Trial Outcomes & Findings for Novel Application of Simulation for Providers to Overcome Decisional Gaps in High-risk Prescribing (NCT NCT04668248)

Last Updated: 2023-02-08

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

47 participants

Primary outcome timeframe

Within 2-week service block of participating provider

Results posted on

2023-02-08

Participant Flow

First-year medical resident physicians (i.e., interns) who provide care on inpatient general medicine services at Brigham and Women's Hospital from March to December 2021 were eligible for this trial if they were assigned to one of the general medicine wards and were scheduled for twilight rotations.

Participant milestones

Participant milestones
Measure	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. Simulation: The simulation will consist of a one-time, short immersive simulation session at the STRATUS Center for Medical Education at BWH. This simulation session consisted of a 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. This scenario was intended to simulate both in-person and virtual interactions that are common in the inpatient setting. During these trainings, we used behavioral principles like time pressure and increasing cognitive load to simulate a "hot state" environment. After the scenarios, the facilitator performed a debriefing session for the interns.	Online Education Intervention (Control) Providers assigned to the control arm will receive online educational training about other poorly-prescribed medications, including albumin, transfusion, and blood product repletion guidelines. 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.
Overall Study STARTED	24	23
Overall Study Sick	1	0
Overall Study Schedule Change	4	0
Overall Study Did Not Complete Training in Time	0	2
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Simulation Intervention n=19 Participants 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. Simulation: The simulation will consist of a one-time, short immersive simulation session at the STRATUS Center for Medical Education at BWH. This simulation session consisted of a 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. This scenario was intended to simulate both in-person and virtual interactions that are common in the inpatient setting. During these trainings, we used behavioral principles like time pressure and increasing cognitive load to simulate a "hot state" environment. After the scenarios, the facilitator performed a debriefing session for the interns.	Online Education Intervention (Control) n=21 Participants Providers assigned to the control arm will receive online educational training about other poorly-prescribed medications, including albumin, transfusion, and blood product repletion guidelines. 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.	Total n=40 Participants Total of all reporting groups
Age, Continuous	28.0 years STANDARD_DEVIATION 2.3 • n=5 Participants	29.0 years STANDARD_DEVIATION 2.5 • n=7 Participants	28.4 years STANDARD_DEVIATION 2.4 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Clinical Service Type, N(%) General Medicine Service	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Clinical Service Type, N(%) Integrated Teaching Unit	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Clinical Service Type, N(%) Faulkner General Medicine Service	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Department, N (%) Medicine	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Department, N (%) Other	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Stage of Training, N(%) May-June 2021	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Stage of Training, N(%) Sept-Dec 2021	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Survey Responses, mean (SD) Baseline State-Trait Anxiety Inventory (STAI)-6 Score, range 0-63 (higher is more anxiety)	14.9 units on a scale STANDARD_DEVIATION 3.2 • n=5 Participants	15.1 units on a scale STANDARD_DEVIATION 3.8 • n=7 Participants	15.0 units on a scale STANDARD_DEVIATION 3.5 • n=5 Participants
Survey Responses, mean (SD) Baseline Reactions to Uncertainty Score, range 8-32 (higher is more certain)	26.9 units on a scale STANDARD_DEVIATION 8.5 • n=5 Participants	28.8 units on a scale STANDARD_DEVIATION 8.5 • n=7 Participants	27.9 units on a scale STANDARD_DEVIATION 8.5 • n=5 Participants

PRIMARY outcome

Timeframe: Within 2-week service block of participating provider

Population: The analysis was conducted among patients of these providers who meet eligibility criteria for inclusion in the analysis (n=522 total).

Outcome measures

Outcome measures
Measure	Simulation Intervention n=259 Participants 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. 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.	Online Education Intervention n=263 Participants Providers assigned to the control arm will receive online educational training about other poorly-prescribed medications, including albumin, transfusion, and blood product repletion guidelines. 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.
High-risk Medication Doses All orders	0.049 No. of med orders by patient per intern Standard Deviation 0.25	0.052 No. of med orders by patient per intern Standard Deviation 0.27
High-risk Medication Doses Standing orders	0.036 No. of med orders by patient per intern Standard Deviation 0.22	0.019 No. of med orders by patient per intern Standard Deviation 0.16
High-risk Medication Doses PRN orders	0.013 No. of med orders by patient per intern Standard Deviation 0.11	0.032 No. of med orders by patient per intern Standard Deviation 0.18
High-risk Medication Doses One-time orders	0.030 No. of med orders by patient per intern Standard Deviation 0.02	0.013 No. of med orders by patient per intern Standard Deviation 0.11

SECONDARY outcome

Timeframe: 2 week follow-up period

Population: The analysis was conducted among patients of these providers who meet eligibility criteria for inclusion in the analysis (n=522 total).

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

Outcome measures

Outcome measures
Measure	Simulation Intervention n=259 Participants 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. 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.	Online Education Intervention n=263 Participants Providers assigned to the control arm will receive online educational training about other poorly-prescribed medications, including albumin, transfusion, and blood product repletion guidelines. 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.
Percentage of Patients Discharged With Inappropriate Medications	27.0 Participants	20.0 Participants

OTHER_PRE_SPECIFIED outcome

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

Population: The denominator for this analysis is the number of providers who were contacted for participation in the study.

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

Outcome measures

Outcome measures
Measure	Simulation Intervention n=97 Participants 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. 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.	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. 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.
Number and Percentage of Participants Signing Consent Forms	48 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 week follow-up period

Population: Number of providers who were randomized to the study and completed the training (n=47 were randomized appropriately).

Rate of simulation training completion or online educational training completion

Outcome measures

Outcome measures
Measure	Simulation Intervention n=24 Participants 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. 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.	Online Education Intervention n=23 Participants Providers assigned to the control arm will receive online educational training about other poorly-prescribed medications, including albumin, transfusion, and blood product repletion guidelines. 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.
Rate of Simulation or Online Educational Training Completion	19 Participants	21 Participants

OTHER_PRE_SPECIFIED outcome

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

Population: Interns randomized to the study and provided data in the endline questionnaire. No feedback or issues were reported in the endline questionnaire.

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

Outcome measures

Outcome measures
Measure	Simulation Intervention n=19 Participants 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. 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.	Online Education Intervention n=21 Participants Providers assigned to the control arm will receive online educational training about other poorly-prescribed medications, including albumin, transfusion, and blood product repletion guidelines. 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.
Feedback and Issues Reported by the Interns or Study Staff	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 week follow-up period

Population: Providers who completed the endline survey.

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.

Outcome measures

Outcome measures
Measure	Simulation Intervention n=19 Participants 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. 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.	Online Education Intervention n=21 Participants Providers assigned to the control arm will receive online educational training about other poorly-prescribed medications, including albumin, transfusion, and blood product repletion guidelines. 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.
Satisfaction With the Intervention	8 Participants	7 Participants

Adverse Events

Simulation Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Online Education Intervention (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julie Lauffenburger, PharmD, PhD

Brigham and Women's Hospital

Phone: 617-525-8865

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place