Shared Decision MakingNCT04045886
Conducting Perioperative Code Status and Goals of Care Discussions: A Bi-Institutional Study to Develop a Novel, Evidence-Based Curriculum for Anesthesiology Trainees
A study testing Online Educational Modules (Videos) in people with Shared Decision Making and End of Life, run by Brigham and Women's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shared Decision Making, End of Life
- What is being tested?
- Online Educational Modules (Videos)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current Anesthesiology Resident at the Brigham and Women's Hospital
Who cannot join
- Not a current anesthesiology resident
- Prior study participation
- Unable to complete both OSCEs during a 1 week rotation
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the detailed 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:
- Creation of a standardized CSD/GOCD Training Program:
- 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.
- 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.
- 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.
- 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:
- 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.
- 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.
- 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%.
- 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.
- 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.
- 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.
- 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
- Conditions
- Shared Decision Making, End of Life
- Being tested
- Online Educational Modules (Videos)
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Educational Modules (Videos)Behavioural
5 educational online modules (videos) about DNR/goals of care discussions that the participant will watch as part of the intervention. This is the only intervention.
| Study group | Role | What they receive |
|---|---|---|
| Online Educational Modules group | Experimental | anesthesia residents are randomized to watch educational videos which is the intervention. Receives: Behavioral: Online Educational Modules (Videos) |
| Reading two research papers group | Active comparator | anesthesia residents are randomized to read 2 research papers which is the active comparator Receives: Behavioral: Online Educational Modules (Videos) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on the assessment/scoring tool.
Assessment tool was designed by the investigators for this study. The scoring tool measures conversation/communication skills based on 4 domains: general patient interviewing skills, discussing goals of care, discussing code status, and responding to emotion. The observed scale is 1-5 (low to high) for each domain. Scores will be then added for all domains to come up with a final score (possible range 4-20). Better values represent a better outcome.
Measured: 1 week, includes evaluation during the OSCE examination, including both pre and post intervention OSCE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Jan 2017
- Primary completion1 Feb 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shared Decision MakingStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University
- Responsible party
- Principal investigator, Richard D Urman, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045886
- Sponsor's protocol ID
- 2015P001375
- Status last verified
- Aug 2022
- First submitted
- 13 Nov 2017
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conducting Perioperative Code Status and Goals of Care Discussions: A Bi-Institutional Study to Develop a Novel, Evidence-Based Curriculum for Anesthesiology Trainees
- ClinicalTrials.gov ID
- NCT04045886
- Acronym / sponsor ID
- 2015P001375
- Conditions
- Shared Decision Making, End of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Vanderbilt University
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Creation of a standardized CSD/GOCD Training Program:
- 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.
- 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.
- 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.
- 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:
- 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.
- 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.
- 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%.
- 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.
- 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.
- 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.
- 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Educational Modules group | Experimental | Behavioral: Online Educational Modules (Videos)anesthesia residents are randomized to watch educational videos which is the intervention. |
| Reading two research papers group | Active comparator | Behavioral: Online Educational Modules (Videos)anesthesia residents are randomized to read 2 research papers which is the active comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current Anesthesiology Resident at the Brigham and Women's Hospital
Key exclusion criteria (3 listed)
- Not a current anesthesiology resident
- Prior study participation
- Unable to complete both OSCEs during a 1 week rotation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Educational Modules (Videos)5 educational online modules (videos) about DNR/goals of care discussions that the participant will watch as part of the intervention. This is the only intervention. | Behavioural | Online Educational Modules group, Reading two research papers group |
Primary outcome
Performance on the assessment/scoring tool.
Time frame: 1 week, includes evaluation during the OSCE examination, including both pre and post intervention OSCE
Assessment tool was designed by the investigators for this study. The scoring tool measures conversation/communication skills based on 4 domains: general patient interviewing skills, discussing goals of care, discussing code status, and responding to emotion. The observed scale is 1-5 (low to high) for each domain. Scores will be then added for all domains to come up with a final score (possible range 4-20). Better values represent a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Educational Modules (Videos) in people with Shared Decision Making and End of Life, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on the assessment/scoring tool. (time frame: 1 week, includes evaluation during the OSCE examination, including both pre and post intervention OSCE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.