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

August 15, 2013 updated by: Kaiser Permanente

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

344

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80014
        • Kaiser Permanente - Aurora
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Kaiser Permanente Center for Health Research - Hawaii
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
      • Boston, Massachusetts, United States, 02215
        • Harvard Pilgrim Health Care
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center for Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Investigators

  • Study Chair: Victor J. Stevens, PhD, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

September 26, 2005

First Submitted That Met QC Criteria

September 26, 2005

First Posted (Estimate)

September 28, 2005

Study Record Updates

Last Update Posted (Estimate)

August 16, 2013

Last Update Submitted That Met QC Criteria

August 15, 2013

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000448865
  • KAISER-U19-CA099193

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe