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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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).
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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