- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03186274
Discussing Death and Dying: An End of Life Curriculum to Empower Residents
April 15, 2019 updated by: Katherine Schultz, Vanderbilt University Medical Center
This study will evaluate how the educational intervention utilized affects pediatric resident comfort level with EOL discussions.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
One of the most challenging roles a physician can serve is delivering life altering and/or bad news to patients and their families, and yet this skill is not widely taught to physicians.
A survey from 2003 of pediatric residents found that not only was there minimal education and training in this area, but that they felt there was no natural improvement in their skills from the first to third year of training.
It has also been shown that the art of eliciting a patient or family's concerns about death and responding to them is felt to be poorly taught.
Worse, residents have indicated that a hidden curriculum in medicine seems to indicate that there is no value to these conversations at all.
Residents are not the only stakeholders involved who have expressed concern with this reality.
Parents of pediatric patients have repeatedly reported wanting increased sensitivity and clarity during sharing of life-altering information.
Up to 75% of parents have reported a negative experience involving end of life (EOL) discussions, and cited inexperience, lack of comfort in communication, and a lack of knowledge as contributing factors to their negative experiences.
Less than 18% of students and residents report receiving formal education in EOL discussions, despite the fact that 90% or more of residents have identified caring for those dying as part of a physician's responsibilities.
Of residents who do get experience with EOL discussions, less than 2/3 receive feedback.
Some residencies, such as internal medicine, have recognized the need for formal instruction on how to have EOL discussions is needed and have implemented formal programs to answer it, and it has even become a standard expectation for many fellowships.
Formal education regarding EOL has also become a standard expectation for many fellowships, including pediatric neonatology, intensive care, and hematology/oncology.
Despite the evidence that there is need for formal intervention and education regarding EOL care, there has been little advancement towards implementing a formal curriculum in pediatric residency programs.
Review of the literature demonstrates that only one study has developed a formal curriculum involving a method called SPIKES (Setting, Perception, Involvement, Knowledge, Empathy, and Summary) that targets pediatric residents.
The initial data from this study is promising and indicates increased comfort level in residents.
However, to date no study has evaluated if the method of instruction affects the resident education, an important consideration as some interventions (ex.
standardized patients) are more costly and time consuming than others (ex.
facilitator guided small group sessions).
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37210
- Monroe Carell Junior Children's Hospital at Vanderbilt
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Post Graduate Year (PGY) 2 or PGY-3 resident participating in the already-required Advocacy rotation at Monroe Carrell Jr. Children's Hospital at Vanderbilt
- Availability to participate in self reflection essays and simulated patient case
- English speaking
Exclusion Criteria:
- Medical students, PGY-1, PGY-4 or PGY-5 residents, fellows or learners not participating in the already-required Advocacy rotation
- Inability to participate in self reflection essays and simulated patient case
- Non-English speaking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Those in the control group (CG) will write a pre and post-study reflection essay discussing their experiences with end of life discussions.
|
|
|
Experimental: Facilitated Group Session
Participants in Facilitated Group Session (previously called Intervention Group 1) will watch a pre-recorded video describing the SPIKES model and then take part of a facilitated guided group session reviewing the model and group interview of standardized/simulated patient encounter.
|
Participants will review the SPIKES model with a facilitator and then participate in a guided and supported simulated patient encounter utilizing aspects of the SPIKES model, with feedback at the end of the session.
|
|
Experimental: CELA Session
Participants in the CELA Session (previously called Intervention Group 2) will watch a pre-recorded video describing the SPIKES model and then participate in an individualized standardized/simulated patient scenario that will be filmed at the Center for Experiential Learning and Assessment (CELA).
|
Participants will review the SPIKES model on their own and then participate in a simulated patient encounter utilizing the SPIKES model.
They will receive feedback following the encounter.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported resident competency
Time Frame: 1 year
|
Residents will complete validated pre- and post-surveys to evaluate their competency in having end of life discussions.
The scale is 1-4, where 1 indicates very comfortable and 4 indicates very uncomfortable.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Travis Crook, MD, Pediatric Hospital Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Tait GR, Hodges BD. Residents learning from a narrative experience with dying patients: a qualitative study. Adv Health Sci Educ Theory Pract. 2013 Oct;18(4):727-43. doi: 10.1007/s10459-012-9411-y. Epub 2012 Oct 6.
- Wolfe AD, Denniston SF, Baker J, Catrine K, Hoover-Regan M. Bad News Deserves Better Communication: A Customizable Curriculum for Teaching Learners to Share Life-Altering Information in Pediatrics. MedEdPORTAL. 2016 Aug 12;12:10438. doi: 10.15766/mep_2374-8265.10438.
- Sullivan AM, Lakoma MD, Block SD. The status of medical education in end-of-life care: a national report. J Gen Intern Med. 2003 Sep;18(9):685-95. doi: 10.1046/j.1525-1497.2003.21215.x.
- Keefer P, Pituch K, Murphy T, et al. A child's last hours - multidisciplinary training in end-of-life care for professionals working in children's hospitals: newborn with lethal congenital anomalies. MedEdPORTAL Publications. 2015;11:10108. http://doi.org/10.15766/mep_2374-8265.10108
- Rock L, Gadmer N, Arnold R, et al. Critical care communication skills training for internal medicine residents. MedEdPORTAL Publications. 2015;11:10212. http://doi.org/10.15766/mep_2374-8265.10212
- Brock K, Cohen H, Sourkes B, et al. Teaching pediatric fellows palliative care through simulation and video intervention: a practical guide to implementation. MedEdPORTAL Publications. 2015;11:10284. http://doi.org/10.15766/mep_2374-8265.10284
- Brown C, Gephardt G, Lloyd C, Swearingen C, Boateng B. Teaching palliative care skills using simulated family encounters. MedEdPORTAL Publications. 2011;7:8507. http://doi.org/10.15766/mep_2374-8265.8507
- Jackson J, Albertini L. Caring for children with chronic health care needs: an introductory curriculum for pediatric residents. MedEdPORTAL Publications. 2012;8:9172. http://doi.org/10.15766/mep_2374-8265.9172
- Mintzer M, Chen A, Conway Copper T, et al. Breaking bad news using role playing: a multimedia instructional activity for teaching medical trainees. MedEdPORTAL Publications. 2014;10:9798. http://doi.org/10.15766/mep_2374-8265.9798
- Reichert J, Parmelee D, Bognar S, Durgans K, Godoy M. A LION IN THE HOUSE module for health care education: pediatric end-of-life case studies. MedEdPORTAL Publications. 2012;8:8362. http://doi.org/10.15766/mep_2374-8265.8362
- Williams D, Fisicaro T, Hargraves R, Berg D. End-of-life communication education program for internal medicine residents. MedEdPORTAL Publications. 2009;5:7945. http://doi.org/10.15766/mep_2374-8265.7945
- Anspacher M, Shah N. Palliative care for the medically complex child. MedEdPORTAL Publications. 2013;9:9538. http://doi.org/10.15766/mep_2374-8265.9538
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 26, 2017
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
June 12, 2017
First Submitted That Met QC Criteria
June 12, 2017
First Posted (Actual)
June 14, 2017
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 15, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 170675
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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