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Evaluation of Alerts in Promoting Bone Densitometry Scans

Sponsor
Geisinger Clinic (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04955652
Collaborator
(none)
0
Enrollment
2
Arms
9
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Health Maintenance Topic
  • Behavioral: Actionable Sidebar Item
  • Behavioral: Best Practice Alert
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1 x 2 factorial design, with randomization happening at the patient level1 x 2 factorial design, with randomization happening at the patient level
Masking:
Double (Participant, Care 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.
Primary Purpose:
Prevention
Official Title:
Evaluation of Best Practice Alerts and an Actionable Sidebar in Electronic Health Records in Promoting Bone Densitometry Scans
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard of Care

A health maintenance topic, actionable sidebar item, and a single-click best practice alert are presented.

Behavioral: Health Maintenance Topic
Alert
Other Names:
  • HMT

    • Behavioral: Actionable Sidebar Item
    Alert
    Other Names:
  • Storyboard

    • Behavioral: Best Practice Alert
    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.

    Behavioral: Health Maintenance Topic
    Alert
    Other Names:
  • HMT

    • Behavioral: Actionable Sidebar Item
    Alert
    Other Names:
  • Storyboard

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bone Densitometry Scan Order Placed [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

    Secondary Outcome Measures

    1. Bone Densitometry Scan Completed [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

    Other Outcome Measures

    1. Bone Densitometry Scan Completion Time [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

    2. Number of Unique Alerts [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

    3. Number of Alerts Fired [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

    4. Total number of BPAs [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

    5. Total number of medication alerts [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. Total number of passive alerts [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

    7. Total number of interruptive alerts [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Geisinger Clinic

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amir Goren, Program Director, Behavioral Insights Team, Geisinger Clinic
    ClinicalTrials.gov Identifier:
    NCT04955652
    Other Study ID Numbers:
    • 2020-0996
    First Posted:
    Jul 9, 2021
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amir Goren, Program Director, Behavioral Insights Team, Geisinger Clinic
    Bone Diseases
    Alerts
    Densitometry
    Dual Energy X-ray Absorptiometry Scan
    Additional relevant MeSH terms:
    Bone Diseases

    Study Results

    No Results Posted as of Mar 31, 2022