LCI-HEM-SCD-ST3P-UP-001: A Comparative Effectiveness Study of Peer Mentoring [PM] Versus Structured Transition Education Based Intervention [STE] for the Management of Care Transitions in Emerging Adults With Sickle Cell Disease (SCD)
Phase: NA
Conditions: Sickle Cell Disease
Sponsor: Wake Forest University Health Sciences

Protocol #: LCI-HEM-SCD-ST3P-UP-001 
Version 6: 12/22/2022 
 
 
TITLE: A Comparative Effectiveness Study of Peer Mentoring [PM] versus Structured 
Transition Education Based Intervention [STE] for the Management of Care Transitions in 
Emerging Adults with Sickle Cell Disease (SCD) 
 
 
The Sickle Cell Trevor Thompson Transition Project (ST3P-UP Trial) 
 
 
Coordinating Center: 
Levine Cancer Institute 
1021 Morehead Medical Drive 
Charlotte NC, 28204 
 
Sponsor-Investigator: 
Payal Desai, MD  
Levine Cancer Institute 
1021 Morehead Medical Drive, Suite 500 
Charlotte, NC 28204 
Phone: (980)442-2000, Fax: (704) 442-5802 
Payal.Desai@atriumhealth.org  
 
 
Statisticians: 
Jim Symanowski, PhD  
Levine Cancer Institute 
1100 Blythe Boulevard, Office 1164 
Charlotte NC 28203 
Phone: (980) 442-2371 
James.Symanowski@atriumhealth.org  
 
Charity Patterson, PhD, MSPH  
University of Pittsburgh 
100 Technology Drive, Suite 210 
Pittsburgh, PA 15219 
Phone: (412) 383-4812 
cgp22@pitt.edu  
 
 
Trial Funded by: 
Patient Centered Outcomes Research Institute (PCORI) 
 
 

Protocol: LCI-HEM-SCD-ST3P-UP-001 
Version 6: 12/22/2022 
 
 
_____________________________________________________________________________ 
The study will be conducted in compliance with the protocol, ICH/GCP and any applicable 
regulatory requirements. 
 
 
 
Throughout this document, symbols indicating proprietary names (®, TM) are not displayed. 
Hence, the appearance of product names without these symbols does not imply that these names 
are not proprietary. 
 
Confidential 
The information provided in this document is strictly confidential and is intended solely for the 
guidance of the clinical investigation. Reproduction or disclosure of this document - whether in part 
or in full - to parties not associated with the clinical investigation, or its use for any other purpose, 
without the prior written consent of the Sponsor-Investigator is not permitted. 

Protocol: LCI-HEM-SCD-ST3P-UP-001 
Version 6: 12/22/2022 
 
PROTOCOL SIGNATURE PAGE 
 
PROTOCOL TITLE: A Comparative Effectiveness Study of Peer Mentoring [PM] 
versus Structured Transition Education Based Intervention [STE] for the Management 
of Care Transitions in Emerging Adults with Sickle Cell Disease (SCD) 
 
The Sickle Cell Trevor Thompson Transition Project (ST3P-UP Trial) 
  
 
The signature below constitutes the approval of this protocol and the attachments, and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable U.S. federal regulations and ICH guidelines. 
 
 
 
 
 
 
 
___________________________________  
_____________________ 
Signature of Sponsor-Investigator 
 
 
Date 
 
 
 
PAYAL DESAI, MD 
Sponsor-Investigator Name (printed) 
 
 
 

Protocol: LCI-HEM-SCD-ST3P-UP-001 
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I 
 
SYNOPSIS 
TITLE 
A Comparative Effectiveness Study of Peer Mentoring [PM] versus 
Structured Transition Education Based Intervention [STE] for the 
Management of Care Transitions in Emerging Adults with Sickle Cell 
Disease (SCD) 
 
STUDY POPULATION 
Emerging Adults with Sickle Cell Disease aged 16 – 25 years 
 
SUMMARY OF STUDY 
RATIONALE 
Emerging adults with sickle cell disease (EA-SCD) experience significant 
difficulties with transition from pediatrics to adult care despite the 
impressive gains in childhood survival. Acute care utilization dramatically 
increases, and quality of life drops along with an increased mortality. 
There is currently no clinical practice standard for transition 
programming for EA-SCD. Recently Got Transition Center for Healthcare 
Transition Improvement recommended an approach that involves 
incorporating the Six Core Elements of Transition into clinical practices 
that provide care for children with special healthcare needs (CSHCN) 
as noted in www.gottransition.org. The American Academy of Pediatrics 
(AAP) in partnership with the American Academy of Family Physicians 
(AAFP) and the American College of Physicians (ACP) proposed these 
Six Core Elements in 2011 in a consensus statement that provided clear 
guidance and a supportive decision algorithm that describes six practice-
based recommendations (Fig 4); 1: transition policy, 2: transition 
youth registry, 3: transition preparation, 4: transition planning, 5: 
transition and transfer of care, and 6: transition completion that 
should be a part of ANY planned health care transition program for all 
CSHCN. They based these recommendations on the premise that optimal 
health care is achieved when individuals of all ages receive “medically 
and developmentally appropriate care” in a process that includes ensuring 
that high- quality, developmentally appropriate health care services 
are available uninterrupted as the person moves from adolescence to 
adulthood.”28 This project seeks 
to establish the 
comparative 
effectiveness of adding peer mentoring to a structured education-based 
transition program to improve self-care skills among EA- SCD. The peer 
mentoring comparator was chosen based on existing evidence of its utility 
in improving transition outcomes in other chronic diseases of childhood 
such as juvenile diabetes and solid organ transplant. We will test the 
hypothesis that the addition of peer mentoring to a structured education-
based transition program will improve acute care reliance, quality of life 
and satisfaction with transition outcomes for EA-SCD using a cluster 
randomized study approach. 
 
The qualitative research portion of the study is aimed at gathering 
substantive qualitative information to evaluate the ST3P-UP Study’s  

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II 
process outcomes, quality improvement, and impact through eliciting 
descriptions of participant experiences with one-to-one peer mentoring 
since we are unable to quantitatively assess the Standard Education + Peer 
Mentoring comparator as originally planned within the ST3P-UP Study. 
 
STUDY DESIGN  
This is a cluster randomized study comparing the effectiveness of adding 
virtual peer mentoring to a structured education-based transition program 
based on the Six Core Elements of transition in improving acute care 
reliance, quality of life and satisfaction with transition process in EA-
SCD. The study will involve 14 clinical sites with a 1:1 randomization at 
the site level. A total of 537 EA-SCD between the ages of 16 and 25 years 
who are currently receiving care in a pediatric SCD program will be 
enrolled and followed prospectively for at least 6 months in pediatrics and 
at least 24 months in adult care. We will use rapid cycle PDSA 
improvement methods to implement the structured education-based 
program in adherence to the 6 core elements and measure adherence to 
these practice guidelines over time. 
 
OBJECTIVES 
Primary Objective:  
• Compare the effectiveness of STE+PM versus STE at decreasing 
the number of acute care visits per year over a 24-month period 
among EA-SCD. 
 
Secondary Objectives: 
• To compare the effectiveness of STE+PM versus STE at 
improving patient- reported outcomes (PROs) among EA-SCD. 
• To compare the effectiveness of STE+PM versus STE at reducing 
healthcare utilization among EA-SCD. 
 
Qualitative Objectives: 
• Identify the facilitators and barriers to enrollment of EA-SCD and 
mentors from multi stakeholder perspectives 
• Assess mentor-mentee experiences with one-to-one peer 
mentoring 
• Assess site experiences with the implementation of Quality 
Improvement methods within their clinical practices 
• Determine the effect of engagement activities on communication 
within the site triad (adult/pediatric physicians, CBOs, patients) 
• Develop a definition of transition success across the triad 
(adult/pediatric physicians, CBOs, and patients) 
 
KEY INCLUSION 
CRITERIA  
• Any Sickle Cell Disease genotype 
• Age 16 – 25 years receiving care in a pediatric sickle cell program 
• Able to complete all study procedures with reasonable 
accommodations 

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III
STATISTICAL 
CONSIDERATIONS 
 
Estimated average acute care utilization rate for EA-SCD is 6 visits / year. 
This study is designed to detect a 20% reduction in the number of acute 
care encounters per year which is considered clinically significant to our 
patient stakeholders. Based on a two- sided alpha = 0.05 significance 
level, 67 subjects per arm would provide approximately 85% power to 
detect a 20% reduction in the number of acute care utilizations under 
individual randomization, assuming the number of encounters follows a 
Poisson distribution for rare events. Sample size was inflated based on the 
cluster size coefficient of variation among our 14 participating clinical 
sites (55%) and the intra-class correlation (ICC) assumed to be 0.05. 
Based on these parameters, 183 subjects per arm (366 total subjects) will 
retain approximately 85% power. The sample size was increased to 537 
total EA-SCD subjects to account for potential missing data and allow for 
robust evaluation of secondary endpoints. It is estimated that this can be 
accomplished with an enrollment rate of 35% of the EA-SCD patient 
population. 
 
NUMBER OF EA-SCD 
PARTICIPANTS 
537 total participants will be enrolled 
Each arm will enroll approximately 269 EA-SCD aged 16 – 25 years 
NUMBER OF 
CLUSTERS 
There will be 14 cluster sites, each cluster site comprised of a pediatric 
SCD clinic, an adult SCD clinic and a SCD CBO. There are 8 large 
cluster sites with ≥40 EA-SCD currently in pediatrics and 6 small cluster 
sites with <40 EA-SCD currently in pediatric care. Based on self-reported 
enrollment targets from each site, 80% of participants will come from 
large clusters. 
 
 
 
 

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IV
SCHEMA 
 
Study Schema Figure 1: Overview of Study Design 
 
 
 
 
Study Schema Figure 2: Overview of Study Implementation Outline 
 
 
 
 
 

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V 
 
Study Schema Figure 3: Peer Mentoring Impact on Clinical Outcomes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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VI
GLOSSARY OF TERMS 
 
ACR 
Acute Care Reliance 
ASCQ-ME 
Adults Sickle Cell Quality of Life Measure 
CAB 
Community Advisory Board 
CBO 
Community-Based Organization 
CHW 
Community Health Workers 
CSHCN 
Children with Special Healthcare Needs 
DCC 
Data Coordinating Center 
DSMC 
Data Safety Monitoring Council 
EA 
Emerging Adult 
EA-SCD 
Emerging Adult with Sickle Cell Disease 
ED 
Emergency Department 
HBCU 
Historically Black Colleges and Universities 
HCT 
Healthcare Transition 
Hgb 
Hemoglobin 
IRB 
Institutional Review Board 
MOS-SSS 
Medical Outcomes Study Social Support Survey 
PDSA 
Plan – Do – Study – Act 
PedsQLTM 
Pediatric Quality of Life 
PM 
Peer Mentoring 
PRO 
Patient Reported Outcomes 
QI 
Quality Improvement 
QI Coordinator 
Quality Improvement Coordinator 
QOL 
Quality of Life 
SAC 
Study Advisory Committee 
SCD 
Sickle Cell Disease 
FSCDQ 
“How Much Do I Know about SCD” Quiz 
SE US 
Southeastern United States 
SOG 
Study Oversight Group 
STE 
Structured Education-Based Transition Program 
 
 

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VII
TABLE OF CONTENTS 
SYNOPSIS ...................................................................................................................................... I 
SCHEMA ..................................................................................................................................... IV 
1. 
BACKGROUND AND RATIONALE ............................................................................. 9 
1.1 
Background .......................................................................................................................... 9 
1.2 
Study Rationale and Study Design .................................................................................... 11 
2. 
STUDY OBJECTIVES .................................................................................................... 14 
2.1 
Primary Objective .............................................................................................................. 14 
2.2 
Secondary Objectives......................................................................................................... 14 
2.3 
Exploratory Objectives ...................................................................................................... 15 
2.4 
Qualitative Research Objectives ........................................................................................ 15 
3. 
SUBJECT SELECTION ................................................................................................. 16 
3.1 
Subject Identification and Recruitment ............................................................................. 16 
3.2 
EA-SCD Eligibility ............................................................................................................ 16 
3.3 
Mentor Eligibility............................................................................................................... 17 
3.4 
Advisor Eligibility ............................................................................................................. 18 
3.5 
Qualitative Research Eligibility ......................................................................................... 19 
3.6 
Screen Failures ................................................................................................................... 19 
4. 
REGISTRATION AND RANDOMIZATION .............................................................. 19 
4.1 
Study ID Number Assignment ........................................................................................... 19 
4.2 
Randomization Method and Stratification Factors ............................................................ 19 
5. 
STUDY PLAN .................................................................................................................. 19 
5.1 
Study Intervention .............................................................................................................. 20 
5.2 
Procedures for Standardizing PM Implementation at Each Site ........................................ 23 
5.3 
Study Outcome Measures .................................................................................................. 27 
6. 
STUDY CALENDAR ...................................................................................................... 30 
6.1 
Site Level Quality Improvement Calendar ........................................................................ 30 
6.2 
Site Level Advisor/Mentor Calendar ................................................................................. 30 
6.3 
EA-SCD Participant Level Assessment Calendar ............................................................. 32 
6.4 
Schedule of Assessments ................................................................................................... 34 
6.5 
Schedule of Assessments (Mentors/Advisors)................................................................... 36 
6.6 
Schedule of Assessments – Quality Improvement (All Clinical Sites) ............................. 36 
7. 
REMOVAL OF SUBJECTS FROM STUDY ............................................................... 37 
7.1 
Off Study ............................................................................................................................ 37 
7.2 
Special Considerations ....................................................................................................... 38 
8. 
DATA AND SAFETY ...................................................................................................... 38 
8.1 
Safety Monitoring .............................................................................................................. 38 
8.2 
Data Monitoring ................................................................................................................. 39 
9. 
POTENTIAL RISKS/UNANTICIPATED PROBLEMS ............................................. 39 
9.1 
Potential Risks ................................................................................................................... 39 
9.2 
Unanticipated Problems (UAP) ......................................................................................... 40 

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VIII 
10. 
STASTICIAL CONSIDERATIONS .............................................................................. 41 
10.1 Milestones .......................................................................................................................... 41 
10.2 Sample Size and Accrual ................................................................................................... 41 
10.3 Endpoints ........................................................................................................................... 42 
10.4 Analysis Populations .......................................................................................................... 44 
10.5 Analysis Methods............................................................................................................... 44 
11. 
STUDY COMPLETION OR TERMINATION ............................................................ 48 
11.1 Completion ......................................................................................................................... 48 
11.2 Termination ........................................................................................................................ 48 
12. 
STUDY MANAGEMENT ............................................................................................... 48 
12.1 IRB Approval ..................................................................................................................... 48 
12.2 Informed Consent............................................................................................................... 49 
12.3 Protocol Adherence ............................................................................................................ 49 
12.4 Changes to Study Documents ............................................................................................ 49 
12.5 Other Protocol Deviations.................................................................................................. 49 
12.6 Retention of Records.......................................................................................................... 50 
12.7 Ethical and Legal Conduct of the Study ............................................................................ 50 
12.8 Confidentiality of Records ................................................................................................. 50 
12.9 Compliance with ClinicalTrials.gov .................................................................................. 50 
13. 
REFERENCES ................................................................................................................. 51 
14. 
APPENDICES .................................................................................................................. 54 

