- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04955652
Evaluation of Alerts in Promoting Bone Densitometry Scans
Evaluation of Best Practice Alerts and an Actionable Sidebar in Electronic Health Records in Promoting Bone Densitometry Scans
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Standard care for bone densitometry scans at Geisinger--i.e., dual-energy x-ray absorptiometry (DXA) scans--involves (1) an alert under the health maintenance topics tab in Epic, (2) an actionable item in a sidebar (Storyboard), (3) and a single-click best practice alert (BPA). Storyboard and the BPA theoretically serve a redundant function, but it is possible that combined alerting is effective. Therefore, the investigators plan to evaluate whether the BPA for DXA scans will increase the percentage of DXA scans ordered and completed.
For this evaluation, the investigators will randomly assign (by odd and even MRN) half of patients who need DXA scans to go through standard care (including the single-click BPA) and half of patients to have no BPA shown to their provider, but only the health maintenance topic and actionable Storyboard alert. This evaluation will help the investigators determine whether redundant, more traditional alerts such as BPAs are helpful or can be removed from alerts for DXA scans.
The randomization of patients to different alert conditions will be in place until 4,200 participants have been reached (estimated sample to detect 4% absolute difference, rounded to nearest hundred) or 6 months, whichever comes first. To account for delays in updating clinical databases, the outcome data will pulled 3 months after each encounter (for a maximum study period of 9 months).
The main analysis will use a logistic regression to compare the two groups. Exploratory analyses will also examine the time from order to completion to examine any effect on timing between arms. Another set of exploratory analyses will also examine the number of other BPAs firing to see if alert fatigue influenced the number of orders or completions or interacted with the experimental conditions.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- In primary care
- Records indicate patient is due for a bone densitometry scan (generally, a high-risk patient that requires this scan or age 65 and older)
Exclusion Criteria:
- Encounters at clinics/sites where the randomization build cannot easily be deployed
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard of Care
A health maintenance topic, actionable sidebar item, and a single-click best practice alert are presented.
|
Alert
Other Names:
Alert
Other Names:
Alert
Other Names:
|
|
Experimental: Silent Best Practice Alert
A health maintenance topic and an actionable sidebar item are presented.
The best practice alert is set to be silent and will not appear in the patient's chart.
|
Alert
Other Names:
Alert
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone Densitometry Scan Order Placed
Time Frame: 6 months or as long as it takes to reach N=4,200, whichever occurs first
|
Binary variable indicating whether or not the order was placed
|
6 months or as long as it takes to reach N=4,200, whichever occurs first
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone Densitometry Scan Completed
Time Frame: 6 months or as long as it takes to reach N=4,200, whichever occurs first
|
Binary variable indicating whether or not the order placed at the encounter was completed
|
6 months or as long as it takes to reach N=4,200, whichever occurs first
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone Densitometry Scan Completion Time
Time Frame: 6 months or as long as it takes to reach N=4,200, whichever occurs first
|
Number of days from order time to completion time
|
6 months or as long as it takes to reach N=4,200, whichever occurs first
|
|
Number of Unique Alerts
Time Frame: 6 months or as long as it takes to reach N=4,200, whichever occurs first
|
Number of unique alerts (BPAs and medication alerts) that fired at the encounter
|
6 months or as long as it takes to reach N=4,200, whichever occurs first
|
|
Number of Alerts Fired
Time Frame: 6 months or as long as it takes to reach N=4,200, whichever occurs first
|
Number of alerts (BPAs and medication alerts) that fired at the encounter
|
6 months or as long as it takes to reach N=4,200, whichever occurs first
|
|
Total number of BPAs
Time Frame: 6 months or as long as it takes to reach N=4,200, whichever occurs first
|
Total number of BPAs that fired at the encounter
|
6 months or as long as it takes to reach N=4,200, whichever occurs first
|
|
Total number of medication alerts
Time Frame: 6 months or as long as it takes to reach N=4,200, whichever occurs first
|
Total number of medication alerts that fired at the encounter
|
6 months or as long as it takes to reach N=4,200, whichever occurs first
|
|
Total number of passive alerts
Time Frame: 6 months or as long as it takes to reach N=4,200, whichever occurs first
|
Total number of passive alerts that fired at the encounter
|
6 months or as long as it takes to reach N=4,200, whichever occurs first
|
|
Total number of interruptive alerts
Time Frame: 6 months or as long as it takes to reach N=4,200, whichever occurs first
|
Total number of interruptive alerts that fired at the encounter
|
6 months or as long as it takes to reach N=4,200, whichever occurs first
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amir Goren, PhD, Program Director, Behavioral Insights Team
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-0996
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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