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Population-based tobacco treatment: study design of a randomized controlled trial.
BMC Public Health. 2012 Mar 06; 12:159.BP

Abstract

BACKGROUND

Most smokers do not receive comprehensive, evidence-based treatment for tobacco use that includes intensive behavioral counseling along with pharmacotherapy. Further, the use of proven, tobacco treatments is lower among minorities than among Whites. The primary objectives of this study are to: (1) Assess the effect of a proactive care intervention (PRO) on population-level smoking abstinence rates (i.e., abstinence among all smokers including those who use and do not utilize treatment) and on utilization of tobacco treatment compared to reactive/usual care (UC) among a diverse population of smokers, (2) Compare the effect of PRO on population-level smoking abstinence rates and utilization of tobacco treatments between African American and White smokers, and (3) Determine the cost-effectiveness of the proactive care intervention.

METHODS/DESIGN

This prospective randomized controlled trial identifies a population-based sample of current smokers from the Department of Veterans Affairs (VA) electronic medical record health factor dataset. The proactive care intervention combines: (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or face-to-face). Proactive outreach includes mailed invitation materials followed by an outreach call that encourages smokers to seek treatment with choice of services. Proactive care participants who choose telephone care receive VA telephone counseling and access to pharmacotherapy. Proactive care participants who choose face-to-face care are referred to their VA facility's smoking cessation clinic. Usual care participants have access to standard smoking cessation services from their VA facility (e.g., pharmacotherapy, smoking cessation clinic) and from their state telephone quitline. Baseline data is collected from VA administrative databases and participant surveys. Outcomes from both groups are collected 12 months post-randomization from participant surveys and from VA administrative databases. The primary outcome is self-reported smoking abstinence, which is assessed at the population-level (i.e., among those who utilize and those who do not utilize tobacco treatment). Primary analyses will follow intention-to-treat methodology.

DISCUSSION

This randomized trial is testing proactive outreach strategies offering choice of smoking cessation services, an innovation that if proven effective and cost-effective, will transform the way tobacco treatment is delivered. National dissemination of proactive treatment strategies could dramatically reduce tobacco-related morbidity, mortality, and health care costs.

CLINICAL TRIALS REGISTRATION

ClinicalTrials.gov: NCT00608426.

Authors+Show Affiliations

VA HSR&D Center for Chronic Disease Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN, USA. Steven.Fu@va.govNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

22394386

Citation

Fu, Steven S., et al. "Population-based Tobacco Treatment: Study Design of a Randomized Controlled Trial." BMC Public Health, vol. 12, 2012, p. 159.
Fu SS, van Ryn M, Sherman SE, et al. Population-based tobacco treatment: study design of a randomized controlled trial. BMC Public Health. 2012;12:159.
Fu, S. S., van Ryn, M., Sherman, S. E., Burgess, D. J., Noorbaloochi, S., Clothier, B., & Joseph, A. M. (2012). Population-based tobacco treatment: study design of a randomized controlled trial. BMC Public Health, 12, 159. https://doi.org/10.1186/1471-2458-12-159
Fu SS, et al. Population-based Tobacco Treatment: Study Design of a Randomized Controlled Trial. BMC Public Health. 2012 Mar 6;12:159. PubMed PMID: 22394386.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Population-based tobacco treatment: study design of a randomized controlled trial. AU - Fu,Steven S, AU - van Ryn,Michelle, AU - Sherman,Scott E, AU - Burgess,Diana J, AU - Noorbaloochi,Siamak, AU - Clothier,Barbara, AU - Joseph,Anne M, Y1 - 2012/03/06/ PY - 2012/01/17/received PY - 2012/03/06/accepted PY - 2012/3/8/entrez PY - 2012/3/8/pubmed PY - 2012/6/21/medline SP - 159 EP - 159 JF - BMC public health JO - BMC Public Health VL - 12 N2 - BACKGROUND: Most smokers do not receive comprehensive, evidence-based treatment for tobacco use that includes intensive behavioral counseling along with pharmacotherapy. Further, the use of proven, tobacco treatments is lower among minorities than among Whites. The primary objectives of this study are to: (1) Assess the effect of a proactive care intervention (PRO) on population-level smoking abstinence rates (i.e., abstinence among all smokers including those who use and do not utilize treatment) and on utilization of tobacco treatment compared to reactive/usual care (UC) among a diverse population of smokers, (2) Compare the effect of PRO on population-level smoking abstinence rates and utilization of tobacco treatments between African American and White smokers, and (3) Determine the cost-effectiveness of the proactive care intervention. METHODS/DESIGN: This prospective randomized controlled trial identifies a population-based sample of current smokers from the Department of Veterans Affairs (VA) electronic medical record health factor dataset. The proactive care intervention combines: (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or face-to-face). Proactive outreach includes mailed invitation materials followed by an outreach call that encourages smokers to seek treatment with choice of services. Proactive care participants who choose telephone care receive VA telephone counseling and access to pharmacotherapy. Proactive care participants who choose face-to-face care are referred to their VA facility's smoking cessation clinic. Usual care participants have access to standard smoking cessation services from their VA facility (e.g., pharmacotherapy, smoking cessation clinic) and from their state telephone quitline. Baseline data is collected from VA administrative databases and participant surveys. Outcomes from both groups are collected 12 months post-randomization from participant surveys and from VA administrative databases. The primary outcome is self-reported smoking abstinence, which is assessed at the population-level (i.e., among those who utilize and those who do not utilize tobacco treatment). Primary analyses will follow intention-to-treat methodology. DISCUSSION: This randomized trial is testing proactive outreach strategies offering choice of smoking cessation services, an innovation that if proven effective and cost-effective, will transform the way tobacco treatment is delivered. National dissemination of proactive treatment strategies could dramatically reduce tobacco-related morbidity, mortality, and health care costs. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov: NCT00608426. SN - 1471-2458 UR - https://www.unboundmedicine.com/medline/citation/22394386/Population_based_tobacco_treatment:_study_design_of_a_randomized_controlled_trial_ L2 - https://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-12-159 DB - PRIME DP - Unbound Medicine ER -