Pulmonary EmbolismNCT05203185
Nudging Provider Adoption of Clinical Decision Support
A study testing Pulmonary Embolism Risk Kalculator (PERK) in people with Pulmonary Embolism, run by NYU Langone Health at 2 sites in United States.
Trial summary
The central hypothesis of this proposal is that the addition of a theory-informed "nudge" to a clinical decision support (CDS) tool will address identified behavioral barriers to use and significantly improve adoption by providers. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Pulmonary Embolism Risk Kalculator (PERK)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,612 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical doctors, nurse practitioners and physician assistants working full time at Huntington Hospital and Long Island Jewish Valley Stream
Who cannot join
- Does not meet the inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Huntington Hospital
Huntington, New York, 11743
Long Island Jewish Valley Stream
Valley Stream, New York, 11580
About this study
The central hypothesis of this proposal is that the addition of a theory-informed "nudge" to a clinical decision support (CDS) tool will address identified behavioral barriers to use and significantly improve adoption by providers. Nudges are applications of behavioral science, defined as positive reinforcement and indirect suggestions that have a non-forced effect on decision making. This study will use a behavioral theory-informed process to develop a new CDS tool that includes a nudge that addresses barriers to adoption.
Read the detailed description
The research team developed and pilot tested two CDS tools for pulmonary embolism (PE) risk stratification in the Emergency Department (ED). One of the tools incorporated two behavioral theory-informed nudges in the user interface. The research team's objective was to pilot test the tools to demonstrate feasibility as well as examine preliminary efficacy of the nudges on provider adoption of the tool. This cluster non-randomized controlled trial took place between September 20th, 2021 and March 3rd, 2022 in two EDs that are a part of a large academic health system in the New York City metropolitan area. All ED providers (physicians, physician assistants and nurse practitioners) seeing patients for the evaluation of PE during this time were included in the trial. The EDs were chosen based on their comparable size and acuity levels.
- Conditions
- Pulmonary Embolism
- Being tested
- Pulmonary Embolism Risk Kalculator (PERK)
- Keywords
- Clinical Decision Support, Pulmonary Embolism, Behavioral Design, Health Informatics
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Embolism Risk Kalculator (PERK)Other
Nudges are applications of behavioral science, defined as positive reinforcement and indirect suggestions that have a non-forced effect on decision making. Nudges will be to the PE CALC CDS tool to develop the new CDS tool, PERK.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Site | Experimental | Full time employed Emergency Department providers will use the new CDS tool, Pulmonary Embolism Risk Kalculator (PERK), which includes nudges to improve use and will be integrated into the electronic medical record and will be accessible for 6 months Receives: Other: Pulmonary Embolism Risk Kalculator (PERK) |
| No Intervention Site | No intervention | Full time employed Emergency Department providers used a CDS tool, Pulmonary Embolism Calculator (PE CALC), without nudges to improve use, to reduce unnecessary imaging in the diagnosis of pulmonary embolism (PE) in the emergency department (ED). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patient Visits Where the Provider Adopted the Pulmonary Embolism Risk Kalculator (PERK) Tool
The tool is considered adopted during a patient visit if the provider accepted the recommendation given by the PERK tool (i.e., a D-dimer was recommended and ordered or a CT pulmonary angiogram (CTPA) was recommended and ordered). This outcome measure is assessed using electronic health record (EHR) data from the patient visit.
Measured: Up to Month 6
Secondary outcomes (1)
Percentage of PE-Designated CTPA Tests That Are Positive for PE
Monitored using EHR reporting data. Calculated as the percentage of CTPA tests ordered to evaluate for PE that are positive for PE.
Measured: Up to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Jul 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,612 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Safiya Richardson, MD, MPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203185
- Sponsor's protocol ID
- 21-01316
- Other IDs
- 5K23HL145114-02
- Status last verified
- Jun 2023
- First submitted
- 10 Jan 2022
- Last updated
- 26 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Richardson S, Dauber-Decker KL, Solomon J, Seelamneni P, Khan S, Barnaby DP, Chelico J, Qiu M, Liu Y, Sanghani S, Izard SM, Chiuzan C, Mann D, Pekmezaris R, McGinn T, Diefenbach MA. Effect of a behavioral nudge on adoption of an electronic health record-agnostic pulmonary embolism risk prediction tool: a pilot cluster nonrandomized controlled trial. JAMIA Open. 2024 Aug 1;7(3):ooae064. doi: 10.1093/jamiaopen/ooae064. eCollection 2024 Oct.
