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

Clinical Testing of a Decision Support System for Tobacco Use Treatment

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.

Study Overview

• Status: Unknown
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Other: survey administration; Other: educational intervention; Other: cancer prevention; Behavioral: computer-assisted smoking cessation intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 630
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05405-0110
      • Recruiting
      • Vermont Cancer Center at University of Vermont
      • Contact: Clinical Trials Office - Vermont Cancer Center at University o; Phone Number: 802-656-2178

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research

What is the study measuring?

Primary Outcome Measures

Outcome 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
Patient perception of physician as measured by the patient exit survey and telephone interview
Prevalence of smoking and associated variables as measured by the patient exit survey
Patient interaction with the smoking cessation-personal digital assistant (SC-PDA) as measured by the patient exit survey and telephone interview
Patient report of physician SC-PDA use as measured by the patient exit survey and telephone interview
Aggregate data on accessing SC-PDA screens by each physician as measured by the SC-PDA server log
Generation of patient handouts as measured by the SC-PDA server log, clinic staff focus groups, and telephone interview
Physician self-reported use of SC-PDA as measured by physician interview
Physician opinion on perceived value and barriers to use as measured by physician interview
Clinic staff opinion on the effect of SC-PDA on clinic workflow as measured by clinic staff focus groups

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Theodore W. Marcy, MD, MPH, University of Vermont

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): August 1, 2010

Study Registration Dates

• First Submitted: March 18, 2009
• First Submitted That Met QC Criteria: March 18, 2009
• First Posted (Estimate): March 19, 2009

Study Record Updates

• Last Update Posted (Estimate): September 20, 2013
• Last Update Submitted That Met QC Criteria: September 19, 2013
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: tobacco use disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: CDR0000629824; VCC-08186; IRB#00000486