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)

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)

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Other: Structured Education Based Transition Program STE; Other: Peer Mentoring [PM]

Detailed Description

This is a multi-center, cluster randomized study comparing the effectiveness of adding virtual peer mentoring (PM) to a structured education-based (STE) transition program based on the 6 core elements of transition in improving acute care reliance, quality of life and satisfaction with transition process in emerging adults with sickle cell disease (EA-SCD). The study will involve a total of 14 large (>80 EA-SCD currently in pediatric care) and small-scale (≤80 EA-SCD currently in pediatric care) clinical sites, with a 1:1 randomization at the site level. The study will involve approximately 700 subjects, 120 peer mentors, and 25 advisors. The primary endpoint of this study will be the average number of acute care visits per year over a minimum of 24 months. Secondary objectives are to compare the effectiveness of STE+PM versus STE alone at improving patient-reported outcomes and reducing healthcare utilization among EA-SCD. Enrollment is anticipated to occur over 18-24 months

• Study Type: Interventional
• Enrollment (Actual): 351
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Mobile, Alabama, United States, 36617
      • University of South Alabama Health System
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Saint Petersburg, Florida, United States, 33701
      • Johns Hopkins All Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta/Emory University
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
    • Charlotte, North Carolina, United States, 28204
      • Novant Health
    • Durham, North Carolina, United States, 27705
      • Duke University
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University (VCU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

EA-SCD Eligibility Criteria:

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Readily available access to a computer with internet
• Have completed and passed a background check
• 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 an advisor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Program Structured Education Based Transition Program; Program Structured Education Based Transition Program [STE]	Other: Structured Education Based Transition Program STE; Education-based program
Experimental: Structured Education Based Transition Program + Peer Mentoring; Structured Education Based Transition Program [STE] + Peer Mentoring [PM]	Other: Structured Education Based Transition Program STE; Education-based program; Other: Peer Mentoring [PM]; Virtual Peer Mentoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of acute care visits	Acute care visits will be calculated for each patient as the average number of acute care visits over a 24-month period. Acute visits include hospital admissions, ED, urgent care, day hospital, or infusion center visits. Acute care visits per 24 months will be calculated as the total number of acute care visits reported on study divided by the months the subject was on study, multiplied by 24 months. Additionally, this will be calculated per 12 months.	Duration of time on study, on average 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adults Sickle Cell Quality of Care Measure (ASCQ-ME QOC) for health-related quality of life	Survey measures patients' self-reported levels of quality of care received. Higher score indicates higher quality of life. Individual questions are scored on a 10-point scale in three ranges (0-6, 7-8, and 9-10). A "0" value is least, and a "10" value is best. A total score for all participants is then reported on a percentage scale of 0-100%.	At enrollment, and 6, 12, 18, and 24 months post-enrollment.
Pediatric Quality of Life - Sickle Cell Module (PedsQL-SCD module) for health-related quality of life	Overall patient's perception of their quality of life. Higher quality of life score is better. There are 43 items with 9 dimensions: Pain and Hurt, Pain Impact, Pain Management, Worry I, Worry II, Emotions, Treatment, Communication I, Communication II. Individual questions are scored on a 5-point Likert scale, (0=never, 4=almost always) and scores are transformed on a scale from 0-100, where 0=100, 1=75, 2=50, 3=25, 4=0. If more than 50% of the items are missing, the scale scores should not be computed. If 50% or more items are completed, the mean of the completed items is imputed for the total score.	At enrollment, and 6, 12, 18, and 24 post-enrollment.
Medical Outcomes Study Social Support Survey (MOS-SSS)	Patient's perceived social support score. A higher score for an individual scale or for the overall support index indicates more support. MOS-SSS includes 19 items, with four separate social support subscales and an overall functional social support index. Each item is a 5-level Likert scale (1=None of the time, 5=All of the time). For each of the 4 subscales, respondent-specific mean scores are calculated, ignoring items with missing values. If at least one valid response is is available on a subscale, a score can be received for that subscale. To calculate overall total, take average of item scores for completed items (range = 1-5, with 5=best possible outcome).	At enrollment, and 6, 12, 18, and 24 months post-enrollment.
Transition Intervention Program Readiness for Transition (TIP-RFT) scale	Patient's readiness to transition scale. A lower score indicates higher readiness. TIP-RFT includes 22 items, with 4 subscales: (1) Independent Living Skills (8 items, range 0-32), (2) Healthcare Knowledge and Skills scale (6 items, range 0-24), (3) Education and Vocational Planning scale (4 items, range 0-16), (4) Social Support Skill set (4 items, range 0-16). For total TIP-RFT, use sum of scales. Total score range (0-88), smaller score is better.	At enrollment, and 6, 12, 18, and 24 months post-enrollment.
Health Care Transition Feedback Survey	Patients' experience with changing to an adult approach to care. Higher score indicates a better experience. Items include a combination of 4-level (Always/A lot = 4, Never/Not at all = 1) and binary (Yes=2, No=1) variables, for a range of scores from 12-36. Relative score will be calculated based on the number of questions that were answered by the patient. If >50% of items are left blank, then the overall score cannot be calculated.	At enrollment, and 12 and 24 months post-enrollment.
Number of ambulatory visits	Ambulatory visits will be calculated for each patient as the average number of ambulatory visits over a 12-month period. Ambulatory visits include primary care visits and visits with the hematology/SCD provider. Ambulatory visits per 12 months will be calculated as the total number of ambulatory visits reported on study divided by the months the subject was on study, multiplied by 12 months. Additionally, this will be calculated per 24 months.	Duration of time on study, on average 24 months
Number of visits with adult provider	Adult provider visits will be calculated for each patient as the average number of ambulatory visits that occurred with adult providers over a 12-month period. Adult provider visits per 12 months will be calculated as the total number of adult provider visits reported on study divided by the months the subject was on study, multiplied by 12 months. Additionally, this will be calculated per 24 months.	Duration of time on study, on average 24 months
Number of hospitalization days	Hospitalization days will be calculated for each patient as the average number of days spent inpatient for hospitalization over a 12-month period. Hospitalization days per 12 months will be calculated as the total number of hospitalization days reported on study divided by the months the subject was on study, multiplied by 12 months. Additionally, this will be calculated per 24 months.	Duration of time on study, on average 24 months
Number of 14-day and 30-day readmissions	30-day (and 14-day) readmissions will be calculated for each patient as the number of admissions that occur within 30 days (14 days) after discharge from a previous admission, averaged over a 12-month period. Additionally, this will be calculated per 24 months. discharge for a previous admission.	Duration of time on study, on average 24 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Care Transition Process Measurement Tool Score	Evaluated at the site level in pediatric and adult clinics. These tools each include 6 components. For pediatric clinics, the components are transition policy (range 0-24), transition tracking and monitoring (range 0-9), transition readiness (range 0-20), transition planning (range 0-23), transfer of care (range 0-14), and transfer completion (range 0-10). For adult clinics, the components are young adult transition care policy (range 0-22), transition tracking and monitoring (range 0-9), orientation to adult practice (range 0-14), integration into adult practice (range 0-9), initial visits (range 0-32), ongoing care (range 0-14). For each of these tools, the final score is the sum of subtotals of components of the score (range 0-100). Higher scores are better.	At baseline, 6, 12, 18, 24, 30, 36, 42, 48, and 54 months post study initiation

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Patient-Centered Outcomes Research Institute; Atrium Health Levine Cancer Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: June 14, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Transition; Emerging Adults; Peer Mentoring
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: LCI-HEM-SCD-ST3P-UP-001; 00027706 (Other Grant/Funding Number: PCORI)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No