Evaluation of Alerts in Promoting Bone Densitometry Scans
Primary Purpose
Bone Diseases, Communication
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Health Maintenance Topic
Actionable Sidebar Item
Best Practice Alert
Sponsored by
About this trial
This is an interventional prevention trial for Bone Diseases focused on measuring Bone Diseases, Alerts, Densitometry, Dual Energy X-ray Absorptiometry Scan
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care
Silent Best Practice Alert
Arm Description
A health maintenance topic, actionable sidebar item, and a single-click best practice alert are presented.
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.
Outcomes
Primary Outcome Measures
Bone Densitometry Scan Order Placed
Binary variable indicating whether or not the order was placed
Secondary Outcome Measures
Bone Densitometry Scan Completed
Binary variable indicating whether or not the order placed at the encounter was completed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04955652
Brief Title
Evaluation of Alerts in Promoting Bone Densitometry Scans
Official Title
Evaluation of Best Practice Alerts and an Actionable Sidebar in Electronic Health Records in Promoting Bone Densitometry Scans
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
A conflicting project required the same sample for a different purpose.
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Geisinger Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Diseases, Communication
Keywords
Bone Diseases, Alerts, Densitometry, Dual Energy X-ray Absorptiometry Scan
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1 x 2 factorial design, with randomization happening at the patient level
Masking
ParticipantCare Provider
Masking Description
The participants and providers will not know that alerts were randomized. Participants will not know the arm to which they were assigned. Providers might notice that a given participant did or did not receive a certain alert, but this is expected to be unlikely, given the volume of alerts to which providers are exposed constantly.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
A health maintenance topic, actionable sidebar item, and a single-click best practice alert are presented.
Arm Title
Silent Best Practice Alert
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Maintenance Topic
Other Intervention Name(s)
HMT
Intervention Description
Alert
Intervention Type
Behavioral
Intervention Name(s)
Actionable Sidebar Item
Other Intervention Name(s)
Storyboard
Intervention Description
Alert
Intervention Type
Behavioral
Intervention Name(s)
Best Practice Alert
Other Intervention Name(s)
BPA
Intervention Description
Alert
Primary Outcome Measure Information:
Title
Bone Densitometry Scan Order Placed
Description
Binary variable indicating whether or not the order was placed
Time Frame
6 months or as long as it takes to reach N=4,200, whichever occurs first
Secondary Outcome Measure Information:
Title
Bone Densitometry Scan Completed
Description
Binary variable indicating whether or not the order placed at the encounter was completed
Time Frame
6 months or as long as it takes to reach N=4,200, whichever occurs first
Other Pre-specified Outcome Measures:
Title
Bone Densitometry Scan Completion Time
Description
Number of days from order time to completion time
Time Frame
6 months or as long as it takes to reach N=4,200, whichever occurs first
Title
Number of Unique Alerts
Description
Number of unique alerts (BPAs and medication alerts) that fired at the encounter
Time Frame
6 months or as long as it takes to reach N=4,200, whichever occurs first
Title
Number of Alerts Fired
Description
Number of alerts (BPAs and medication alerts) that fired at the encounter
Time Frame
6 months or as long as it takes to reach N=4,200, whichever occurs first
Title
Total number of BPAs
Description
Total number of BPAs that fired at the encounter
Time Frame
6 months or as long as it takes to reach N=4,200, whichever occurs first
Title
Total number of medication alerts
Description
Total number of medication alerts that fired at the encounter
Time Frame
6 months or as long as it takes to reach N=4,200, whichever occurs first
Title
Total number of passive alerts
Description
Total number of passive alerts that fired at the encounter
Time Frame
6 months or as long as it takes to reach N=4,200, whichever occurs first
Title
Total number of interruptive alerts
Description
Total number of interruptive alerts that fired at the encounter
Time Frame
6 months or as long as it takes to reach N=4,200, whichever occurs first
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Goren, PhD
Organizational Affiliation
Program Director, Behavioral Insights Team
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Evaluation of Alerts in Promoting Bone Densitometry Scans
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