Back to resultsLCI-HEM-SCD-ST3P-UP-001: The Sickle Cell Trevor Thompson Transition Project (ST3P-UP Study) (ST3P-UP)
Primary Purpose
Sickle Cell Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Mentoring [PM]
Structured Education Based Transition Program STE
Sponsored by
About this trial
This is an interventional health services research trial for Sickle Cell Disease focused on measuring Transition, Emerging Adults, Peer Mentoring
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
- University of South Alabama Health System
- University of Miami
- Johns Hopkins All Children's Hospital
- Children's Healthcare of Atlanta/Emory University
- University of Louisville
- Montefiore Medical Center
- Levine Cancer Institute
- Novant Health
- Duke University
- East Carolina University
- Wake Forest Baptist Hospital
- Greenville Health System
- Virginia Commonwealth University (VCU)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Program Structured Education Based Transition Program
Structured Education Based Transition Program + Peer Mentoring
Arm Description
Program Structured Education Based Transition Program [STE]
Structured Education Based Transition Program [STE] + Peer Mentoring [PM]
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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%.
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.
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).
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03593395
First Posted
June 14, 2018
Last Updated
April 18, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Patient-Centered Outcomes Research Institute, Atrium Health Levine Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT03593395
Brief Title
LCI-HEM-SCD-ST3P-UP-001: The Sickle Cell Trevor Thompson Transition Project (ST3P-UP Study)
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Patient-Centered Outcomes Research Institute, Atrium Health Levine Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
Transition, Emerging Adults, Peer Mentoring
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster Randomized Parallel group study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
351 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Program Structured Education Based Transition Program
Arm Type
Active Comparator
Arm Description
Program Structured Education Based Transition Program [STE]
Arm Title
Structured Education Based Transition Program + Peer Mentoring
Arm Type
Experimental
Arm Description
Structured Education Based Transition Program [STE] + Peer Mentoring [PM]
Intervention Type
Other
Intervention Name(s)
Peer Mentoring [PM]
Intervention Description
Virtual Peer Mentoring
Intervention Type
Other
Intervention Name(s)
Structured Education Based Transition Program STE
Intervention Description
Education-based program
Primary Outcome Measure Information:
Title
Number of acute care visits
Description
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.
Time Frame
Duration of time on study, on average 24 months
Secondary Outcome Measure Information:
Title
Adults Sickle Cell Quality of Care Measure (ASCQ-ME QOC) for health-related quality of life
Description
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%.
Time Frame
At enrollment, and 6, 12, 18, and 24 months post-enrollment.
Title
Pediatric Quality of Life - Sickle Cell Module (PedsQL-SCD module) for health-related quality of life
Description
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.
Time Frame
At enrollment, and 6, 12, 18, and 24 post-enrollment.
Title
Medical Outcomes Study Social Support Survey (MOS-SSS)
Description
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).
Time Frame
At enrollment, and 6, 12, 18, and 24 months post-enrollment.
Title
Transition Intervention Program Readiness for Transition (TIP-RFT) scale
Description
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.
Time Frame
At enrollment, and 6, 12, 18, and 24 months post-enrollment.
Title
Health Care Transition Feedback Survey
Description
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.
Time Frame
At enrollment, and 12 and 24 months post-enrollment.
Title
Number of ambulatory visits
Description
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.
Time Frame
Duration of time on study, on average 24 months
Title
Number of visits with adult provider
Description
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.
Time Frame
Duration of time on study, on average 24 months
Title
Number of hospitalization days
Description
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.
Time Frame
Duration of time on study, on average 24 months
Title
Number of 14-day and 30-day readmissions
Description
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.
Time Frame
Duration of time on study, on average 24 months.
Other Pre-specified Outcome Measures:
Title
Health Care Transition Process Measurement Tool Score
Description
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.
Time Frame
At baseline, 6, 12, 18, 24, 30, 36, 42, 48, and 54 months post study initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Payal Desai, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raymona Lawrence, DRPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of South Alabama Health System
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Children's Healthcare of Atlanta/Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Novant Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Wake Forest Baptist Hospital
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Virginia Commonwealth University (VCU)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36669729
Citation
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.
Results Reference
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LCI-HEM-SCD-ST3P-UP-001: The Sickle Cell Trevor Thompson Transition Project (ST3P-UP Study)
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