LCI-HEM-SCD-ST3P-UP-001: The Sickle Cell Trevor Thompson Transition Project (ST3P-UP Study)

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Other: Peer Mentoring [PM]
* Other: Structured Education Based Transition Program STE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster Randomized Parallel group study
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transition, Emerging Adults, Peer Mentoring