Clinical trial NCT00865553: Computer-Assisted Stop-Smoking Program in Helping Doctors Counsel Patients Who Smoke Cigarettes
Official title: Clinical Testing of a Decision Support System for Tobacco Use Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tobacco Use Disorder
Keywords: tobacco use disorder
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-03-19
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 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

Primary outcomes:
measure: 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
measure: Patient perception of physician as measured by the patient exit survey and telephone interview
measure: Prevalence of smoking and associated variables as measured by the patient exit survey
measure: Patient interaction with the smoking cessation-personal digital assistant (SC-PDA) as measured by the patient exit survey and telephone interview
measure: Patient report of physician SC-PDA use as measured by the patient exit survey and telephone interview
measure: Aggregate data on accessing SC-PDA screens by each physician as measured by the SC-PDA server log
measure: Generation of patient handouts as measured by the SC-PDA server log, clinic staff focus groups, and telephone interview
measure: Physician self-reported use of SC-PDA as measured by physician interview
measure: Physician opinion on perceived value and barriers to use as measured by physician interview
measure: Clinic staff opinion on the effect of SC-PDA on clinic workflow as measured by clinic staff focus groups
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Vermont Cancer Center at University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Theodore W. Marcy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: