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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03593395
Recruitment Status : Suspended (Accrual temporarily suspended during COVID-19 pandemic)
First Posted : July 20, 2018
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Ifeyinwa (Ify) Osunkwo MD MPH, Atrium Health

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 841 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 18, 2018
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593395


Locations
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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
Ifeyinwa (Ify) Osunkwo MD MPH
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Ifeyinwa Osunkwo, MD, MPH Atrium Health
Principal Investigator: Raymona Lawrence, DRPH Atrium Health
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Responsible Party: Ifeyinwa (Ify) Osunkwo MD MPH, Medical Director, Sickle Cell Disease Enterprise, Atrium Health
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    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ifeyinwa (Ify) Osunkwo MD MPH, Atrium Health:
Transition
Emerging Adults
Peer Mentoring
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn