Creating a Flexible Curriculum Tool for Pediatric Palliative Care Rotating Learners
Phase: NA
Conditions: Palliative Care Education
Sponsor: Children's National Research Institute

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Creating a Flexible Curriculum Tool for 
Pediatric Palliative Care Rotating Learners 
 
 
 
 
 
 
CN IRB Protocol Number: STUDY00001648 
Principal Investigator: Ashley Lanzel, MD/MA 
Funding Sponsor (if applicable): Division of Pediatric Hospital Medicine Pilot Grant 
 
 
 
 
 
 
Protocol Version Number: 6 
 Month/Day/Year: 02/11/2026 
 
 
 

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Table of Contents 
PROTOCOL REVISION HISTORY 
 
 
 
 
 
 
4 
 
LIST OF ABBREVIATIONS 
 
 
 
 
 
 
 
5 
 
PROTOCOL SUMMARY 
 
 
 
 
 
 
 
 
6 
 
Section 1 
KEY ROLES  
 
 
 
 
 
 
 
8 
 
Section 2 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC  
 
 
RATIONALE  
 
 
 
 
 
 
 
8 
 
 
2.1 
Background Information and Relevant Literature 
 
 
2.2 
Scientific Rationale 
 
 
2.3 
Potential Risks 
 
 
2.4 
Potential Benefits 
 
Section 3 
OBJECTIVES AND ENDPOINTS  
 
 
 
 
10 
 
 
3.1 
Primary Objective(s) 
 
 
3.2 
Secondary Objective(s) 
 
 
3.3 
Primary Outcome Measure(s) 
 
 
3.4 
Secondary Outcome Measure(s) 
 
Section 4 
STUDY DESIGN 
 
 
 
 
 
 
 
11 
 
Section 5 
STUDY ENROLLMENT AND WITHDRAWAL 
 
 
 
11 
 
 
5.1 
Study Population, Recruitment Retention 
 
 
5.2 
Inclusion Criteria 
 
 
5.3 
Exclusion Criteria 
 
 
5.4 
Vulnerable Subjects 
 
 
5.5 
Recruitment 
 
 
5.6 
Retention 
 
 
5.7 
End of Participation Criteria and Procedures 
 
Section 6 
STUDY PROCEDURES 
 
 
 
 
 
 
13 
 
 
6.1 
Informed Consent/Assent and HIPAA Authorization 
 
 
6.2 
Screening Process 
 
 
6.3 
Study Interventions and Follow-Up 
 
 
6.4 
Description of Study Procedures/Evaluations 
 
 
6.5 
Study Team Training and Intervention Reliability 
 
 
6.6 
Concomitant Interventions and Procedures 
 
Section 7 
SAFETY ASSESSMENTS AND REPORTING  
 
 
15 
 
Section 8 
STATISTICAL CONSIDERATIONS AND ANALYSIS  
 
16 

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8.1 
Statistical and Analytical Plans (SAPs) 
 
 
8.2 
Statistical Hypotheses 
 
 
8.3 
Analysis Datasets 
 
 
8.4 
Description of Statistical Methods 
 
 
8.5 
Sample Size 
 
 
8.6 
Measures of Minimize Bias 
 
Section 9 
DATA QUALITY AND OVERSIGHT 
 
 
 
 
18 
 
 
9.1 
Study Team Quality Assurance and Quality Control 
 
 
9.2 
Data Safety and Monitoring Plan 
 
Section 10 
ETHICAL CONSIDERATIONS 
 
 
 
 
 
19 
10.1  Ethical Standard 
10.2 Institutional Review Board (IRB) 
10.3 Maintaining Subject Privacy 
10.4 Maintaining Study Data Confidentiality 
10.5 Study Support and Conflicts of Interest 
 
Section 11 
DATA HANDLING AND RECORD KEEPING 
 
 
 
20 
 
 
11.1 Data Management Responsibilities 
 
 
11.2 Data Capture Methods 
 
 
11.3 Study Record Retention Policy 
 
Section 12 
PUBLICATION POLICY 
 
 
 
 
 
 
21 
 
Section 13 
REFERENCES 
 
 
 
 
 
 
 
21 
 
 

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Protocol Revision History 
 
Protocol Version with Summary of Changes  
 
 
    Version Date 
Initial Submission v1 
08/27/2025 
Revision v2 
11/20/2025 
Revision v3 
11/21/2025 
Revision v4 
11/24/2025 
Revision v5 (for ClinicalTrials.gov to remove personal 
pronouns) 
02/04/2026 
Revision v6 (for ClinicalTrials.gov to remove personal 
pronouns) 
02/11/2026 
 
 
. 
 
