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

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ClinicalTrials.gov Identifier: NCT03593395
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : June 4, 2021
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Ifeyinwa (Ify) Osunkwo MD MPH, Atrium Health

Tracking Information
First Submitted Date  ICMJE June 14, 2018
First Posted Date  ICMJE July 20, 2018
Last Update Posted Date June 4, 2021
Actual Study Start Date  ICMJE January 18, 2018
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • 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%.
  • 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
  • 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.
  • 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
  • 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
  • Hospitalization days [ Time Frame: 1 year pre-enrollment, 1 year post-enrollment, and 2 years post-enrollment. ]
    Number of days spent inpatient
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 10, 2018)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE LCI-HEM-SCD-ST3P-UP-001: The Sickle Cell Trevor Thompson Transition Project (ST3P-UP Study)
Official Title  ICMJE 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)
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Cluster Randomized Parallel group study
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE
  • Other: Peer Mentoring [PM]
    Virtual Peer Mentoring in addition to Structured Education Transition QI
  • Other: Structured Education Based Transition Program STE
    Education-based program without Peer Mentoring
Study Arms  ICMJE
  • Active Comparator: Arm 1-A
    Small sized Program Structured Education Based Transition Program [STE]
    Intervention: Other: Structured Education Based Transition Program STE
  • Experimental: Arm 1-B
    Small sized program Structured Education Based Transition Program [STE] + Peer Mentoring [PM]
    Intervention: Other: Peer Mentoring [PM]
  • Active Comparator: Arm 2-A
    Large sized program Structured Education Based Transition Program [STE]
    Intervention: Other: Structured Education Based Transition Program STE
  • Experimental: 2-B
    Large sized program Structured Education Based Transition Program [STE] + Peer Mentoring [PM]
    Intervention: Other: Peer Mentoring [PM]
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2018)
841
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nirav Shah 916-607-9054 Nirav.R.Shah@atriumhealth.org
Contact: Ifeyinwa Osunkwo, MD, MPH 980-442-5119 ify.osunkwo@atriumhealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03593395
Other Study ID Numbers  ICMJE LCI-HEM-SCD-ST3P-UP-001
00027706 ( Other Grant/Funding Number: PCORI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ifeyinwa (Ify) Osunkwo MD MPH, Atrium Health
Study Sponsor  ICMJE Ifeyinwa (Ify) Osunkwo MD MPH
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Ifeyinwa Osunkwo, MD, MPH Atrium Health
Principal Investigator: Raymona Lawrence, DRPH Atrium Health
PRS Account Atrium Health
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP