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

Tobacco Use Disorder Clinical Trial

Official title:

Clinical Testing of a Decision Support System for Tobacco Use Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00865553
• Other study ID #: CDR0000629824
• Secondary ID: VCC-08186IRB#000
• Status: Recruiting
• Phase: Phase 2
• First received: March 18, 2009
• Last updated: September 19, 2013
• Start date: March 2009

Study information

• Verified date: March 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 630
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• computer-assisted smoking cessation intervention

Other:
• cancer prevention

• educational intervention

• survey administration

Locations

Country	Name	City	State
United States	Vermont Cancer Center at University of Vermont	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Primary	Patient perception of physician as measured by the patient exit survey and telephone interview			No
Primary	Prevalence of smoking and associated variables as measured by the patient exit survey			No
Primary	Patient interaction with the smoking cessation-personal digital assistant (SC-PDA) as measured by the patient exit survey and telephone interview			No
Primary	Patient report of physician SC-PDA use as measured by the patient exit survey and telephone interview			No
Primary	Aggregate data on accessing SC-PDA screens by each physician as measured by the SC-PDA server log			No
Primary	Generation of patient handouts as measured by the SC-PDA server log, clinic staff focus groups, and telephone interview			No
Primary	Physician self-reported use of SC-PDA as measured by physician interview			No
Primary	Physician opinion on perceived value and barriers to use as measured by physician interview			No
Primary	Clinic staff opinion on the effect of SC-PDA on clinic workflow as measured by clinic staff focus groups			No