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

NCT04668248 | Completed Results DMC

• 2 other identifiers: 2020P0036435P30AG064199-02
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Administered in Error; Antipsychotics and Neuroleptics Toxicity

Keywords

Simulation; Behavioral principles; Drug; Education; Pharmacology; Intervention

Outcome Measures

Primary Outcomes (1)

• 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)

  Within 2-week service block of participating provider

Secondary Outcomes (1)

• Percentage of Patients Discharged With Inappropriate Medications

  2 week follow-up period

Other Outcomes (4)

• Number and Percentage of Participants Signing Consent Forms

  Between study initiation and end of recruitment up to 10 months

• Rate of Simulation or Online Educational Training Completion

  2 week follow-up period

• Feedback and Issues Reported by the Interns or Study Staff

  Between study initiation and end of recruitment up to 10 months

Study Arms (2)

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.

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.

Other: Online educational training

Interventions

Simulation 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.

Simulation intervention

Online educational training 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.

Online education intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Ideas42: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Related Publications (2)

• 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.

  PMID: 38456561 DERIVED

• 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.

  PMID: 35475982 DERIVED

Results Point of Contact

• Title: Julie Lauffenburger, PharmD, PhD
• Organization: Brigham and Women's Hospital

jlauffenburger@bwh.harvard.edu

617-525-8865

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 16, 2020
• Study Start: March 29, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 8, 2023
• Results First Posted: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)