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

• ClinicalTrials.gov Identifier: NCT04668248
• Recruitment Status: Completed
• First Posted: December 16, 2020
• Results First Posted: February 8, 2023
• Last Update Posted: February 8, 2023
• Sponsor: Brigham and Women's Hospital
• Collaborators: Ideas42; National Institute on Aging (NIA)
• Information provided by (Responsible Party): Julie Lauffenburger, Brigham and Women's Hospital

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
Medication Administered in Error; Antipsychotics and Neuroleptics Toxicity	Other: Simulation; Other: Online educational training	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 47 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: March 29, 2021
• Actual Primary Completion Date: December 31, 2021
• Actual Study Completion Date: December 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 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.
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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02120

Sponsors and Collaborators

Brigham and Women's Hospital

Ideas42

National Institute on Aging (NIA)

  Study Documents (Full-Text)

Documents provided by Julie Lauffenburger, Brigham and Women's Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] February 9, 2021

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Julie Lauffenburger, Assistant Professor, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT04668248
• Other Study ID Numbers: 2020P003643; 5P30AG064199-02 ( U.S. NIH Grant/Contract )
• First Posted: December 16, 2020
• Results First Posted: February 8, 2023
• Last Update Posted: February 8, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• 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, Brigham and Women's Hospital:

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