Novel Application of Simulation for Providers to Overcome Decisional Gaps in High-risk Prescribing

NCT ID: NCT04668248

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2021-12-31

Brief 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. 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")

Conditions

Medication Administered in Error; Antipsychotics and Neuroleptics Toxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Simulation intervention

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.

Group Type: EXPERIMENTAL

Simulation

Intervention Type: OTHER

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 education intervention

Providers assigned to the control arm will receive online educational training about other poorly-prescribed medications, including albumin, transfusion, and blood product repletion guidelines.

Group Type: ACTIVE_COMPARATOR

Online educational training

Intervention Type: OTHER

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.

Interventions

Simulation

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.

Intervention Type: OTHER

Online educational training

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ideas42

INDUSTRY

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Julie Lauffenburger

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38456561 (View on PubMed)

Lauffenburger 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.

Reference Type: DERIVED

PMID: 35475982 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5P30AG064199-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020P003643

Identifier Type: -

Identifier Source: org_study_id