Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04045886 |
| Other study ID # |
2015P001375 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2017 |
| Est. completion date |
July 1, 2019 |
Study information
| Verified date |
August 2022 |
| Source |
Brigham and Women's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Despite the importance of preoperative code status and goals of care discussion (CSD/GOCD), a
formal curriculum for anesthesiology residents is lacking. Residents are often uncomfortable
conducting these conversations and there is a lack of research investigating the
effectiveness of formal, evidence-based teaching during anesthesia training. The
investigators propose to develop a novel skills training program with the aims to assess its
immediate effect on CSD/GOCD skills, long-term internalization of the CSD training, and the
authenticity, feasibility and acceptability of the CSD program and observed standardized
patient encounter (OSCE) interaction. In this prospective, randomized study, first year
anesthesia residents will be assigned to the study or control group. Both groups will undergo
pre- and post-intervention OSCEs. The control group will complete the online modules only,
while the study group will complete the entire skills training program consisting of online
modules, self-assessments, and small group exercises. To measure CSD/GOCD proficiency, all
participants will interview trained patient actors in pre-and post intervention OSCE.
Investigators will use existing scoring systems and surveys. Standard patient encounters will
be video recorded and reviewed by two blinded clinician graders. The pre- and
post-participation survey will assess comfort and experience with CSD/GOCD. The follow up
surveys will assess long-term retention of training, comfort and interim experiences.
Investigators will perform a validation of the existing CSD/GOCD assessment tools for use in
the perioperative setting. If there is a clinically significant demonstrable benefit,
investigators expect that the results will lead to a formalization of this innovative
curriculum on a national scale.
Description:
Despite the importance of code status discussions (CSD) and goals of care discussions (GOCD)
before surgery, formal training for anesthesiology residents surrounding these patient
interactions is lacking. Investigators propose to develop a novel CSD/GOCD skills training
and testing program for anesthesiology residents. Resident participants will receive one of
two educational interventions: a) online learning modules (Group A, Control group) or b)
online learning modules followed by facilitated small group discussion and active learning
exercises (Group B, Study group). All residents will undergo competency assessment of CSD and
GOCD via an Objective Standardized Clinical Examination (OSCE). Accordingly, this study will
test the central hypothesis that participants in the group with facilitated discussions and
active learning will score more highly during the OSCE competency assessments immediately
after training and at 3 and 6 months. Testing of this hypothesis will be accomplished through
the following three Specific Aims:
1. Creation of a standardized CSD/GOCD Training Program:
1. Online modules: This component of the training program will consist of online
materials that can be consumed by residents at their convenience over the 3 week
training period. Both Groups A and B will be given access to this material.
2. Self-Assessment and Small group exercises: This component of the training program
will consist of facilitated discussions, role playing, and guided reflective
writing in order to advance upon the material received in the online training. Only
Group B will receive this training prior to OSCE competency assessments.
2. Development and validation of a CSD/GOCD OSCE: Published best-practice principles for
the development of OSCE competency assessments will be used to create separate
experiences for CSD and GOCD. While keeping the core components of examinations the
same, several clinical stems will be created for each OSCE to prevent recall bias.
3. Validation of the existing CSD/GOCD assessment tools for the perioperative setting: A
previously described modified Delphi technique will be used to further develop the
itemized and global assessment tools. Then, a standard setting method will be used to
determine the minimum passing score (MPS) for the OSCE competency assessment.
EXPERIMENTAL DESIGN and METHODS:
Investigators will perform a prospective randomized controlled trial as detailed below. The
overall hypothesis of this study is that anesthesiology residents who receive facilitated
discussions and active learning will score more highly during the OSCE competency assessments
immediately after training and at 3 and 6 months. This will be tested through the following
Specific Aims:
1. Creation of a standardized CSD/GOCD Training Program: Investigators will develop a novel
curriculum consisting of online modules covering the skills needed to Prepare for the
Discussion, address Values and Goals of Care, explain Informed Consent for Code Status
Discussions, and Summarize the Discussion for the patient. It will consist of
evidence-based, best practices content covering professional (i.e. ASA) guidelines,
current literature, and effective communication strategies. The Program will be
completed over 1 week. Group A will receive the Online Modules components and Group B
will receive two papers on CSD/GOCD topics.
Online Modules: This component of the training program will consist of online materials
that can be consumed by residents at their convenience over the 3 week training period.
A series of short videos with lectures by various experts in the field which will
include a detailed review of key scientific and educational research literature as well
as a practical 'how-to' guide for CSD and GOCD.
2. Development and validation of a CSD OSCE and GOCD OSCE: Published best-practice
principles for the development of OSCE competency assessments will be used to create
separate experiences for CSD and GOCD. While keeping the core components of examinations
the same, several clinical stems will be created for each OSCE to prevent recall bias.
3. Investigators will develop and validate a standardized OSCE curriculum with an input
from a multidisciplinary team, including representatives from surgery, anesthesiology,
palliative medicine, nursing, and chaplaincy. CSD/GOCD skills will be assessed using a
validated Code Status Discussion Checklist. The training program will be based on
previous work developing similar programs and simulation scenarios for the Operating
Room Emergency Checklists. This program resulted in an increase from 75% of key items
completed to 94%.
4. Case Development: Two case scenarios will be utilized, building on experience from our
preliminary data. These were described in Preliminary Studies: both will be oncology
patients with an active do not resuscitate (DNR) and no not intubate (DNI) order: One
with cholecystitis presenting for a cholecystectomy, and the other with an impending
pathological femur fracture presenting for an open reduction and internal fixation.
5. Validation and further development of existing CSD and GOCD assessment tools: A
previously described modified Delphi technique will be used to create the itemized and
global assessment tools. Then, a Standard Setting method will be used to determine the
minimum passing score (MPS) for the OSCE competency assessment.
a. Checklist Creation: i. Step 1: Engage a group of educational and content experts from
at least 3 institutions to create the checklist items through a modified Delphi
technique.
ii. Step 2: Convene a face-to-face meeting of experts to perform an standard setting
process to determine a minimum passing score (MPS).
iii. Step 3: All OSCE performances will be videotaped and a group of raters will be
engaged to grade all of the resident performances. Their ratings will be assessed for
interrater and intra-rater reliability, which is one component of validity assessment.
b. Training for Standardized Patients and Graders: Both the standardized patient and the
graders will undergo training to familiarize them with the grading tools and the study
scenarios.
Assessment: Using validated tools, investigators will assess the impact of the study by
analyzing the initial baseline survey, graded performance on Pre- and Post-Intervention
OSCE, and the 3 and 6 month follow-up survey. Specific outcomes analyzed will include:
- The immediate effect of the training program intervention on improving CSD/GOCD
skills
- Long-term effect and internalization of the CSD/GOCD training
- The authenticity of the OSCE interaction
- The feasibility and acceptability of the training program and OSCE
