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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

Using Electronic Medical Records to Measure and Improve Adherence to Tobacco Treatment Guidelines in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227786
• Other study ID #: CDR0000448865
• Secondary ID: KAISER-U19-CA099
• Status: Completed
• Phase: N/A
• First received: September 26, 2005
• Last updated: August 15, 2013
• Start date: January 2003
• Est. completion date: May 2006

Study information

• Verified date: November 2005
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tobacco Use Disorder
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Behavioral:
• smoking cessation intervention

Other:
• counseling intervention

Locations

Country	Name	City	State
United States	Kaiser Permanente - Aurora	Aurora	Colorado
United States	Harvard Pilgrim Health Care	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Kaiser Permanente Center for Health Research - Hawaii	Honolulu	Hawaii
United States	Kaiser Permanente Center for Health Research	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No