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

Primary Purpose

Tobacco Use Disorder, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
smoking cessation intervention
counseling intervention
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tobacco Use Disorder focused on measuring unspecified adult solid tumor, protocol specific, tobacco use disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente - Aurora
  • Kaiser Permanente Center for Health Research - Hawaii
  • Massachusetts General Hospital Cancer Center
  • Harvard Pilgrim Health Care
  • Kaiser Permanente Center for Health Research

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 26, 2005
Last Updated
August 15, 2013
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT00227786
Brief Title
Primary Care Physicians' Use of Stop-Smoking Plans to Help Patients Who Are Smokers
Official Title
Using Electronic Medical Records to Measure and Improve Adherence to Tobacco Treatment Guidelines in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
unspecified adult solid tumor, protocol specific, tobacco use disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
344 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
smoking cessation intervention
Intervention Type
Other
Intervention Name(s)
counseling intervention
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor J. Stevens, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Study Chair
Facility Information:
Facility Name
Kaiser Permanente - Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Facility Name
Kaiser Permanente Center for Health Research - Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Harvard Pilgrim Health Care
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Kaiser Permanente Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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