Medication Administered in ErrorNCT04668248
Novel Application of Simulation for Providers to Overcome Decisional Gaps in High-risk Prescribing
A study testing Simulation and Online educational training in people with Medication Administered in Error and Antipsychotics and Neuroleptics Toxicity, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This pilot project aims to reduce the prescribing of high-risk medications, such as antipsychotics and benzodiazepines, to hospitalized older adults. To accomplish this, this project consists of two phases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Administered in Error, Antipsychotics and Neuroleptics Toxicity
- What is being tested?
- Simulation and Online educational training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2021to 31 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Residents and interns at Brigham and Women's Hospital will be eligible for this trial if they care for older adults (age 65+) admitted to one of the general medicine wards during an evening shift.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
This pilot project aims to reduce the prescribing of high-risk medications, such as antipsychotics and benzodiazepines, to hospitalized older adults. To accomplish this, this project consists of two phases. The purpose is to determine whether a novel simulation-based training program reduces prescribing of suboptimal medications for older adults. A 2-arm pilot randomized controlled trial will be conducted to test a simulation-based, principle-driven intervention targeting high-risk prescribing practices versus control.
Read the detailed description
The overarching goal is to determine whether a newly-designed simulation-based training program for providers based on underlying principles of System 1 and System 2 thinking reduces prescribing of high-risk medications for hospitalized older adults versus control, with the ultimate goal of improving patient safety. Subsequent prescribing for patients cared for by other providers and other adoption and implementation outcomes will be measured to explore the extent to which the intervention could be used at scale.
36 interns practicing on the general medicine inpatient service at Brigham and Women's Hospital will be assigned to the "twilight" team. Interns who consent will be randomized in a 1:1 ratio to one of 2 arms: (a) Arm 1: simulation training and (b) Arm 2: control (online educational training).
Patients who will be included in the analysis will include adults ≥65 years old who are admitted to the BWH/BWFH general medicine service under the care of one of the consenting interns (specifically, with the intern listed as the "Responding Clinician")
- Being tested
- Simulation, Online educational training
- Keywords
- Simulation, Behavioral principles, Drug, Education, Pharmacology, Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulationOther
The simulation will consist of a one-time, short immersive simulation session at the STRATUS Center for Medical Education at BWH. The session will be conducted for up to one intern at the same time, in accordance with social distancing practices at BWH. This simulation session will consist of one short, hands-on scenario of simulated patient experiences with expert facilitators in the simulated hospital rooms to help providers identify when they are in the hot state and their reactions, and work on improving communication skills, differential diagnoses, and alternative therapeutic options. These scenarios are intended to simulate both in-person and virtual interactions that are common in the inpatient setting. During these trainings, we will use behavioral principles like time pressure and increasing cognitive load to simulate a "hot state" environment. After the scenarios, the facilitator will perform a debriefing session for the interns.
Online educational trainingOther
Providers assigned to the control arm will receive online educational training about other poorly-prescribed medications, including albumin, transfusion, and blood product repletion guidelines. This information will be in the form of electronically-delivered links to information already housed and available at BWH, including reviewing BWH guidelines and literature about transfusion reactions. The interns will be asked to answer several clinical questions about optimal prescribing. Albumin and related products are also high-risk medications often overprescribed on twilight shifts.
| Study group | Role | What they receive |
|---|---|---|
| Simulation intervention | Experimental | Providers assigned to the intervention arm will participate in a short simulation training at the beginning of their 2-week block (planned for their second day). The training will take place at the Neil and Elise Wallace STRATUS Center for Medical Simulation at Brigham and Women's Hospital and will follow all of their recommended and hospital-recommended practices on social distancing, including the learning limits. Receives: Other: Simulation |
| Online education intervention | Active comparator | Providers assigned to the control arm will receive online educational training about other poorly-prescribed medications, including albumin, transfusion, and blood product repletion guidelines. Receives: Other: Online educational training |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-risk Medication Doses
This will include the number of pills or injection order of high-risk medications (i.e., anti-psychotics, benzodiazepines, and sedative hypnotic "Z-drugs") administered to eligible patients (i.e., those 65 or older not previously on one of these medications)
Measured: Within 2-week service block of participating provider
Secondary outcomes (1)
Percentage of Patients Discharged With Inappropriate Medications
Percentage of patients discharged with inappropriate medications, measured through electronic health record data
Measured: 2 week follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start29 Mar 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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 Medication Administered in ErrorStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ideas42, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Julie Lauffenburger, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668248
- Sponsor's protocol ID
- 2020P003643
- Other IDs
- 5P30AG064199-02
- Status last verified
- Jan 2023
- First submitted
- 19 Nov 2020
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lauffenburger JC, DiFrancesco MF, Bhatkhande G, Crum KL, Kim E, Robertson T, Oran R, Hanken KE, Haff N, Coll MD, Avorn J, Choudhry NK. Pragmatic trial evaluating the impact of simulation training on high-risk prescribing to older adults by junior physicians. J Am Geriatr Soc. 2024 May;72(5):1420-1430. doi: 10.1111/jgs.18862. Epub 2024 Mar 8.
