Use of Electronic Health Records for Addressing Overweight and Obesity in Primary Care
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Obesity tools in the electronic health record
Sponsored by
About this trial
This is an interventional health services research trial for Overweight focused on measuring Overweight, Obesity, Body mass index, Weight, Primary care
Eligibility Criteria
Inclusion Criteria:
- All adult patients (ages >= 20 years) who have a visit at a primary care practice at Brigham and Women's Hospital during the intervention period
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Obesity tools in electronic health record
Standard care
Arm Description
This arm will consist of a new set of tools within the electronic health record to help primary care clinicians address overweight and obesity with their patients.
This arm is standard care for overweight/obesity.
Outcomes
Primary Outcome Measures
weight change over 6 months
Change in weight from first visit during Stage 2 of intervention period until approximately 6 months later, among patients with BMI >= 25
weight change over 12 months
Change in weight from first visit during Stage 2 of intervention period until approximately 12 months later, among patients with BMI >= 25
Secondary Outcome Measures
Documentation of height
Percentage of patients with height recorded in the electronic health record
Documentation of weight
Percentage of patients with weight recorded in electronic health record within past year
Documentation of body mass index
Percentage of patients with body mass index calculated in electronic health record within past year
Diagnosis of overweight and obesity
Percentage of patients with BMI >= 25 with Overweight or Obesity on the Problem List in the electronic health record
Management of overweight and obesity
Percentage of patients with BMI >= 25 with evidence of treatment for overweight or obesity in the electronic health record
Full Information
NCT ID
NCT01480466
First Posted
November 21, 2011
Last Updated
April 28, 2014
Sponsor
Brigham and Women's Hospital
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Boston Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01480466
Brief Title
Use of Electronic Health Records for Addressing Overweight and Obesity in Primary Care
Official Title
Use of Electronic Health Records for Addressing Overweight and Obesity in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Boston Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Overweight and obesity are highly significant clinical and public health issues, affecting more than two-thirds of adults in this country; however, primary care clinicians often do not document overweight or obesity or discuss weight management with their patients. The objectives of the proposed research are to develop and evaluate a set of tools within electronic health records (EHRs) to assist primary care clinicians with the diagnosis and treatment of overweight and obesity and to help patients manage their weight.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obesity, Body mass index, Weight, Primary care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65278 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obesity tools in electronic health record
Arm Type
Experimental
Arm Description
This arm will consist of a new set of tools within the electronic health record to help primary care clinicians address overweight and obesity with their patients.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
This arm is standard care for overweight/obesity.
Intervention Type
Other
Intervention Name(s)
Obesity tools in the electronic health record
Intervention Description
The intervention is a set of new tools within the Partners electronic health record that are designed to assist primary care clinicians with the assessment and management of overweight and obesity in their patients.
Primary Outcome Measure Information:
Title
weight change over 6 months
Description
Change in weight from first visit during Stage 2 of intervention period until approximately 6 months later, among patients with BMI >= 25
Time Frame
Baseline, 6 months
Title
weight change over 12 months
Description
Change in weight from first visit during Stage 2 of intervention period until approximately 12 months later, among patients with BMI >= 25
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Documentation of height
Description
Percentage of patients with height recorded in the electronic health record
Time Frame
Baseline, 6 months, 12 months
Title
Documentation of weight
Description
Percentage of patients with weight recorded in electronic health record within past year
Time Frame
Baseline, 6 months, 12 months
Title
Documentation of body mass index
Description
Percentage of patients with body mass index calculated in electronic health record within past year
Time Frame
Baseline, 6 months, 12 months
Title
Diagnosis of overweight and obesity
Description
Percentage of patients with BMI >= 25 with Overweight or Obesity on the Problem List in the electronic health record
Time Frame
Baseline, 6 months, 12 months
Title
Management of overweight and obesity
Description
Percentage of patients with BMI >= 25 with evidence of treatment for overweight or obesity in the electronic health record
Time Frame
Baseline, 6 months, 12 months
Other Pre-specified Outcome Measures:
Title
Primary care clinician attitudes about management of overweight and obesity
Description
Primary care clinician attitudes about management of overweight and obesity, assessed via an electronic survey
Time Frame
baseline, 12 months
Title
Patient attitudes and behaviors around weight management
Description
Patient attitudes, beliefs, and behaviors around weight management (including diet, physical activity)
Time Frame
baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All adult patients (ages >= 20 years) who have a visit at a primary care practice at Brigham and Women's Hospital during the intervention period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather J Baer, ScD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25810449
Citation
Baer HJ, Wee CC, DeVito K, Orav EJ, Frolkis JP, Williams DH, Wright A, Bates DW. Design of a cluster-randomized trial of electronic health record-based tools to address overweight and obesity in primary care. Clin Trials. 2015 Aug;12(4):374-83. doi: 10.1177/1740774515578132. Epub 2015 Mar 25.
Results Reference
derived
Learn more about this trial
Use of Electronic Health Records for Addressing Overweight and Obesity in Primary Care
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