Tobacco Use Disorder Clinical Trial
Official title:
Computerized EMR-Assisted Smoking Cessation (CEASCE)
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.
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.
;
Allocation: Randomized, Masking: Open Label
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