Antipsychotics and Neuroleptics Toxicity, Medication Administered in Error
Conditions
Keywords
Simulation, Behavioral principles, Drug, Education, Pharmacology, Intervention
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)
Interventions
OTHERSimulation
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.
OTHEROnline 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.
Sponsors
Ideas42
National Institute on Aging (NIA)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Discharged With Inappropriate Medications | 2 week follow-up period | Percentage of patients discharged with inappropriate medications, measured through electronic health record data |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants Signing Consent Forms | 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) |
| Rate of Simulation or Online Educational Training Completion | 2 week follow-up period | Rate of simulation training completion or online educational training completion |
| 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) |
| Satisfaction With the Intervention | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 21 |
| Total | 40 |
Baseline characteristics
| Characteristic | Online Education Intervention (Control) | Simulation Intervention | Total |
|---|---|---|---|
| Age, Continuous | 29.0 years STANDARD_DEVIATION 2.5 | 28.0 years STANDARD_DEVIATION 2.3 | 28.4 years STANDARD_DEVIATION 2.4 |
| Clinical Service Type, N(%) Faulkner General Medicine Service | 2 Participants | 3 Participants | 5 Participants |
| Clinical Service Type, N(%) General Medicine Service | 9 Participants | 9 Participants | 18 Participants |
| Clinical Service Type, N(%) Integrated Teaching Unit | 10 Participants | 7 Participants | 17 Participants |
| Department, N (%) Medicine | 13 Participants | 12 Participants | 25 Participants |
| Department, N (%) Other | 8 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 15 Participants | 9 Participants | 24 Participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 19 Participants |
| Stage of Training, N(%) May-June 2021 | 7 Participants | 5 Participants | 12 Participants |
| Stage of Training, N(%) Sept-Dec 2021 | 14 Participants | 14 Participants | 28 Participants |
| Survey Responses, mean (SD) Baseline Reactions to Uncertainty Score, range 8-32 (higher is more certain) | 28.8 units on a scale STANDARD_DEVIATION 8.5 | 26.9 units on a scale STANDARD_DEVIATION 8.5 | 27.9 units on a scale STANDARD_DEVIATION 8.5 |
| Survey Responses, mean (SD) Baseline State-Trait Anxiety Inventory (STAI)-6 Score, range 0-63 (higher is more anxiety) | 15.1 units on a scale STANDARD_DEVIATION 3.8 | 14.9 units on a scale STANDARD_DEVIATION 3.2 | 15.0 units on a scale STANDARD_DEVIATION 3.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 21 |
| other Total, other adverse events | 0 / 19 | 0 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 |
Outcome results
Primary
High-risk Medication Doses
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)
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Simulation Intervention | High-risk Medication Doses | PRN orders | 0.013 No. of med orders by patient per intern | Standard Deviation 0.11 |
| Simulation Intervention | High-risk Medication Doses | All orders | 0.049 No. of med orders by patient per intern | Standard Deviation 0.25 |
| Simulation Intervention | High-risk Medication Doses | One-time orders | 0.030 No. of med orders by patient per intern | Standard Deviation 0.02 |
| Simulation Intervention | High-risk Medication Doses | Standing orders | 0.036 No. of med orders by patient per intern | Standard Deviation 0.22 |
| Online Education Intervention | High-risk Medication Doses | One-time orders | 0.013 No. of med orders by patient per intern | Standard Deviation 0.11 |
| Online Education Intervention | High-risk Medication Doses | All orders | 0.052 No. of med orders by patient per intern | Standard Deviation 0.27 |
| Online Education Intervention | High-risk Medication Doses | PRN orders | 0.032 No. of med orders by patient per intern | Standard Deviation 0.18 |
| Online Education Intervention | High-risk Medication Doses | Standing orders | 0.019 No. of med orders by patient per intern | Standard Deviation 0.16 |
Secondary
Percentage of Patients Discharged With Inappropriate Medications
Percentage of patients discharged with inappropriate medications, measured through electronic health record data
Time frame: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Simulation Intervention | Percentage of Patients Discharged With Inappropriate Medications | 27.0 Participants |
| Online Education Intervention | Percentage of Patients Discharged With Inappropriate Medications | 20.0 Participants |
Other Pre-specified
Feedback and Issues Reported by the Interns or Study Staff
Feedback and issues reported by the interns or study staff (measured in the endline questionnaire)
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Simulation Intervention | Feedback and Issues Reported by the Interns or Study Staff | 0 Participants |
| Online Education Intervention | Feedback and Issues Reported by the Interns or Study Staff | 0 Participants |
Other Pre-specified
Number and Percentage of Participants Signing Consent Forms
Percentage of consenting providers out of those eligible (measured by the Amion scheduling system)
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Simulation Intervention | Number and Percentage of Participants Signing Consent Forms | 48 Participants |
Other Pre-specified
Rate of Simulation or Online Educational Training Completion
Rate of simulation training completion or online educational training completion
Time frame: 2 week follow-up period
Population: Number of providers who were randomized to the study and completed the training (n=47 were randomized appropriately).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Simulation Intervention | Rate of Simulation or Online Educational Training Completion | 19 Participants |
| Online Education Intervention | Rate of Simulation or Online Educational Training Completion | 21 Participants |
Other Pre-specified
Satisfaction With the Intervention
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.
Time frame: 2 week follow-up period
Population: Providers who completed the endline survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Simulation Intervention | Satisfaction With the Intervention | 8 Participants |
| Online Education Intervention | Satisfaction With the Intervention | 7 Participants |