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): 291
• 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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC)	Specific item from ASQC-ME QOC. The survey measures patients' self-reported levels of quality of care received. This item was scored on a 10-point scale categorized to three ranges (0-6, 7-8, and 9-10). A "0" value is least, and a "10" value is best. 0-6 indicate the worst care, 7-8 indicate average care, 9-10 indicate the best care. Higher score indicates higher quality of care.	6 and 12 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 6 and 12 months post-enrollment
Medical Outcomes Study Social Support Survey (MOS-SSS) Overall Social Support	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 and transform to 0-100 scale (100 is best possible outcome).	At 6 and 12 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. If any items were missing, the scores were not computed.	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?	Specific item from the Health Care Transition Feedback Survey, created by Got Transition. The survey evaluated patients' experience with changing from a pediatric to an adult approach to care. This question evaluated how often the health care provider explained things in a way that was easy to understand. Answer categories for this item were Always, Usually, Sometimes, and Never.	12 months post-enrollment.
Health Care Transition Feedback Survey: How Often do You Schedule Your Own Appointments With Your Health Care Provider?	Specific item from the Health Care Transition Feedback Survey, created by Got Transition. The survey evaluated patients' experience with changing from a pediatric to an adult approach to care. This question evaluated how often the the patient scheduled their own appointments with their health care provider. Answer categories for this item were Always, Usually, Sometimes, and Never.	12 months post-enrollment.
Health Care Transition Feedback Survey: Does Your Health Care Provider Update and Share a Medical Summary With You?	Specific item from the Health Care Transition Feedback Survey, created by Got Transition. The survey evaluated patients' experience with changing from a pediatric to an adult approach to care. This question evaluated if the health care provider updated and shared a medical summary with the patient. Answer categories for this item were Yes or No.	12 months post-enrollment.
Number of Ambulatory Visits Per Year	Ambulatory visits was calculated for each patient as the average number of ambulatory visits per year. Ambulatory visits were identified by manual chart reviews and included primary care visits, visits with the hematology/SCD provider, and other outpatient specialty visits. Ambulatory visits per year was calculated as the total number of ambulatory visits reported over the duration of time on study (from enrollment to discontinuation of study participation).	Duration of time on study up, on average 23 months
Number of Visits With Adult Provider	Adult provider visits was calculated for each patient as the average number of ambulatory visits that occurred with adult providers. These visits were identified by manual chart reviews. Adult provider visits per year was calculated as the total number of adult provider visits reported on study over the time from first visit with adult provider to end of study participation.	Adult duration of time on study, on average 16.5 months
Number of Hospitalization Days	Hospitalization days was calculated for each patient as the average number of days spent inpatient for hospitalization per year. Inpatient dates were identified by manual chart reviews. Hospitalization days per year was calculated as the total number of hospitalization days reported on study over the total duration on study (from enrollment to discontinuation of study participation).	Duration of time on study, on average 23 months
Number of 14-day Readmissions	14-day readmissions was calculated for each patient as the number of hospital admissions that occur within 14 days after discharge from a previous admission, per year. Hospital admissions were identified by manual chart reviews and total number of readmissions within 14 days were counted over the duration of time on study.	Duration of time on study, on average 23 months.
Number of 30-day Readmissions	30-day readmissions will be calculated for each patient as the number of hospital admissions that occur within 30 days after discharge from a previous admission, per year. Hospital admissions were identified by manual chart reviews and total number of readmissions within 30 days were counted over the duration of time on study.	Duration of time on study, on average 23 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
• Investigators: Principal Investigator: Payal Desai, MD, Wake Forest University Health Sciences; Principal Investigator: Raymona Lawrence, DRPH, Wake Forest University Health Sciences

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): September 3, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

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