Tobacco Use DisorderNCT00383461
Computer-Based Stop Smoking Program in Assisting Doctors in Helping Adults Stop Smoking
A study testing smoking cessation intervention and counseling intervention in people with Tobacco Use Disorder, run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- smoking cessation intervention and counseling intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,314 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, 02115
About this study
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.
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.
- Conditions
- Tobacco Use Disorder
- Being tested
- smoking cessation intervention, counseling intervention
- Keywords
- tobacco use disorder
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessation interventionBehavioural
counseling interventionOther
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2006 (estimated)
- Study startApr 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 4,314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jennifer S. Haas, MD, MSPH, Brigham and Women's Hospital
- Investigators
- Jennifer Haas, MD, MSPH, Principal investigator, Dana-Farber/Brigham and Women's Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383461
- Sponsor's protocol ID
- BWH-2004-P-001029/2
- Other IDs
- R21CA121906
- Status last verified
- May 2013
- First submitted
- 29 Sep 2006
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized EMR-Assisted Smoking Cessation (CEASCE)
- ClinicalTrials.gov ID
- NCT00383461
- Acronym / sponsor ID
- BWH-2004-P-001029/2
- Conditions
- Tobacco Use Disorder
- Keywords
- tobacco use disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,314 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 3 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smoking cessation intervention | Behavioural | – |
| counseling intervention | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
- Derived from this study: PubMed 19398690Linder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Haas, MD, MSPH principal investigator
Dana-Farber/Brigham and Women's Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smoking cessation intervention and counseling intervention in people with Tobacco Use Disorder, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00383461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013.