Tobacco Use DisorderNCT00227786
Primary Care Physicians' Use of Stop-Smoking Plans to Help Patients Who Are Smokers
A study testing smoking cessation intervention and counseling intervention in people with Tobacco Use Disorder and Unspecified Adult Solid Tumor, Protocol Specific, run by Kaiser Permanente at 5 sites in United States.
Trial summary
RATIONALE: Stop-smoking plans suggested by physicians may help patients quit smoking. Studying how physicians give stop-smoking treatment as family doctors may increase the chance of smokers receiving such treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- smoking cessation intervention and counseling intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 344 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2003to May 2006
- 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 physician, meeting all of the following criteria:
- Practicing medicine in a family practice or internal medicine clinic
- Scheduled to see adult primary care patients for ≥ 2½ days (or 5 half days or equivalent combination of full and half days) per week
- Planning to continue full-time practice in their participating organization for at least the next 2 years
- At least 1 year of experience working with the local electronic medical record system
- Patient
- Adult smoker who visited a study physician within the past month
PATIENT CHARACTERISTICS:
Age
- Adult
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Kaiser Permanente - Aurora
Aurora, Colorado, 80014
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Harvard Pilgrim Health Care
Boston, Massachusetts, 02215
Kaiser Permanente Center for Health Research - Hawaii
Honolulu, Hawaii, 96817
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
Official title: Using Electronic Medical Records to Measure and Improve Adherence to Tobacco Treatment Guidelines in Primary Care
RATIONALE: Stop-smoking plans suggested by physicians may help patients quit smoking. Studying how physicians give stop-smoking treatment as family doctors may increase the chance of smokers receiving such treatment.
PURPOSE: This randomized clinical trial is studying physicians' practice patterns to see if regular feedback to the physician increases the chance of adult smokers receiving stop-smoking treatment.
Read the detailed description
OBJECTIVES:
- Develop an automated coding system using existing electronic medical records (EMRs) to assess adherence to national tobacco-cessation treatment guidelines by individual physicians in the primary care setting at 4 health maintenance organizations.
- Compare the validity of the automated coding system with that of coding performed by medical record abstractors.
- Determine the effect of performance feedback on tobacco treatment practice patterns over 2 years among primary care physicians.
- Provide recommendations for recording tobacco-cessation treatment services in EMR systems and evaluating adherence to treatment guidelines.
- Produce a set of computer programs that can be easily adopted in diverse health care settings for assessing adherence to the national tobacco-cessation treatment guidelines using data from EMRs.
OUTLINE: This is a randomized, controlled, multicenter study. Physicians from each participating center are sorted into pairs according to their rate of providing advice to quit smoking to identified adult smokers and the number of identified adult smokers seen in the 3-month baseline observation period. Each physician in the pair is then randomized to 1 of 2 arms.
- Arm I (automated coding system feedback): Physicians receive reports from an automated coding system regarding their performance in administering tobacco-cessation services in each of the five A's (Ask, Advise, Assess, Assist, and Arrange) to identified smokers in comparison with their past performance and in comparison with their anonymous colleagues once every 3 months. One year after randomization, these physicians are further randomized, using the same paired-group approach, to either continue receiving automated coding system feedback for 1 additional year OR to stop receiving feedback.
Physicians receive a survey at the end of 2-year period regarding the usefulness of each aspect of the feedback reports and the feedback program in general.
- Arm II (control): Physicians do not receive any information regarding their performance in administering tobacco-cessation services in each of the five A's to identified smokers.
A questionnaire about tobacco-cessation services in primary care is sent to patients of all physicians within two weeks of each patient's primary care visit and then at the end of the first year of providing feedback to physicians to compare patient report of tobacco-cessation services with what is documented in the electronic medical record for that primary care visit.
PROJECTED ACCRUAL: At least 40 primary care physicians per participating center and 1,000 patients (250 per participating center) will be accrued for this study.
