A Randomized Trial to Implement the AHCPR Smoking Cessation Guideline
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 14, 2001 | ||||
| Last Updated Date | April 18, 2013 | ||||
| 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 | Complete list of historical versions of study NCT00013013 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Randomized Trial to Implement the AHCPR Smoking Cessation Guideline | ||||
| Official Title ICMJE | A Randomized Trial to Implement the AHCPR Smoking Cessation Guideline | ||||
| Brief Summary | Among veterans, smoking is the single most important risk factor for preventable mortality and morbidity, and studies suggest a higher prevalence of smoking among veterans than the general population. The VHA has encouraged adoption of the AHCPR Guideline for Smoking Cessation, yet most hospitals have poorly developed smoking cessation programs. |
||||
| Detailed Description | Background: Among veterans, smoking is the single most important risk factor for preventable mortality and morbidity, and studies suggest a higher prevalence of smoking among veterans than the general population. The VHA has encouraged adoption of the AHCPR Guideline for Smoking Cessation, yet most hospitals have poorly developed smoking cessation programs. Objectives: The present study is designed to investigate the effectiveness of an organizational strategy to increase compliance with the AHCPR guideline. Short term goals of the study include increasing the rate of identification of smokers and increasing the delivery of brief smoking cessation interventions. Long term goals include reducing tobacco consumption among veterans. Methods: Twenty VAMC�s with active primary care clinics have been randomly assigned to either control (usual practice; UP) or intervention (organizational support; OS) groups. The intervention hospitals receive staff training and site consultation; all hospitals will receive the AHCPR guideline. Rate of identification of smokers in the medical record, smoking cessation rates, provision of smoking cessation services (e.g., NRT, counseling), and costs of NRT will be determined via telephone interviews with patients, chart review, and electronic records. Status: Baseline data collection is nearly complete, and the intervention period will be complete in September, 2000. We have completed telephone surveys with approximately 4500 veterans. Analysis of study data is ongoing, and manuscript preparation will begin within the next few months. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Procedure: Systems Support | ||||
| Study Arm (s) | Arm 1
Intervention: Procedure: Systems Support |
||||
| Publications * | Joseph AM, Arikian NJ, An LC, Nugent SM, Sloan RJ, Pieper CF; GIFT Research Group. Results of a randomized controlled trial of intervention to implement smoking guidelines in Veterans Affairs medical centers: increased use of medications without cessation benefit. Med Care. 2004 Nov;42(11):1100-10. | ||||
|
* 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 | 4000 | ||||
| Completion Date | August 2001 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Subjects must be smokers. Exclusion Criteria: |
||||
| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00013013 | ||||
| Other Study ID Numbers ICMJE | CPG 97-039 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | February 2007 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||