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Clinical Trials (PDQ®)

  • First Published: 9/23/2005
  • Last Modified: 6/22/2006

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Randomized Study of Using Electronic Medical Records to Measure and Improve Primary Care Physician Adherence to National Tobacco-Cessation Treatment Guidelines of Patients at Health Maintenance Organizations

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Primary Care Physicians' Use of Stop-Smoking Plans to Help Patients Who Are Smokers

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedPreventionClosedAdultNCIKAISER-U19-CA099193
NCT00227786

Objectives

  1. 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.
  2. Compare the validity of the automated coding system with that of coding performed by medical record abstractors.
  3. Determine the effect of performance feedback on tobacco treatment practice patterns over 2 years among primary care physicians.
  4. Provide recommendations for recording tobacco-cessation treatment services in EMR systems and evaluating adherence to treatment guidelines.
  5. 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 Contact Information

Trial Lead Organizations

Kaiser Permanente Center for Health Research

Victor Stevens, PhD, Protocol chair
Ph: 503-335-6751
Email: victor.j.stevens@kpchr.org

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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