 
 

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List of Abbreviations 
 
ACGME 
Accreditation Council for Graduate Medical Education 
DSMB 
Data Safety Monitoring Board 
GME 
Graduate Medical Education 
HIPAA 
Health Insurance Portability and Accountability Act 
IRB 
Institutional Review Board 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
RE 
Reportable Event 
 

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Protocol Summary 
 
Title:  
 
 
Brief Summary: 
 
Creating a Flexible Curriculum Tool for Pediatric 
Palliative Care Rotating Learners  
 
The overall objective of this study is to determine if a 
flexible curriculum tool can improve the experience 
of rotators with the pediatric palliative care team, 
measured by their perception that the rotation helped 
achieve standard and their personal learning 
objectives. This is a pilot study that will compare 
rotation evaluations before and after implementing a 
flexible curriculum tool that uses a database of 
resources to supplement the clinical rotation 
education and tailor it to the needs of each learner. 
 
Study Population:  
The target population will be a convenience sample 
of trainees rotating with the palliative care team. This 
will include physicians in training (hospice and 
palliative medicine fellows, pediatric subspecialty 
fellows, pediatric and other residents, medical 
students), NP students, pharmacy residents, allied 
health professional students and fellows, research 
associates, and any other learner who does clinical 
shadowing. The investigators expect to have about 
30 learners over the course of the year, based on 29 
last year. 
 
Study Site(s):  
 
Number of Participants: 
Children’s National Hospital 
 
The investigators anticipate a maximum of 30 
participants – 15 for the control group and 15 for the 
intervention group 
 
Accrual Ceiling: 
 
Study Duration: 
40 participants 
 
24 months 
 
Subject Duration:  
2-7 months (depending on timing of their rotation 
compared to the focus group) 
 
Objective(s):  
 
 
 
 
Primary: To evaluate if use of a flexible education 
tool using a palliative care education database is 
more effective than standard educational practices in 
meeting standard learning objectives. 
 

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Methodology: 
 
Secondary: To evaluate if use of a flexible education 
tool using a palliative care education database is 
more effective than standard educational practices in 
meeting learner-specific rotation objectives. 
 
Unblinded pilot medical education study with 
convenience sampling and control group to compare 
to intervention group 
 
Outcome Measures: 
Primary: response to the question “I achieved the 
standard objectives of the rotation (which will be 
provided to the learner).” It will be quantified using a 
Likert scale with five choices, 1-5, with 1 set to 
strongly disagree and 5 set to strongly agree. 
 
Secondary: response to the question “I achieved my 
specific objectives for the rotation (which the learner 
provided at the start of the rotation).” It will be 
quantified using a Likert scale with five choices, 1-5, 
with 1 set to strongly disagree and 5 set to strongly 
agree. 
 
Study 
Intervention/Procedures: 
 
 
 
 
 
 
 
 
 
 
 
 
Statistical Analysis: 
This is a single center, unblinded pilot study 
evaluating the use of a flexible curriculum tool to 
improve the experience of rotators with the palliative 
care team, measured by how well the rotation helps 
them meet standard as well as individualized 
learning objectives. All learners in the first half of the 
study period will be in the control group and all 
learners in the second half of the study period will be 
in the intervention group. Outcomes will be 
measured on post-rotation evaluation surveys, sent 
to each trainee after their rotation is complete. 
Qualitative data will be further interrogated with a 
focus group of trainees in the intervention group. 
 
Demographic data will be reported using descriptive 
statistics. A Mann-Whitney U test will be used to 
compare distribution of responses to Likert scale 
questions between control and intervention groups 
and inductive thematic analysis to analyze 
responses to open-ended survey questions and 
focus group transcriptions. 

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Section 1: Key Roles 
 
Principal Investigator 
Co-Principal Investigator 
Ashley Lanzel, MD/MA 
 
Palliative Care Attending 
Physician, Hospice and 
Palliative Medicine Fellowship 
Program Director 
Nimisha Bajaj, MD/PhD 
 
Palliative Care Attending 
Physician, Hospice and Palliative 
Medicine Fellowship Associate 
Program Director 
Children’s National Hospital  
Children’s National Hospital  
111 Michigan Ave NW, 
Washington, DC 20010 
111 Michigan Ave NW, 
Washington, DC 20010 
706-726-0631 
765-714-1886 
alanzel@childrensnational.org 
nbajaj@childrensnational.org 
There are no study leadership committees. The principal investigator will provide 
oversight of the data. The investigators do not expect to have many adverse or 
unexpected events (see more in detail below), but they will respond to any complaints 
or adverse or unexpected events as required by the Children’s National OPHS policy on 
reportable events. 
Section 2: Introduction, Background Information and Scientific 
Rationale 
 
2.1 
Background Information and Relevant Literature 
It estimated that 2017, more than 21 million children worldwide would have 
benefited from pediatric palliative care services, and over 8 million would benefit 
from pediatric palliative care services delivered by a specialist.1 Palliative care is 
accepted as a part of standard of care for children with severe illnesses,2 but this 
need is not being met, partially because of a lack of educational opportunities.3 
 
To that end, there have been many educational interventions developed for 
education of trainees4,5 as well as pediatric specialists in principles of palliative 
care.6 While there are developed standards of education for pediatric palliative 
care education, by the Accreditation Council for Graduate Medical Education 
(ACGME) in the United States, as well as by other groups in the United 
Kingdom,7 many learners also have individual goals uniquely suited to their 
practice needs, especially if they do not primarily practice pediatric palliative 
medicine.8 
 
Some educators in pediatric palliative care have utilized more tailored 
interventions for learners, but they target balancing the patient versus trainee 
experience,9 not necessarily aligning the trainee experience with their 

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individualized learning goals, especially within the limitations of clinical rotations 
in a busy training program. 
 
2.2 
Scientific Rationale 
The pediatric palliative care team at Children’s National Hospital supports 
learners at various levels, with different experiences and goals during their 
clinical rotations. Some seek to learn about primary palliative care skills, to learn 
about palliative care careers, or to develop expertise in pediatric palliative care. 
The team attempts to tailor educational experiences to standard and 
individualized learning goals and timeframes on service (half day to a few 
months). It would be helpful to have a database of resources to support these 
learners for the time on rotation and afterwards. There are multiple databases 
that exist to serve as tools for medical education, including PubMED, Cochrane 
Central, MedEdPORTAL, Embase, and ERIC. They provide access to primary 
literature and books, supporting evidence-based practice, but do not include 
podcasts, modules, videos, and lectures that are powerful educational tools. 
Palliative care clinicians utilize ad hoc methods to meet learner goals by 
providing literature that compliments patient encounters or learner inquiries. 
Tailoring education to meet individualized learning goals at the appropriate level 
for the learner and the length of their rotation takes energy and time to execute, 
so it is difficult to do well. 
 
The purpose of this pilot project is to use the Framework for Flexible Education10 
to develop and evaluate a flexible curriculum tool that permits quick connections 
to resources for educators and learners that are stored in a bespoke and 
updatable database. The investigators would like to assess if it improves 1) 
meeting standard objectives and “elective objectives” and 2) the experience of 
trainees during their rotation. The hypothesis is that it will improve the ability of 
the rotation to meet learners’ objectives as measured by Likert-scale-based end 
of rotation evaluations as well as open-ended questions and a focus group. 
 
The study population is a convenience sample of learners who choose to rotate 
with the palliative care team. The control condition was chosen to be 
approximately half of the academic year with the intervention the other half. The 
palliative care team does not have rotators (outside of the pediatric palliative care 
fellow) during July, so that month was excluded. This pilot study will be 
performed over the course of the academic year in order to facilitate the teaching 
team’s ability to improve education for the next year of learners. 
 
2.3 
Potential Risks 
Minimal risk to subjects is expected. Survey data will be de-identified. Expected 
time commitment for survey participants is 5 minutes for survey completion, in 
addition to possible participation in the focus group. For those who participate in 
the focus group, there is a risk that information shared in the group will not be 
kept private by other participants.  
 

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2.4 
Potential Benefits 
There is minimal likelihood of direct benefit to subjects, as they would benefit 
from the educational intervention whether they participate in the study. Indirect 
benefits may include laying groundwork for future improvement of palliative care 
education. 
 
Section 3: Objectives and Endpoints 
 
The overall objective of this study is to determine if a flexible curriculum tool can 
improve the experience of rotators with the pediatric palliative care team, measured by 
their perception that the rotation helped achieve standard and personal learning 
objectives. The hypothesis is that the rotators who rotate when the tool is in use will be 
more likely to agree or strongly agree that learning objectives will be met. 
 
3.1 
Primary Objective(s) 
To evaluate if use of a flexible education tool using a palliative care education 
database is more effective than standard educational practices on the pediatric 
palliative care team in meeting standard rotation learning objectives. 
 
3.2 
Secondary Objective(s) 
To evaluate if use of a flexible education tool using a palliative care education 
database is more effective than standard educational practices on the pediatric 
palliative care team in meeting learner-specific rotation objectives. 
 
3.3 
Primary Outcome Measure(s)  
The primary outcome measure is response to the question “I achieved the 
standard objectives of the rotation (which will be provided to the learner).” It will 
be quantified using a Likert scale with five choices, 1-5, with 1 set to strongly 
disagree and 5 set to strongly agree. 
 
3.4 
Secondary Outcome Measure(s) 
The secondary outcome measure is response to the question “I achieved my 
specific objectives for the rotation (which the learner provided at the start of the 
rotation).” It will be quantified using a Likert scale with five choices, 1-5, with 1 set 
to strongly disagree and 5 set to strongly agree. 
 
Other outcome measures include whether (via Likert scale, scores ranging from 
Strongly Disagree to Strongly Agree as defined above): 
• 
The learner was provided with a variety of resources to meet their learning 
objectives 
• 
The education they received matched their level of training 
• 
Their education was appropriate to their previous exposure to hospice and 
palliative medicine 
• 
The education matched their learning style 
• 
They felt the rotation was valuable 

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• 
The clinical educators promoted an open, respectful, and safe 
environment for discussion, learning, and improvement 
• 
They would recommend this rotation to others 
 
Open-ended feedback will be elicited regarding strengths of the rotation, areas 
for improvement, and practice changes, both on the survey and during the focus 
group. 
 
Lastly, learners will be assessed on their confidence in meeting each standard 
rotation objective, on a Likert scale of 1-5, both before and after the rotation. 
 
All of this allows the team to gather more information to understand why there 
was benefit for the flexible learning curriculum, if indeed there was one. 
 
Section 4: Study Design 
 
This is a single-center pilot study evaluating the use of a flexible curriculum tool to 
improve the experience of rotators with the palliative care team, measured by how well 
the rotation helps them meet standard as well as individualized learning objectives. It 
will not be blinded.  
 
All learners will be sent a welcome email that will include a pre-rotation self- 
assessment, identifying type of learner and personal experience with palliative care, 
self-identified preferred ways of learning, length of time on the rotation, and personal 
learning goals. 
 
All learners in the first half of the study period will be in the control group, and all 
learners in the second half of the study period will be in the intervention group. 
Outcomes will be measured on post-rotation evaluation surveys, one for each trainee, 
sent to them after their rotation is complete. Qualitative data will be more deeply 
interrogated with a focus group of trainees who participated in the intervention. 
 
Section 5: Study Enrollment and Withdrawal 
 
5.1 
Study Population, Recruitment and Retention 
• 
Target sample size: This will be a convenience sample of learners already 
scheduled to rotate with the palliative care team. There is an anticipated 
approximately 20 learners per group screened and hope to recruit about 
15 per group 
• 
Anticipated accrual rate: 60-75% 
• 
Training site: Children’s National Hospital 
• 
Recruitment site: only those who rotate with the palliative care team at 
Children’s National Hospital 
• 
Restrictions to enrollment: none 

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• 
Participation will not be limited based on health, only that they need to be 
healthy enough to participate in the palliative care rotation for at least ½ 
day, as the target population is trainees 
• 
Participants will be incentivized to participate in the focus group with a $20 
gift card to a location approved by the IRB to compensate them for their 
time 
 
5.2 
Inclusion Criteria 
• 
Age: Must be an adult, greater than or equal to 18 years old 
• 
Must have rotated with the pediatric palliative care team for at least ½ day 
during the study period 
• 
Must speak English 
 
5.3 
Exclusion Criteria 
• 
There are no exclusion criteria for this study 
 
5.4  
Vulnerable Subjects 
The purpose of this study is to improve the training and educational process for 
trainees (students and other learners), who will already be taking part in the 
palliative care rotation. 
 
Their status as a trainee within the program will not be negatively affected if they 
decide that they do not want to participate in the study, and they will not be 
pressured to participate in the study due to their status as a trainee. 
 
5.5 
Recruitment 
The subject population will come from trainees who have rotated with the 
palliative care team during the study period. They will not be required to 
participate in the study to rotate with the team; however, they will be emailed 
rotation evaluation surveys soon after their rotation. On the first page of the 
evaluation survey, they can consent to participate in the study. If they participate 
in the study in the intervention group, they can indicate that they would be willing 
to participate in a focus group and will be sent a separate link (disconnected from 
their survey data) to indicate that interest. Subjects who indicate interest will be 
invited to participate in a focus group. The evaluations will be done using Redcap 
software to protect the privacy of the learners’ responses. Any data that is 
downloaded for analysis will be de-identified and stored on password protected 
computers on the Children’s National Hospital network. Only authorized study 
team members will have access to the data. 
 
5.6  
Retention 
• 
All study subjects in the control group will only participate in the study for 
the extent of one survey 
• 
Study subjects in the intervention group will participate in the study for the 
extent of one survey 

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• 
Subjects in the intervention group will then be recruited to possibly 
participate in a single focus group 
• 
Participants will be incentivized to participate in the focus group with a $20 
gift card to a location approved by the IRB to compensate them for their 
time 
 
5.7 
End of Participation Criteria and Procedures 
Participants are free to withdraw from participation in the study at any time upon 
request. Their participation in the study is only when they complete their 
evaluation form and if they choose to participate in the focus group. For those 
that require evaluations for their training programs, study participation does not 
affect their ability to participate successfully in a rotation with the palliative care 
team or receive positive evaluations, since the processes are independent. 
 
Participants may also withdraw during the focus group. 
Section 6: Study Procedures 
 
6.1 
Informed Consent/Assent and HIPAA Authorization  
Informed consent is a process that is initiated prior to the individual agreeing to 
participate in the study. It continues throughout the individual’s study 
participation. Because HIPAA-protected information will not be collected in this 
study, a Waiver of Consent Documentation will be requested, and an information 
sheet will be used to recruit participants. 
• 
All study subjects will be adults who are fluent in English (as they are 
rotating with the palliative care team), so will provide their own informed 
consent 
• 
When study subjects receive emails with their evaluation for the rotation, 
they will also be sent the information sheet attached to the email 
• 
If they choose to participate in the study, they can indicate their agreement 
by clicking on the evaluation survey link that will be housed on the 
information sheet 
• 
Subject privacy will be assured as there will be nothing linking their identity 
to their survey responses 
• 
The evaluation form will be sent to all rotators. That email will also include 
an information sheet describing the study, and they will be able to decide 
whether to complete the form and whether to have their data contribute to 
the study at the point that they fill it out. The information sheet will be 
written, with no names attached, and it will be sent after their rotation is 
complete, and their evaluations are sent. They will have four weeks to 
complete the evaluation survey, so they are able to discuss it with others 
prior to agreeing to participate. All of this is to minimize any sense of 
obligation or coercion. 
• 
The participants may withdraw their consent at any time throughout the 
course of the study. 

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• 
A copy of the information sheet will be given to the participants for their 
records via email 
• 
The rights and welfare of the participants will be protected by emphasizing 
that the quality of their education will not be adversely affected if they 
decline to participate in this study. Additionally, they will be consenting 
post intervention, so they will be receiving education without bias from the 
faculty.  
• 
Because names and email addresses will be collected for the focus group 
scheduling and not tied to participants’ medical information, HIPAA 
Section is not applicable.  
 
 
6.2 
Screening Process 
All trainees rotating with the palliative care team who are 18 years or older and 
participated in at least ½ day with the team clinically within the study period are 
eligible to participate. The program director and associate program director are 
the two key personnel in this study and have access to the contact information of 
the trainees. They will all be included and sent an evaluation form for the rotation 
within two weeks after the last date of their rotation. They choose whether to 
participate in the study before completing their evaluation form. 
 
6.3 
Study Interventions and Follow-Up 
Database Development. Initial database development will be done in Microsoft 
Excel until June 2026. This database will include links to a variety of resources in 
the following categories, to be used alongside experiential and on-the-fly 
teaching: didactics (lectures by palliative care faculty, seminars from other 
sources, online lectures, videos, and podcasts), interactive resources (online 
modules, interactive websites, simulations), and written resources (books, 
articles, handouts, and websites or blogs). Topics covered will include palliative 
care symptom management, communication in different circumstances, 
diagnostic, prognostic and treatment information, decision making, ethics, active 
resources for patients and families, hospice, psychosocial and spiritual support of 
patients and families, end of life care, and well-being and self-care. 
 
Every resource will be characterized based on questions answered in a learning 
self-assessment, when a trainee begins their rotation. It will ask about standard 
objectives and elective objectives, level of training, experience in hospice and 
palliative medicine, learning style, and time on service. Starting in July 2026, for 
each trainee in the intervention group, a curriculum will be built per their rotation 
specifications. Following the tailored curriculum, learners will be given an 
evaluation to evaluate how effective the rotation experience was at meeting the 
objectives. 
 
Intervention Implementation. Between January – June 2026, the rotation 
education will continue as normal for the control group. Rotators will be sent an 

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introductory email with standard rotation goals and learning objectives and 
resources. They will share their individual learning objectives on the first day of 
the rotation. Preceptors will provide resources and clinical opportunities in an ad 
hoc manner for learning based on their individual learning objectives, as is the 
standard right now. Between July – December 2026, learners with the team will 
be asked to provide answers to the self-assessment approximately one month 
before the start of the rotation, and the flexible curriculum tool will be used to 
generate a tailored set of resources for them. Of note, some rotators organize 
their rotation on a shorter time frame, and for those learners, the self-assessment 
will be sent when they set up their rotation to be done as soon as possible. 
 
The final evaluation survey will be sent within two weeks of the last day of their 
rotation. They will be given four weeks to complete the evaluation. 
 
6.4 
Description of Study Procedures/Evaluations 
 
The primary deviation from standard education is described above in intervention 
implementation. The behavioral intervention is the use of the flexible curriculum 
tool to systematically tailor rotation resources to each learner. It will be utilized by 
one of the study personnel who are also the program director and associate 
program director of the fellowship program and primarily responsible for 
coordinating rotator education. The tool will output the recommended resources 
for each learner, which will then be passed along. A description of the tool, as 
well as a standard operating procedure for its utilization, is attached. 
 
Self-Evaluations: All learners will be sent a self-evaluation describing their level 
of training and palliative care experience, preferred learning styles, time on the 
rotation and personalized learning goals.  
 
Rotation Evaluation: Following the rotation, all learners have an opportunity to 
evaluate the rotation. Individuals not participating in the study can access a 
separate QR code/link in the body of the first survey email sent to them to 
provide rotation feedback in RedCap system. The QR code is in the Panda 
Palliative Care Office on the door and is available for all learners to provide 
anonymous feedback to faculty. The evaluations are provided at the end of the 
year to faculty. As standard of practice for the rotation, the program/rotation site 
director sends an email at the end of the rotation to the trainees with the same 
QR code as a reminder to complete these evaluations. This information can be 
found in document called 
 
For those participating in the survey, a separate evaluation process will be 
utilized. Similar to standard of practice, evaluations will be sent via email and 
submitted through a different RedCap Survey. It is called “Post Rotation 
Evaluation.” 
 

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The focus group will be organized once all intervention group participants have 
submitted their evaluations by the end of January 2027. It will take place in 
February to early March 2027 over Microsoft Teams teleconferencing software 
and will use the attached focus group guide, developed using best practices.11 
 
As time rotating on the palliative care service can be emotionally distressing in 
general due to the nature of the work, trainees are offered frequent check-ins 
with faculty as well as psychosocial colleagues. They are also reminded of 
resources that they have through their training programs for mental health 
support, such as EAP, resident counseling, chaplain support, etc. Confidential 
information can be sent to palliative care administrators, trainee program 
directors, or CNH graduate medical education (GME) staff. Trainee performance 
or personal evaluations will not be impacted by their evaluations of the rotation. 
This will be the same for both control and intervention groups. 
 
6.5 
Study Team Training and Intervention Reliability 
The intervention will be administered by the key personnel of the study. The 
flexible curriculum tool and database will not be updated during the intervention 
period, so all rotators during that period will have the same experience with the 
tool. It will be standardized, with standard operating procedures, which are 
attached, so it can be used by any user and yield the same recommendations for 
each learner based on the answers to their self-assessment. 
 
6.6  
Concomitant Interventions and Procedures 
Participants are allowed to continue using any other educational tools while on 
the palliative care rotation. This does not limit their participation in the rotation or 
in the study. 
 
Section 7: Safety Assessments and Reporting 
 
Rotation with the palliative care team in general can be an emotionally difficult 
experience; however, there is no anticipated increased risk of adverse events during 
participation in the study, whether routine, severe, or unexpected and therefore would 
find no reason for the study to be halted. 
 
Section 8: Statistical Considerations and Analysis  
 
8.1 
Statistical and Analytical Plans (SAP) 
Because of the simple nature of this pilot study, there will not be a formal 
Statistical and Analytical Plan (SAP) apart from what is included in the IRB 
protocol. 
 
8.2 
Statistical Hypotheses 
Primary Outcome Measure: 
• 
Hypotheses: 

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o 
Null: There is no difference (in terms of central tendency) between 
the two groups in their response (using a Likert scale) to the 
question, “I achieved the standard objectives of the rotation.” 
o 
Alternative: There IS a difference (in terms of central tendency) 
between the two groups in their response (using a Likert scale) to 
the question, “I achieved the standard objectives of the rotation.” 
 
Secondary Outcome Measures: 
• 
Hypotheses: 
o 
Null: There is no difference (in terms of central tendency) between 
the two groups in their response (using a Likert scale) to the 
question, “I achieved my specific objectives for the rotation.” 
o 
Alternative: There IS a difference (in terms of central tendency) 
between the two groups in their response (using a Likert scale) to 
the question, “I achieved my specific objectives for the rotation.” 
 
For the remaining secondary outcome measures evaluated using a Likert Scale, 
the hypotheses will be like those of the above measures, as they are all 
evaluated using Likert scales. 
 
For the secondary outcome measures evaluating using Likert Scales at pre- and 
post-participation time points, the hypothesis is as follows: 
• 
Hypotheses: 
o 
Null: There is no difference in mean between the two groups in the 
degree of change between pre- and post-intervention confidence 
(for each individual objective) 
o 
Alternative: There IS a difference in mean between the two groups 
in the degree of change between pre- and post-intervention 
confidence (for each individual objective) 
 
There are no hypotheses for the analysis of the open-ended survey questions 
and focus group data, as they will be analyzed using inductive thematic 
analysis.12,13 
 
8.3 
Analysis Datasets 
While the flexible education tool and database will be used for all participants in 
the intervention group to provide them with relevant resources, each individual 
learner is responsible for utilizing the resources themselves. Therefore, all 
participating subjects will be included in an intention-to-treat analysis dataset as 
opposed to per-protocol. 
 
8.4 
Description of Statistical Methods 
This study is a pre-/post-interventional study; however, different participants will 
receive the intervention than those that receive the control education because of 
the nature of the palliative care rotation. Essentially, for the first 6 months of the 
study period, rotators will receive the control education, and for the next 6 

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months of the study period, they will receive education using the intervention, the 
flexible education tool. All evaluations from each 6-month period will be 
aggregated to preserve anonymity, and there will be no learners who are in both 
groups. 
 
Demographic data will be collected during the self-assessment and reported 
using descriptive statistics: 
• 
Level of training (categorically in percentages) 
• 
Amount of experience in hospice and palliative medicine (categorically in 
percentage) 
• 
Learning style (categorically in percentages) 
• 
Time on palliative care service (categorically in percentages) 
 
For all outcome measures that use Likert scales (ordinal data), the sample size is 
so small that it is assumed data will not fall within a normal distribution, so a 
Mann-Whitney U test will be to analyze it and report z-test statistic and p-value, 
as well as the interquartile range. A p-value of 0.05 will be used for statistical 
significance. 
 
