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

Primary Purpose

Tobacco Use Disorder

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
computer-assisted smoking cessation intervention
cancer prevention
educational intervention
survey administration
Sponsored by
University of Vermont
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tobacco Use Disorder focused on measuring tobacco use disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vermont Cancer Center at University of VermontRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 18, 2009
Last Updated
September 19, 2013
Sponsor
University of Vermont
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00865553
Brief Title
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

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Vermont
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
tobacco use disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Enrollment
630 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
computer-assisted smoking cessation intervention
Intervention Type
Other
Intervention Name(s)
cancer prevention
Intervention Type
Other
Intervention Name(s)
educational intervention
Intervention Type
Other
Intervention Name(s)
survey administration
Primary Outcome Measure Information:
Title
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
Title
Patient perception of physician as measured by the patient exit survey and telephone interview
Title
Prevalence of smoking and associated variables as measured by the patient exit survey
Title
Patient interaction with the smoking cessation-personal digital assistant (SC-PDA) as measured by the patient exit survey and telephone interview
Title
Patient report of physician SC-PDA use as measured by the patient exit survey and telephone interview
Title
Aggregate data on accessing SC-PDA screens by each physician as measured by the SC-PDA server log
Title
Generation of patient handouts as measured by the SC-PDA server log, clinic staff focus groups, and telephone interview
Title
Physician self-reported use of SC-PDA as measured by physician interview
Title
Physician opinion on perceived value and barriers to use as measured by physician interview
Title
Clinic staff opinion on the effect of SC-PDA on clinic workflow as measured by clinic staff focus groups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore W. Marcy, MD, MPH
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vermont Cancer Center at University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405-0110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Vermont Cancer Center at University o
Phone
802-656-2178

12. IPD Sharing Statement

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

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