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1. BACKGROUND AND RATIONALE 
1.1 
Background 
Nearly 100,000 individuals are living with sickle cell disease (SCD) in the United States (US), 
60% are adults (≥18y) and a third are emerging adults (16-25y; EA-SCD).1-4 The disease 
predominantly affects minorities with over 30% residing in the region planned for this intervention 
(southeastern [SE] US).2 SCD is characterized by a spectrum of symptoms and complications, 
including periods of unpredictable acute pain, debilitating chronic pain, multi-organ injury, 
reduced quality of life (QOL), and shortened lifespan.2,5 Over 95% of children with SCD will 
survive into adulthood, due to early diagnosis, innovative preventative therapies, and improved 
comprehensive care.6 Unfortunately, mortality rates continue to rise for adults with SCD, in part 
due to a dire lack of access to high-quality care for the influx of EA-SCD who are surviving into 
adulthood.7 Healthcare systems have not adjusted to the shifting epidemiology of SCD in adults 
that need complex care coordination and support to optimally manage the medical and 
psychosocial comorbidities that increase with age.8 While the mortality rates among children with 
SCD have declined ~3% per year between 1979 to 2005, there has been a steady 1% per year 
increase in adult mortality rates.7 Median life expectancy for individuals with SCD in the US in 
the 1990s ranged between 42-48 years for hemoglobin SS (Hgb SS) and 60-68 years for 
hemoglobin SC (Hgb SC).9 A more recent population-based SCD surveillance report from CA and 
GA cites tripling of all-cause mortality rates amongst 15-24 year olds (y) compared to those under 
age 14.10 All-cause mortality rates remain higher for SCD compared to all African Americans 
(AA) and the general US population.10 
 
Transition from pediatrics to adult care is a critical time for EA-SCD. The emergency department 
(ED) becomes a primary source for care, with ED visits and admissions per year doubling, and 
avoidable acute care visits rising to account for two-thirds of all SCD hospitalizations.8,11,12 Data 
from the Healthcare Cost and Utilization Project State Inpatient Databases and State Emergency 
Department Databases from eight states showed that EA-SCD (18–30y) had the highest acute care 
utilization rates compared to children 10-17y (3.61 vs 2.04 visits/patient/year).13 The 30-day 
readmission rate doubled from 27.4% to 48.9% respectively.13 Data from the Registry and 
Surveillance for Hemoglobinopathies (RuSH) Project cite an increase in acute care utilization rates 
among EA-SCD (Fig 1). In GA, utilization rose from 0.8 to 3.0/person/year among individuals 10- 
19y of age compared to those 20 - 49y.14 In NC, the average annual acute care visits per person 
increased from 5 in those <18 years to 12 among 18-35y.4 Disparities also exist with school 
absenteeism, and EA-SCD miss an average of 20-40 school days/year due to illness, have worse 
standardized test scores, higher rates of repeat grades and lower overall school attainment 
compared to controls.15 There is limited research to support evidence-based interventions that 
effectively reduce the high mortality, morbidity, and poor QOL during transition. 
 
Barriers to Transition: 
 
Several identified patient, provider and health system factors contribute to the poor health 
outcomes of EA-SCD during transition.16-18 EA-SCD struggle emotionally with adjusting from a 
more paternalistic pediatric model to the adult “individualistic” model of care. Adherence to 
disease modifying treatment drops significantly as they struggle with the developmental 
maturation process.19 Changes or lapses in insurance lead to gaps in comprehensive care - 

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10
specialized and primary - during transition, amplifying existing barriers to accessing crucial 
services as disease burden is increasing.20,21 A retrospective study showed that patients who are 
transitioning received 46% fewer transfusions by age 22y compared to children and were 4.7 times 
less likely to receive iron chelation by age 25y.21 At Atrium Health (formerly known as Carolinas 
Healthcare System), a large healthcare system in the SE US that provides care for 1300 adults and 
400 children with SCD, only 8-14% of EA-SCD accessed a scheduled visit with their primary 
care/SCD provider in 2015 with mean acute care reliance (ACR; number of acute care visits per 
year/ [all acute care visits + all ambulatory care visits]) rates of 42% (Fig 2). Mean acute care 
visits/year rose significantly from 2.1 ± 2.9 among 16- 18y to 4.2 ± 6.8 among 19 - 21y and was 
highest among 21 - 25y at 5.3 ± 8.5 (p<0.01). ACR (≥0.33) is an indicator of inadequate access to 
primary and preventative care.22 EA-SCD report having inadequate information about adult care 
and a poor understanding of their disease and how it becomes more complex with age.14, 16 There 
are significant knowledge gaps and poor communication between pediatric and adult providers 
that worsen the problem created by a lack of standardized EA-SCD patient education curriculum. 
 
Limited evidence on effective transition programming: 
 
A population-based approach to care coordination provided through effective and culturally 
acceptable delivery models during and after the transition is essential to reduce the unacceptable 
morbidity and mortality of EA-SCD. Healthcare transition refers to “the purposeful and planned 
movement of adolescents and young adults with chronic physical and medical conditions from 
child- centered to adult-oriented health care systems”.23 A planned and structured transition 
process will maximize lifelong functioning and well-being, optimize health and assist EA-SCDs in 
reaching their full potential by providing support in acquiring independent health care and life 
skills, preparing for the differences in an adult model of care, and transferring successfully to new 
adult providers without disruptions in care. Transition planning that involves engagement between 
EAs, their caregivers and providers has been shown to lead to improvements in adherence to, 
continuity with, and overall satisfaction with healthcare.11,24 When transition education is targeted 
and structured there is increased probability of achieving independent self-care among EA-SCD.25 
A recent report on the state of transition practices for children with special health care needs 
(CSHCN) revealed a lack of established best practices for EA transition, with only 25 programs 
nationwide that evaluated transition care in juvenile diabetes, SCD, solid organ transplant and 
other chronic childhood conditions.26 Education-based interventions, use of a multidisciplinary 
team and a transition coordinator were common themes. Most programs evaluated disease status, 
adherence to adult appointments or medical regimen and patient satisfaction. A study by Maslow 
et al included a structured mentoring program showing improved self-efficacy and transition 
readiness among participants.27 Only two studies were randomized trials, and none had a 
concurrent comparison group. The review highlighted the need for further prospective studies with 
concurrent comparison groups utilizing well-defined transition outcomes to measure the entire 
transition process. Additional evidence gaps identified include the need to involve health systems 
in the transition process, have longer follow up (> 1y), increase use of Quality Improvement (QI) 
initiatives to help identify best practices and overcome the challenges with patient level 
randomization, and use of validated tools to assess patient reported outcomes (PROs). Patient 
education was common to all 25 identified transition programs; therefore, our choice for a 
standard comparative transition model for this proposal will evaluate an education-based, 
structured transition program that utilizes a QI approach to standardize the transition process 
across clinical sites and integrate this into routine care for all EA-SCD. 

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11
1.2 
Study Rationale and Study Design 
 
 
Figure 4: Core Elements of Transition 
 
The disparities in health outcomes during transition for EA-SCD result from a complex interplay 
of factors related to the patients, their families and social networks, communities, healthcare 
providers and systems, practice settings, and government policies. There is currently no 
community standard for EA-SCD transition; however, there has been a resounding request from 
the SCD community and stakeholders (providers, healthcare systems, insurance payors, 
community-based organizations (CBO’s), and patients, etc.) for a standardized transition process 
to be established. The high ACR rates for EA-SCD have garnered significant attention, as SCD is 
a leading reason for readmission and increased length of stay in most hospital systems. The topic 
of pediatric to adult transition has been featured in regional and national forums repeatedly with 
increasing urgency over the past 6 years. In 2011, the American Academy of Pediatrics (AAP) in 
partnership with the American Academy of Family Physicians (AAFP) and the American College 
of Physicians (ACP) co-authored a consensus statement that provided clear guidance and a 
supportive decision algorithm that describes practice- based recommendations and Six Core 
Elements (Fig 4; 1: transition policy, 2: transition youth registry, 3: transition preparation, 4: 
transition planning, 5: transition and transfer of care, and 6: transition completion) that should be a 
part of ANY planned health care transition program for all CSHCN based on the premise that 
“optimal health care is achieved when individuals of all ages receive medically and 
developmentally appropriate care in a process that includes ensuring that high-quality, 
developmentally appropriate health care services are available uninterrupted as the person moves 
from adolescence to adulthood.”28 Further expansions of the Six Core Elements of optimal 
transition was refined by the Got Transition/Center for Health Care Transition Improvement, 
which resulted in an open access comprehensive toolkit (www.gottransition.com). 
 
A QI time-series comparative study of change was done in five large pediatric and adult academic 
primary care practices in the District of Columbia by the Got Transition team. Using the Health 
Care Transition Process Measurement Tools (pediatric and adult versions) to examine 
improvements in the six specific core indicators of transition performance, they found measurable 
improvements in all quality indicators over a 2 year QI learning collaborative that resulted in the 
development of a systematic clinical transition process.29 Another pediatric-to-adult managed care 
transition pilot project for EA with chronic mental health challenges used the QI process to 
incorporate the "Six Core Elements of Health Care Transition (2.0)" into routine care showing 
significant improvement in the Transition Index and all six core elements over an 18-month 

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12
period.30 In the southeast USA, twenty- one clinical sites participated in a needs assessment 
reporting a formal SCD transition program (60%); process for tracking and monitoring EA-SCD 
through transition (62%); readiness assessment protocol (48%); transition planning process (71%); 
established referral network of adult providers with a protocol for transfer (52%) with only 38% 
having a formal process of contacting the EA-SCD three to six months after transfer and only 10% 
having a formal process for ongoing communication with the receiving adult provider. The Health 
Care Transition Process Measurement Tools (pediatric and adult versions) will be used to examine 
the adherence to and adoption of the Six Core Elements of Transition practice performance at 14 
pediatric and adult clinical sites. The rapid Plan–Do–Study– Act (PDSA) cycles will be utilized to 
implement the QI process to prospectively evaluate both the process and outcome of implementing 
the 6 core elements. 
 
Study Design and Outcomes: 
 
This will be a cluster-randomized study involving 14 clinical sites with randomization occurring at 
the site level. All clinical sites will implement a structured education-based transition program 
(STE) that will be implemented across all sites using quality improvement methodology. 
Implementation of this STE program will be monitored for adherence to QI process and for 
improvement in clinical outcomes over the 5 years of the study with the goal to fully implement 
the standard process within the first 18-24 months and allow for 24 months of ongoing follow up. 
EA-SCD participants will be enrolled while still in pediatrics and must spend a minimum of 6 
months and maximum of 12 months in pediatrics to allow them to benefit from the STE 
intervention prior to transfer to adult care where this intervention will continue. Sites will be 
randomized 1:1 to receive peer mentoring or no peer mentoring [PM]. Mentoring will occur 
through a virtual platform and include structured frequent contacts between mentor and mentee for 
a minimum of 30 months. Primary outcome measures include acute care reliance (reductions in 
acute care visits and admissions and increase in ambulatory preventative care). Secondary 
outcomes include improvements in transition readiness, quality of life measures including social 
support, dexterity with self-care, satisfaction with transition experience for EA-SCD participants 
and providers, and improvements in quality of care experienced. 
 
Rationale for Structured Education Based Transition Program [STE]: 
 
Increase in disease knowledge, independence with self-care skills, and improved pediatric and 
adult provider EA-SCD transition support and knowledge is a critical goal of transition readiness. 
Structured patient education increases disease knowledge, provides self-management skills and is 
effective at increasing autonomy, self-efficacy and disease self-management that reduces acute 
complications in juvenile diabetes.16 An education-based intervention tested for feasibility 
revealed twice as many EA-SCD in the intervention arm completing their first adult healthcare 
visit within 3 months of leaving pediatric care.25 Patient education to achieve optimal transition 
readiness will use a standardized module entitled the “Who, What, Where, When, Sickle Cell 
Transition Education Module” or other site standard SCD education.31-34 Each site will be given a 
QI change package that includes details of the Six Core Elements, the QI process training, the 
standard education module, and supplemental resources on QI and Transition. An EA-SCD will be 
identified to become a member of the transition team at each clinical site to provide the patient’s 
perspective during the QI process. 
 
 

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Rationale for Peer Mentoring [PM] as Comparator: 
 
This project will compare the effectiveness of STE+PM over STE alone in improving health 
outcomes in EA-SCD. While most transition coordination models utilize specific education to 
address patient-level barriers to care (medication adherence, disease knowledge, transition 
readiness), they neglect the more complex societal environment within which the EA-SCD must 
navigate independently in adulthood.35 Challenges remain with how to establish, sustain, and 
measure optimal support within and outside the adult medical setting to keep EA-SCD engaged in 
comprehensive care through the trajectory of transition. Health system-based interventions alone 
are inadequate to address all the needs of EA-SCD during transition, particularly with establishing 
social networks outside of healthcare. EA-SCD have also identified isolation as a key challenge as 
they navigate transition and learning from someone who has been through the process is a 
desirable component of a transition program.17, 35 PM targets the social aspects of transitioning and 
helps model better self-management skills. The importance of PM, where an older peer with 
experience provides support and guidance, emerged as a desired approach repeatedly over the past 
year during our dialogue with patient partners. Various studies have confirmed that without 
sustained support, outcomes, e.g., costly hospitalizations and increased complications worsen.36 
PM can effectively sustain support for EA-SCD by reducing isolation and improving community 
engagement and self-efficacy, while modeling independent life skills without the high-cost of 
professional support systems.37 A peer with lived experience that provides support and mentoring 
was considered a desired part of transition coordination by patient partners as it reduces social 
isolation and increases community engagement, while teaching independent life skills. PM 
provides the opportunity for a reciprocal relationship between two individuals with a shared 
experience where the more experienced “mentor” encourages and assists the less experienced 
“mentee” to develop his or her full potential while offering both individuals an opportunity for 
development and growth.37 There is robust literature to support PM in assisting youth in acquiring 
the optimal skills, knowledge and attitudes to be more successful.38 While there is little 
comparative evidence on the efficacy of PM for EA-SCD, previous studies have demonstrated 
improved EA outcomes using PM for juvenile idiopathic arthritis (JIA) and other chronic disease 
groups.39-42 A waitlist pilot randomized control study of EA with JIA “iPeer2Peer Program” 
deployed trained mentors to provide support and self-management education over 8 weeks using 
Skype video calls.39. Fifty percent of pairings completed the intervention, average time on calls 
was twice the required duration (44.72+/- 15.76 min) and participant engagement level was robust 
8.53/10 (range 7-10). The Adolescent Leadership Council (ALC) mentoring program designed by 
Maslow et al used a group mentoring and leadership framework to promote the psychosocial 
development of EA with chronic physical illness focusing heavily on structured mentoring and 
leadership skills.27 Additional studies of PM have been described and support PM as a reasonable 
intervention during transition.41- 45 
 
Patient stakeholders chose a PM program that draws from the “Chronic Disease Self-Management 
(CDSM) Program” in combination with mentoring techniques that focus on the African American 
population.46 The conceptual models considered relied on the need for a deliberate focus that 
points youth toward a more positive and productive future rather than just a buddy system.47-49 Our 
patient stakeholders also requested that mentors be paired with “advisors” who can provide the 
mentors with additional support to reduce burnout in what they referred to as the “village”. 
 

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Rationale for Use of Supplemental Qualitative Methods: 
 
The qualitative portion of the research plan is designed to supplement the original ST3P-UP study 
aims and will be approved as a separate protocol through Georgia Southern University. The 
supplemental qualitative aims will provide a viable and robust approach that will allow for 
evaluation of the study’s processes, quality improvement, impact, and outcomes including: 1) the 
identification of the facilitators and barriers to enrollment of EA-SCD and mentors from multi 
stakeholder perspectives; 2) an assessment of mentor-mentee experiences with one-to-one peer 
mentoring; 3) an assessment of site experiences with the implementation of Quality Improvement 
methods within their clinical practices; 4) a determination of the effect of engagement activities on 
communication within the site triad (adult/pediatric physicians, CBOs, and patients); and 5) the 
development of a definition of transition success across the triad (adult/pediatric physicians, CBOs, 
and patients). 
  
A deeper dive into the lessons learned related to the peer mentoring comparator within the ST3P-
UP study will be gleaned from these supplemental qualitative aims.  
 
Conceptual Model: 
 
Based on the review of the literature on SCD Transition, the bio-psychosocial ecological model 
was identified as the best theoretical framework to address the comparative multi-level 
interventions that are needed to optimize transition outcomes in this population.10,22,38 This model 
proposes that it is necessary to examine an individual’s health by considering the interactions of 
biology, psychology and social factors within the individual’s environment to produce a more 
effective, multi-dimensional approach to chronic disease management. The model removes the 
focus from “microscopic” individual level factors (e.g. adherence, individual conduct) and 
broadens the view of the individual to understand “macroscopic” (communities, health care 
systems, etc.) influences on illness and behavior and allows practitioners to view the individual in 
constant interaction with their environment. Thus, we chose a health system approach to 
improving transition processes within the clinical setting that included individual level education. 
Our hypothesis is that the addition of a PM intervention that influences social interactions and the 
microsystem that touches the EA-SCD will be more effective than a STE-based transition program 
alone in improving acute care utilization. 
 
2. STUDY OBJECTIVES  
2.1 
Primary Objective 
 
The primary objective of this study is to compare the effectiveness of STE+PM versus STE at 
decreasing the number of acute care visits per year over a 24-month period among EA-SCD. 
2.2 
Secondary Objectives 
 

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2.2.1 Patient-Reported Outcomes 
To compare the effectiveness of STE+PM versus STE at improving patient-reported 
outcomes (PROs) among EA-SCD (Appendix A). Surveys used to evaluate PROs will 
include: 
• 
Adults Sickle Cell QOC Measure (ASCQ-ME QOC) for health-related quality of 
life 
• 
PedsQLTM-SCD module for health-related quality of life 
• 
Medical Outcomes Study Social Support Survey (MOS-SSS) 
• 
Transition Readiness Score as measured by the TIP-RFT scale 
• 
Health Care Transition Feedback Survey for Youth and Young Adults 
2.2.2 Healthcare Utilization  
To compare the effectiveness of STE+PM versus STE at reducing healthcare utilization 
among EA- SCD. 
 
Measures to assess healthcare utilization will include: 
• 
The number of acute care visits per year over the entire study period 
• 
The number of ambulatory visits per year over the entire study period 
• 
The number of visits with adult providers over the entire study period 
• 
The number of hospitalization days over the entire study period 
• 
14-day and 30-day readmissions over the entire study period 
2.2.3 Intervention Fidelity (PM Intervention Feasibility) 
• 
Number of consented mentor candidates that complete each step of eligibility and 
training activities 
• 
Timelines for major milestones for mentors 
• 
Time from consent to enrollment for EA-SCDs 
• 
Frequency of mentor-EA-SCD contacts via the platform  
2.2.4 ST3P-UP Application Usage 
• 
Frequency of contacts between study subjects (EA-SCD, Mentor, or Advisor) and 
transition coordinator 
• 
Frequency of contacts between investigators and transition coordinators 
• 
Frequency of contacts between investigators 
• 
Frequency of education resource views from application 
2.3 
Exploratory Objectives 
• 
Evaluate the adoption of and adherence to the Six Core Elements of transition 
practice performance at each site. 
• 
Identify through a modified Delphi process and other qualitative research methods 
the patient and stakeholder determined optimal outcome(s) of transition and 
compare to predetermined outcome of acute care reliance. 
2.4 
Qualitative Research Objectives 
• 
Determine the facilitators and barriers to enrollment of EASCDs and mentors from 
multi stakeholder perspectives. 
• 
Describe mentor-mentee experiences with one-to-one peer mentoring. 

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• 
Assess site triad experiences with implementing quality improvement within their 
clinical practices. 
• 
Determine the effect of engagement activities on communication within the site 
triad (adult/pediatric physicians, CBOs, patients). 
• 
Develop a multi-stakeholder, ecologically focused definition of transition success. 
 
3. SUBJECT SELECTION 
3.1 
Subject Identification and Recruitment 
 
EA-SCD Subject Recruitment 
 
EA-SCD subjects will be recruited at Atrium Health and other participating institutions. 
Recruitment will include patients with SCD 16 to 25 years of age who are currently receiving care 
in a pediatric SCD program. Recruitment will include both males and females, and all race and 
ethnicity classifications. 
 
Mentor Subject Recruitment 
 
Mentor subjects will be recruited at Atrium Health and other participating institutions. 
Recruitment will include individuals with SCD age 26 years or older receiving care from an adult 
SCD provider. Recruitment will include both males and females, and all race and ethnicity 
classifications. 
 
Advisor Subject Recruitment 
 
Advisor subjects will be recruited at Atrium Health and other participating institutions. 
Recruitment will include individuals with SCD age 36 years or older receiving care from an adult 
SCD provider.  Recruitment will include both males and females, and all race and ethnicity 
classifications. 
 
Qualitative Participant Recruitment 
 
Sites will be provided the IRB approved Qualitative Participant Recruitment script to ask 
participants for permission to share their names with Georgia Southern University faculty. 
Participant names will be entered into REDCap (Atrium Health’s Secure Electronic Data Capture 
System). Sites will document a yes/no response from the participant in REDCap.  
 
3.2 
EA-SCD Eligibility 
3.2.1 Inclusion Criteria 
Subject must meet all the following applicable inclusion criteria to participate in this study: 
 

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1. Informed consent signed by subject or parent/ guardian (where applicable) and HIPAA 
authorization for release of personal health information. NOTE: HIPAA authorization 
may be included in the informed consent or obtained separately. 
 
2. Assent will be obtained in appropriately aged subjects per IRB or institutional guidelines. 
 
3. Age ≥ 16 and ≤ 25 years at the time of consent AND being cared for in a PEDIATRIC 
SICKLE CELL PROGRAM 
 
4. Any sickle cell genotype 
 
5. Not known to be currently pregnant 
 
6. Readily available access to a computer with internet and phone 
 
7. Ability to read and understand the English language 
8. Subject is planned to be transferred to an adult sickle cell program within 6 -12 months 
of consent. If an EASCD subject, at a peer mentor site, is reconsented due to a delay in 
matching the EASCD subject must continue to meet eligibility from the date of 
reconsent. 
3.2.2 Exclusion Criteria 
 
Subjects meeting any of the criteria below may not participate in the study: 
 
1. Already receiving one on one peer mentoring as part of a transition program 
2. As determined by the Investigator, uncontrolled undercurrent medical, psychiatric, or 
cognitive condition, or social situation that would limit compliance with study 
requirements: 
• 
pregnant, incarcerated, or otherwise unable to attend all study related visits 
 
• 
lack of easy access to the technology required to complete study surveys (e.g., 
internet in home setting, public area or at local CBO) or to conduct mentoring 
sessions 
  
• 
other factors that would cause harm or increase risk to the participant or close 
contacts, or preclude the participant’s adherence with or completion of the study 
3.3 
Mentor Eligibility  
To be eligible to serve as a mentor, individual must meet all the following applicable inclusion 
criteria to participate in this study: 
 
1. Informed consent signed by subject and HIPAA authorization for release of personal health 
information. NOTE: HIPAA authorization may be included in the informed consent or 
obtained separately. 
 

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2. Be an adult living with SCD who has successfully transitioned to adult care (defined as 
having had at least 3 clinical visits with an adult SCD provider/clinic within the past 24 
months).  
 
3. Age ≥ 26 years old 
 
4. Readily available access to a computer with internet and phone 
 
5. Have completed and passed a background check that reflects no prior convictions with the 
exception of minor traffic violations, parking tickets, and/or any dismissals 
 
6. Ability to read and understand the English language 
 
7. Endorsed by their healthcare provider as reliable and able to meet the physical, 
psychological and cognitive requirements for serving as a mentor 
 
8. Have successfully completed Peer Mentoring University training 
 
There are no exclusion criteria to list. 
3.4 
Advisor Eligibility  
To be eligible to serve as an advisor, individual must meet all the following applicable inclusion 
criteria to participate in this study: 
 
1. Informed consent signed by subject and HIPAA authorization for release of personal health 
information. NOTE: HIPAA authorization may be included in the informed consent or 
obtained separately. 
 
2. Be an adult living with SCD who has successfully transitioned to adult care (defined as 
having had at least 3 documented visits of continuous care with a SCD provider/clinic 
within 24 months. 
 
3. Age ≥ 36 years old 
 
4. Readily available access to a computer with internet and phone 
 
5. Ability to read and understand the English language 
 
6. Endorsed by their healthcare provider as reliable and able to meet the physical, 
psychological and cognitive requirements for serving as an advisor 
 
7. Have successfully completed Peer Mentor University training 
 
There are no exclusion criteria to list. 
 

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3.5 
Qualitative Research Eligibility 
Participants who have been an active member of one of the site triads (adult/pediatric providers, 
community based organization, patient), a mentor or EA-SCD who enrolled in the study, or a 
patient or patient caregiver who interacted with the triad will be eligible to be contacted for future 
qualitative research.  
3.6 
Screen Failures 
A consented subject who, for any reason (e.g., failure to satisfy the eligibility criteria or withdraws 
consent for study participation), terminates his/her study participation before enrollment (as 
defined in section 10.1) is regarded as a “screen failure.” All screen failures will be recorded in the 
ST3P-UP Study REDCap database. 
 
The Sponsor Investigator requests sites to also record pre-screen failures through REDCap.  
Pre-screen failure is defined as a subject that did not sign informed consent but was considered for 
potential study participation. 
4. REGISTRATION AND RANDOMIZATION  
4.1 
Study ID Number Assignment 
Following informed consent, subjects will be assigned a study ID number as determined by the 
Data Coordinating Center. This number will be used to register the participant into the study 
database (REDCap). Sites should complete all screening and baseline study assessments 
accordingly. Subject study assignment numbers will be issued by the DCC once the registration 
form has been uploaded and reviewed for completeness. This process may take up to 72 hours 
therefore sites should continue all study related assessments regardless of study number 
assignment. 
4.2 
Randomization Method and Stratification Factors 
Sites will be randomized in a 1:1 fashion to either the STE+PM arm or the STE arm. To avoid 
cross- contamination, the randomization will be constrained so that the Novant and Atrium Health 
(formerly known as Carolinas Healthcare System) sites will be randomized to the same treatment 
arm. Prior to study activation, the LCI Department of Cancer Biostatistics will perform 
randomization. A stratified block randomization will be utilized, stratifying on site size (large 
[≥ 40 subjects] versus small [< 40 subjects]) to reduce confounding of comparisons between the 
treatment arms. Sites must have subcontracts executed and subjects must be registered and 
consented prior to starting study intervention. The study intervention is not blinded to the subject 
or the investigator. 
5. STUDY PLAN 
See Schema (page IV). 
 
This multi-site, cluster randomized trial is designed to compare the effectiveness of transition 
programs that comprise of structured education-based transition program plus peer mentoring to 
structured education-based transition program alone in improving acute care reliance among EA- 
SCD. Using rapid cycle PDSA we will implement standardized transition processes within clinical 
practices in adherence to the Six Core Elements of transition as positioned by the Got Transition / 
Center for Healthcare Transition Improvement over 18 - 24 months. 

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The combination [STE+PM] intervention will be evaluated to determine if it results in a reduction 
of acute care reliance among EA-SCD and improves patient reported outcomes as measured by 
validated tools specific to the SCD population. 
 
This study will last 5 years and includes at least 24 months of QI work to implement the Six Core 
Elements of transition within pediatric and adult SCD practices. Enrolled subjects will be tracked 
longitudinally for a minimum of 6 months in pediatrics to a minimum of 24 months in adult care 
to determine the impact of adding PM to standard education-based transition programming on 
clinical outcomes. 
 
Enrollment in this study is voluntary and will not impact clinical care. ALL subjects seen at study 
sites may benefit from the QI work that will be offered, regardless of enrollment status on this 
study. 
5.1 
Study Intervention 
5.1.1 Implementing a Structured Education Based Health Care Transition Quality 
Improvement Process [STE] within pediatric and adult SCD clinics 
This intervention will involve incorporating the Six Core Elements of Health Care Transition 
into the pediatric and adult SCD clinics at each clinical site using quality improvement 
strategies. There will be 14 clinical sites enrolled in this trial. Each site is comprised of a 
pediatric SCD clinic, and adult SCD clinic and their partner CBO. Buy-in from both the 
adult and pediatric clinical leadership and the community has been obtained. 
 
A study kick-off meeting will be held to orient all investigators, patient partners and research 
team to study procedures and to begin training on the QI process. Each of the 14 clinical sites 
and their corresponding CBOs will be provided funds to purchase a HIPAA compliant 
electronic tablet to facilitate education and training of site staff, stakeholders and study 
participants. 
5.1.2 Transition QI Objective 
The implementation of the Six Core Elements of health care transition into the clinical 
process will be evaluated every six months to assess the level of adherence to a standard 
process for transition for EA- SCD in both the pediatric and adult SCD clinics. This will be 
measured using a Health Care Transition (HCT) Process Measurement Tool. Specifically, 
sites with higher adherence are considered those with a higher than average score by the end 
of 24 months. 
5.1.3 Starting a Transition Quality Improvement Process Using the Six Core Elements 
of Health Care Transition 
Experience has offered some basic lessons to help start or improve a transition process for 
youth transitioning to adult care. Below are suggested initial steps that are applicable 
whether youth are moving from a pediatric practice and/or pediatric approach to care to an 
adult practice and/or adult approach to care. These are intended for use in pediatric, family 
medicine, medicine-pediatrics, and internal medicine practices (both primary care and 
specialty practices), and health systems. The outlined steps are interrelated and often occur at 
the same time, and the tips for success have been learned from transition improvement 

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21
projects across the United States. Transition tools and measurement resources to accompany 
these suggestions are available at: www.gottransition.org and in the study QI Binder. A 
compendium of resources and open access tools will be provided to each site in the form of a 
Transition QI “Change Package” to support the QI work that sites will be doing. 
5.1.4 ST3P-UP Application 
This mobile app based on both Android and iOS platforms will be deployed to all site 
investigators and their clinical team, as well as all mentors, advisors and transition 
coordinators. This app will provide access to decision support tools to enhance the transition 
experience of all patients as they see their provider. It will provide ready access to the 2014 
National Heart, Lung, And Blood Institute [NHLBI] SCD clinical guidelines and ambulatory 
care clinical pathway for management of SCD according to genotype and age/gender. This 
app will also house the “Who, What, Where, When, Sickle Cell Transition Education 
Module” that can be deployed during clinic visits and other patient encounters to ensure that 
the appropriate educational content is made available to the EASCD patient. An important 
feature of this app is the “Reach Out” feature that allows the ST3P UP site PIs the ability to 
communicate amongst themselves within the protocol network to address specific clinical 
dilemmas and questions in close to real time. In addition, the ST3P UP app allows the 
Transition Coordinators the ability to communicate with ST3P-UP study participants to 
address questions that will facilitate adherence to study procedures and clinical 
appointments. 
 
Table for Structured Transition Program [STE] Collaborative Change Package 
A. Initiating a Transition QI Project 
° 
Raise staff awareness of need for the Structured Transition Program 
✓ Introduction to Six Core Elements 
° 
Establish a Transition team with identified roles 
° 
Introduction to Quality Improvement Process 
✓ Develop an Aim statement 
✓ Understand the PDSA process 
° 
Complete practice assessment or organizational assessment 
B. Professional Education 
° 
Webinar 1 – Care Coordination: Starting a Transition Process 
° 
Webinar 2 – Care Coordination: Transition Preparation 
° 
Webinar 3 – Care Coordination: Transfer to Adult Care 
° 
Webinar 4 – Care Coordination: Integration into Adult Care 
° 
Webinar 5 – Care Coordination: Youth/Young Adult and Parent Engagement 
C. Transition Policy 
° 
Process developed for review of Transition Policy by patient/parent with transition team 
° 
Process developed for sharing Transition Policy with all patients 
° 
Communication with patients and family 
D. Patient Tracking and Monitoring 
° 
Process developed for tracking patients of transition age 
° 
Options (paper checklist, excel, Redcap, EMR) 
° 
What is tracked – demographic, diagnostic data, date received each core element 
E. Readiness Assessment 
° 
Process for administering TIP-RFT 
° 
Review TIP-RFT 

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F. Transition Planning 
° 
Goal setting based on TIP-RFT readiness assessment tool 
° 
Start updating the Transition Summary 
° 
Prepare youth for adult approach to care – should start at age 18y 
° 
Transition Checklist 
° 
Provide links and resources for insurance, emergency care plan, legal documents, etc. 
G. Transfer of Care 
° 
Confirm date for first adult provider appointment 
° 
Complete Transfer package 
° 
Confirm appointment was made 
H. Transfer Completion 
° 
Ensure ongoing adult follow up every 3 months for up to 24 months 
° 
Contact young adult regularly to confirm transfer occurred and remains in adult care 
° 
Communicate with adult practice confirming completion of transfer process and help as needed 
° 
Build ongoing collaborative relationship with adult practice  
 
5.1.5 Implementation of a Virtual Peer Mentoring Program for EA-SCD at sites 
randomized to Peer Mentoring 
The PM Arm of the study will be supported using technology via the InquisitHealthTM 
Mentor 1to1TM platform. InquisitHealthTM Mentor 1to1TM is a full-service virtual 
mentoring platform vendor focused on improving clinical outcomes of high risk, high cost 
patients by connecting them to peer mentoring support that is standardized and structured 
without burdening resources. Mentor 1to1TM will be used to connect mentors to mentees and 
will be the sole method for conducting the secure mentor-mentee communication required 
for the study. 
 
The Peer Mentoring program is a telephone-based health coaching intervention. The program 
pairs emerging adults transitioning from pediatric to adult care with mentors who themselves 
have successfully navigated their own transitions in the context of SCD. Through Mentor 
1to1TM, the mentee and mentor arrange a time to speak via the platform on a regular basis 
and can also securely communicate via text messages within the platform. During the phone 
calls, trained and supervised mentors guide mentees through adaptive behavioral changes 
specific to SCD transition. 
 
Peer Mentoring Platform Structure: We will utilize a virtual mentoring platform called 
Mentor1to1TM. The Mentor1to1TM platform creates the foundation for effective, scalable 
delivery of 1-on-1 peer mentoring. It is a HIPAA-compliant 1-to-1 Mentoring Platform that 
provides a variety of tools that allow mentors to communicate with their mentees (via 
phone/SMS) while they also effectively manage mentee-mentor relationships and track their 
mentee’s progress. The platform was built with two purposes in mind: bring maximum 
efficiency to mentors while using insights and data to tailor the mentoring journey for each 
mentee - all in a secure shell. Mentor1to1TM provides two platforms that facilitate the 
mentoring process: 
 
• 
 Administrator Platform: The administrator platform will be used by the study 
project manager or designee to track advisor-mentor chat messages and mentor-mentee 
phone calls for quality assurance and ongoing training purposes. The study project 

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manager or designee will monitor advisor-mentor and mentor-mentee assignment ratio to 
ensure it remains consistent with protocol requirements. Individual sites will not be 
allowed to access the administrator platform. 
 
• 
 Mentor Platform: The mentor platform will be used by advisors, mentors, and 
mentees for all advisor-mentor and mentor-mentee communication. Advisors will use the 
platform to accept mentor assignments and send messages via the chat feature to the 
mentors. Mentors will use the platform to accept mentee assignments, initiate phone calls 
with mentees, and to access a list of suggested talking points geared to improve disease 
self-management. The mentor platform also allows advisors and mentors to complete 
escalation forms for issues that go beyond their scope or comfort (e.g. medication 
supply/cost, gaps in/loss of insurance coverage, stress/mental health, etc.). The DCC will 
be notified by InquisitHealthTM and will have 72 business hours from this time to inform 
the appropriate clinical site. For urgent needs, the mentor is advised to instruct the mentee 
to call their provider or 911. Individual sites will not be allowed to access the mentoring 
platform. 
5.1.6 Peer Support for Mentors from dedicated “Advisors” 
At the request of the community, we have incorporated the concept of “Advisors” into this 
PM program. An Advisor is an older individual living with SCD who has also successfully 
navigated the transition into adult care and who provides support to the Mentors enrolled in 
this project. 
 
The Advisor Arm of the study will be supported using technology via the InquisitHealthTM 
Mentor 1to1TM platform to enroll and train advisors (similar to the mentor training but 
without practice calls). Mentor 1to1TM will be used to connect advisors to mentors and will 
be the sole method for conducting the secure 1:1 advisor-mentor communication required for 
the study. Through Mentor 1to1TM, the advisor can send secure messages to their assigned 
mentor using the chat feature within the platform on, at least, a monthly basis. The purpose 
of this communication is to offer additional support and encouragement for the mentor as 
they proceed along their mentoring journey. 
5.2 
Procedures for Standardizing PM Implementation at Each Site 
Peers are individuals who share some common characteristics, attributes or circumstances. These 
may relate to age, ability, interests, etc. Peer mentors are individuals who have more experience 
within a common area along with additional training in how to assist another in acquiring skills, 
knowledge and attitudes to be more successful. Peer mentoring is a process through which a more 
experienced individual encourages and assists a less experienced individual to develop his or her 
potential within a shared area of interest. 
5.2.1 Mentor / Advisor Recruitment Strategies 
Recruitment strategies used in this project will include: 
• 
Direct contact by site transition coordinator 
• 
Promotion of the project within CBOs, adult clinics, etc. using recruitment 
flyers including using social media. 
• 
Distribution of IRB-approved recruitment material provided by the Sponsor by 
direct email, via US mail, or in-person at community events. 
• 
Contacting hematology colleagues to explain the project and seek referrals 

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• 
Giving presentations to student or community groups, conferences and other 
venues 
• 
Contacting individuals with SCD with prior interest in peer support projects 
5.2.2 Identifying Mentors/Advisors 
Clinical sites will identify mentors and advisors via a collaborative effort between the site’s 
pediatric and adult SCD clinics and the affiliated community-based organization (CBO) 
during the enrollment phase of the study. Clinical and CBO staff will determine if identified 
mentors/advisors are interested in participating in the project and the potential 
mentor/advisor will be referred to their partner adult SCD Clinic for consenting, eligibility 
verification and enrollment onto study (if their partner clinic is randomized to be a peer 
mentoring site). If their partner adult SCD clinic is not randomized to peer mentoring, the 
potential mentor/advisor will be referred to the DCC, who will then refer them to an 
appropriate peer mentoring site for completion of consent and eligibility verification. CBOs 
and pediatric clinics will not be consenting mentors/advisors. Once a potential 
mentor/advisor has been consented, eligibility will be confirmed (including a background 
check for mentors). Checkr™ is a company that provides modern and compliant background 
checks for InquisitHealthTM, and, once cleared and deemed eligible, potential mentor/advisor 
will be enrolled and scheduled for formal orientation and training. Cleared and deemed 
eligible is defined as having no prior convictions with the exception of minor traffic 
violations, parking tickets, and/or any dismissals. The DCC will communicate the pass/fail 
result of the background check to the appropriate peer-mentoring site. Training for mentors 
and advisors will include orientation to the Mentor1to1TM Platform. 
5.2.3 Mentor/Mentee and Advisor/Mentor Matching 
A mentor’s experience with managing their disease supported by a written endorsement 
recommendation by an adult sickle cell provider will be a consideration in being selected to 
participate in this project as a mentor. Similarly, an advisor’s experience with managing their 
disease supported by a written endorsement recommendation by an adult sickle cell provider 
will be a consideration in being selected to participate in this project as an advisor. 
 
Matching of mentors to mentees will be facilitated via the Mentor1to1TM platform, with 
matching based on age (at least 5-year age difference between mentor/mentee), availability 
for scheduling mentoring phone calls, and mentee’s gender preference as indicated in the 
informed consent form (ICF). 
 
Matching of advisors to mentors will be facilitated via the study EDC (REDCap) platform, 
with matching based on age (at least 5-year age difference between advisor/mentor, unless 
the mentor is greater than 40 years of age) and availability for taking on an additional mentor 
as indicated in the ICF. Matching of advisors to mentors will not be facilitated via the 
Mentor1to1TM platform with oversight from the DCC, however all contact between advisors 
and mentors will be only through the Mentor1to1TM platform. 
 
To reduce the potential for mentor / mentee or advisor/ mentor communication outside of the 
platform, mentees will be matched to mentors outside of their local site and mentors will be 
matched to advisors also outside of their local site. 
 

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25
•Mentors will be assigned mentees based on a mentor:mentee ratio of up to 1:3 at any point 
in time, and mentorship will continue until the end of study. The Mentor1to1TM platform and 
study EDC platform will track the number of assigned mentees to each mentor and only add 
an additional mentee when review of mentoring progress shows that mentor is comfortable 
and successful in working with current mentee(s) with capacity to add another. 
 
• Should a mentee go off study prior to end of study, the mentor will have 
availability to be assigned a new mentee. 
• Should a mentor go off study prior to end of study, the mentees assigned to 
that mentor will be reassigned to another mentor. 
• If a mentor is unable to continue with their study related activities, an 
alternate mentor will be recruited. 
• Should a mentor be consented, but not initiate training within 30 days 
and/or complete training within 60 days of consent, he/she will be deemed a 
screen fail.  
• Should a mentor consent to study but fail to be enrolled within 90 days 
consent or reconsent he/she will be deemed a screen fail.  
• Reconsent will be obtained according to Advarra IRB’s policy.  
 
•Advisors will be assigned mentors based on an advisor:mentor ratio of up to 1:5 at any point 
in time, and mentorship will continue until the end of study. Advisors will communicate with 
their mentors at least once monthly through the platform. The study EDC platform will track 
the number of assigned mentors to each advisor and only add an additional mentor when 
review of advisor ratio is under the maximum allowed of 1:5. 
 
• Should a mentor go off study prior to end of study, the advisor will have 
availability to be assigned a new mentor. 
• Should an advisor go off study prior to end of study, the mentors assigned to 
that advisor will be reassigned to another advisor. 
• If an advisor is unable to continue with their study related activities, an 
alternate advisor will be recruited. 
• Should an advisor be consented to study, but not initiate training within 30 
days and/or complete training within 60 days of consent, he/she will be 
deemed a screen fail.  
• Should an advisor consent to study but fail to be enrolled within 90 days of 
consent or reconsent, he/she will be deemed a screen fail. 
• Reconsent will be obtained according to Advarra IRB’s policy. 
5.2.4 Mentor/Advisor Training 
Once mentors /advisors are recruited and deemed eligible they will be scheduled to receive 
8- 10 hours of structured virtual training that will be conducted via the Peer Mentor 
University platform. The virtual training is expected to be completed in no more than 3 
weeks (+/- 1 week) from enrollment. Once this virtual training is complete, the mentor / 
advisor will then be trained on how to access and use the Mentor1to1TM platform to make the 
required mentoring contacts via telephone (mentors to mentees only) and contacts via SMS 
messaging (required for all advisor and mentor contacts). SMS messaging can be used as a 
supplementary resource for mentor to mentee contacts). Mentors will receive an automated 

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26
email from InquisitHealthTM to establish an account which prompts them to proceed with 
platform training. 
 
Mentor/advisor education material specific to SCD have been created for use with the 
Mentor1to1TM platform and was prepared in line with evidence-based “Elements of 
Effective Practice for Mentoring” prepared by the National Mentoring Partnership (Elements 
for Effective Practice for Mentoring, 2015) following the guidelines provided in Chronic 
Disease Self-Management (CDSM) program. 
 
Mentor contact via telephone calls (and supplemental SMS messaging) will be monitored 
and evaluated through the Mentor1to1TM Administrator Platform. Calls between mentors and 
mentees will be recorded and monitored periodically for quality assurance. All transcripts of 
mentor–mentee supplemental communication via SMS messaging through the platform will 
also be available for review for quality assurance by platform administrator. 
 
Mentors will initially be assigned 1 mentee and will complete 1-2 calls with their mentee. 
These initial calls will be monitored retrospectively by the platform administrators or 
designee to determine adherence to talking points, quality of mentorship, and to determine 
any areas of improvement for the mentor. Based on completion of at least four Mentor-
Mentee calls, Mentors will be evaluated and assigned additional mentees (up to a maximum 
of 3) or a plan for improvement in mentoring skills.  
 
• Mentors are expected to have at least 4 calls within a calendar month with mentees 
during the first 3 months after enrollment.  
• Once a total of 12 calls have been completed AND at least 3 months have elapsed 
since enrollment, mentors are expected to have at least 2 calls per calendar month 
with mentees until the completion of the study.  
• This call frequency will be used for both prospective evaluation and retrospective 
data to help define potential deviations.  
 
In rare cases, it may be determined that the individual is not a good fit for the role of a 
mentor. In these cases, the individual will be provided with feedback and will be disenrolled 
from the platform by the administrator. 
 
• Advisor contact with a mentor via SMS messaging through the platform will be 
expected to occur at least monthly but may occur more often based on the 
relationship built between advisor and mentor. All advisor to mentor 
communication transcripts will be available for review for quality assurance by 
platform administrator. 
• Supplemental mentor / advisor training will be provided virtually and facilitated by 
the partner CBO and/or will occur during the annual PM conference. Supplemental 
mentor / advisor training will occur within 6 mo (+/- 1 mo) of initiation of 
mentoring role (defined as first mentor-mentee or advisor-mentor call). 
 
Annual refresher training will be provided at the PM conferences (either in-person or 
virtually) to all mentors and advisors. 
 

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27
Virtual supplemental training will also be available if mentors and advisors are not able to 
attend the annual PM conferences. 
5.2.5 Mentor – Mentee and Advisor – Mentor Communication 
Participants will ONLY communicate using the Mentor1to1TM application via a laptop or 
desktop computer. Each participant will be asked to create a unique password to access the 
application. 
 
