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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04668248
Collaborator
Ideas42 (Industry), National Institute on Aging (NIA) (NIH)
40
1
2
9.1
4.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Simulation
  • Other: Online educational training
N/A

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

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Novel Application of Simulation for Providers to Overcome Decisional Gaps in High-risk Prescribing
Actual Study Start Date :
Mar 29, 2021
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: 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 4 interns at the same time, in accordance with social distancing practices at BWH. This simulation session will consist of 2 short, hands-on scenarios 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.

Active Comparator: 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.

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. Receiving education about another high-risk medication will reduce contamination and allow the ability to measure outcomes to other high-risk medications.

Outcome Measures

Primary Outcome Measures

  1. High-risk medication doses [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 Outcome Measures

  1. Proportion of patients discharged with inappropriate medications [2 week follow-up period]

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

Other Outcome Measures

  1. Rate of consent [Between study initiation and end of recruitment up to 10 months]

    Rate of consenting and non-consenting providers (measured by the Amion scheduling system)

  2. Rate of simulation or online educational training completion [2 week follow-up period]

    Rate of simulation training completion or opening of the online educational training

  3. Feedback and issues reported by the interns or study staff [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 [2 week follow-up period]

    Satisfaction with the intervention (measured in the endline questionnaire)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02120

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Julie Lauffenburger, Assistant Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT04668248
Other Study ID Numbers:
  • 2020P003643
  • 5P30AG064199-02
First Posted:
Dec 16, 2020
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Julie Lauffenburger, Assistant Professor, Brigham and Women's Hospital

Study Results

No Results Posted as of Feb 1, 2022