Evaluation of Alerts in Promoting Bone Densitometry Scans

March 16, 2022 updated by: Amir Goren, Geisinger Clinic

Evaluation of Best Practice Alerts and an Actionable Sidebar in Electronic Health Records in Promoting Bone Densitometry Scans

The purpose of this study is to assess, prospectively, the effect of provider-facing alerts for bone densitometry scans with and without a single-click best practice alert (BPA) on scan orders and completions. The investigators hypothesize that the remaining alerts left in place (via health maintenance topics and an actionable item in the electronic health record sidebar) will be as effective without the BPA compared to the alerts with a BPA.

Study Overview

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

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • HMT
Alert
Other Names:
  • Storyboard
Alert
Other Names:
  • BPA
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:
  • HMT
Alert
Other Names:
  • Storyboard

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Amir Goren, PhD, Program Director, Behavioral Insights Team

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 22, 2021

First Submitted That Met QC Criteria

June 29, 2021

First Posted (Actual)

July 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

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)?

Yes

IPD Plan Description

Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings. The PI did not examine or analyze any data from this study prior to this registration.

IPD Sharing Time Frame

The data will become available after publication of study results in a scientific journal and will be available as long as the Open Science Framework hosts the data.

IPD Sharing Access Criteria

The data on the Open Science Framework will be open to anyone requesting that information.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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