The Mentor1to1TM web-based application software uses two-way line-bridging technology 
and text messaging to facilitate peer mentoring relationships. The system uses a generic 
phone number to call the mentor and mentee separately then bridges the line together. Phone 
numbers are not exchanged between the mentee and mentor, and thus calls are not possible 
during non-scheduled times. Mentees can respond to phone calls from their mentor through 
the system generated phone number; they will be prompted to leave a voice message that is 
delivered to the mentor. 
• Mentors are expected to have at least 4 calls within a calendar month with mentees 
during the first 3 months after enrollment.  
• Once a total of 12 calls have been completed AND at least 3 months have elapsed 
since enrollment, mentors are expected to have at least 2 calls per calendar month 
with mentees until the completion of the study.  
• This call frequency will be used for both prospective evaluation and retrospective 
data to help define potential deviations.  
• Advisors should have contact with mentors monthly. 
• Automated phone calls may be generated by Mentor1to1TM platform to the 
mentees if they become hard to reach. Similar alerts are sent to the mentors if they 
have not made their required mentoring contacts and/or have incomplete mentoring 
workbooks after a mentoring call. Structured responses, as appropriate will be sent 
with specific instructions (best time to call, etc.). 
5.2.6 Mentor/Advisor Retention 
CBOs will be responsible for engaging mentors/advisors in activities such as Community 
Advisory Board Meetings, community engagement activities and support groups. 
• Mentors will be assigned advisors to provide ongoing support and to help reduce 
mentor burnout. 
• Mentors and advisors will be invited to attend an annual mentor conference to 
provide ongoing education and training, improve the mentoring experience, and 
enhance mentor and advisor retention. The annual mentor conference will occur 
every year until the end of the study 
5.2.7 Mentor/Advisor Compensation 
If permitted under applicable regional laws or regulatory guidelines, mentor/advisors may be 
reimbursed for time and effort directly related to their role and responsibilities as outlined in 
the ICF. 
5.3 
Study Outcome Measures 
Study-related surveys will be completed on paper, administered via study-supplied iPad or tablet 
either within a healthcare setting or sent electronically to the EA-SCD participants via a link 

Protocol: LCI-HEM-SCD-ST3P-UP-001 
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28
through REDCap by email. EA-SCD participants will be encouraged to access their ongoing study 
assessments online, or on paper either at home or during a scheduled study-related clinic visit to 
optimize study data capture. 
5.3.1 PedsQLTM Sickle Cell Disease Module 
The PedsQLTM Sickle Cell Disease Module 3.0 comprises 6 domains and was derived from 
qualitative methods involving patient/parent interviews and expert opinion across multiple 
sites and has been validated for use in the evaluation of SCD specific health related quality 
of life in research and clinical practice.50 This 43-item scale measured on a 5-point Likert-
type scale shows excellent feasibility, excellent reliability for the Total Scale Scores (patient 
self-report α = 0.95; parent proxy- report α = 0.97), and good reliability for the nine 
individual scales (patient self-report α = 0.69–0.90; parent proxy-report α = 0.83–0.97). 
5.3.2 ASCQ-Me QOC 
Adult sickle cell disease care poses significant challenges resulting from poor access to 
knowledgeable providers and suboptimal treatment in the Emergency departments. The 
ASCQ-Me quality of care measure was developed to assess the quality of ambulatory and 
emergency department care experienced by persons living with SCD. The SCD quality of 
care survey questions were developed and pilot tested in 557 patients using methodology 
consistent with the Consumer Assessment of Healthcare Providers and Systems survey. This 
measure is useful in documenting and tracking disparities in quality of care for SCD. 51 
5.3.3 Sickle Cell Transition Intervention Program – Readiness for Transition (TIP-
RFT) Assessment 
The Sickle Cell TIP-RFT instrument was developed to provide a validated SCD specific 
readiness for transition assessment tool with established reliability for routine use in the 
clinical domain.17 The current TIP-RFT has 4 subscales and 54 items that quantifies 
knowledge, skills and attitudes necessary for a successful transition from pediatric to adult 
care.16,52 The domains assessed include knowledge and skills in medical self-care, social 
support, health benefits, independent living and educational/vocational skills. The TIP-RFT 
assessment will be used to guide interventions to improve transition readiness and can 
provide a foundation for future research on other variables that might be associated with 
transition readiness. 
5.3.4 Medical Outcomes Study – Social Support Scale (MOS-SSS) 
The Medical Outcomes Study - Social Support Survey (MOS-SSS) was developed as a brief 
multidimensional social support survey for persons living with chronic illness.53 MOS-SSS 
assesses support ranked on a 5-point Likert-type scale along four dimensions, emotional 
/informational, tangible, affectionate, and positive social interaction, to give an overall 
functional social support index.53 
5.3.5 Healthcare Transition Feedback Survey for Youth/Young Adult 
This survey will provide feedback information on the experiences of youth and young adults 
with the transition process. This 13-question survey solicits EA-SCD subject-reported 
feedback on their clinical experiences while in the process of transition from a pediatric SCD 
clinic to an adult SCD clinic. 

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29
5.3.6 Health Care Transition (HCT) Process Measurement Tool 
To determine the level of improvement in a practice with adherence to the Six Core 
Elements, each pediatric and adult practice will be scored according to whether some or all 
of the implementation steps have been completed using the HCT Process Measurement Tool 
developed by GotTransition.org. Scores for each step will vary depending on complexity or 
importance. Each practice will be scored every six months to determine the degree to which 
they move closer to adherence to the desired standardized clinical practice pattern. 
 
 
 
 
 
 
 

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30
 
6. STUDY CALENDAR 
6.1 
Site Level Quality Improvement Calendar 
Site Level Quality Improvement 
Study Month 
Baseline 
3 6 9 
12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60 
Health Care Transition Process 
Measurement Tools (Pediatric Clinic) 
● 
Every 6 months 
Health Care Transition Process 
Measurement Tools (Adult Clinic) 
● 
Every 6 months 
Satisfaction with Transition Services 
(Provider) 
● 
Annually 
 
6.2 
Site Level Advisor/Mentor Calendar 
Site Level Peer Mentoring 
Study Month 
Screening 
Baseline 
1 2 
3 
6 9 
12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60 
Informed Consent 
• 
Determine Eligibility 
• 
Demographics/Disease 
Characteristics 
• 
Mentor Role Training 
• 
• 
Advisor/Mentor sign W-8 or W-9 
Form 
• 
 
• 
 
 
 
 Distribution of Greenphire Clincard 
 to Advisor/Mentor                
• 
 
• 
Train on Mentor 1to1 Platforma 
• 
Test Mentor-Mentee call(s)b 
• 

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31
Assign Menteec 
• 
Supplemental mentor/advisor in 
person trainingd 
Mentor- Mentee Contacts 4 times 
a month for first 3 monthsc 
• • 
• 
Mentor- Mentee Contacts 2 times 
per monthc 
Mentor contacts Mentee 2 times per month starting in month 4 
Advisor- Mentor contacts monthly 
Advisor contacts Mentor monthly throughout study 
Attend CBO Engagement Activitya 
Attend bi-annual CBO engagement activities and CAB meetings 
Annual Refresher Traininge 
PM Sites 
Only 
Annual beginning in year 2 
a -  Mentor training must be initiated within 30 days of consent and training must be complete within 60 days of consent. 
b - Test or “mock” Mentor -Mentee call(s) will be done through the platform with a DCC designee as part of initial Mentor/Advisor Training. 
c - Additional mentees may be added, as appropriate up to a maximum of 3 per mentor at any given time, after completion of at least four Mentor-
Mentee calls or DCC approval of additional mentee.  Mentors are expected to have at least 4 calls within a calendar month with mentees during the 
first 3 months after enrollment. Once a total of 12 calls have been completed AND at least 3 months have elapsed since enrollment, mentors are 
expected to have at least 2 calls per calendar month with mentees until the completion of the study. 
d - Supplemental mentor / advisor training at the partner CBO /PM conference will occur within 3 mo +/- 1 mo after mentoring has started. This can also 
be provided via 1:1 virtual training by the DCC consultant 
e - Mentors and advisors will be invited to participate in an annual mentor/advisor conference, but attendance is optional; for those 
unable to attend, and virtual training will be available. 
 
 
 
 
 
 
 
 
 
 

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32
6.3 
EA-SCD Participant Level Assessment Calendar 
EA-SCD Participant Level Assessment Calendar 
Study Month 
Screening 
 
Baseline 
 
 
 
3 
 
 
 
6 
 
 
 
9 
 
 
 
12 
 
 
 
15 
 
 
 
18 
 
 
 
21 
 
 
 
24 
 
 
 
27 
 
 
 
30 
 
 
 
33 
 
 
 
36 
 
 
 
39 
 
 
 
42 
 
 
 
45 
 
 
 
48 
 
 
 
51 
 
 
 
54 
 
 
 
57 
 
 
 
 60 
 
 
Off 
Study 
All Sites 
Peer 
Mentor 
Sites 
Only 
Eligibility Screening 
● 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Informed Consent 
/ Assent 
● 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics/Disease 
Characteristicsa 
● 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
● 
Mentor Matchingb 
●g 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Acute and Ambulatory 
Care Visit Data Collectionc 
 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
Transition 
Education 
Intervention Q3 
 
•h 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
PedsQL-SCD Module 
 
•h 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
● 
MOS-SSS 
 
•h
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
● 
TIP-RFT 
 
•h
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
● 
ASCQ-ME QOC 
 
•h
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
 
● 
● 
Health Care Transition 
Feedback Survey 
for Youth/Young 
 
•h 
 
 
 
 
● 
 
 
 
 
● 
 
 
 
 
● 
 
 
 
 
● 
 
 
 
 
● 
 
● 
ST3P-Up App 
Downloade 
 
Downloadf ● 
● 
● 
● 
● 
● 
● 
● 
● 
● 
● 
● 
● 
● 
● 
● 
● 
● 
● 
● 
● 
a - Demographic information collected at baseline will be re-assessed at end of study for updates and/or changes 
b - During screening, EA-SCD subjects are required to provide their day/time availability for peer mentoring calls to facilitate mentor matching. These 
subjects MUST be matched to a mentor prior to administering baseline surveys 
c - Ambulatory and acute care visits will be collected for the preceding 12 months (a month is defined, numerically, as 30.4375 days, and visit windows are 
based on the date of enrollment). Ambulatory visits will include visits within the healthcare setting, primary care visits, and virtual visits via telephone 
ONLY. Acute care visits may include, but are not limited to ED, urgent care, day hospitals, infusion centers, and hospital admissions. 
d - Study visits will occur with a +/- 4 weeks window for q3mo visits. EA-SCD subject must be seen by their SCD provider during these visits. However, 
these visits may occur in other locations within the healthcare setting where SCD care is provided or virtually as long as required structured and targeted 
transition education is provided  

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33
e - ST3P-UP App contains “Who, What, Where, When” Sickle Cell Transition Education Modules that are required for 3-month visits.  If app is not available, 
the education modules are provided to the sites in the QI Change Package and via PowerPoint from the DCC.  Alternatively, sites can utilize any standard 
SCD education module. 
f - Patients are encouraged but not required to download the ST3P-UP App. Directions to access the ST3P-UP app and instructions for use will be provided to 
participants by local site Transition Coordinators. Transition Coordinators are encouraged to use study- provided tablets and/or iPads to facilitate follow- up 
visit adherence communication and for structured transition education. 
g - For PM sites, mentee availability should be captured in the REDCap database at the time of consent. For subjects with delayed enrollment, confirmation of 
availability should be revisited at the time of Mentor-Mentee matching. 
h - Every effort should be made to complete the baseline survey within a healthcare setting but if administration occurs via survey link, this must be provided 
to the participant within 72 hours from the date of consent (for the STE arm) or from the date of match (for the PM arm). The survey link will expire within 2 
weeks of receipt. If the survey remains incomplete after two weeks, please discontinue efforts to contact the participant for completion of the baseline survey. 
 
 
 
 
 

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34
6.4 
Schedule of Assessments 
6.4.1 Screening  
Subjects who consent for participation and meet the eligibility criteria for enrollment into 
this study will undergo the following screening assessments (See Section 3.2 for additional 
details on assessments): 
 
• Collection of baseline demographic and disease characteristics: 
o Date of birth 
o Age 
o Race 
o Ethnicity 
o Gender 
o Sickle cell genotype 
o Zip code of residence (for urban vs rural residency status) 
o Presence of a sibling, parent, or child (first degree relative) with SCD 
o Academic achievement 
o Disability status 
o Marital status 
o Employment status  
o Living arrangement  
o Household income 
  
• Mentor matching (Peer Mentoring sites only) 
o Mentee day/time availability information capture 
o Match facilitated through the Mentor1to1TM platform 
6.4.2 Baseline 
Subjects who are enrolled into this study will undergo the following baseline assessments 
(See Section 3.3 for additional details on assessments): 
 
• SCD Provider Clinic Visit 
• Historical Healthcare Utilization Data Collection: acute care utilization history (ED/ 
urgent  
• care visits and hospital admissions) and ambulatory visits (SCD provider and Primary 
Care provider) in the preceding 12 months from the date of enrollment 
• TIP-RFT 
• MOS-SSS 
• ASCQ-Me QOC 
• PedsQL-SCD Module 
• Health Care Transition Feedback Survey for Youth/Young Adults 
6.4.3 Every 3 months after enrollment 
• SCD Provider Clinic Visit 
 

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35
A Study Visit will be defined as a touch point with the healthcare team (either in 
person or virtually) during which the participant receives the structured transition 
education intervention. The education can be shared with a participant during the 
virtual visit and providing review or sharing the educational tools via email and 
requesting a response in review of the information. 
   
• Healthcare Utilization Data Collection: acute care utilization history (ED/urgent care 
visits and hospital admissions) and ambulatory visits (SCD provider and Primary Care 
provider) in the preceding 3 months 
 
• “Who, What, Where, When, Sickle Cell Transition Education Module” and/or 
other sickle cell structured transition education will be shared with the patient either 
during a SCD clinic visit, at other locations where care is received within the 
healthcare system or virtually every 3 months to ensure ongoing structured transition 
education support. 
6.4.4 Every 6 months after enrollment 
 
• 
TIP-RFT 
• 
MOS-SSS 
• 
ASCQ-Me QOC 
• 
PedsQL-SCD Module 
6.4.5 Every 12 months after enrollment 
 
• 
Health Care Transition Feedback Survey for Youth/Young Adults 
6.4.6 End of Study 
 
• 
Demographic update: any change in participant’s demographics (e.g. zip code 
of residence, presence of a sibling, parent or child with SCD, academic 
achievement, disability status, marital status, employment status, living 
arrangement, and household income) 
• 
Healthcare Utilization Data Collection: acute care utilization history (ED/ 
urgent care visits and hospital admissions) and ambulatory care visits (SCD 
provider and primary care provider) in the preceding 3 months 
• 
TIP-RFT 
• 
MOS-SSS 
• 
ASCQ-Me QOC 
• 
PedsQL-SCD Module 
• 
Health Care Transition Feedback Survey for Youth/Young Adults 

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36
6.5 
Schedule of Assessments (Mentors/Advisors) 
6.5.1 Screening 
Subjects who consent for participation and meet the eligibility criteria for enrollment into 
this study as mentors or advisors will undergo the following screening assessments (See 
Section 3.4 for additional details on assessments): 
 
• 
Date of birth 
• 
Race 
• 
Ethnicity 
• 
Gender 
• 
Sickle cell genotype 
• 
Zip code of residence (to determine urban or rural residency status) 
• 
Presence of a sibling, parent, or child (first degree relative) with SCD 
• 
Academic achievement 
• 
Disability status 
• 
Marital status 
• 
Employment status 
• 
Living arrangement 
• 
Household income 
• 
Age at transfer to adult care 
• 
Type of SCD adult provider (primary care versus specialty) 
• 
Mentor matching (Peer Mentoring sites only) 
• 
Advisor matching (Peer Mentoring sites only) 
 
6.5.2 Study Completion 
 
• 
Demographic update: any change in participant’s demographics (e.g. zip code 
of residence, presence of a sibling, parent, or child with SCD, academic 
achievement, disability status, marital status, employment status, living 
arrangement, and household income). 
6.6 
Schedule of Assessments – Quality Improvement (All Clinical Sites) 
6.6.1 Baseline QI Assessment 
• 
Health Care Transition Process Measurement Tools: 
o For Transitioning Youth to Adult Healthcare Providers (pediatric clinics) 
o For Integrating Young Adults to Adult Healthcare Providers (adult clinics) 
 
• 
Provider Satisfaction with Transition Programming Feedback survey 
6.6.2 Monthly QI Activities After Baseline Assessment 
• 
Site Transition Team will meet monthly to work on implementing the Six 
Core Elements of transition 
• 
Sites will attend monthly coaching calls hosted by the study QI team 

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37
• 
Sites will be directed to submit their progress on QI initiatives (specifically 
monthly chart audits on the number of completed readiness basement and 
emergency care plans) once they have completed the training on QI data 
collection 
• 
Sites will participate in ongoing Community Advisory Board meetings with 
local Community-Based Organization per CBO required calendar. 
6.6.3 Every 6 months QI Assessment 
• Health Care Transition Process Measurement Tools 
o For Transitioning Youth to Adult Healthcare Providers (pediatric clinics) 
o For Integrating Young Adults to Adult Healthcare Providers (adult clinics) 
 
• A formal ST3P-UP study site visit by the coordinating center’s QI team will be 
done with each site to review progress and support QI initiatives in addition to 
reviewing overall study progress as the site. This may be either in person or 
virtually. 
6.6.4 Every 12 months QI Assessment 
• 
Provider Satisfaction with Transition Programming Feedback survey is 
administered annually 
 
7. REMOVAL OF SUBJECTS FROM STUDY 
7.1 
Off Study 
Subjects may stop their participation in this study at any time if they no longer wish to 
participate, or if the investigator believes this to be in the best interest of the subject. When 
subjects are removed from the study, the reason for study removal and date the subject was 
removed should be documented in the ST3P UP REDCap database. Reasons a subject may be 
removed from study include, but are not limited to: 
 
• 
Subject non-compliance with study participation, in the opinion of the investigator 
• 
The subject or legal representative (such as a parent or legal guardian) withdraws study 
consent 
• 
The subject is lost to follow-up 
• 
Study completion 
• 
Investigator’s decision to withdraw the subject 
• 
Subject death 
 
Subjects who have been lost to follow-up for a period without three documented follow up 
attempts, should be transitioned off study due to lack of compliance with the study required visits 
per protocol. The off-study date should be documented in the EDC as the day the PI deems the 
subject as coming off study. This date must correlate with the end of available utilization data 
after every effort has been made to collect and enter available utilization and survey data. In the 
event of discrepancy between the documented consecutive attempts to reach the patient and 
utilization data, please review the data with the DCC PIs to ensure the most appropriate date for 

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38
lost to follow up is documented.  HIPAA guidelines must be followed. A copy of all 
communication sent to the subject will be maintained in the research chart. 
   
