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

• ClinicalTrials.gov Identifier: NCT03593395
• Recruitment Status: Completed
• First Posted: July 20, 2018
• Last Update Posted: March 24, 2023
• Sponsor: Wake Forest University Health Sciences
• Collaborators: Patient-Centered Outcomes Research Institute; Atrium Health Levine Cancer Institute
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Sickle Cell Disease	Other: Peer Mentoring [PM]; Other: Structured Education Based Transition Program STE	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 351 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Cluster Randomized Parallel group study
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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)
• Actual Study Start Date: January 10, 2019
• Actual Primary Completion Date: February 28, 2023
• Actual Study Completion Date: February 28, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Arm 1-A; Small sized Program Structured Education Based Transition Program [STE]	Other: Structured Education Based Transition Program STE; Education-based program without Peer Mentoring
Experimental: Arm 1-B; Small sized program Structured Education Based Transition Program [STE] + Peer Mentoring [PM]	Other: Peer Mentoring [PM]; Virtual Peer Mentoring in addition to Structured Education Transition QI
Active Comparator: Arm 2-A; Large sized program Structured Education Based Transition Program [STE]	Other: Structured Education Based Transition Program STE; Education-based program without Peer Mentoring
Experimental: 2-B; Large sized program Structured Education Based Transition Program [STE] + Peer Mentoring [PM]	Other: Peer Mentoring [PM]; Virtual Peer Mentoring in addition to Structured Education Transition QI

Outcome Measures

Primary Outcome Measures :

1. Change in Average Number of Acute Care Visits Per Year [ Time Frame: 1 year pre-enrollment, 1 year post-enrollment, and 2 years post-enrollment. ]
   Average number of acute care visits per year over a minimum of 24 months up to 36 months.

Secondary Outcome Measures :

1. Adults Sickle Cell Quality of Care Measure (ASCQ-ME QOC) for health-related quality of life [ Time Frame: At enrollment, and 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months post-enrollment. ]
   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%.
2. Acute Care Reliance [ Time Frame: 1 year pre-enrollment, 1 year post-enrollment and 2 years post-enrollment. ]
   Number of acute care visits compared to acute care and ambulatory visits
3. Pediatric Quality of Life - Sickle Cell Module (PedsQL-SCD module) for health-related quality of life [ Time Frame: At enrollment, and 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months post-enrollment. ]

   Overall patients perception of their quality of life Higher quality of life score is better, 43 items, 9 dimensions : pain and hurt, pain impact, pain management, worry I, worry II, Emotions, Treatment, Communication I, Communication II Likert scale, (0=never, 4=almost always) , scores transformed on a scale from 0-100 .. where 0=100, 1=75, 2=50, 3=25, 4=0 Total score: sum of all items /number of items answered on all 9 dimensions.

   **note: if more than 50% of the items are incomplete, cannot use the scale.

4. Medical Outcomes Study Social Support Survey (MOS-SSS) [ Time Frame: At enrollment, and 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months post-enrollment. ]
   Patients perceived social support score, four separate social support subscales and an overall functional social support index. A higher score for an individual scale or for the overall support index indicates more support. To calculate overall total, take average of scores. (range = 1-5) , 5=best possible outcome
5. The number of ambulatory visits [ Time Frame: 1 year pre-enrollment, 1 year post-enrollment, and 2 years post-enrollment. ]
   The number of visits with adult providers in the out patient setting
6. Hospitalization days [ Time Frame: 1 year pre-enrollment, 1 year post-enrollment, and 2 years post-enrollment. ]
   Number of days spent inpatient
7. 14-day and 30-day readmission rates [ Time Frame: 1 year pre-enrollment, 1 year post-enrollment and 2 years post-enrollment. ]
   Rates of readmission to the hospital within 14 and 30 days of discharge
8. Transition Intervention Program Readiness for Transition (TIP-RFT) scale [ Time Frame: At enrollment, and 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months post-enrollment. ]
   Change in patients score on validated readiness to transition scale 4 subscales: 1. Independent Living Skills (range 0-8), 8 = best, 2. Healthcare Knowledge and Skills scale (range 0-6), 6= best, 3. Education and Vocational Planning scale (range 0-4) 4= best 4. Social Support Skill set (range 0-4), 4=best For total TIP-RFT, use sum of scales. 22= best score possible

Other Outcome Measures:

1. Health Care Transition Process Measurement Tool Score [ Time Frame: At enrollment, and 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months post-enrollment. ]

   Pediatrics clinic: higher score = better outcome 6 components:

   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), transfer completion. (range 0-10) 6 components: 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) Final score: sum of subtotals of component of the score, 0-100

2. Health Care Transition Feedback Survey [ Time Frame: At enrollment, and 1,2,3,4 and 5 years post-enrollment. ]
   Patients satisfaction with transition process, higher score = better

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

University of South Alabama Health System

Mobile, Alabama, United States, 36617

United States, Florida

University of Miami

Miami, Florida, United States, 33136

Johns Hopkins All Children's Hospital

Saint Petersburg, Florida, United States, 33701

United States, Georgia

Children's Healthcare of Atlanta/Emory University

Atlanta, Georgia, United States, 30322

United States, Kentucky

University of Louisville

Louisville, Kentucky, United States, 40202

United States, New York

Montefiore Medical Center

Bronx, New York, United States, 10467

United States, North Carolina

Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

Novant Health

Charlotte, North Carolina, United States, 28204

Duke University

Durham, North Carolina, United States, 27705

East Carolina University

Greenville, North Carolina, United States, 27834

Wake Forest Baptist Hospital

Winston-Salem, North Carolina, United States, 27157

United States, South Carolina

Greenville Health System

Greenville, South Carolina, United States, 29605

United States, Virginia

Virginia Commonwealth University (VCU)

Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Wake Forest University Health Sciences

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

  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

Informed Consent Form  [PDF] August 26, 2020

More Information

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03593395
• Other Study ID Numbers: LCI-HEM-SCD-ST3P-UP-001; 00027706 ( Other Grant/Funding Number: PCORI )
• First Posted: July 20, 2018
• Last Update Posted: March 24, 2023
• Last Verified: March 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:

Transition; Emerging Adults; Peer Mentoring

Additional relevant MeSH terms:

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn