NCT04955652

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

June 22, 2021

Last Update Submit

March 16, 2022

Conditions

Keywords

Bone DiseasesAlertsDensitometryDual Energy X-ray Absorptiometry Scan

Outcome Measures

Primary Outcomes (1)

  • Bone Densitometry Scan Order Placed

    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 Outcomes (1)

  • Bone Densitometry Scan Completed

    6 months or as long as it takes to reach N=4,200, whichever occurs first

Other Outcomes (7)

  • Bone Densitometry Scan Completion Time

    6 months or as long as it takes to reach N=4,200, whichever occurs first

  • Number of Unique Alerts

    6 months or as long as it takes to reach N=4,200, whichever occurs first

  • Number of Alerts Fired

    6 months or as long as it takes to reach N=4,200, whichever occurs first

  • +4 more other outcomes

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Behavioral: Health Maintenance TopicBehavioral: Actionable Sidebar ItemBehavioral: Best Practice Alert

Silent Best Practice Alert

EXPERIMENTAL

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 TopicBehavioral: Actionable Sidebar Item

Interventions

Alert

Also known as: HMT
Silent Best Practice AlertStandard of Care

Alert

Also known as: Storyboard
Silent Best Practice AlertStandard of Care

Alert

Also known as: BPA
Standard of Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Encounters at clinics/sites where the randomization build cannot easily be deployed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bone DiseasesCommunication

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesBehavior

Study Officials

  • Amir Goren, PhD

    Program Director, Behavioral Insights Team

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 1 x 2 factorial design, with randomization happening at the patient level
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director, Behavioral Insights Team

Study Record Dates

First Submitted

June 22, 2021

First Posted

July 9, 2021

Study Start

March 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
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.
Access Criteria
The data on the Open Science Framework will be open to anyone requesting that information.