Web-based Smoking Cessation Intervention: Transition From Inpatient to Outpatient
17 de junio de 2015 actualizado por: 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.
Descripción general del estudio
Estado
Estado
Terminado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
Inscripción
1548
Fase
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- The University of Alabama at Birmingham - Lung Health Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
19 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Otro: Usual Care
Standard smoking cessation information provided to all hospitalized patients as part of discharge packet.
|
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.
Otros nombres:
|
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Experimental: 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.
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Smoking abstinence
Periodo de tiempo: 6 months
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Biochemically-verified (cotinine) and self-reported tobacco abstinence
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6 months
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Smoking abstinence
Periodo de tiempo: 3 and 12 months
|
self-reported tobacco abstinence
|
3 and 12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Kathleen F Harrington, PhD, MPH, The University of Alabama at Birmingham
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Shields M. Smoking-prevalence, bans and exposure to second-hand smoke. Health Rep. 2007 Aug;18(3):67-85. No abstract available.
- 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.
- California Department of Health Services, Section TC. Adult Smoking Prevalence. http.//www.dhs.ca.gov/tobacco. Accessed January 6, 2010.
- 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.
- 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.
- 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.
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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.
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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.
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
1 de julio de 2011
Finalización primaria (Actual)
Finalización primaria
1 de septiembre de 2014
Finalización del estudio (Actual)
Finalización del estudio
1 de noviembre de 2014
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
12 de enero de 2011
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
13 de enero de 2011
Publicado por primera vez (Estimar)
Publicado por primera vez
14 de enero de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización publicada
19 de junio de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
17 de junio de 2015
Última verificación
Última verificación
1 de junio de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
Otros números de identificación del estudio
- 1U01DA031515 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .