Computer-Assisted Stop-Smoking Program in Helping Doctors Counsel Patients Who Smoke Cigarettes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00865553
First received: March 18, 2009
Last updated: September 19, 2013
Last verified: March 2011
  Purpose

RATIONALE: A computer-assisted stop-smoking program may help doctors counsel patients who smoke and may help increase the number of patients who stop smoking.

PURPOSE: This phase II trial is studying how well a computer-assisted stop-smoking program works in helping doctors counsel patients who smoke cigarettes.


Condition Intervention Phase
Tobacco Use Disorder
Behavioral: computer-assisted smoking cessation intervention
Other: cancer prevention
Other: educational intervention
Other: survey administration
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Health Services Research
Official Title: Clinical Testing of a Decision Support System for Tobacco Use Treatment

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Physician adherence to the United States Public Health Service's Tobacco Use and Dependence Treatment guideline (USPHS Guideline) as measured by the patient exit survey [ Designated as safety issue: No ]
  • Patient perception of physician as measured by the patient exit survey and telephone interview [ Designated as safety issue: No ]
  • Prevalence of smoking and associated variables as measured by the patient exit survey [ Designated as safety issue: No ]
  • Patient interaction with the smoking cessation-personal digital assistant (SC-PDA) as measured by the patient exit survey and telephone interview [ Designated as safety issue: No ]
  • Patient report of physician SC-PDA use as measured by the patient exit survey and telephone interview [ Designated as safety issue: No ]
  • Aggregate data on accessing SC-PDA screens by each physician as measured by the SC-PDA server log [ Designated as safety issue: No ]
  • Generation of patient handouts as measured by the SC-PDA server log, clinic staff focus groups, and telephone interview [ Designated as safety issue: No ]
  • Physician self-reported use of SC-PDA as measured by physician interview [ Designated as safety issue: No ]
  • Physician opinion on perceived value and barriers to use as measured by physician interview [ Designated as safety issue: No ]
  • Clinic staff opinion on the effect of SC-PDA on clinic workflow as measured by clinic staff focus groups [ Designated as safety issue: No ]

Estimated Enrollment: 630
Study Start Date: March 2009
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Test the hypothesis that the clinical decision support system will improve the rate at which physicians assist their patients with smoking cessation by providing information and recommendations on smoking cessation resources.
  • Assess whether exposure to information and recommendations facilitated by the smoking cessation-personal digital assistant (SC-PDA) will increase the rate at which patients make at least 1 attempt to quit smoking in the month following the physician visit.
  • Assess whether exposure to information and recommendations facilitated by the SC-PDA will increase the reported use of counseling and pharmacotherapy during those attempts over that observed with a smoking status identification system alone.
  • Evaluate the acceptance of the SC-PDA into the workflow of ambulatory care clinics.

OUTLINE: In weeks 1-12, physicians have access to a smoking status identification system (SSID) that reminds the physician the smoking status of the patient they are evaluating. In weeks 6-12, physicians have access to a computerized smoking cessation clinical decision support system using a hand-held personal digital assistant (SC-PDA) that they can use in the exam room with their patients who smoke. The SC-PDA system assists physicians in recommending and prescribing approved pharmacotherapy; facilitates referral of patients to local counseling resources; prints a tailored handout for a patient listing specific recommendations, instructions, and cessation resources; and generates the necessary documentation to support billing for this intervention.

Patients who visit their physician in weeks 2-6 or weeks 8-12 complete a survey after their clinic visit and undergo a telephone interview 1 month later. Physicians undergo interviews and focus groups are conducted with clinic staff in weeks 12-16.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Current smoker, defined as self-reported smoking most days or every day (patient)
  • Seeks care at a participating Fletcher Allen Health Care primary care clinic (patient)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865553

Locations
United States, Vermont
Vermont Cancer Center at University of Vermont Recruiting
Burlington, Vermont, United States, 05405-0110
Contact: Clinical Trials Office - Vermont Cancer Center at University o    802-656-2178      
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Theodore W. Marcy, MD, MPH University of Vermont
  More Information

Additional Information:
No publications provided

Responsible Party: Theodore W. Marcy, Vermont Cancer Center at University of Vermont
ClinicalTrials.gov Identifier: NCT00865553     History of Changes
Other Study ID Numbers: CDR0000629824, VCC-08186, IRB#00000486
Study First Received: March 18, 2009
Last Updated: September 19, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
tobacco use disorder

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on October 22, 2014