Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 10:16 PM
Study NCT ID:
NCT00383461
Status:
COMPLETED
Last Update Posted:
2013-05-29
First Post:
2006-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer-Based Stop Smoking Program in Assisting Doctors in Helping Adults Stop Smoking
Sponsor:
Brigham and Women's Hospital
Organization:
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.
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 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.
* 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.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R21CA121906 | NIH | None | https://reporter.nih.gov/quic… | View |