Skip to main content
OpenTrials
Completed

NCT Number: NCT04668248

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

About this study

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")

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Percentage of Patients Discharged With Inappropriate Medications

    Time frame: 2 week follow-up period

    Percentage of patients discharged with inappropriate medications, measured through electronic health record data

Other outcomes

  1. Number and Percentage of Participants Signing Consent Forms

    Time frame: Between study initiation and end of recruitment up to 10 months

    Percentage of consenting providers out of those eligible (measured by the Amion scheduling system)

  2. Rate of Simulation or Online Educational Training Completion

    Time frame: 2 week follow-up period

    Rate of simulation training completion or online educational training completion

  3. Feedback and Issues Reported by the Interns or Study Staff

    Time frame: Between study initiation and end of recruitment up to 10 months

    Feedback and issues reported by the interns or study staff (measured in the endline questionnaire)

  4. Satisfaction With the Intervention

    Time frame: 2 week follow-up period

    Satisfaction with the intervention (measured in the endline questionnaire). This item was measured using several validated questions. The final summary question is used to summarize satisfaction, with the percentage of those strongly agreeing with the statement that "I learned new information during participation in the study that I would not have learned otherwise" shown by each arm below.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Ideas42
  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2020
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.