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CompletedNCT00012987Updated Apr 7, 2015

Implementing Guidelines for Smoking Cessation: A Randomized Trial of Evidence-Based Quality Improvement

An interventional study of Quality Improvement in Smoking, Smoking Cessation and Quality Improvement, sponsored by US Department of Veterans Affairs. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
2,500
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Smoking is a serious and common health risk among veterans. Given the press of national initiatives and local incentives to improve smoking cessation care in response to VA performance measures, this study tests a widely applicable approach to clinical practice guidelines implementation, namely evidence-based quality improvement, which is directly relevant to the translation of efficacious treatments into enhancements in VA health care policy and practice. Evidence-Based Quality Improvement (EBQI) focuses on improved provider adherence to smoking cessation guidelines and a decrease in patient smoking rates in a manner designed to produce short- and long-term health improvements and cost benefits at the organizational level.

Read the detailed description

Background:

Smoking is a serious and common health risk among veterans. Given the press of national initiatives and local incentives to improve smoking cessation care in response to VA performance measures, this study tests a widely applicable approach to clinical practice guidelines implementation, namely evidence-based quality improvement, which is directly relevant to the translation of efficacious treatments into enhancements in VA health care policy and practice. Evidence-Based Quality Improvement (EBQI) focuses on improved provider adherence to smoking cessation guidelines and a decrease in patient smoking rates in a manner designed to produce short- and long-term health improvements and cost benefits at the organizational level.

Objectives:

Adherence to smoking cessation guidelines requires practice changes at the patient, provider, and system levels to achieve optimal quit rates. The objective of this study was to evaluate the effectiveness of evidence-based quality improvement (EBQI)�an expert-designed and locally implemented clinical reorganization of smoking cessation care�on changes in smoking cessation (SC) practice among primary care providers and health outcomes among veteran smokers.

Methods:

An evidence-based quality improvement intervention comprising provision of physician and patient educational materials, local priority setting with leadership and providers, and local adaptation of expert-designed protocols was implemented in experimental VA primary care practices (n=9). VA control sites (n=9), matched on size and academic affiliation, received smoking cessation guideline copies. We randomly sampled, consented, screened and surveyed primary care patients at all 18 sites (n=1,941 smokers) and used computer-assisted telephone interviewing to assess sociodemographics, health status, function, and smoking behavior, attitudes and treatment experience. Post-intervention 12-month follow-up interviews were completed using the same measures (n=1,080). We used multiple imputation using hotdeck techniques and applied both enrollment and attrition weights to the patient-level data. We used weighted logistic regression to evaluate intervention effects, controlling for patient-level predictors of quit attempts and quit status (e.g., level of addiction, readiness to change, age, health).

Status:

The project is completed. Analysis is ongoing for manuscripts.

02

Conditions studied

  • Smoking
  • Smoking Cessation
  • Quality Improvement
03

In context

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

VA Medical Center or outpatient clinics with at least 3000 patients.

Exclusion criteria

Exclusion Criteria:

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
2,500 participants (estimated)

Study arms

  • Other
    Arm 1

    Behavioral: Quality Improvement

Interventions

  • BehavioralQuality Improvement
06

Study locations

2 sites
  • VA Palo Alto Health Care System, Palo Alto, CA
    Palo Alto, California 94304-1290, United States
  • VA Greater Los Angeles Healthcare System, Sepulveda, CA
    Sepulveda, California 91343, United States
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References and documents

Publications

  • Sherman SE, Yano EM, York LS, Lanto AB, Chernof BA, Mittman BS. Assessing the structure of smoking cessation care in the Veterans Health Administration. Am J Health Promot. 2006 May-Jun;20(5):313-8. doi: 10.4278/0890-1171-20.5.313. PubMed 16706001 ↗
  • Sherman SE, Fu SS, Joseph AM, Lanto AB, Yano EM. Gender differences in smoking cessation services received among veterans. Womens Health Issues. 2005 May-Jun;15(3):126-33. doi: 10.1016/j.whi.2005.01.001. PubMed 15894198 ↗
  • Sherman SE, Joseph AM, Yano EM, Simon BF, Arikian N, Rubenstein LV, Parkerton P, Mittman BS. Assessing the institutional approach to implementing smoking cessation practice guidelines in veterans health administration facilities. Mil Med. 2006 Jan;171(1):80-7. doi: 10.7205/milmed.171.1.80. PubMed 16532880 ↗
  • Jonk YC, Sherman SE, Fu SS, Hamlett-Berry KW, Geraci MC, Joseph AM. National trends in the provision of smoking cessation aids within the Veterans Health Administration. Am J Manag Care. 2005 Feb;11(2):77-85. PubMed 15726855 ↗
  • Sherman SE, Yano EM, Lanto AB, Simon BF, Rubenstein LV. Smokers' interest in quitting and services received: using practice information to plan quality improvement and policy for smoking cessation. Am J Med Qual. 2005 Jan-Feb;20(1):33-9. doi: 10.1177/1062860604273776. PubMed 15782753 ↗
  • Meredith LS, Yano EM, Hickey SC, Sherman SE. Primary care provider attitudes are associated with smoking cessation counseling and referral. Med Care. 2005 Sep;43(9):929-34. doi: 10.1097/01.mlr.0000173566.01877.ac. PubMed 16116358 ↗
  • Sherman SE, Lanto AB, Nield M, Yano EM. Smoking cessation care received by veterans with chronic obstructive pulmonary disease. J Rehabil Res Dev. 2003 Sep-Oct;40(5 Suppl 2):1-12. doi: 10.1682/jrrd.2003.10.0001. PubMed 15074449 ↗
  • Mojica WA, Suttorp MJ, Sherman SE, Morton SC, Roth EA, Maglione MA, Rhodes SL, Shekelle PG. Smoking-cessation interventions by type of provider: a meta-analysis. Am J Prev Med. 2004 Jun;26(5):391-401. doi: 10.1016/j.amepre.2004.02.014. PubMed 15165655 ↗
  • Yano EM, Rubenstein LV, Farmer MM, Chernof BA, Mittman BS, Lanto AB, Simon BF, Lee ML, Sherman SE. Targeting primary care referrals to smoking cessation clinics does not improve quit rates: implementing evidence-based interventions into practice. Health Serv Res. 2008 Oct;43(5 Pt 1):1637-61. doi: 10.1111/j.1475-6773.2008.00865.x. Epub 2008 Jun 3. PubMed 18522670 ↗
  • Lombardero A, Campbell DG, Harris KJ, Chaney EF, Lanto AB, Rubenstein LV. Prevalence and correlates of smoking status among veterans affairs primary care patients with probable major depressive disorder. Addict Behav. 2014 Mar;39(3):538-45. doi: 10.1016/j.addbeh.2013.10.030. Epub 2013 Nov 4. PubMed 24290879 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00012987
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Mar 16, 2001
Completion
Dec 2002
Last update
Apr 7, 2015

Study contacts

Scott E Sherman, MD MPH
principal investigator · VA Greater Los Angeles Healthcare System, Sepulveda, CA
Elizabeth M. Yano, PhD MSPH
principal investigator · VA Greater Los Angeles Healthcare System, Sepulveda, CA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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