Gestational Weight Gain and the Electronic Medical Record (WATE)
Primary Purpose
Pregnancy, Weight Gain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EMR Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant with a single intrauterine gestation
- Present for new OB visit up to 13 weeks and 6 days gestation
Exclusion Criteria:
- They have a multiple gestation pregnancy
- They are under the age of 18
- They do not speak English
Sites / Locations
- Loyola University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
EMR intervention
Control
Arm Description
Patients will have an electronic medical record popup/highlight in their chart, displaying the recommended guidelines for weight gain in pregnancy.
The patient's medical record will be displayed as usual, with no flag or highlight for weight gain recommendations
Outcomes
Primary Outcome Measures
Weight gain
Primary outcome will be measured as the percent of patients who achieve their recommended weight gain goal in pregnancy (IOM guidelines)
Secondary Outcome Measures
Patient perception
Survey to patients at the end of pregnancy regarding how patients perceive and are influenced by EMR notifications and counseling
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01987141
Brief Title
Gestational Weight Gain and the Electronic Medical Record
Acronym
WATE
Official Title
WATE Study - Gestational Weight Gain and the Electronic Medical Record
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Less than one third of pregnant women actually achieve the Institute of Medicine's (IOM) recommended weight gain. To date, there are no randomized controlled trials studying the use of the electronic medical record to alert providers to initiate the counseling of patients on the IOM gestational weight gain recommendations.
In the investigator's planned study intervention, using the EPIC EMR system, an electronic alert (Best Practice Advisory) will appear for providers at each prenatal care visit. This alert will remind providers to counsel patients on the recommendations for gestational weight gain. The control group will receive standard prenatal care, without electronic alerts generated regarding BMI and gestational weight gain.
The investigators hypothesize that a higher percentage of patients who receive the intervention will meet the IOM guidelines for weight gain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Weight Gain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMR intervention
Arm Type
Experimental
Arm Description
Patients will have an electronic medical record popup/highlight in their chart, displaying the recommended guidelines for weight gain in pregnancy.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The patient's medical record will be displayed as usual, with no flag or highlight for weight gain recommendations
Intervention Type
Other
Intervention Name(s)
EMR Intervention
Intervention Description
Electronic medical record flag/notification in the patient's chart
Primary Outcome Measure Information:
Title
Weight gain
Description
Primary outcome will be measured as the percent of patients who achieve their recommended weight gain goal in pregnancy (IOM guidelines)
Time Frame
At delivery, average of 40 weeks from enrollment
Secondary Outcome Measure Information:
Title
Patient perception
Description
Survey to patients at the end of pregnancy regarding how patients perceive and are influenced by EMR notifications and counseling
Time Frame
At end of pregnancy, average of 40 weeks from enrollment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant with a single intrauterine gestation
Present for new OB visit up to 13 weeks and 6 days gestation
Exclusion Criteria:
They have a multiple gestation pregnancy
They are under the age of 18
They do not speak English
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Gestational Weight Gain and the Electronic Medical Record
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