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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Withdrawn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
Geisinger Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    June 22, 2021
    Last Updated
    March 16, 2022
    Sponsor
    Geisinger Clinic
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    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    Withdrawn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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