Subjects that are off study will not participate in future or additional study-related procedures, 
including data collection. 
 
Subjects who remain enrolled at the completion of the funded project will be off study on the 
date of study completion. 
 
Subjects that are consented (but not enrolled on study) and withdraw participation will not be 
required to complete the end of study CRF. Documentation of study withdrawal should be 
maintained in the research chart.  
7.2 
Special Considerations 
 
• 
Pregnancy: If pregnancy should occur post enrollment, the site PI should consult with 
the Sponsor to determine if the subject should continue to participate in the study. 
• 
Subject Relocation: If subjects relocate away from a study site, the site PI should 
consult with the sponsor  to determine the impact this will have on the subject’s 
continued study participation. 
• 
Other Forms of Mentoring: As part of this project, clinical sites cannot implement 
concurrent 1:1 mentoring program for patients in their practice regardless of site 
randomization status. Partner CBOs also cannot implement 1:1 mentoring for their 
clients with SCD. Many sites offer group mentoring activities such as support groups, 
girl/guy talks, etc. This is acceptable regardless of sites’ randomization status. 
• 
The use of Community Health Workers (CHW) is also common practice among CBO 
partners and is commonly used in clinical care. Therefore, with the exclusion on 1:1 
mentoring, CHW can serve as a source of support for SCD clients regardless of 
randomization status. 
  
8. DATA AND SAFETY 
8.1 
Safety Monitoring 
This protocol will be monitored according to the processes in effect for all LCI investigator-
initiated studies and the protocol-specific monitoring plan and will abide by standard operating 
procedures (SOPs) set forth by both Atrium Health (formerly known as Carolinas Healthcare 
System) Office of Clinical and Translational Research and LCI (and/or other participating 
institutional SOPs). It is the responsibility of the Sponsor-Investigator to monitor any safety data 
(i.e., unanticipated problems/potential risks, as per Section 9, regularly to monitor subject 
consents, enrollment and retention, safety data, and validity/integrity of the data. Documentation 
of these meetings will be kept with the study records. The LCI Data and Safety Monitoring 
Committee will provide central monitoring oversight for this study. This will be performed under 
the auspices of the LCI Data Safety Monitoring Plan. The Sponsor-Investigator will submit data 
to the LCI Data and Safety Monitoring Committee as required. 

Protocol: LCI-HEM-SCD-ST3P-UP-001 
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39
8.2 
Data Monitoring 
This study will be organized, performed, and reported in compliance with the study protocol, 
SOPs of the LCI and Atrium Health (formerly known as Carolinas Healthcare System) Offices of 
Clinical and Translational Research (and/or other participating institutional SOPs), and other 
applicable regulations and guidelines (e.g. ICH GCP). 
 
Subjects will be monitored by each participating institution, as per their guidelines and policies. 
The LCI Research QA Department and the DCC will maintain central oversight. Data from this 
study will be collected on paper and/or electronic case report forms (eCRFs) and from study-
specific applications. Monitoring will be done by comparing source documentation to the eCRFs. 
Any variation between the two data sets will be discussed with the Investigator and/or other 
study team members as appropriate. Investigators and their relevant personnel must be available 
during the monitoring visits and must allocate enough time to be devoted to the monitoring 
process. 
 
Levine Cancer Institute (of Atrium Health, formerly known as Carolinas Healthcare System) will 
be the central data coordination and monitoring center for this study and will provide monthly 
progress reports to the Scientific Oversight Group. This will include monitoring of enrollment, 
derivation of study endpoints, data logic checks, assessment of data missingness, attrition, and 
safety. Importantly, ongoing estimation and monitoring of the coefficient of variation of site 
enrollment size will be conducted. This will allow risk-mitigating adjustments to the study 
enrollment strategy in the event it becomes apparent that the cluster size coefficient of variation 
markedly deviates from initial assumptions. Similarly, ongoing estimates and monitoring of the 
intra-class correlation [ICC] for acute care utilizations will be conducted. The cadence of the 
central monitoring will be monthly. Comprehensive monitoring reports will be provided to the 
Sponsor-Investigator, while reports focusing on enrollment, subject disposition, and safety will 
be provided to the Scientific Oversight Group. The goals of the data coordination and monitoring 
function include assurance of subject safety, and risk mitigation regarding enrollment targets, 
key design assumptions, and data quality. 
 
9. POTENTIAL RISKS/UNANTICIPATED PROBLEMS 
9.1 
Potential Risks 
In general, involving clinical practices in QI processes to standardize care delivery is widespread 
and accepted as posing no additional risk to the patient. 
9.1.1 Subject Confidentiality 
All data and records generated during this study will be kept confidential in accordance 
with Institutional policies on subject privacy and HIPAA; the investigators and other site 
personnel will not use such data and records for any purpose other than conducting the 
study. No breach of confidentiality is anticipated as no records will be shared with any 
personnel outside the research team. All medical information including assessments and 
other medical records will be recorded and stored in a database. The database will exist on 
password protected secured servers. All records will be kept confidential. 
 

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Calls between mentors and mentees will be recorded and may be monitored for safety 
purposes. Contacts between advisors and mentors via SMS messaging will be saved and 
may be monitored for safety purposes. 
 
To minimize risks to confidentiality, data will only be monitored by the Principal 
Investigators and trained research staff. At a minimum, research staff will have completed 
basic human subject protection research training that includes content on vulnerable 
subjects (children). 
 
Study platform vendor (InquisitHealth™) will utilize a 3rd party vendor (CheckrTM) to 
conduct background checks for mentors and advisors and will make every effort to ensure 
confidentiality and protection of participants’ information. Mentors and advisors will be 
asked to complete a W9 to facilitate participant reimbursement (if applicable). SickleSoft, 
Inc LLC, the ST3P UP Application developer, will provide oversight and manage access 
for sites roles within the application. They will make every effort to ensure confidentiality 
and protection of participants’ information. 
9.1.2 Emotional Distress 
Some study activities can make participants feel uncomfortable, anxious, and/or 
emotionally fatigued which are symptoms of emotional distress. If an EA-SCD, mentor, or 
advisor experiences and reports emotional distress, study activities will be paused until the 
issue is resolved (see reporting in Section 9.2.2). 
9.2 
Unanticipated Problems (UAP) 
9.2.1 Definition 
A UAP is any incidence, experience or outcome that is unexpected (e.g., a lost or stolen 
laptop computer that contains sensitive study information) given the information provided 
in research- related documentation (e.g., informed consent) and the study population 
characteristics, that is related or possibly related to participation in the research study and 
places the participant at an increased risk. 
9.2.2 Reporting 
All EA-SCD UAPs related to study activities will be reported to the site study team by the 
participant. It is the responsibility of the site to report the event in the study REDCap UAP 
form within 5 business days of event awareness and to the central IRB within 10 business 
days of event awareness. 
 
All mentor and advisor UAPs related to study activities will be reported through the 
InquisitHealth™ escalation form located within the platform. The DCC will be notified by 
InquisitHealthTM and will have 72 business hours from this time to inform the appropriate 
site. It is the responsibility of the site to report it in the study REDCap UAP form within 5 
business days of event awareness, and to the central IRB within 10 business days of event 
awareness. 
.   

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10. STASTICIAL CONSIDERATIONS 
10.1 Milestones 
10.1.1 Registration Date 
 
For all Participants: 
 
The date the subject signs the informed consent. 
10.1.2 Enrollment Date 
 
EA-SCD Participants: 
 
The date the baseline survey is administered to a subject (either within a healthcare setting 
or via survey link).  
 
For participants on the PM arm, administration of the baseline survey and completion of 
the enrollment CRF occurs after confirmation of mentor matching from the DCC (see study 
calendar 6.3).  
 
Mentor and Advisor Participants: 
 
The date the participant completes all training activities. For mentors, this is the date the 
participant completes practice call 2. For advisors, this is the date the participant completes 
Peer Mentor University training.  
10.1.3 Off Study Date 
 
For All Participants: 
 
The date the subject terminates participation on the study or is removed from the study per 
the criteria in Section 7.1. 
10.2 Sample Size and Accrual 
 
Sample size calculations are based on the primary endpoint of acute care utilization visits per 
year (at the EA-SCD participant level). Utilizing a randomized cluster design, seven clinical sites 
will be randomized per arm. The sample size calculation strategy is to calculate the required 
minimum sample size based on an individual patient randomized design, and then inflate the 
sample size based on cluster randomized considerations.54 A conservative estimate of the 
average acute care utilization rate for EA-SCD is 6 acute care visits per year based on data for 
North Carolina reported by the RuSH population surveillance project.4 In South Carolina, the 
acute care utilization rates among 18-30 y with SCD was reported as 7.17 (95% CI 6.34-7.99).55 
At Atrium Health (formerly known as Carolinas Healthcare System), 295 EA-SCD had 1972 
emergency department visits and 221 hospital admissions in 2015 with an average acute care 

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utilization rate of 6.82 visits per year. This study is designed to detect a 20% reduction in the 
number of acute care encounters per year (assuming a base case of 6 encounters). A 20% 
reduction in acute care utilization is considered clinically significant based on patient partners 
reporting that 1 less acute care visit a year is meaningful. Based on a two- sided alpha = 0.05 
significance level, 67 EA-SCD participants per arm would provide approximately 85% power to 
detect a 20% reduction in the number of acute care utilizations under individual randomization, 
assuming the number of encounters follows a Poisson distribution for rare events. The sample 
size will be inflated based on two parameters: the cluster size coefficient of variation and the 
intra-class correlation (ICC).54 The cluster size coefficient of variation observed among the 14 
participating clinical sites is 55%. Therefore, the coefficient of variation is assumed to be 60% 
and the ICC is assumed to be 0.05.56 Based on these parameters, a minimum of 183 EA-SCD 
participants per arm (366 total EA-SCD participants) will retain approximately 85% power. To 
account for potential missing data and allow for robust evaluation of secondary endpoints the 
sample size will be increased to a total of 537 EA-SCD participants. It is estimated that this 
enrollment can be accomplished with an enrollment rate of 35% of the EA-SCD patient 
population. 
10.3 Endpoints 
10.3.1 Definition of Primary Endpoint 
Acute care visits will be calculated for each EA-SCD participant as the average number of 
acute care visits over a24-month period. Acute care visits will also be calculated for each 
EA-SCD participant as the average number of acute care visits per year over the entire 
study as a secondary endpoint. Acute care visits may include, but are not limited to 
hospital admissions, ED, urgent care, day hospital, or infusion center visits. The 
calculations for these endpoints are below: 
 
𝑀𝑜𝑛𝑡ℎ𝑠 𝑜𝑛 𝑠𝑡𝑢𝑑𝑦= (𝑂𝑓𝑓 𝑆𝑡𝑢𝑑𝑦 𝐷𝑎𝑡𝑒−𝐸𝑛𝑟𝑜𝑙𝑙𝑚𝑒𝑛𝑡 𝐷𝑎𝑡𝑒)
30.4375
 
 
𝐴𝑐𝑢𝑡𝑒 𝑐𝑎𝑟𝑒 𝑣𝑖𝑠𝑖𝑡𝑠 𝑝𝑒𝑟 24 𝑚𝑜𝑛𝑡ℎ𝑠= 𝑇𝑜𝑡𝑎𝑙 # 𝑎𝑐𝑢𝑡𝑒 𝑐𝑎𝑟𝑒 𝑣𝑖𝑠𝑖𝑡𝑠 𝑟𝑒𝑝𝑜𝑟𝑡𝑒𝑑 𝑜𝑛 𝑠𝑡𝑢𝑑𝑦
𝑀𝑜𝑛𝑡ℎ𝑠 𝑜𝑛 𝑠𝑡𝑢𝑑𝑦
∗24 𝑚𝑜𝑛𝑡ℎ𝑠 
 
𝐴𝑐𝑢𝑡𝑒 𝑐𝑎𝑟𝑒 𝑣𝑖𝑠𝑖𝑡𝑠 𝑝𝑒𝑟 12 𝑚𝑜𝑛𝑡ℎ𝑠= 𝑇𝑜𝑡𝑎𝑙 # 𝑎𝑐𝑢𝑡𝑒 𝑐𝑎𝑟𝑒 𝑣𝑖𝑠𝑖𝑡𝑠 𝑟𝑒𝑝𝑜𝑟𝑡𝑒𝑑 𝑜𝑛 𝑠𝑡𝑢𝑑𝑦
𝑀𝑜𝑛𝑡ℎ𝑠 𝑜𝑛 𝑠𝑡𝑢𝑑𝑦
∗12 𝑚𝑜𝑛𝑡ℎ𝑠 
10.3.2 Definition of Secondary Endpoint 
Quantitative EA-SCD participant-reported outcome scores will be captured longitudinally 
for each subject. Data will be collected for each subject using the following scales: 
 
• 
Adults Sickle Cell QOC Measure (ASCQ-ME QOC) for health-related quality 
of life 
• 
PedsQLTM-SCD module for health-related quality of life 
• 
Medical Outcomes Study Social Support Survey (MOS-SSS) 
• 
Transition Readiness Score as measured by the TIP-RFT scale 
• 
Health Care Transition Feedback Survey 
 

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Count variables capturing healthcare utilization will be calculated for each EA-SCD 
participant for the following variables. These will be annualized to 12-month and 24-
month periods as described above. 
 
