Bone DiseasesNCT04955652
Evaluation of Alerts in Promoting Bone Densitometry Scans
A study testing Health Maintenance Topic, Actionable Sidebar Item and Best Practice Alert in people with Bone Diseases and Communication, run by Geisinger Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Diseases, Communication
- What is being tested?
- Health Maintenance Topic, Actionable Sidebar Item and Best Practice Alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Encounters at clinics/sites where the randomization build cannot easily be deployed
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Diseases, Communication
- Being tested
- Health Maintenance Topic, Actionable Sidebar Item, Best Practice Alert
- Keywords
- Bone Diseases, Alerts, Densitometry, Dual Energy X-ray Absorptiometry Scan
- Medical subject headings
- Bone Diseases, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Maintenance TopicBehavioural
Also called HMT
Alert
Actionable Sidebar ItemBehavioural
Also called Storyboard
Alert
Best Practice AlertBehavioural
Also called BPA
Alert
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | A health maintenance topic, actionable sidebar item, and a single-click best practice alert are presented. Receives: Behavioral: Health Maintenance Topic; Behavioral: Actionable Sidebar Item; Behavioral: 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. Receives: Behavioral: Health Maintenance Topic; Behavioral: Actionable Sidebar Item |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Densitometry Scan Order Placed
Binary variable indicating whether or not the order was placed
Measured: 6 months or as long as it takes to reach N=4,200, whichever occurs first
Secondary outcomes (1)
Bone Densitometry Scan Completed
Binary variable indicating whether or not the order placed at the encounter was completed
Measured: 6 months or as long as it takes to reach N=4,200, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study startMar 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: A conflicting project required the same sample for a different purpose.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 x 2 factorial design, with randomization happening at the patient level
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Goren, Geisinger Clinic
- Investigators
- Amir Goren, PhD, Principal investigator, Program Director, Behavioral Insights Team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955652
- Sponsor's protocol ID
- 2020-0996
- Status last verified
- Mar 2022
- First submitted
- 22 Jun 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Best Practice Alerts and an Actionable Sidebar in Electronic Health Records in Promoting Bone Densitometry Scans
- ClinicalTrials.gov ID
- NCT04955652
- Acronym / sponsor ID
- 2020-0996
- Conditions
- Bone Diseases, Communication
- Keywords
- Bone Diseases, Alerts, Densitometry, Dual Energy X-ray Absorptiometry Scan
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A conflicting project required the same sample for a different purpose.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 1 x 2 factorial design, with randomization happening at the patient level
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Behavioral: Health Maintenance Topic, Behavioral: Actionable Sidebar Item, Behavioral: Best Practice AlertA health maintenance topic, actionable sidebar item, and a single-click best practice alert are presented. |
| Silent Best Practice Alert | Experimental | Behavioral: Health Maintenance Topic, Behavioral: Actionable Sidebar ItemA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Encounters at clinics/sites where the randomization build cannot easily be deployed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Maintenance TopicAlso: HMTAlert | Behavioural | Silent Best Practice Alert, Standard of Care |
| Actionable Sidebar ItemAlso: StoryboardAlert | Behavioural | Silent Best Practice Alert, Standard of Care |
| Best Practice AlertAlso: BPAAlert | Behavioural | Standard of Care |
Primary outcome
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
1 secondary outcome
Bone Densitometry Scan Completed
Time frame: 6 months or as long as it takes to reach N=4,200, whichever occurs first
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Goren, PhD principal investigator
Program Director, Behavioral Insights Team
Questions about this trial
What is this clinical trial studying?
A study testing Health Maintenance Topic, Actionable Sidebar Item and Best Practice Alert in people with Bone Diseases and Communication, run by Geisinger Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Densitometry Scan Order Placed (time frame: 6 months or as long as it takes to reach N=4,200, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.