NCT04045886

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

2.1 years

First QC Date

November 13, 2017

Last Update Submit

August 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 week, includes evaluation during the OSCE examination, including both pre and post intervention OSCE

Study Arms (2)

Online Educational Modules group

EXPERIMENTAL

anesthesia residents are randomized to watch educational videos which is the intervention.

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

Behavioral: Online Educational Modules (Videos)

Interventions

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.

Online Educational Modules groupReading two research papers group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current Anesthesiology Resident at the Brigham and Women's Hospital

You may not qualify if:

  • Not a current anesthesiology resident
  • Prior study participation
  • Unable to complete both OSCEs during a 1 week rotation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Death

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesia

Study Record Dates

First Submitted

November 13, 2017

First Posted

August 6, 2019

Study Start

January 1, 2017

Primary Completion

February 1, 2019

Study Completion

July 1, 2019

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations