NCT00865553

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Last Updated

September 20, 2013

Status Verified

March 1, 2011

Enrollment Period

1.4 years

First QC Date

March 18, 2009

Last Update Submit

September 19, 2013

Conditions

Keywords

tobacco use disorder

Outcome Measures

Primary Outcomes (10)

  • 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

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05405-0110, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Theodore W. Marcy, MD, MPH

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
HEALTH SERVICES RESEARCH
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 18, 2009

First Posted

March 19, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2010

Last Updated

September 20, 2013

Record last verified: 2011-03

Locations