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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00012987
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information
First Submitted Date  ICMJE March 14, 2001
First Posted Date  ICMJE March 16, 2001
Last Update Posted Date April 7, 2015
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implementing Guidelines for Smoking Cessation: A Randomized Trial of Evidence-Based Quality Improvement
Official Title  ICMJE Implementing Guidelines for Smoking Cessation: A Randomized Trial of Evidence-Based Quality Improvement
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Smoking
  • Smoking Cessation
  • Quality Improvement
Intervention  ICMJE Behavioral: Quality Improvement
Study Arms  ICMJE Arm 1
Intervention: Behavioral: Quality Improvement
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
2500
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00012987
Other Study ID Numbers  ICMJE CPG 97-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Office of Research and Development ( US Department of Veterans Affairs )
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott E Sherman, MD MPH VA Greater Los Angeles Healthcare System, Sepulveda, CA
Principal Investigator: Elizabeth M. Yano, PhD MSPH VA Greater Los Angeles Healthcare System, Sepulveda, CA
PRS Account VA Office of Research and Development
Verification Date February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP