Clinical trial NCT03593395: LCI-HEM-SCD-ST3P-UP-001: The Sickle Cell Trevor Thompson Transition Project (ST3P-UP Study)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Transition
Emerging Adults
Peer Mentoring
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Atrium Health Levine Cancer Institute
First posted: 2018-07-20
Enrollment: 291
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Parallel group study
Primary purpose: HEALTH_SERVICES_RESEARCH

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)

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

Eligibility criteria: 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

Primary outcomes:
measure: Acute Care Visits (Visits Per Year)
timeFrame: Duration of time on study, on average 23 months
Secondary outcomes:
measure: Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC)
timeFrame: 6 and 12 months post-enrollment.
measure: Pediatric Quality of Life - Sickle Cell Module (PedsQL-SCD Module) for Health-related Quality of Life
timeFrame: At 6 and 12 months post-enrollment
measure: Medical Outcomes Study Social Support Survey (MOS-SSS) Overall Social Support
timeFrame: At 6 and 12 months post-enrollment.
measure: Transition Intervention Program Readiness for Transition (TIP-RFT) Scale
timeFrame: At 6 and 12 months post-enrollment.
measure: Health Care Transition Feedback Survey Item: How Often Does Your Health Care Provider Explain Things in a Way That is Easy to Understand?
timeFrame: 12 months post-enrollment.
measure: Health Care Transition Feedback Survey: How Often do You Schedule Your Own Appointments With Your Health Care Provider?
timeFrame: 12 months post-enrollment.
measure: Health Care Transition Feedback Survey: Does Your Health Care Provider Update and Share a Medical Summary With You?
timeFrame: 12 months post-enrollment.
measure: Number of Ambulatory Visits Per Year
timeFrame: Duration of time on study up, on average 23 months
measure: Number of Visits With Adult Provider
timeFrame: Adult duration of time on study, on average 16.5 months
measure: Number of Hospitalization Days
timeFrame: Duration of time on study, on average 23 months
measure: Number of 14-day Readmissions
timeFrame: Duration of time on study, on average 23 months.
measure: Number of 30-day Readmissions
timeFrame: Duration of time on study, on average 23 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama Health System
state: Alabama
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta/Emory University
state: Georgia
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Hospital
state: North Carolina
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University (VCU)
state: Virginia
Study officials:
affiliation: Wake Forest University Health Sciences
name: Payal Desai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Raymona Lawrence, DRPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.