• 
The number of ambulatory visits 
• 
The number of visits with adult providers 
• 
The number of hospitalization days 
• 
14-day and 30-day readmission rates 
10.3.3 Definition of Intervention Fidelity (PM Intervention Feasibility) Endpoint 
• 
The number of consented mentor candidates that complete each step of 
eligibility and training activities (i.e., background check, practice call 1, PMU 
training, practice call 2, match with EA-SCD) 
• 
Timelines for major milestones for Mentors 
o Time from consent to background check result 
o Time from background check result to practice call 1 
o Time from practice call 1 to completion of PMU training 
o Time from completion of PMU training to practice call 2 
(enrollment/completion of training activities) 
o Time from practice call 2 to first match with EA-SCD (post-
enrollment) 
• 
Time from first consent date to enrollment for EA-SCDs on the PM arm 
• 
Frequency of mentor-mentee contacts via the platform 
10.3.4 Definition of ST3P UP Application Usage 
• 
Usage will be documented in two ways for each study subject (EA-SCD, 
mentor, and advisor): 
o Frequency of contacts between subjects and transition coordinator 
o Frequency of educational resource views 
• 
Usage will also be documented on the investigator and transition coordinator 
level, as frequency of contacts between investigator and transition coordinator 
and contacts between investigators across sites within the project. 
10.3.5 Definition of Site-Level Endpoints 
 
Health Care Transition Feedback Survey for providers: 
• 
Provider satisfaction with transition services will be collected using a standard 
5-point Likert scale. 
 
Health Care Transition Process Measurement Tools: 
• 
For Transitioning Youth to Adult Healthcare Providers (pediatric clinics) 
• 
For Integrating Young Adults to Adult Healthcare Providers (adult clinics) 
 
These elements of healthcare transition will be captured longitudinally for each site and 
will consist of the Core Elements of Health Care Transition. Scores will be self-reported by 
sites and then confirmed by the QI Coordinator. All Core Elements scores will be a 

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weighted sum of the individual items, and the overall HCT score will be a sum of the Six 
Core Element scores. 
10.4 Analysis Populations 
 
All EA-SCD participant-level analyses will be conducted on the population of all enrolled EA-
SCD participants (consented EA-SCD participants who are enrolled per section 10.1.2), 
regardless of how long the EA-SCD participant was on study or regardless of the extent of data 
missingness. 
10.5 Analysis Methods 
10.5.1 Timing of Analysis 
 
Study outcomes will be evaluated on an ongoing basis to monitor enrollment, derivation of 
study endpoints, assessment of missingness, and attrition. Additionally, the cluster size 
coefficient of variation and ICC will be evaluated on an ongoing basis to assess design 
assumptions. 
 
A planned interim analysis will be performed as described in Section 10.5.8. A final 
analysis will be conducted after all EA-SCD participants are off study. 
10.5.2 Subject Disposition 
 
EA-SCD participant disposition will be provided in terms of a CONSORT diagram with an 
extension to cluster randomized trials. This will include all EA-SCDs consented, those 
initiating transition, and EA-SCD withdrawals. Reasons for EA-SCD withdrawals will be 
provided as well as a summary of the number of and reasons for missing data for key 
outcome measures. 
10.5.3 Baseline Subject Characteristics 
 
A summary of EA-SCD participant demographics, disease characteristics, and 
acute/ambulatory care utilization in the 12 months prior to enrollment will be assessed. 
 
A summary of mentor/advisor demographics and disease characteristics will also be 
completed. 
10.5.4 Primary Analysis 
 
To evaluate the impact of PM, the acute care utilization rate per year will be compared 
between the PM+STE and STE arms. This will be accomplished using generalized linear 
mixed model with a Poisson distribution-log link construct. The model will include fixed 
effects for baseline acute care visits per year, the stratification factor (large sites vs small 
sites) and treatment arm, and a random effect for clinical site. Corresponding 95% 
confidence intervals will be calculated for the estimated ACU rate in each treatment arm.  

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Supportive and sensitivity analyses will be conducted to include potential confounding 
factors such as urban versus rural sites, education level, older first degree relative with 
SCD, genotype, age at transfer to adult care, and type of receiving provider (primary versus 
specialty). Univariate models will be fit for each factor, and those identified to be 
individually prognostic will be included in a multivariable model, and backward 
elimination followed by forward selection will be used to identify factors that are 
independently prognostic and to establish a final base model. Finally, treatment arm will be 
added to the base model to evaluate the impact of the intervention adjusting for significant 
baseline factors.  
 
Two analyses will be conducted to estimate the impact of differential accrual between arms 
over time: (1) An additional term of year of enrollment will be added to the GLMM as a 
categorical variable; (2) We will subset the analyses to EA-SCD who were 
contemporaneously enrolled. Comparison of the PM+STE and STE ACU estimates from 
this subset to those results including all enrolled with and without controlling for year of 
enrollment will provide a comprehensive assessment of the potential bias due to differential 
accrual between arms over time. ACU rate in the STE only arm will be compared to 
historical ACU rates which were used for the original power calculations. Although these 
are comparisons to historical controls, this will provide preliminary evidence using a robust 
sample size of the potential impact of the structure transition education. 
 
An additional sensitivity analysis will be conducted to assess the impact of the cluster of 
mentees/patients within mentors for the intervention arm. We will analyze the data using 
the recommended heteroscedastic partially nested mixed effects model (Candlish et al 
BMC Medical Research Methodology 2018 18:105) and compare the results to the primary 
analysis which only adjusts for the clustering within site.  
 
Additionally, the number of ambulatory visits, the number of visits with adult providers, 
hospitalizations, and readmissions will be analyzed in a similar fashion as described above. 
An acute care reliance measure will be estimated based on the model-based estimates of 
Acute Care Visits / [Acute Care Visits + Ambulatory visits]. 
10.5.5 Secondary Analysis 
 
EA-SCD PRO’s will be analyzed quantitatively using linear mixed models for repeated 
measures. The models will include fixed factors for baseline scales, the site size 
stratification factor, treatment arm, assessment time point, and the treatment arm by time 
point interaction. Random factors will include investigational site and subject within site to 
account for correlation in responses within individual sites and within the same subject. 
Model-based estimates of PRO scores will be used to estimate percentage change between 
the treatment arms. Additionally, PRO will be analyzed using survival analysis techniques. 
For each EA-SCD participant, the time from baseline to a 10% worsening (TTW) in the 
scale will be calculated. For EA-SCD participants not experiencing a 10% worsening, 
TTW will be censored at the last patient reported outcome assessment. TTW will be 
analyzed using Kaplan-Meier techniques and Cox proportional hazards models. The 

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proportional hazards models will include the same factors as described for the primary 
analysis. Planned sensitivity analysis will be conducted to evaluate time to worsening for 
worsening thresholds ranging from 10% to 30%. The repeated measures and survival 
analyses of the EA-SCD PRO’s will also include supportive and sensitivity analyses to 
account for potential baseline confounders as previously described in the primary analysis. 
EA-SCD satisfaction with transition services will be summarized descriptively. 
 
Intervention fidelity will be analyzed descriptively. A CONSORT-type diagram will be 
provided, including a summary of all mentors who consented, had a background check, 
passed the background check, completed practice call 1, completed Peer Mentor University 
online training, completed practice call 2, and were matched with at least one EA-SCD. 
Timelines for mentors and EA-SCDs on the PM arm will be summarized descriptively. 
Frequency of mentor contacts will be analyzed descriptively in terms expected contacts per 
protocol versus actual. This will include calls placed (mentor to EA-SCD), calls answered 
(EA-SCD to mentor), messages sent (mentor to EA-SCD), and messages received (EA-
SCD to mentor).  
 
ST3P UP application usage will be analyzed descriptively in terms of number of contacts 
between study subjects and transition coordinators, transition coordinators and PIs, and 
between PIs. Additionally, the use of education resources in the application will be 
summarized descriptively for the study subjects. Associations between EA-SCD outcomes 
(particularly acute care utilizations) and contact frequency, will be analyzed similarly to the 
methods described above for the primary analysis, with treating the app usage as a 
continuous covariate. Additionally, application usage will be correlated with EA-SCD 
PROs (specifically TIP-RFT assessments) similarly to the methods described above, 
treating the app usage as a continuous covariate. For the analysis described about regarding 
application usage, this will be done in two ways: (1) including all subjects and, for subjects 
who did not use the application, usage would be equal to zero; (2) only including the subset 
of subjects who used the application and looking at the impact of amount of usage on 
outcomes. 
 
Composite QI-validated scores of the Six Core Elements provided by the sites in 6-month 
intervals will be analyzed using linear mixed models for repeated measures. One goal of 
the QI analyses is to assess the convergence in scores between pediatric and adult practices. 
This will be accomplished with a model that includes baseline QI score, clinic (pediatric 
versus adult), time, and the provider by time interaction as fixed factors. Site will be 
included as a random factor to account for repeated observations over time. Importantly, 
the type of provider will also be evaluated. This will be accomplished using a similar 
model as described above but will use provider type: Pediatrician to Pediatrician; 
Pediatrician to Internist; Pediatrician to Med/Peds Specialist, Med/Peds specialist to Med 
Peds specialist as the treatment factor. Additionally, composite QI-validated scores will be 
compared with site self-reported scores for concordance over time. Provider satisfaction 
with transition services will be summarized descriptively. 

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10.5.6 Missing Data 
The impact of missingness in the covariates will be evaluated in several ways. 
Multivariable models will be based on complete case analyses. The robustness of the 
complete case analyses will be evaluated by comparing key baseline characteristics 
between the full dataset and the complete case dataset. Additionally, unadjusted outcome 
results will be compared between the two datasets. Multiple imputation methods will be 
utilized to complete baseline missingness, and these baseline-adjusted results will be 
compared to the complete case adjusted results. The proposed mixed models for repeated 
measures are valid under the missing at random mechanism (MAR) to address missingness 
in the PRO. The pattern of missingness in PRO will be assessed to evaluate the MAR 
assumption. 
 
If data from questionnaires are missing, when possible, the reason for the missing data will 
be categorized and documented as follows: 
• 
subject felt too ill 
• 
clinician or nurse felt the subject was too ill 
• 
subject felt it was inconvenient or took too much time 
• 
subject felt it was a violation of privacy 
• 
subject didn't understand the actual language or was illiterate 
• 
administrative failure to distribute the questionnaire 
• 
not required at this time point 
• 
other, specify 
• 
unknown 
10.5.7 Exploratory Analysis 
Heterogeneity of Treatment Effects: We will evaluate the consistency of the intervention 
across site and patient level characteristics. The heterogeneity of treatment effects (HTE) 
will be evaluated using potential treatment effect modifiers measured prior to 
randomization. Site level factors will include cluster size (large vs small) and urban vs rural 
sites, while subject level factors are those previously listed in the multivariable modeling 
description. For each factor, subgroup analysis will be conducted on each of the mutually 
exclusive factor levels. Evaluation of the HTE will be performed qualitatively by 
comparing the treatment group differences across the factor levels. More formally, each 
subject- level factor will be evaluated using models to include treatment arm, the baseline 
factor, and the treatment by factor interaction. 
10.5.8 Qualitative Methods 
 
Participants will be asked for permission to contact them for future qualitative research 
related to the ST3P-UP Study. Future research will be approved separately through Georgia 
Southern University. Participant information will be kept confidential and will only be 
provided to authorized personnel.  
10.5.9 Interim Analysis 
A planned interim analysis of primary and secondary endpoints, as well as QI data will take 
place in year 3. The study is designed with no formal stopping rules and no alpha spend 

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will occur. The interim analysis will be in support of the interim progress report. We 
estimate that the interim analysis will include 60% of the total enrollment and the median 
follow up time for subjects included in the interim analysis is estimated to be 
approximately 11 months. 
 
11. STUDY COMPLETION OR TERMINATION 
11.1 Completion 
The study will be considered complete when one or more of the following conditions is met: 
 
• 
All subjects have withdrawn from the study 
• 
All subjects have discontinued from the study 
• 
The IRB, LCI DSMC, or Sponsor-Investigator discontinues the study because 
of safety considerations 
• 
The Sponsor-Investigator defines an administrative or clinical cut-off date 
11.2 Termination 
The study will be terminated when one or more of the following conditions occur: 
 
• If risk-benefit ratio becomes unacceptable owing to, for example, 
o Safety findings from this study (e.g., UAPs) 
o Results of parallel clinical studies 
o If the study conduct (e.g., recruitment rate, drop-out rate, data quality, 
protocol compliance) does not suggest a proper completion of the trial within 
a reasonable time frame 
• The Sponsor-Investigator has decided to withdraw funding support at any time before 
trial completion 
• Study participation will be terminated at study sites if study conduct does not achieve 
expected agreed upon milestones, there is concern for violation of study procedures or 
other impropriety, for recurrent failure to adhere to study procedures including 
submission of required data, or failure to achieve expected subject recruitment. 
 
For any of the above closures, the following applies: 
 
• 
Closures should occur only after consultation between involved parties. 
• 
All affected institutions must be informed as applicable according to local 
law. 
• 
In case of a partial study closure, ongoing subjects, including those in follow- 
up, must be taken care of in an ethical manner. 
12. STUDY MANAGEMENT 
12.1 IRB Approval 
This study requires reliance on Advarra IRB as the Central IRB.  
 

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The site must submit site- and investigator-specific information to the central IRB to obtain 
approval for participation in the study. This includes the Sponsor informed consent 
document with any site- required language included. The Sponsor will obtain electronic 
copies of approval documents within the central IRB portal on behalf of the site.  
 
For sites using a local IRB in addition to the central IRB:  
If the local IRB requires/requests changes to the site documents, the site must submit the 
changes to the Sponsor for review and approval. Once changes are approved by the 
Sponsor, the site will submit a modification to the central IRB for approval prior to 
implementing changes. 
12.2 Informed Consent 
Before recruitment and enrollment onto this study, the subject and/or his/her 
parent/guardian will be given a full explanation of the study and will be given the 
opportunity to review the subject consent form. Prior to a subject’s participation in the 
trial, the informed consent process shall be administered (by each participating site) in 
accordance with applicable laws, federal regulations, and institutional and IRB policies. 
The informed consent form should be signed and dated by the subject (and/or 
parent/guardian, as applicable) and by the person who conducted the informed consent 
discussion. Assent will be obtained in appropriately aged subjects per institutional 
guidelines. If reconsent is required and the subject is out of visit window, reconsenting 
may be done according to Advarra’s consent policy.  
 
Informed consent will also be obtained from all mentors and advisors prior to their 
participation in the study. 
12.3 Protocol Adherence  
Except for an emergency in which proper care for the protection, safety, and well-being of 
the study subject requires alternative treatment, the study shall be conducted exactly as 
described in the approved protocol. 
12.4 Changes to Study Documents 
If it is necessary for the study protocol, the informed consent/assent, or other study 
documents to be revised, the revised documents must be approved by the Sponsor-
Investigator and the Sponsor IRB in advance of implementation. 
 
If a site requires additional revisions to its site-specific consent(s), the site must provide the 
tracked amended site consents/assents to the Sponsor for review and approval prior to IRB 
submission. 
12.5 Other Protocol Deviations 
If an unexpected deviation occurs, the event should be reported via REDCap to the 
Sponsor as soon as possible, but within no more than 5 business days of becoming aware 
of the event. Any IRB reportable event that occurs must be reported to the central IRB per 
IRB policies. 
 

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NOTE: Protocol deviations that, in the Investigator’s judgment, potentially caused harm to 
participants or others or indicates that the participants or others are at an increased risk of 
harm or has adversely impacted data integrity will be reported promptly to the IRB per 
IRB reporting requirements. 
 
