NCT01065493

Brief Summary

QuitAdvisorMD: A point-of-care tool for brief smoking cessation interventions Under a Phase II SBIR grant supported by NIH/NIDA, we are developing QUITAdvisorMD: a point-of-care, patient-centered resource for counseling patients who smoke or use tobacco products. It is based on the principles of Motivational Interviewing, a non-confrontational and very effective method for intervening and treating these patients; the 5 A's of behavioral interventions; and the Transtheoretical Model of Change. Through a point and click interface, the tool uses a series of interview questions designed to motivate patients to stop smoking by first assessing their stage of change and then offering effective stage-based interventions and interview techniques. The tool also offers stage-tailored patient information, a clinician educational reference, and the ability to communicate support information patients via email and/or text message.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2011

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

4.2 years

First QC Date

February 8, 2010

Last Update Submit

November 18, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • The goal of the evaluation is to assess the ability of QuitAdvisorMD to influence smoking cessation as measured by the primary outcome of the increase in physician initiated smoking cessation counseling.

    12 Months

Secondary Outcomes (1)

  • Secondary outcomes will include, 1) the increase in ability of clinicians to provide appropriate stage-based smoking cessation assistance, and 2) the increase in patient quit attempts.

    12 Months

Study Arms (2)

Software Assisted Lifestyle Counseling

EXPERIMENTAL
Other: QuitAdvisorMD Software Algorithm

Lifestyle Counseling

ACTIVE COMPARATOR

Status quo smoking cessation counseling.

Behavioral: Standard Smoking Cessation Counseling

Interventions

QuitAdvisorMD, a set of brief clinical assessments, counseling scripts and intervention instruments for smoking cessation in primary care settings

Software Assisted Lifestyle Counseling

Standard Smoking Cessation Counseling

Lifestyle Counseling

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • any physician providing care for members of Southern Health through primary care and have access to a point-of-care computing device (Smartphone, desktop PC, etc) during patient visits.

You may not qualify if:

  • Lack of appropriate computing device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

SmokingTobacco Use Disorder

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • George Reynolds, BA

    Silverchair, Inc

    PRINCIPAL INVESTIGATOR
  • Scott Strayer, MD

    University of Virginia Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 9, 2010

Study Start

January 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations