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

Sickle Cell Disease Clinical Trial

— ST3P-UP  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03593395
• Other study ID #: LCI-HEM-SCD-ST3P-UP-001
• Secondary ID: 00027706
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: February 28, 2023

Study information

• Verified date: April 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Other:
• Peer Mentoring [PM]
Virtual Peer Mentoring
• Structured Education Based Transition Program STE
Education-based program

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta/Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Montefiore Medical Center	Bronx	New York
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Novant Health	Charlotte	North Carolina
United States	Duke University	Durham	North Carolina
United States	East Carolina University	Greenville	North Carolina
United States	Greenville Health System	Greenville	South Carolina
United States	University of Louisville	Louisville	Kentucky
United States	University of Miami	Miami	Florida
United States	University of South Alabama Health System	Mobile	Alabama
United States	Virginia Commonwealth University (VCU)	Richmond	Virginia
United States	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida
United States	Wake Forest Baptist Hospital	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Atrium Health Levine Cancer Institute, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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.