- Being tested
- smoking cessation intervention, counseling intervention
- Keywords
- unspecified adult solid tumor, protocol specific, 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tobacco cessation care delivery of the 5 A's (Ask, Advise, Assess, Assist, and Arrange) and in the percentage of smokers receiving assistance as measured by MediClass classification at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor J. Stevens, PhD, Study chair, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227786
- Sponsor's protocol ID
- CDR0000448865
- Other IDs
- KAISER-U19-CA099193
- Status last verified
- Nov 2005
- First submitted
- 26 Sep 2005
- Last updated
- 16 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Electronic Medical Records to Measure and Improve Adherence to Tobacco Treatment Guidelines in Primary Care
- ClinicalTrials.gov ID
- NCT00227786
- Acronym / sponsor ID
- CDR0000448865
- Keywords
- unspecified adult solid tumor, protocol specific, tobacco use disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 28 Sep 2005 (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: Stop-smoking plans suggested by physicians may help patients quit smoking. Studying how physicians give stop-smoking treatment as family doctors may increase the chance of smokers receiving such treatment.
PURPOSE: This randomized clinical trial is studying physicians' practice patterns to see if regular feedback to the physician increases the chance of adult smokers receiving stop-smoking treatment.
Detailed description
OBJECTIVES:
- Develop an automated coding system using existing electronic medical records (EMRs) to assess adherence to national tobacco-cessation treatment guidelines by individual physicians in the primary care setting at 4 health maintenance organizations.
- Compare the validity of the automated coding system with that of coding performed by medical record abstractors.
- Determine the effect of performance feedback on tobacco treatment practice patterns over 2 years among primary care physicians.
- Provide recommendations for recording tobacco-cessation treatment services in EMR systems and evaluating adherence to treatment guidelines.
- Produce a set of computer programs that can be easily adopted in diverse health care settings for assessing adherence to the national tobacco-cessation treatment guidelines using data from EMRs.
OUTLINE: This is a randomized, controlled, multicenter study. Physicians from each participating center are sorted into pairs according to their rate of providing advice to quit smoking to identified adult smokers and the number of identified adult smokers seen in the 3-month baseline observation period. Each physician in the pair is then randomized to 1 of 2 arms.
- Arm I (automated coding system feedback): Physicians receive reports from an automated coding system regarding their performance in administering tobacco-cessation services in each of the five A's (Ask, Advise, Assess, Assist, and Arrange) to identified smokers in comparison with their past performance and in comparison with their anonymous colleagues once every 3 months. One year after randomization, these physicians are further randomized, using the same paired-group approach, to either continue receiving automated coding system feedback for 1 additional year OR to stop receiving feedback.
Physicians receive a survey at the end of 2-year period regarding the usefulness of each aspect of the feedback reports and the feedback program in general.
- Arm II (control): Physicians do not receive any information regarding their performance in administering tobacco-cessation services in each of the five A's to identified smokers.
A questionnaire about tobacco-cessation services in primary care is sent to patients of all physicians within two weeks of each patient's primary care visit and then at the end of the first year of providing feedback to physicians to compare patient report of tobacco-cessation services with what is documented in the electronic medical record for that primary care visit.
PROJECTED ACCRUAL: At least 40 primary care physicians per participating center and 1,000 patients (250 per participating center) will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
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
Change in tobacco cessation care delivery of the 5 A's (Ask, Advise, Assess, Assist, and Arrange) and in the percentage of smokers receiving assistance as measured by MediClass classification at 18 months
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 16 Aug 2013.
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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.
Victor J. Stevens, PhD study chair
Kaiser Permanente
5 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 and Unspecified Adult Solid Tumor, Protocol Specific, run by Kaiser Permanente at 5 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 16 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does the primary outcome measure?
Change in tobacco cessation care delivery of the 5 A's (Ask, Advise, Assess, Assist, and Arrange) and in the percentage of smokers receiving assistance as measured by MediClass classification at 18 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2013.