LCI-HEM-SCD-ST3P-UP-001: The Sickle Cell Trevor Thompson Transition Project (ST3P-UP Study)
ST3P-UP
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)
2 other identifiers
interventional
291
1 country
14
Brief Summary
This multi-center study will compare the effectiveness of adding virtual peer mentoring (PM) to a structured education-based (STE) transition program for emerging adults with sickle cell disease to determine its effect on decreasing the number of acute care visits per year, improving patient-reported outcomes, and reducing healthcare utilization among emerging adults with sickle cell disease (EA-SCD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2018
CompletedFirst Posted
Study publicly available on registry
July 20, 2018
CompletedStudy Start
First participant enrolled
January 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedResults Posted
Study results publicly available
September 3, 2024
CompletedSeptember 3, 2024
April 1, 2024
4.1 years
June 14, 2018
August 30, 2023
April 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute Care Visits (Visits Per Year)
Acute care visits was calculated for each patient as the number of acute care visits over the duration of follow-up (time from enrollment to discontinuation of study participation). Acute visits were identified by manual chart reviews and included hospital admissions, ED, urgent care, day hospital, or infusion center visits. Acute care visits were calculated as the total number of acute care visits reported on study over the years the subject was on study.
Duration of time on study, on average 23 months
Secondary Outcomes (12)
Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC)
6 and 12 months post-enrollment.
Pediatric Quality of Life - Sickle Cell Module (PedsQL-SCD Module) for Health-related Quality of Life
At 6 and 12 months post-enrollment
Medical Outcomes Study Social Support Survey (MOS-SSS) Overall Social Support
At 6 and 12 months post-enrollment.
Transition Intervention Program Readiness for Transition (TIP-RFT) Scale
At 6 and 12 months post-enrollment.
Health Care Transition Feedback Survey Item: How Often Does Your Health Care Provider Explain Things in a Way That is Easy to Understand?
12 months post-enrollment.
- +7 more secondary outcomes
Study Arms (2)
Program Structured Education Based Transition Program
ACTIVE COMPARATORProgram Structured Education Based Transition Program \[STE\]
Structured Education Based Transition Program + Peer Mentoring
EXPERIMENTALStructured Education Based Transition Program \[STE\] + Peer Mentoring \[PM\]
Interventions
Virtual Peer Mentoring
Education-based program
Eligibility Criteria
You may qualify if:
- Age 16 and \< 25 years at the time of consent AND being cared for in a PEDIATRIC SICKLE CELL PROGRAM
- Any sickle cell genotype
- Not known to be currently pregnant
- Ability to read and understand the English language
- Subject is planned to be transferred to an adult sickle cell program within 6-12 months of consent
You may not qualify if:
- Already receiving one on one peer mentoring as part of a transition program -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 participants adherence with or completion of the study.
- Mentor Eligibility Criteria:
- Be an adult living with SCD or a caregiver of an adult living with SCD who has successfully transitioned to adult care (defined as having had at least 3 visits or a year of continuous care with an adult sickle cell provider)
- Age 26-35 years
- Readily available access to a computer with internet
- Have completed and passed a background check
- Legally able to work in the United States
- Ability to read and understand the English language
- Endorsed by their healthcare provider as reliable and able to meet the physical, psychological and cognitive requirements for serving as a mentor
- Advisor Eligibility Criteria:
- Be an adult living with SCD or a caregiver of an adult living with SCD who has successfully transitioned to adult care (defined as having had at least 3 visits or a year of continuous care with an adult sickle cell provider)
- Age ≥ 36 years
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of South Alabama Health System
Mobile, Alabama, 36617, United States
University of Miami
Miami, Florida, 33136, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Children's Healthcare of Atlanta/Emory University
Atlanta, Georgia, 30322, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Novant Health
Charlotte, North Carolina, 28204, United States
Duke University
Durham, North Carolina, 27705, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Wake Forest Baptist Hospital
Winston-Salem, North Carolina, 27157, United States
Greenville Health System
Greenville, South Carolina, 29605, United States
Virginia Commonwealth University (VCU)
Richmond, Virginia, 23298, United States
Related Publications (1)
Osunkwo I, Lawrence R, Robinson M, Patterson C, Symanowski J, Minniti C, Bryant P, Williams J, Eckman J, Desai P. Sickle Cell Trevor Thompson Transition Project (ST3P-UP) protocol for managing care transitions: Methods and rationale. Contemp Clin Trials. 2023 Mar;126:107089. doi: 10.1016/j.cct.2023.107089. Epub 2023 Jan 18.
PMID: 36669729BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Because we did not complete enrollment and had imbalances in enrollment over time between the arms, we are not reporting p-values for comparisons between arms.
Results Point of Contact
- Title
- Chair of Biostatistics Department
- Organization
- Levine Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Payal Desai, MD
Wake Forest University Health Sciences
- PRINCIPAL INVESTIGATOR
Raymona Lawrence, DRPH
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2018
First Posted
July 20, 2018
Study Start
January 10, 2019
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
September 3, 2024
Results First Posted
September 3, 2024
Record last verified: 2024-04