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CompletedNCT00383461Updated May 29, 2013

Computer-Based Stop Smoking Program in Assisting Doctors in Helping Adults Stop Smoking

An interventional study of smoking cessation intervention and counseling intervention in Tobacco Use Disorder, sponsored by Brigham and Women's Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-29.

Sponsored by Brigham and Women's Hospital · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
4,314
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Computer-based stop smoking programs may assist doctors in helping patients stop smoking.

PURPOSE: This randomized clinical trial is studying how well a computer-based stop smoking program works in assisting doctors in helping adults stop smoking.

Read the detailed description

OBJECTIVES:

  • Develop an electronic medical record (EMR)-based strategy, the Computerized EMR-Assisted Smoking Cessation Effort (CEASCE), for assisting physicians in treating tobacco use in adults who are currently smokers.
  • Assess the reach and effectiveness of CEASCE by conducting a randomized controlled trial in the Brigham and Women's Primary Care Practice-Based Research Network to determine its effectiveness in increasing the proportion of smokers who receive treatment.
  • Assess the adoption, implementation, and short-term maintenance of CEASCE by measuring the proportion and characteristics of providers who use CEASCE, the consistency with which providers use the components of CEASCE, and changes in the use of CEASCE over time.

OUTLINE: This is a randomized, controlled, multicenter study. Clinics are stratified according to socioeconomic mix of patients and clinic type (community health center vs hospital based vs community-based). Clinics are randomized to 1 of 2 intervention arms.

  • Arm I (intervention): Primary care providers utilize the Computerized Electronic Medical Record (EMR)-Assisted Smoking Cessation Effort (CEASCE) decision support system comprising a 5-step algorithm (i.e., the "5 A's"). CEASCE provides reminders to primary care providers to document smoking status using the "5 A's" (Ask, Advise, Assess, Assist, and Arrange). Primary care providers input information into the CEASCE, including asking the patient about their smoking status (Ask), the date they advised the patient to quit (Advise), an assessment of the patient's readiness to quit (Assess), and the action that was taken by the physician (Assist). When the primary care provider inputs information, CEASCE automatically presents actions that are tailored to the smoker's readiness to quit. Actions offered include setting a quit date, prescribing medications, referral to a smoking-cessation counselor, discussing barriers to quitting, counseling about the health risks of smoking, and an offer to help the smoker when she is ready to quit. CEASCE automatically prints educational materials and sends an e-mail to a smoking cessation counselor for patients who are agreeable to having a smoking cessation counselor contact them. The smoking cessation counselor makes 4 attempts to contact the patient by telephone within 30 days. If the patient is ready, the counselor facilitates enrollment into a smoking cessation program and documents the outcome of the referral. The referring primary care provider then receives an e-mail message regarding the outcome.

Primary care providers complete surveys after ≥ 6 months of experience with the intervention. Some patients participate in an exit interview immediately after their primary care visit.

  • Arm II (control): Patients receive current standard of care, including documentation of smoking status and contact from a smoking-cessation counselor only after receiving a referral.

PROJECTED ACCRUAL: A total of 4,314 participants (primary care providers and patients) will be accrued for this study.

02

Conditions studied

  • Tobacco Use Disorder

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Keywords

  • tobacco use disorder
03

In context

Tobacco Use Disorder

988 studies on the registry are indexed under Tobacco Use Disorder; 125 are open to participants now.

This study's planned enrollment of 4,314 is above the median of 90 across 863 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Primary care providers and their patients in the Brigham and Women's Primary Care Practice-Based Research Network
  • Patient is currently a smoker

PATIENT CHARACTERISTICS:

  • Must speak English or Spanish
  • No significant cognitive impairment (e.g., dementia or active psychosis)

PRIOR CONCURRENT THERAPY:

  • Not specified
05

Study design

Phase
Not applicable
Allocation
Randomized
Masking
None (open label)
Enrollment
4,314 participants (estimated)

Interventions

  • Behavioralsmoking cessation intervention
  • Othercounseling intervention
06

Study locations

2 sites
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Dana-Farber/Brigham and Women's Cancer Center
    Boston, Massachusetts 02115, United States
07

References and documents

Publications

  • Linder JA, Rigotti NA, Schneider LI, Kelley JH, Brawarsky P, Haas JS. An electronic health record-based intervention to improve tobacco treatment in primary care: a cluster-randomized controlled trial. Arch Intern Med. 2009 Apr 27;169(8):781-7. doi: 10.1001/archinternmed.2009.53. PubMed 19398690 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00383461
Responsible party
Jennifer S. Haas, MD, MSPH (Professor of Medicine, Brigham and Women's Hospital) — Principal investigator
First posted
Oct 3, 2006
Start date
Apr 2006
Primary completion
Sep 2007
Completion
Sep 2007
Last update
May 29, 2013

Study contacts

Jennifer Haas, MD, MSPH
principal investigator · Dana-Farber/Brigham and Women's Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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