Individual participant data will not be published. 
 
Confidence ratings will be compared at pre-post time points for significant 
improvements within each group using a paired t-test. Overall improvement 
between control and intervention groups will be compared using a student’s t-test 
to compare the change in confidence. A p-value of 0.05 will be used for statistical 
significance. 
 
Qualitative data, including responses to open-ended survey questions and focus 
group data, as mentioned in 8.2, will be analyzed using inductive thematic 
analysis using DeDoose software. 
 
8.5 
Sample Size 
Because this is a pilot study to improve the education of an existing population 
on a rotation with a small team, the sample will be a convenience sample of 
learners who rotate with the palliative care team. It is expected that there will be 
approximately 20 learners to recruit and screen for each (control and 
intervention) group and to enroll at least 10 and up to 15 for each group. It is 
accepted that the statistical analysis may be underpowered, which is why the 
pilot study will be supplemented with qualitative data. 
 
8.6 
Measures to Minimize Bias 
Enrollment/Randomization/Masking Procedures 
• 
There will be no randomization, as it is a convenience sample based on 
when learners have room in their schedule to rotate with the palliative care 
team 

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• 
Based on the way the intervention will be implemented, it is impossible to 
blind the educators or the rotators as to whether the rotators are in the 
control or intervention group 
• 
The control and intervention survey data will not be analyzed until after all 
data is compiled (control data in August 2026 and intervention data in 
February 2027), and data will have all identifying information (timestamps, 
etc.) removed. 
• 
Bias will be minimized in the qualitative data using triangulation – 
independent analysis by multiple personnel as well as comparison of 
open-ended survey data with focus group data 
Section 9: Data Quality and Oversight 
 
Survey data will be de-identified and collected via REDCap. It will be stored in their 
database until completion and publication of the study. It will be accessible only to 
authorized users via password. Data downloaded for analysis in an Excel file will have 
data and timestamps removed. 
 
Focus group data will be de-identified when it is transcribed. It will be conducted over 
teleconference software (Teams) but recorded via audio recorders outside of the Teams 
software, so as to not capture visual data. Additionally, participant names will not be 
used, and they will be referred to as “participant 1”, “participant 2”, etc. Recording will be 
transcribed using Rev AI transcription software. Recordings and transcriptions will be 
stored on a password protected shared drive. 
 
9.1 
Study Team Quality Assurance and Quality Control 
The highest risk for deviations in data quality is in the qualitative data, especially 
that which will be transcribed from the focus group. The Principal Investigator is 
responsible for maintaining quality control of the data. 
 
9.2 
Data Safety and Monitoring Plan 
There is not an anticipated need for a Data Safety and Monitoring Plan 
considering the minimal risk of adverse events to subjects. 
Section 10: Ethical Considerations 
 
10. 1 Ethical Standard 
The study team will ensure that this study is conducted in full conformity with the 
Regulations for the Protection of Human Subjects of Research codified in 45 Part 
46 of the Code of Federal Regulations, Children’s National Policies and 
Procedures and Good Clinical Practices.  
 
10.2 Institutional Review Board (IRB) 
The protocol, informed consent form(s), recruitment materials, and all participant 
materials will be submitted to the Children’s National IRB for review and 

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approval. Approval of both the protocol and the consent form will be obtained 
before any participant has given consent. Any change to the protocol, consent, 
recruitment materials and participant information sheets or letters will require IRB 
approval before implementation and use.  The IRB will determine whether 
previously consented participants need to be re-consented  
 
The IRB will be notified of study team updates via an amendment. Data Safety 
Monitoring Board (DSMB) Reports will not be submitted at the time of the 
continuing review or with another applicable IRB transaction due to the minimally 
risky nature of this study.   
 
Other study events (e.g., protocol deviations, data monitoring reports) will be 
submitted per the Children’s National IRB Reportable Events Module. 
 
10.3 Maintaining Subject Privacy 
Initial patient recruitment for the survey portion of the study will be done via 
email, and their data will be entered in Redcap. It is impossible to fully limit 
subject privacy during a focus group, so subjects will be informed in the 
information sheet that there is a risk of loss of privacy of the information they 
share in the focus group, as the researchers are not able to control the actions of 
the other participants. However, there will be an explicit expectation of respect for 
information shared with all participants, and the focus group will be conducted in 
a private virtual space. 
 
10.4 Maintaining Study Data Confidentiality 
Participant confidentiality is strictly held in trust by the participating investigators, 
their staff, the sponsor, and their agents. This confidentiality is extended to cover 
educational information relating to participants. Therefore, the study protocol, 
documentation, data, and all other information generated will be held in strict 
confidence. No information concerning the study or the data will be released to 
any unauthorized third party without prior written approval of the sponsor. 
  
The sponsor's representatives and regulatory authorities (e.g., IRB, OHRP) may 
inspect all documents and records required to be maintained by the investigator. 
The clinical study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at each study 
site for internal use during the study. At the end of the study, all research records 
will be stored in a secure location for the time period dictated by the sponsor and 
institutional regulations. 
 
