Cimino JJ, Barrows RA. Cognitive evaluation of the user interface and vocabulary of an outpatient information system. Proc AMIA Annu Fall Symp. 1996:22-6.
citation: Nagle AL, Hensley MJ, Schofield MJ, Koschel AJ. A randomised controlled trial to evaluate the efficacy of a nurse-provided intervention for hospitalised smokers. Aust N Z J Public Health. 2005 Jun;29(3):285-91. doi: 10.1111/j.1467-842x.2005.tb00770.x.
citation: Lancaster T, Silagy C, Fowler G. Training health professionals in smoking cessation. Cochrane Database Syst Rev. 2000;(3):CD000214. doi: 10.1002/14651858.CD000214.
citation: Grimshaw GM, Stanton A. Tobacco cessation interventions for young people. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003289. doi: 10.1002/14651858.CD003289.pub4.
citation: Dijkstra A, Vonk JM, Jongepier H, Koppelman GH, Schouten JP, ten Hacken NH, Timens W, Postma DS. Lung function decline in asthma: association with inhaled corticosteroids, smoking and sex. Thorax. 2006 Feb;61(2):105-10. doi: 10.1136/thx.2004.039271. Epub 2005 Nov 24.
citation: Bandura A. Social Foundations of Thought and Action. Englewood Cliffs, N.J.: Prentice-Hall; 1986.
citation: Fiore MC, Jaen CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service; 2008.
citation: http://www.pewinternet.org/. Accessed January 12, 2010, 2010.
citation: Birmingham-Hoover Metropolitan area. Sterling's BestPlaces [http://www.bestplaces.net/Metro/Birmingham-Hoover-Alabama.aspx#. Accessed January 10, 2010.
citation: Wolfenden L, Campbell E, Wiggers J, Walsh RA, Bailey LJ. Helping hospital patients quit: what the evidence supports and what guidelines recommend. Prev Med. 2008 Apr;46(4):346-57. doi: 10.1016/j.ypmed.2007.12.003. Epub 2007 Dec 8.
citation: SRNT Subcommittee on Biochemical Verification. Biochemical verification of tobacco use and cessation. Nicotine Tob Res. 2002 May;4(2):149-59. doi: 10.1080/14622200210123581. No abstract available.
citation: Connor Gorber S, Schofield-Hurwitz S, Hardt J, Levasseur G, Tremblay M. The accuracy of self-reported smoking: a systematic review of the relationship between self-reported and cotinine-assessed smoking status. Nicotine Tob Res. 2009 Jan;11(1):12-24. doi: 10.1093/ntr/ntn010. Epub 2009 Jan 27.
citation: Gold MR, Siegel JE, Russel LB, Weinstein MC. Cost-effectiveness in Health and Medicine. New York: Oxford University Press; 1996.
citation: Briggs AH, O'Brien BJ, Blackhouse G. Thinking outside the box: recent advances in the analysis and presentation of uncertainty in cost-effectiveness studies. Annu Rev Public Health. 2002;23:377-401. doi: 10.1146/annurev.publhealth.23.100901.140534. Epub 2001 Oct 25.
citation: Doshi JA, Glick HA, Polsky D. Analyses of cost data in economic evaluations conducted alongside randomized controlled trials. Value Health. 2006 Sep-Oct;9(5):334-40. doi: 10.1111/j.1524-4733.2006.00122.x.
citation: Barber JA, Thompson SG. Analysis of cost data in randomized trials: an application of the non-parametric bootstrap. Stat Med. 2000 Dec 15;19(23):3219-36. doi: 10.1002/1097-0258(20001215)19:233.0.co;2-p.
citation: Triant VA, Grossman E, Rigotti NA, Ramachandran R, Regan S, Sherman SE, Richter KP, Tindle HA, Harrington KF. Impact of Smoking Cessation Interventions Initiated During Hospitalization Among HIV-Infected Smokers. Nicotine Tob Res. 2020 Jun 12;22(7):1170-1177. doi: 10.1093/ntr/ntz168.
citation: Kathleen F H, Young-Il K, Meifang C, Rekha R, Maria P, Rajani S S, Thomas K H, William C B. Web-Based Intervention for Transitioning Smokers From Inpatient to Outpatient Care: An RCT. Am J Prev Med. 2016 Oct;51(4):620-9. doi: 10.1016/j.amepre.2016.04.008.
citation: 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.
citation: Harrington KF, McDougal JA, Pisu M, Zhang B, Sadasivam RS, Houston TK, Bailey WC; CHART Collaborative Group. Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial. Trials. 2012 Aug 1;13:123. doi: 10.1186/1745-6215-13-123.