The local Investigator is responsible for informing the Sponsor of any planned deviation 
from the protocol prior to implementation and in accordance with local requirements. 
12.6 Retention of Records 
Essential documentation (e.g., informed consents), including all IRB correspondence, will 
be retained for at least 2 years after the investigation is completed. Documentation will be 
readily available upon request. 
12.7 Ethical and Legal Conduct of the Study 
The procedures set out in this protocol pertaining to the conduct, evaluation, and 
documentation of this study, are designed to ensure that the Investigator abide by GCP 
guidelines. The study will also be carried out in full conformity with the ICH E6 and in 
keeping with applicable local law(s) and regulation(s). 
 
Documented approval from appropriate agencies (e.g., IRB) will be obtained at 
participating centers before any subject enrollment can occur at these sites, according to 
GCP, local laws, regulations and organizations. 
 
Strict adherence to all specifications laid down in this protocol is required for all aspects of 
study conduct; the investigators may not modify or alter the procedures described in this 
protocol. 
 
The Sponsor-Investigator is responsible for the conduct of the trial at the sites in 
accordance with the Declaration of Helsinki. The Sponsor-Investigator is responsible for 
overseeing all study subjects. The Sponsor-Investigator must assure that all study site 
personnel, including sub-investigators and other study staff members, adhere to the study 
protocol and all applicable regulations and guidelines regarding clinical trials both during 
and after study completion. 
 
The Investigator will be responsible for assuring that all the required data will be collected 
and properly documented. 
12.8 Confidentiality of Records 
All records identifying the subject will be kept confidential and, to the extent permitted by 
the applicable laws and/or regulations, will not be made publicly available. 
12.9 Compliance with ClinicalTrials.gov 
The Sponsor-Investigator is solely responsible for determining whether the trial and its 
results are subject to the requirements for submission to ClinicalTrials.gov 
(http://www.clinicaltrials.gov). 
 

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13. REFERENCES 
 
1. U.S. Department of Health and Human Services; National Institutes of Health; National 
Heart Lung and Blood institute. Evidence –Based Management of Sickle Cell Disease: 
Expert Panel report, 2014. 
2. Brousseau DC, Panepinto JA, Nimmer M, et al. The number of people with sickle-cell 
disease in the United States: national and state estimates. Am J Hematol. 2010; 85:77–78. 
3. Hassell 
KL. 
Am 
J 
Prev 
Med. 
2010 
Apr;38(4 
Suppl): 
S512-21. 
doi: 
10.1016/j.amepre.2009.12.022. Population estimates of sickle cell disease in the U.S. 
4. https://www.cdc.gov/ncbddd/sicklecell/documents/scd_in_nc_providers.pdf. 
5. Schnog JB, Duits AJ, Muskiet FA, ten Cate H, Rojer RA, Brandjes DP. Sickle cell disease; 
a general overview. Neth J Med. 2004;62(10):364-374. 
6. Quinn CT, Rogers ZR, McCavit TL, Buchanan GR. Improved survival of children 
and adolescents with sickle cell disease. Blood. 2010;115(17):3447-3452. 
7. Lanzkron S, Carroll CP, Haywood C. Mortality rates and age at death from sickle cell 
disease: U.S., 1979-2005. Public Health Rep. 2013;128(2):110-116. 
8. Adams-Graves P, Bronte-Jordan L. Recent treatment guidelines for managing adult 
patients with sickle cell disease: challenges in access to care, social issues, and adherence. 
Expert Rev Hematol. 2016 Jun;9(6):541-52. doi: 10.1080/17474086.2016.1180242 
9. Platt OS, Brambilla DJ, Rosse WF, et al. Mortality in sickle cell disease. Life expectancy 
and risk factors for early death. N Engl J Med. 1994; 330:1639–1644. 
10. Paulukonis ST, Eckman JR, Snyder AB, et al. Defining sickle cell disease mortality 
using a population-based surveillance system, 2004 through 2008. Public Health Rep. 
2016; 131:367–375. 
11. Treadwell M, Telfair J, Gibson RW, Johnson S, Osunkwo I. Transition from pediatric to 
adult care in sickle cell disease: establishing evidence-based practice and directions for 
research. Am J Hematol. 2011 Jan;86(1):116-20. 
12. Steiner CA, Miller JL. Sickle Cell Disease Patients in U.S. Hospitals, 2004. HCUP 
Statistical Brief #21. December 2006. Agency for Healthcare Research and Quality, 
Rockville, MD. [cited 2015 Sep 29]. 
13. Brousseau DC, Owens PL, Mosso AL, et al. Acute care utilization and re-hospitalizations 
for sickle cell disease. JAMA. 2010; 303:1288–1294. 
14. https://www.cdc.gov/ncbddd/sicklecell/documents/scd_in_ga.pdf]. 
15. Schwartz LA, Radcliffe J and Barakat LP. Associates of School Absenteeism in 
Adolescents with Sickle Cell Disease. Pediatr Blood Cancer. 2009 Jan; 52(1): 92–96. 
16. Treadwell M, Johnson S, Sisler I, Bitsko M, Gildengorin G, Medina R, Barreda F, Major 
K, Telfair J, Smith WR. Self-efficacy and readiness for transition from pediatric to adult 
care in sickle cell disease. Int J Adolesc Med Health. 2016 Nov 1;28(4):381-388. doi: 
10.1515/ijamh- 2015-0014. 
17. Sobota AE, Umeh E, Mack JW. Young Adult Perspectives on a Successful Transition 
from Pediatric to Adult Care in Sickle Cell Disease. J Hematol Res. 2015 Dec;2(1):17-24. 
18. Bemrich-Stolz CJ, Halanych JH, Howard TH, Hilliard LM, Lebensburger JD. Exploring 
Adult Care Experiences and Barriers to Transition in Adult Patients with Sickle Cell 

Protocol: LCI-HEM-SCD-ST3P-UP-001 
Version 6: 12/16/2022 
 
52
Disease. Int J Hematol Ther. 2015; 1(1): 10.15436/2381-1404.15.003.     
19. Sturman DA, Moghaddam B. The neurobiology of adolescence: changes in brain 
architecture, functional dynamics, and behavioral tendencies. Neurosci Biobehav Rev. 
2011 Aug; 35(8):1704-12. 
20. Kanter J, Kruse-Jarres R. Blood Rev. 2013 Nov;27(6):279-87. doi: 
10.1016/j.blre.2013.09.001. Epub 2013 Sep 19. Management of sickle cell disease 
from childhood through adulthood. 
21. Blinder MA, Vekeman F, Sasane M, et al. Age-related treatment patterns in sickle cell 
disease patients and the associated sickle cell complications. 
22. Kroner EL, Hoffmann RG, Brousseau DC. Emergency department reliance: a 
discriminatory measure of frequent emergency department users. Pediatrics. 2010 
Jan;125(1):133-8. doi: 10.1542/peds.2009-0960. Epub 2009 Dec 14. 
23. Blum R, Garell D, Hodgman C, et al. (1993) Transition from child-centered to adult 
health- care systems for adolescents with chronic conditions. A position paper of the 
Society for Adolescent Medicine. J Adolesc Health 14:570–576. 
24. Crowley R, Wolfe I, Lock K, McKee M. Improving the transition between paediatric 
and adult healthcare: a systematic review. Arch Dis Child. 2011 Jun;96(6):548-53. 
25. Hankins JS, Osarogiagbon R, Adams-Graves P et al. A transition pilot program for 
adolescents with sickle cell disease. J Pediatr Health Care. 2012 Nov-Dec;26(6): e45-9. 
26. Davis AM, Brown RF, Taylor JL, Epstein RA, McPheeters ML. Transition care for 
children with special health care needs. Pediatrics. 2014 Nov;134(5):900-8. doi: 
10.1542/peds.2014- 1909. 
27. Maslow G, Adams C, Willis M, et al. An evaluation of a positive youth development 
program for adolescents with chronic illness. J Adolesc Health. 2013;52(2):179–185. 
28. Cooley WC, Sagerman PJ, Sagerman PJ White PH et al. Supporting the health care 
transition from adolescence to adulthood in the medical home. 2011 Jun 27. 
American Academy of Pediatrics; American Academy of Family Physicians; 
American College of Physicians; Transitions Clinical Report Authoring Group, Cooley 
WC, Sagerman PJ. Collaborators (13) Pediatrics. 2011 Jul;128(1):182-200. doi: 
10.1542/peds.2011-0969. 
29. McManus M, White P, Barbour A, et al. Pediatric to adult transition: a quality 
improvement model for primary care. J Adolesc Health. 2015 Jan;56(1):73-8. doi: 
10.1016/j.jadohealth.2014.08.006. 
30. McManus M, White P, Pirtle R, Hancock C, Ablan M, Corona-Parra R.. Incorporating 
the Six Core Elements of Health Care Transition into a Medicaid Managed Care 
Plan: Lessons Learned from a Pilot Project. J Pediatr Nurs. 2015 Sep-Oct;30(5):700-
13. doi: 10.1016/j.pedn.2015.05.029. 
31. Smith GM, Lewis VR, Whitworth E, Gold DT, Thornburg CD. Growing Up With Sickle 
Cell Disease: A Pilot Study of a Transition Program for Adolescents With Sickle Cell 
Disease. 
32. Kinney TR, Ware RE. The adolescent with sickle cell anemia. Hematol Oncol Clin North 
Am.1996; 10:1255–1264. 
33. Butler DJ, Beltran LR. Functions of an adult sickle cell group: education, task orientation, 
and support. Health Soc Work. 1993; 18:49–56. 

Protocol: LCI-HEM-SCD-ST3P-UP-001 
Version 6: 12/16/2022 
 
53
34. Baskin ML, Collins MH, Brown F, et al. Psychosocial considerations in sickle cell 
disease (SCD): the Transition from Adolescence to Young Adulthood. J Clin Psychol 
Med Setting. 1998; 5:315–341. 
35. Griffin A; Gilleland J; Johnson A; Cummings L; New T; Brailey T; Eckman J; 
Osunkwo I. Applying a developmental–ecological framework to sickle cell disease 
transition. Clinical Practice in Pediatric Psychology, Vol 1(3), Sep 2013, 250-263. 
http://dx.doi.org/10.1037/cpp000002. 
36. DiMatteo MR, Giordani PJ, Lepper HS, Croghan TW. Patient adherence and medical 
treatment outcomes: a meta-analysis. Med Care 2002 Sep;40(9):794-811. 
37. Dennis C-L. Peer support within a health care context: a concept analysis. Int J Nurs 
Stud. 2003;40(3):321–32. 
38. Ahola Kohut S, Stinson JN, Giosa L, Luca S, van Wyk M. Systematic review of peer 
support interventions for adolescents with chronic illness: a narrative analysis. Int J 
Child Adoles Health. 2014;7(3):183–97. 
39. Stinson J, Ahola Kohut S, Forgeron P et al. The iPeer2Peer Program: a pilot 
randomized controlled trial in adolescents with Juvenile Idiopathic Arthritis. Pediatr 
Rheumatol Online J. 2016 Sep 2;14(1):48. 
40. Sandhu S, Veinot P, Embuldeniya G et al. Peer-to-peer mentoring for individuals with 
early inflammatory arthritis: feasibility pilot BMJ Open. 2013 Mar 1;3(3). pii: 
e002267. doi: 10.1136/bmjopen-2012-002267. 
41. Daley BJ Sponsorship for adolescents with diabetes. Health Soc Work. 1992 
Aug;17(3):173- 82. 
42. Powers, L. E., Turner, A., Westwood, D., Matuszewski, J., Wilson, R., & Phillips, A. 
(2001). TAKE CHARGE for the future: A controlled field-test of a model to 
promote student involvement in transition planning. Career Development for 
Exceptional Individuals, 24(1), 89-104. 
43. Olsson, Craig A., Boyce, Mark F., Toumbourou, John and Sawyer, Susan M. 2005, The 
role of peer support in facilitating psychosocial adjustment to chronic illness in 
adolescence, Clinical child psychology and psychiatry, vol. 10, no. 1, pp. 78-87 
44. Blake, J. E. (1997). A mentoring program for adolescents with diabetes. Diabetes Educ, 
23(6),681-684. 
45. Smith-Jentsch KA, Scielzo SA, Yarbrough CS, Rosopa PJ. A comparison of face-to-face 
and electronic peer-mentoring: Interactions with mentor gender Journal of Vocational 
Behavior Volume 72, Issue 2, April 2008, Pages 193–206. 
46. Corbie-Smith G, Thomas SB, Williams MV, et al. Attitudes and beliefs of African 
Americans toward participation in medical research. J Gen Intern Med. 1999; 14:537–
546. 
47. Haywood C, Lanzkron S, Diener-West M, Haythornthwaite, Strouse J, Bediako S, 
Onojobi G, MD, Beach MC for the IMPORT Investigators. Attitudes Towards Clinical 
Trials Among Patients with Sickle Cell Disease. Clin Trials. 2014 Jun; 11(3): 275–283. 
48. Sequeira PA, Pyatak EA, Weigensberg MJ, et al. Let's Empower and Prepare 
(LEAP): Evaluation of a Structured Transition Program for Young Adults with 
Type 1 Diabetes. Diabetes Care. 2015 Aug;38(8):1412-9. 
 

Protocol: LCI-HEM-SCD-ST3P-UP-001 
Version 6: 12/16/2022 
 
54
 
49. Treadwell MJ, Hassell K, Levine R, Keller S. Adult sickle cell quality-of-life 
measurement information system (ASCQ-Me): conceptual model based on review of 
the literature and formative research. Clin J Pain. 2014 Oct;30(10):902-14.  doi: 
10.1097/AJP.0000000000000054. 
50. Panepinto, J. A., Torres, S., & Varni, J. W. (2012). Development of the PedsQLTM 
sickle cell disease module items: qualitative methods. Quality of Life Research, 
21(2), 341–357. http://doi.org/10.1007/s11136-011-9941-4. 
51. Evensen, C. T., Treadwell, M. J., Keller, S., Levine, R., Hassell, K. L., Werner, E. 
M., & Smith, W. R. (2016). Quality of care in sickle cell disease: Cross-sectional 
study and development of a measure for adults reporting on ambulatory and 
emergency department care. Medicine, 95(35), e4528. 
http://doi.org/10.1097/MD.0000000000004528. 
52. Treadwell M, Johnson S, Sisler I, Bitsko M, Gildengorin G, Medina R, Barreda F, Major 
K,Telfair J, Smith WR. Development of a sickle cell disease readiness for transition 
assessment Int J Adolesc Med Health. 2016 May 1;28(2):193-201. doi: 10.1515/ijamh-
2015- 0010. 
53. Hays, RD (1994). The Medical Outcomes Study (MOS) Social Support Survey. 
Retrieved May 21, 2018 from the RAND Corporation web site: 
https://www.rand.org/health/surveys_tools/mos/social-support/survey-
instrument.html 
54. Hemming K, Girling AJ, Sitch AJ, Marsh J, Lilford RJ. Sample size calculations for 
cluster randomised controlled trials with a fixed number of clusters. BMC Med Res 
Methodol. 2011 Jun;11:102. doi: 10.1186/1471-2288-11-102. 
55. Schlenz AM, Boan AD, Lackland DT, Adams RJ, Kanter J. Needs Assessment for 
Patients with Sickle Cell Disease in South Carolina, 2012. Public Health Rep. 2016 
Jan- Feb;131(1):108-16. 
56. Campbell MK, Fayers PM, Grimshaw JM: Determinants of the intracluster correlation 
coefficient in cluster randomized trials: the case of implementation research. Clinical 
Trials. 2005 2:99-107. doi: 10.1191/1740774505cn071oa. 
 
14. APPENDICES 
Appendix A: Peds QL-SCD QOLs (Adult, Teen, Young Adult) 
 
 
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