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

NCT ID: NCT00865553

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 630 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31

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.

Conditions

Tobacco Use Disorder

Keywords

tobacco use disorder

Study Design

• Primary Study Purpose: HEALTH_SERVICES_RESEARCH

Interventions

computer-assisted smoking cessation intervention

Intervention Type: BEHAVIORAL

cancer prevention

Intervention Type: OTHER

educational intervention

Intervention Type: OTHER

survey administration

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Vermont Cancer Center at University of Vermont

Principal Investigators

Theodore W. Marcy, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

Vermont Cancer Center at University of Vermont

Burlington, Vermont, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Clinical Trials Office - Vermont Cancer Center at University o

Role: primary

Other Identifiers

VCC-08186

Identifier Type: -

Identifier Source: secondary_id

IRB#00000486

Identifier Type: -

Identifier Source: secondary_id

CDR0000629824

Identifier Type: -

Identifier Source: org_study_id