The research data will not include the participant’s contact or identifying 
information. Rather, individual participants and their research data will be 
identified by a unique study identification number. The study data entry and study 
management systems used by research staff will be secured and password 

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protected. At the end of the study, all study databases will be archived at 
Children’s National. 
 
10.5 Study Support and Conflicts of Interest 
Salary support for this study is provided by the Children’s National Division of 
Pediatric Hospital Medicine. REDCap® support is provided by The Clinical and 
Translational Science Institute (CTSI) at Children’s National. Grant support for 
this pilot project is provided by the Division of Pediatric Hospital Medicine Pilot 
Grant. 
 
All key study personnel will follow the Human Research Protections Program 
Investigator, Study Staff, and Family Member Conflicts of Interest (COI) Policy. 
Section 11: Data Handling and Record Keeping 
 
11.1 Data Management Responsibilities 
Initial survey data will be entered into Redcap via a survey managed by key trial 
personnel. In August 2026 (control data) and February 2027 (intervention data), 
the study coordinator will remove identifying information (timestamps, etc.) and 
compile the data into an Excel file to be saved on a password-protected shared 
drive. 
 
Statistical analysis will be done using the assistance of a statistician consultant 
and by the key personnel. 
 
The focus group will be conducted over a recorded teleconference on Microsoft 
Teams and recording will be transcribed using Rev AI transcription software. 
DeDoose software will be used to analyze responses to the open-ended survey 
question and focus group transcriptions. 
 
11.2 Data Capture Methods 
The PI is responsible for ensuring the accuracy, completeness, legibility, 
timeliness and completeness of the data reported. 
 
Research data will be entered into REDCap®, a password protected, secure, 
Health Insurance Portability and Accountability Act (HIPAA) compliant, web-
based electronic database with a built-in audit trail. It will be entered via a survey. 
 
Focus group data will be collected by audio recording of a Teams teleconference 
focus group. 
 
11.3 Study Record Retention Policy 
Study records will be maintained for at least 3 years after study closure. There 
will be no physical records. Any data that is retained will be de-identified. 

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Section 12: Publication Policy 
 
Pursuant to receipt of the Pediatric Hospital Medicine pilot grant, authorship, including 
authorship order, has already been determined. It also requires presentation at local 
regional meetings as well as submission to national meetings. 
Section 13: References 
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Care for Children: A Cross-sectional Analysis. J Pain Symptom Manage. 2017 
Feb;53(2):171-177. 
2) 
Committee on Approaching Death. Dying in America: Improving quality and 
honoring individual preferences near the end of life. Washington, D.C.: The 
National Academies Press., 2015. 
3) 
Institute of Medicine (US) and National Research Council (US) National Cancer 
Policy Board; Foley KM, Gelband H, eds.Washington, D.C.: National Academies 
Press (US); 2001. 
4) 
Boland JW, Brown MEL, Duenas A, et al. How effective is undergraduate 
palliative care teaching for medical students? A systematic literature review. BMJ 
Open 2020;10:e036458. 
5) 
Moody K, McHugh M, Baker R, et al. Providing Pediatric Palliative Care 
Education Using Problem-Based Learning. J Palliat Med. 2018 Jan;21(1):22-27. 
6) 
Friedrichsdorf SJ, Remke S, Hauser J, et al. Development of a Pediatric 
Palliative Care Curriculum and Dissemination Model: Education in Palliative and 
End-of-Life Care (EPEC) Pediatrics. J Pain Symptom Manage. 2019 
Oct;58(4):707-720.e3. 
7) 
Neilson S, Randall D, McNamara K, et al. Children’s palliative care education 
and training: developing an education standard framework and audit. BMC Med 
Educ. 2021;21(539). 
8) 
Postier AC, Wolfe J, Hauser J, et al. Education in Palliative and End-of-Life Care-
Pediatrics: Curriculum Use and Dissemination. J Pain Symptom Manage. 2022 
Mar;63(3):349-358. 
9) 
Smith S. Controlling the Crowd: Balancing Patient Care and Education in 
Pediatric Palliative Care. Pediatrics. 2019;144(2_MeetingAbstract):439. 
10) 
Snow Andrade M, Alden-Rivers B. Developing a framework for sustainable 
growth of flexible learning opportunities. Higher Education Pedagogies. 
2019;4(1):1-16. 
11) 
Stalmeijer RE, Mcnaughton N, Van Mook WNKA. Using focus groups in medical 
education research: AMEE Guide No. 91. Med Teach. 2014;36(11):923-939. 
12) 
Naeem M, Ozuem W, Howell K, Ranfagni S. A Step-by-Step Process of 
Thematic Analysis to Develop a Conceptual Model in Qualitative 
Research. International Journal of Qualitative Methods. 2023;22:1-18. 
13) 
Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research 
in Psychology. 2006;3(2):77-101.