PubMed 38456561Lauffenburger JC, DiFrancesco MF, Barlev RA, Robertson T, Kim E, Coll MD, Haff N, Fontanet CP, Hanken K, Oran R, Avorn J, Choudhry NK. Overcoming Decisional Gaps in High-Risk Prescribing by Junior Physicians Using Simulation-Based Training: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Apr 27;11(4):e31464. doi: 10.2196/31464.
PubMed 35475982
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Application of Simulation for Providers to Overcome Decisional Gaps in High-risk Prescribing
- ClinicalTrials.gov ID
- NCT04668248
- Acronym / sponsor ID
- 2020P003643
- Keywords
- Simulation, Behavioral principles, Drug, Education, Pharmacology, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Ideas42, National Institute on Aging (NIA)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot project aims to reduce the prescribing of high-risk medications, such as antipsychotics and benzodiazepines, to hospitalized older adults. To accomplish this, this project consists of two phases. The purpose is to determine whether a novel simulation-based training program reduces prescribing of suboptimal medications for older adults. A 2-arm pilot randomized controlled trial will be conducted to test a simulation-based, principle-driven intervention targeting high-risk prescribing practices versus control.
Detailed description
The overarching goal is to determine whether a newly-designed simulation-based training program for providers based on underlying principles of System 1 and System 2 thinking reduces prescribing of high-risk medications for hospitalized older adults versus control, with the ultimate goal of improving patient safety. Subsequent prescribing for patients cared for by other providers and other adoption and implementation outcomes will be measured to explore the extent to which the intervention could be used at scale.
36 interns practicing on the general medicine inpatient service at Brigham and Women's Hospital will be assigned to the "twilight" team. Interns who consent will be randomized in a 1:1 ratio to one of 2 arms: (a) Arm 1: simulation training and (b) Arm 2: control (online educational training).
Patients who will be included in the analysis will include adults ≥65 years old who are admitted to the BWH/BWFH general medicine service under the care of one of the consenting interns (specifically, with the intern listed as the "Responding Clinician")
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation intervention | Experimental | Other: SimulationProviders assigned to the intervention arm will participate in a short simulation training at the beginning of their 2-week block (planned for their second day). The training will take place at the Neil and Elise Wallace STRATUS Center for Medical Simulation at Brigham and Women's Hospital and will follow all of their recommended and hospital-recommended practices on social distancing, including the learning limits. |
| Online education intervention | Active comparator | Other: Online educational trainingProviders assigned to the control arm will receive online educational training about other poorly-prescribed medications, including albumin, transfusion, and blood product repletion guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SimulationThe simulation will consist of a one-time, short immersive simulation session at the STRATUS Center for Medical Education at BWH. The session will be conducted for up to one intern at the same time, in accordance with social distancing practices at BWH. This simulation session will consist of one short, hands-on scenario of simulated patient experiences with expert facilitators in the simulated hospital rooms to help providers identify when they are in the hot state and their reactions, and work on improving communication skills, differential diagnoses, and alternative therapeutic options. These scenarios are intended to simulate both in-person and virtual interactions that are common in the inpatient setting. During these trainings, we will use behavioral principles like time pressure and increasing cognitive load to simulate a "hot state" environment. After the scenarios, the facilitator will perform a debriefing session for the interns. | Other | Simulation intervention |
| Online educational trainingProviders assigned to the control arm will receive online educational training about other poorly-prescribed medications, including albumin, transfusion, and blood product repletion guidelines. This information will be in the form of electronically-delivered links to information already housed and available at BWH, including reviewing BWH guidelines and literature about transfusion reactions. The interns will be asked to answer several clinical questions about optimal prescribing. Albumin and related products are also high-risk medications often overprescribed on twilight shifts. | Other | Online education intervention |
Primary outcome
High-risk Medication Doses
Time frame: Within 2-week service block of participating provider
This will include the number of pills or injection order of high-risk medications (i.e., anti-psychotics, benzodiazepines, and sedative hypnotic "Z-drugs") administered to eligible patients (i.e., those 65 or older not previously on one of these medications)
1 secondary outcome
Percentage of Patients Discharged With Inappropriate Medications
Time frame: 2 week follow-up period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38456561Lauffenburger JC, DiFrancesco MF, Bhatkhande G, Crum KL, Kim E, Robertson T, Oran R, Hanken KE, Haff N, Coll MD, Avorn J, Choudhry NK. Pragmatic trial evaluating the impact of simulation training on high-risk prescribing to older adults by junior physicians. J Am Geriatr Soc. 2024 May;72(5):1420-1430. doi: 10.1111/jgs.18862. Epub 2024 Mar 8.
- Derived from this study: PubMed 35475982Lauffenburger JC, DiFrancesco MF, Barlev RA, Robertson T, Kim E, Coll MD, Haff N, Fontanet CP, Hanken K, Oran R, Avorn J, Choudhry NK. Overcoming Decisional Gaps in High-Risk Prescribing by Junior Physicians Using Simulation-Based Training: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Apr 27;11(4):e31464. doi: 10.2196/31464.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation and Online educational training in people with Medication Administered in Error and Antipsychotics and Neuroleptics Toxicity, run by Brigham and Women's Hospital 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?
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 8 Feb 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 8 Feb 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?
High-risk Medication Doses (time frame: Within 2-week service block of participating provider). 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 NCT04668248, 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 8 Feb 2023.