CClinicalTrials.gg
Status unknownNCT00865553Updated Sep 20, 2013

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

A Phase 2 interventional study of computer-assisted smoking cessation intervention and cancer prevention in Tobacco Use Disorder, sponsored by University of Vermont. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-20.

Sponsored by University of Vermont · Phase 2, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Mar 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
630
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Tobacco Use Disorder

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Keywords

  • tobacco use disorder
03

In context

Tobacco Use Disorder

968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.

This study's planned enrollment of 630 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.

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

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Health services research
Enrollment
630 participants (estimated)

Interventions

  • Behavioralcomputer-assisted smoking cessation intervention
  • Othercancer prevention
  • Othereducational intervention
  • Othersurvey administration
06

What researchers measure

Primary outcomes

  1. 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

  2. Patient perception of physician as measured by the patient exit survey and telephone interview

  3. Prevalence of smoking and associated variables as measured by the patient exit survey

  4. Patient interaction with the smoking cessation-personal digital assistant (SC-PDA) as measured by the patient exit survey and telephone interview

  5. Patient report of physician SC-PDA use as measured by the patient exit survey and telephone interview

  6. Aggregate data on accessing SC-PDA screens by each physician as measured by the SC-PDA server log

  7. Generation of patient handouts as measured by the SC-PDA server log, clinic staff focus groups, and telephone interview

  8. Physician self-reported use of SC-PDA as measured by physician interview

  9. Physician opinion on perceived value and barriers to use as measured by physician interview

  10. Clinic staff opinion on the effect of SC-PDA on clinic workflow as measured by clinic staff focus groups

07

Study locations

1 of 1 sites recruiting
  • Vermont Cancer Center at University of Vermont
    Burlington, Vermont 05405-0110, United States
    • Clinical Trials Office - Vermont Cancer Center at University o · Contact · 802-656-2178
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00865553
Lead sponsor
University of Vermont
Collaborators
National Cancer Institute (NCI)
First posted
Mar 19, 2009
Start date
Mar 2009
Primary completion
Aug 2010 (estimated)
Last update
Sep 20, 2013

Study contacts

Theodore W. Marcy, MD, MPH
principal investigator · University of Vermont
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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