Education, MedicalNCT03186274
Discussing Death and Dying: An End of Life Curriculum to Empower Residents
A study testing Facilitated Group Session and CELA Session in people with Education, Medical and Education, Medical, Graduate, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study will evaluate how the educational intervention utilized affects pediatric resident comfort level with EOL discussions. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Education, Medical, Education, Medical, Graduate, Care, Palliative
- What is being tested?
- Facilitated Group Session and CELA Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2017to 1 Jul 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe Carell Junior Children's Hospital at Vanderbilt
Nashville, Tennessee, 37210
About this study
This study will evaluate how the educational intervention utilized affects pediatric resident comfort level with EOL discussions.
Read the 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).
- Being tested
- Facilitated Group Session, CELA Session
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated Group SessionBehavioural
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 SessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Those in the control group (CG) will write a pre and post-study reflection essay discussing their experiences with end of life discussions. |
| Facilitated Group Session | Experimental | 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. Receives: Behavioral: Facilitated Group Session |
| CELA Session | Experimental | 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). Receives: Behavioral: CELA Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start26 Jun 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Education, MedicalStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Schultz, Vanderbilt University Medical Center
- Investigators
- Travis Crook, MD, Study chair, Pediatric Hospital Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186274
- Sponsor's protocol ID
- 170675
- Status last verified
- Apr 2019
- First submitted
- 12 Jun 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23053870Wolfe 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.
PubMed 31139729Sullivan 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.
PubMed 12950476Keefer 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
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.
PubMed 18929686Jackson 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 at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discussing Death and Dying: An End of Life Curriculum to Empower Residents
- ClinicalTrials.gov ID
- NCT03186274
- Acronym / sponsor ID
- 170675
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 14 Jun 2017 (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.
This study will evaluate how the educational intervention utilized affects pediatric resident comfort level with EOL discussions.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Those in the control group (CG) will write a pre and post-study reflection essay discussing their experiences with end of life discussions. |
| Facilitated Group Session | Experimental | Behavioral: Facilitated Group SessionParticipants 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. |
| CELA Session | Experimental | Behavioral: CELA SessionParticipants 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Facilitated Group SessionParticipants 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. | Behavioural | Facilitated Group Session |
| CELA SessionParticipants 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. | Behavioural | CELA Session |
Primary outcome
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.
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 16 Apr 2019.
- Background: PubMed 23053870Tait 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.
- Background: PubMed 31139729Wolfe 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.
- Background: PubMed 12950476Sullivan 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.
- BackgroundKeefer 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
- BackgroundRock 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
- BackgroundBrock 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
- BackgroundBrown 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
- Background: PubMed 18929686Harris 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.
- BackgroundJackson 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
- BackgroundMintzer 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
- BackgroundReichert 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
- BackgroundWilliams 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
- 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.
Travis Crook, MD study chair
Pediatric Hospital Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated Group Session and CELA Session in people with Education, Medical and Education, Medical, Graduate, run by Vanderbilt University Medical Center 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 3 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 16 Apr 2019. 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?
Self-reported resident competency (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03186274, which also lists 13 linked publications.
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 16 Apr 2019.