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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03186274
Other study ID # 170675
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 26, 2017
Est. completion date July 1, 2018

Study information

Verified date April 2019
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate how the educational intervention utilized affects pediatric resident comfort level with EOL discussions.


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).


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date July 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Behavioral:
Facilitated Group Session
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.
CELA Session
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.

Locations

Country Name City State
United States Monroe Carell Junior Children's Hospital at Vanderbilt Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (13)

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

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

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. — View Citation

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

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

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

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

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. — View Citation

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. — View Citation

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

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 Publications. 2016;12:10438. http://doi.org/10.15766/mep_2374-8265.10438

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported resident competency 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
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