Clinical trial NCT04668248: Novel Application of Simulation for Providers to Overcome Decisional Gaps in High-risk Prescribing
Official title: Novel Application of Simulation for Providers to Overcome Decisional Gaps in High-risk Prescribing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Administered in Error
Antipsychotics and Neuroleptics Toxicity
Keywords: Simulation
Behavioral principles
Drug
Education
Pharmacology
Intervention
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Ideas42
name: National Institute on Aging (NIA)
First posted: 2020-12-16
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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")

Eligibility 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.

Primary outcomes:
measure: High-risk Medication Doses
timeFrame: Within 2-week service block of participating provider
Secondary outcomes:
measure: Percentage of Patients Discharged With Inappropriate Medications
timeFrame: 2 week follow-up period
Other outcomes:
measure: Number and Percentage of Participants Signing Consent Forms
timeFrame: Between study initiation and end of recruitment up to 10 months
measure: Rate of Simulation or Online Educational Training Completion
timeFrame: 2 week follow-up period
measure: Feedback and Issues Reported by the Interns or Study Staff
timeFrame: Between study initiation and end of recruitment up to 10 months
measure: Satisfaction With the Intervention
timeFrame: 2 week follow-up period
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
citation: 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.