PubMed 39091509
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudging Provider Adoption of Clinical Decision Support
- ClinicalTrials.gov ID
- NCT05203185
- Acronym / sponsor ID
- 21-01316
- Conditions
- Pulmonary Embolism
- Keywords
- Clinical Decision Support, Pulmonary Embolism, Behavioral Design, Health Informatics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,612 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Posted 26 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The central hypothesis of this proposal is that the addition of a theory-informed "nudge" to a clinical decision support (CDS) tool will address identified behavioral barriers to use and significantly improve adoption by providers. Nudges are applications of behavioral science, defined as positive reinforcement and indirect suggestions that have a non-forced effect on decision making. This study will use a behavioral theory-informed process to develop a new CDS tool that includes a nudge that addresses barriers to adoption.
Detailed description
The research team developed and pilot tested two CDS tools for pulmonary embolism (PE) risk stratification in the Emergency Department (ED). One of the tools incorporated two behavioral theory-informed nudges in the user interface. The research team's objective was to pilot test the tools to demonstrate feasibility as well as examine preliminary efficacy of the nudges on provider adoption of the tool. This cluster non-randomized controlled trial took place between September 20th, 2021 and March 3rd, 2022 in two EDs that are a part of a large academic health system in the New York City metropolitan area. All ED providers (physicians, physician assistants and nurse practitioners) seeing patients for the evaluation of PE during this time were included in the trial. The EDs were chosen based on their comparable size and acuity levels.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Site | Experimental | Other: Pulmonary Embolism Risk Kalculator (PERK)Full time employed Emergency Department providers will use the new CDS tool, Pulmonary Embolism Risk Kalculator (PERK), which includes nudges to improve use and will be integrated into the electronic medical record and will be accessible for 6 months |
| No Intervention Site | No intervention | –Full time employed Emergency Department providers used a CDS tool, Pulmonary Embolism Calculator (PE CALC), without nudges to improve use, to reduce unnecessary imaging in the diagnosis of pulmonary embolism (PE) in the emergency department (ED). |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical doctors, nurse practitioners and physician assistants working full time at Huntington Hospital and Long Island Jewish Valley Stream
Key exclusion criteria (1 listed)
- Does not meet the inclusion criteria
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 |
|---|---|---|
| Pulmonary Embolism Risk Kalculator (PERK)Nudges are applications of behavioral science, defined as positive reinforcement and indirect suggestions that have a non-forced effect on decision making. Nudges will be to the PE CALC CDS tool to develop the new CDS tool, PERK. | Other | Intervention Site |
Primary outcome
Percentage of Patient Visits Where the Provider Adopted the Pulmonary Embolism Risk Kalculator (PERK) Tool
Time frame: Up to Month 6
The tool is considered adopted during a patient visit if the provider accepted the recommendation given by the PERK tool (i.e., a D-dimer was recommended and ordered or a CT pulmonary angiogram (CTPA) was recommended and ordered). This outcome measure is assessed using electronic health record (EHR) data from the patient visit.
1 secondary outcome
Percentage of PE-Designated CTPA Tests That Are Positive for PE
Time frame: Up to Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39091509Richardson S, Dauber-Decker KL, Solomon J, Seelamneni P, Khan S, Barnaby DP, Chelico J, Qiu M, Liu Y, Sanghani S, Izard SM, Chiuzan C, Mann D, Pekmezaris R, McGinn T, Diefenbach MA. Effect of a behavioral nudge on adoption of an electronic health record-agnostic pulmonary embolism risk prediction tool: a pilot cluster nonrandomized controlled trial. JAMIA Open. 2024 Aug 1;7(3):ooae064. doi: 10.1093/jamiaopen/ooae064. eCollection 2024 Oct.
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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.
Safiya Richardson, MD, MPH principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Embolism Risk Kalculator (PERK) in people with Pulmonary Embolism, run by NYU Langone Health at 2 sites in United States.
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 1 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: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 26 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patient Visits Where the Provider Adopted the Pulmonary Embolism Risk Kalculator (PERK) Tool (time frame: Up to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05203185, which also lists 1 linked publication.
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 26 Jun 2023.