Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Primary Care Physicians' Use of Stop-Smoking Plans to Help Patients Who Are Smokers
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Prevention | Closed | Adult | NCI | KAISER-U19-CA099193 NCT00227786 |
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.
Entry Criteria
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
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Patient Characteristics:
Age
- Adult
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Expected Enrollment
At least 40 primary care physicians per participating center and 1,000 patients (250 per participating center) will be accrued for this study.
Outcomes
Primary Outcome(s)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
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.
Trial Lead Organizations
Kaiser Permanente Center for Health Research
| Victor Stevens, PhD, Protocol chair |
| |||
| Registry Information | ||
| Official Title | Using Electronic Medical Records to Measure and Improve Adherence to Tobacco Treatment Guidelines in Primary Care | |
| Trial Start Date | 2003-01-30 | |
| Registered in ClinicalTrials.gov | NCT00227786 | |
| Date Submitted to PDQ | 2005-07-21 | |
| Information Last Verified | 2005-11-08 | |
| NCI Grant/Contract Number | U19-CA099193 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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