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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00973661
Other study ID # STU00013264
Secondary ID
Status Completed
Phase N/A
First received September 8, 2009
Last updated July 26, 2011
Start date March 2010
Est. completion date September 2010

Study information

Verified date July 2011
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to design and assess the impact of an electronic alert and tool set to assist with physician identification and counseling of overweight patients.


Description:

Overweight adults (Body Mass Index [BMI] 25-29.9) are at high risk for developing obesity, but rates of physician identification and counseling of overweight adults are low. Alerts and tools embedded in the electronic medical record have shown promise in enhancing quality improvement efforts.

Our aim is to design and assess the impact of an electronic alert and tool set to assist with identification and counseling of overweight patients with a BMI 27-29.9. Although the category of overweight patients spans BMI 25-29.9, we are including only patients with BMI 27-29.9 in order to focus resources on the most at-risk pre-obese population.

We will develop a tool set including the following components: automatic calculation of BMI, alert for overweight status, counseling template for weight loss goal-setting, linkage to referral options, and access to relevant patient handouts. Physicians in the Northwestern Memorial Faculty Foundation General Internal Medicine (NMFF GIM) practice who consent to participate in the study will be randomized into two groups, with one group of physicians receiving access to these tools. The other group of physicians will continue to provide their usual care for overweight patients. Outcome measures will include the following: tool usage; documentation of overweight in the problem list, encounter diagnosis, or note text; counseling for overweight and documentation of specific behavioral goals. Measures will be obtained via retrospective chart review.


Recruitment information / eligibility

Status Completed
Enrollment 2600
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria (physicians):

- Consenting physicians from the Northwestern Memorial General Internal Medicine (NMFF GIM) practice

Exclusion Criteria (physicians):

- Study investigators will be excluded from participation (Dr. David Baker, Dr. Joyce Tang)

Inclusion Criteria (patients):

- Adults ages 18-65 seen at the NMFF GIM who are patients of consenting physicians

- Have at least one appointment at the NMFF GIM clinic between 9/1/09-2/28/10

- Body mass index (BMI) 27-29.9 at one or more visits between 9/1/09-2/28/10

Exclusion Criteria (patients):

- Patients without at least one recorded height measurement from any prior visit or without weight information from a visit within the 6 month target window will be excluded due to inability to calculate BMI.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Electronic tool set for counseling overweight patients
Physicians randomized to the "electronic tools" arm will receive access to a tool set to aid with counseling of overweight patients. This tool set includes the following components: automatic calculation of BMI, alert for overweight status, counseling template for weight loss goal-setting, linkage to referral options, and access to relevant patient handouts. Physicians randomized to the "usual care" arm will not receive access to these tools, and will continue to provide their usual care for overweight patients.

Locations

Country Name City State
United States Northwestern Memorial Faculty Foundation General Internal Medicine Clinic Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Northwestern University Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Documented diagnosis of overweight September 1, 2009-February 28, 2010 No
Secondary Documented counseling for overweight. September 1, 2009-February 28, 2010 No
Secondary Documentation of specific behavior change goals September 1, 2009-February 28, 2010 No
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