Trauma InjuryNCT05168579

Developing a Deliberate Practice Intervention to Recalibrate Physician Heuristics in Trauma Triage

A study testing Deliberate practice in people with Trauma Injury, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Trauma Injury
What is being tested?: Deliberate practice
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: 15 Dec 2021to 1 Dec 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

Board certified physicians who work at non-trauma centers in the United States

Who cannot join

Physicians without board certification (i.e., residents). Physicians who work only at trauma centers in the US.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

The objective of this study is to test the feasibility of using deliberate practice - goal-oriented training in the presence of a coach who can provide personalized, immediate feedback - to increase engagement. The research design involves recruitment of a national convenience sample of board-certified emergency physicians who will serve as trainees (n=30), pairing of the trainees with a coach, delivery of three 30-minute coaching sessions using the existing games as the training task, and assessment of the effect of the combined intervention on performance in the laboratory. The specific aims are:

To assess the fidelity of intervention delivery by measuring coaching skill acquisition, coaching skill drift and protocol adherence.
To assess the potential effect size of the intervention by comparing trainee performance on a validated virtual simulation with a control group of physicians (n=30).
To assess the acceptability of the intervention by using a mixture of validated instruments and semi-structured debriefing interviews with trainees to assess their engagement with the intervention.

Read the detailed description

Deliberate practice - goal-oriented training in the presence of a coach who can provide personalized, immediate feedback - has successfully improved performance across multiple domains, including sports, music, and combat. When used in conjunction with simulation to improve surgical skill, it has a large effect on educational outcomes. It has characteristics that make its application in this context potentially powerful (e.g. personalized feedback/relationship with coach increase engagement) but also potentially challenging (e.g. the diagnostic process does not lend itself easily to assessment). The objective of this study is to test the feasibility of using deliberate practice to amplify the effect of a video game intervention. The team will recruit a national sample of board-certified emergency physicians (n=30) to serve as trainees, with members of the team (n=3) serving as coaches. Trainee-coach dyads will meet for 30 minutes/week for 3 weeks, by video-conferencing, to play one of the existing video games and to use it to practice pattern recognition. Aims are:

To assess the fidelity of intervention delivery. Approach: the team will standardize coaching skill during an 'on-boarding session,' measure skill drift over the course of training sessions, and measure protocol adherence (primary outcome). Hypothesis: >90% of dyads will complete three training sessions.
To assess the potential effect size of the intervention. Approach: the team will compare performance of trainees (n=30) with a control group of physicians (n=30) on a validated virtual simulation. Hypothesis: Trainees will make ≥25% fewer diagnostic errors than control physicians (large effect size).
To assess the acceptability of the intervention. Approach: the team will conduct semi-structured debriefing interviews with trainees, assessing elements of the intervention that promote engagement.

This proposal will inform a future Stage III trial to compare the effect of different interventions on diagnostic error in trauma triage. If successful, this program of research will have an impact on patients by reducing the burden imposed by injury and by addressing the refractory problem of diagnostic error. It is novel conceptually in its effort to make heuristics a source of power, methodologically in its use of deliberate practice to improve diagnosis, and translationally in its use of video game technology. It is feasible because the investigative team has clinical and behavioral science expertise, experience developing deliberate practice interventions, and a track record of successfully building video games that can transform physician behavior. It responds to two national research priorities: 1) improving the diagnostic process; 2) maintaining health and independent living among the aging.

Conditions: Trauma Injury
Being tested: Deliberate practice
Medical subject headings: Accidental Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Deliberate practiceBehavioural
As above

Study groups in NCT05168579
Study group	Role	What they receive
Deliberate practice	Experimental	Trainees will be paired with a coach, and will meet, once per week for thirty minutes, over a three week period. During the training session, coach-trainee dyads will play a puzzle video game, and will discuss contextual cues that should inform triage decisions. At the completion of the three weeks, trainees will complete a semi-structured, debriefing interview and a virtual simulation to assess triage performance. Receives: Behavioral: Deliberate practice
Control	No intervention	Participants in the control group will complete a virtual simulation.

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Signed up for the Intervention That Completed All 3 Coaching Sessions.
A summary of the number of trainees who signed up for coaching sessions and completed all three sessions as assigned.
Measured: 3 week intervention period

Secondary outcomes (2)

Under-triage
Proportion of severely injured patients NOT transferred to trauma centers/total number of severely injured patients evaluated during a validated virtual simulation
Measured: 3 weeks post-intervention (deliberate practice) or 3 weeks post-enrollment (control)
Number of Participants Who Describe Coaching as Acceptable.
Derived from semi-structured interviews conducted by members of the investigative team at the conclusion of the 3 week training period. These interviews will focus on participant perceptions of the acceptability of the intervention.
Measured: 2- weeks post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 20211 Dec 2022

First posted23 Dec 2021
Study start15 Dec 2021
Primary completion11 Mar 2022
Study completion1 Dec 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 (2)Papers the sponsor has linked to this study.
Other trials for Trauma InjuryStudies of the same condition, open and under way.
More trials run by University of PittsburghThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: two arm randomized trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05168579
Sponsor's protocol ID: STUDY20120026
Other IDs: R21AG072072
Status last verified: Mar 2023
First submitted: 8 Dec 2021
Last updated: 5 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified participant data will be shared with researchers conditional on approval from the University of Pittsburgh Office of Research

