Viewing Study NCT00383461



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Study NCT ID: NCT00383461
Status: COMPLETED
Last Update Posted: 2013-05-29
First Post: 2006-09-29

Brief Title: Computer-Based Stop Smoking Program in Assisting Doctors in Helping Adults Stop Smoking
Sponsor: Brigham and Womens Hospital
Organization: Brigham and Womens Hospital

Study Overview

Official Title: Computerized EMR-Assisted Smoking Cessation CEASCE
Status: COMPLETED
Status Verified Date: 2013-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
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 Womens 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 ie the 5 As CEASCE provides reminders to primary care providers to document smoking status using the 5 As 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 patients 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 smokers 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 4314 participants primary care providers and patients will be accrued for this study

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R21CA121906 NIH None httpsreporternihgovquickSearchR21CA121906