Web-based Smoking Cessation Intervention: Transition From Inpatient to Outpatient
17 czerwca 2015 zaktualizowane przez: University of Alabama at Birmingham
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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
1548
Faza
- Faza 4
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35294
- The University of Alabama at Birmingham - Lung Health Center
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
19 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Inny: Usual Care
Standard smoking cessation information provided to all hospitalized patients as part of discharge packet.
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Web-based smoking cessation program that includes a "transition coach" to hospitalized patients who will assist them in quitting as they are discharged from the hospital.
Intervention arm participants will have access to a tailored web-based intervention that will include e-messages and activities that are tailored to their recent hospital stay.
Inne nazwy:
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Eksperymentalny: Smoking Cessation Program
Web-based program tailored to patients who smoke and are hospitalized.
Program is tailored to participant's specific hospital experience and other characteristics.
E-messages, social support and a "transition coach" are provided to each participant in this condition.
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Web-based smoking cessation program that includes a "transition coach" to hospitalized patients who will assist them in quitting as they are discharged from the hospital.
Intervention arm participants will have access to a tailored web-based intervention that will include e-messages and activities that are tailored to their recent hospital stay.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Smoking abstinence
Ramy czasowe: 6 months
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Biochemically-verified (cotinine) and self-reported tobacco abstinence
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6 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Smoking abstinence
Ramy czasowe: 3 and 12 months
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self-reported tobacco abstinence
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3 and 12 months
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Kathleen F Harrington, PhD, MPH, The University of Alabama at Birmingham
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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- 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. Erratum In: Arch Intern Med. 2009 Jul 13;169(13):1194.
- 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. Erratum In: MMWR Morb Mortal Wkly Rep. 2008 Nov 28;57(47):1281.
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- 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.
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- Shields M. Smoking-prevalence, bans and exposure to second-hand smoke. Health Rep. 2007 Aug;18(3):67-85. No abstract available.
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- The Joint Commission. Comprehensive Accreditation Manual for Hospitals. http://www.jcrinc.com/Joint-Commission-Requirements/Hospitals/. Accessed January 13, 2010.
- 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.
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- 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.
- 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.
- 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. Erratum In: MMWR Morb Mortal Wkly Rep. 2009 Feb 6;58(4):91.
- 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.
- 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.
- 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.
- Prochazka AV, Palisoc A. What is the best intervention to help hospitalized patients quit smoking? The Hospitalist. 2008(June 2008).
- Committee on Quality of Health Care in America IoM. Crossing the Quality Chasm. Washington, DC: National Academy Press; 2001.
- Personal Health Working Group. Connecting for Health. New York, NY: Markle Foundation, (www.connectingforhealth.org); 2006.
- 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.
- 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/
- 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.
- 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.
- 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.
- 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.
- 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.
- eRisk Guidelines: ERisk Working Group for Healthcare http://www.medem.com/phy/phy_eriskguidelines.cfm. 2005.
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- 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.
- 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.
- 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.
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- 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.
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 lipca 2011
Zakończenie podstawowe (Rzeczywisty)
1 września 2014
Ukończenie studiów (Rzeczywisty)
1 listopada 2014
Daty rejestracji na studia
Pierwszy przesłany
12 stycznia 2011
Pierwszy przesłany, który spełnia kryteria kontroli jakości
13 stycznia 2011
Pierwszy wysłany (Oszacować)
14 stycznia 2011
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
19 czerwca 2015
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
17 czerwca 2015
Ostatnia weryfikacja
1 czerwca 2015
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 1U01DA031515 (Grant/umowa NIH USA)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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