Publications

Mohan D, Elmer J, Arnold RM, Forsythe RM, Fischhoff B, Rak K, Barnes JL, White DB. Testing a Novel Deliberate Practice Intervention to Improve Diagnostic Reasoning in Trauma Triage: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2313569. doi: 10.1001/jamanetworkopen.2023.13569.
PubMed 37195666
Mohan D, Elmer J, Arnold RM, Forsythe RM, Fischhoff B, Rak K, Barnes JL, White DB. Testing the feasibility, acceptability, and preliminary effect of a novel deliberate practice intervention to reduce diagnostic error in trauma triage: a study protocol for a randomized pilot trial. Pilot Feasibility Stud. 2022 Dec 12;8(1):253. doi: 10.1186/s40814-022-01212-y.
PubMed 36510328

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Trauma Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Developing a Deliberate Practice Intervention to Recalibrate Physician Heuristics in Trauma Triage
ClinicalTrials.gov ID: NCT05168579
Acronym / sponsor ID: STUDY20120026
Conditions: Trauma Injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 15 Dec 2021 (actual)
Primary completion: 11 Mar 2022 (actual)
Study completion: 1 Dec 2022 (actual)
First posted: 23 Dec 2021 (actual)
Results: Posted 5 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the fidelity of intervention delivery by measuring coaching skill acquisition, coaching skill drift and protocol adherence.
To assess the potential effect size of the intervention by comparing trainee performance on a validated virtual simulation with a control group of physicians (n=30).
To assess the acceptability of the intervention by using a mixture of validated instruments and semi-structured debriefing interviews with trainees to assess their engagement with the intervention.

Detailed description

To assess the fidelity of intervention delivery. Approach: the team will standardize coaching skill during an 'on-boarding session,' measure skill drift over the course of training sessions, and measure protocol adherence (primary outcome). Hypothesis: >90% of dyads will complete three training sessions.
To assess the potential effect size of the intervention. Approach: the team will compare performance of trainees (n=30) with a control group of physicians (n=30) on a validated virtual simulation. Hypothesis: Trainees will make ≥25% fewer diagnostic errors than control physicians (large effect size).
To assess the acceptability of the intervention. Approach: the team will conduct semi-structured debriefing interviews with trainees, assessing elements of the intervention that promote engagement.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: two arm randomized trial

Arm	Type	Receives
Deliberate practice	Experimental	Behavioral: Deliberate practiceTrainees will be paired with a coach, and will meet, once per week for thirty minutes, over a three week period. During the training session, coach-trainee dyads will play a puzzle video game, and will discuss contextual cues that should inform triage decisions. At the completion of the three weeks, trainees will complete a semi-structured, debriefing interview and a virtual simulation to assess triage performance.
Control	No intervention	–Participants in the control group will complete a virtual simulation.

Who may qualify

Ages: 25 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Board certified physicians who work at non-trauma centers in the United States

Key exclusion criteria (1 listed)

Physicians without board certification (i.e., residents). Physicians who work only at trauma centers in the US.

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
Deliberate practiceAs above	Behavioural	Deliberate practice

Primary outcome

Percentage of Participants Who Signed up for the Intervention That Completed All 3 Coaching Sessions.
Time frame: 3 week intervention period
A summary of the number of trainees who signed up for coaching sessions and completed all three sessions as assigned.

2 secondary outcomes

Under-triage
Time frame: 3 weeks post-intervention (deliberate practice) or 3 weeks post-enrollment (control)
Number of Participants Who Describe Coaching as Acceptable.
Time frame: 2- weeks post intervention

Results and safety

Results posted to the registry on 5 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Deliberate Practice	36	30
Control	36	21

Primary outcome: Percentage of Participants Who Signed up for the Intervention That Completed All 3 Coaching Sessions.

Time frame: 3 week intervention period. Count of participants. Unit: Participants

Measure	Deliberate Practice n = 36	Control n = 36
Completed 3 coaching sessions	28	0
Completed 2 coaching sessions	2	0
Completed 1 coaching session	0	0
Not assigned to coaching sessions	6	36

Population analysed: Board-certified emergency physicians who triage and treat adult patients in the emergency department of either a non-trauma center or a Level III/IV trauma center in the United States.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Deliberate Practice	0 of 36 (0%)	0 of 36 (0%)	0 of 36
Control	0 of 36 (0%)	0 of 36 (0%)	0 of 36

Limitations and caveats (from the sponsor): First, we used a passive rather than an active control as the comparator, which may have magnified the effect of the intervention. Second, the differential rate of attrition for completing the virtual simulation in the control and intervention groups could introduce bias, if missingness was not random. Third, we used a simulation to assess behavior, albeit one with evidence of criterion validity, which limited inference about the efficacy of the intervention.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37195666Mohan D, Elmer J, Arnold RM, Forsythe RM, Fischhoff B, Rak K, Barnes JL, White DB. Testing a Novel Deliberate Practice Intervention to Improve Diagnostic Reasoning in Trauma Triage: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2313569. doi: 10.1001/jamanetworkopen.2023.13569.
Derived from this study: PubMed 36510328Mohan D, Elmer J, Arnold RM, Forsythe RM, Fischhoff B, Rak K, Barnes JL, White DB. Testing the feasibility, acceptability, and preliminary effect of a novel deliberate practice intervention to reduce diagnostic error in trauma triage: a study protocol for a randomized pilot trial. Pilot Feasibility Stud. 2022 Dec 12;8(1):253. doi: 10.1186/s40814-022-01212-y.
Individual participant dataSharing planned: Yes. De-identified participant data will be shared with researchers conditional on approval from the University of Pittsburgh Office of Research

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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.

Deepika Mohan, MD principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Deliberate practice in people with Trauma Injury, run by University of Pittsburgh at 1 site 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 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 5 Apr 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 Participants Who Signed up for the Intervention That Completed All 3 Coaching Sessions. (time frame: 3 week intervention period). 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 NCT05168579, which also lists 2 linked publications.

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 5 Apr 2023.