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)
Brief Title
LCI-HEM-SCD-ST3P-UP-001: The Sickle Cell Trevor Thompson Transition Project (ST3P-UP Study)
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
Categories
Completion Date
Completion Date Type
Actual
Conditions
Sickle Cell Disease
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
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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Transition
Emerging Adults
Peer Mentoring
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
16 Years
NCT Id
NCT03593395
Org Class
Other
Org Full Name
Wake Forest University Health Sciences
Org Study Id
LCI-HEM-SCD-ST3P-UP-001
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
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)
Primary Outcomes
Outcome Description
Acute care visits was calculated for each patient as the number of acute care visits over the duration of follow-up (time from enrollment to discontinuation of study participation). Acute visits were identified by manual chart reviews and included hospital admissions, ED, urgent care, day hospital, or infusion center visits. Acute care visits were calculated as the total number of acute care visits reported on study over the years the subject was on study.
Outcome Measure
Acute Care Visits (Visits Per Year)
Outcome Time Frame
Duration of time on study, on average 23 months
Secondary Ids
Secondary Id
00027706
Secondary Outcomes
Outcome Description
Specific item from ASQC-ME QOC. The survey measures patients' self-reported levels of quality of care received. This item was scored on a 10-point scale categorized to three ranges (0-6, 7-8, and 9-10). A "0" value is least, and a "10" value is best. 0-6 indicate the worst care, 7-8 indicate average care, 9-10 indicate the best care. Higher score indicates higher quality of care.
Outcome Time Frame
6 and 12 months post-enrollment.
Outcome Measure
Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC)
Outcome 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.
Outcome Time Frame
At 6 and 12 months post-enrollment
Outcome Measure
Pediatric Quality of Life - Sickle Cell Module (PedsQL-SCD Module) for Health-related Quality of Life
Outcome 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 and transform to 0-100 scale (100 is best possible outcome).
Outcome Time Frame
At 6 and 12 months post-enrollment.
Outcome Measure
Medical Outcomes Study Social Support Survey (MOS-SSS) Overall Social Support
Outcome 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. If any items were missing, the scores were not computed.
Outcome Time Frame
At 6 and 12 months post-enrollment.
Outcome Measure
Transition Intervention Program Readiness for Transition (TIP-RFT) Scale
Outcome Description
Specific item from the Health Care Transition Feedback Survey, created by Got Transition. The survey evaluated patients' experience with changing from a pediatric to an adult approach to care. This question evaluated how often the health care provider explained things in a way that was easy to understand. Answer categories for this item were Always, Usually, Sometimes, and Never.
Outcome Time Frame
12 months post-enrollment.
Outcome Measure
Health Care Transition Feedback Survey Item: How Often Does Your Health Care Provider Explain Things in a Way That is Easy to Understand?
Outcome Description
Specific item from the Health Care Transition Feedback Survey, created by Got Transition. The survey evaluated patients' experience with changing from a pediatric to an adult approach to care. This question evaluated how often the the patient scheduled their own appointments with their health care provider. Answer categories for this item were Always, Usually, Sometimes, and Never.
Outcome Time Frame
12 months post-enrollment.
Outcome Measure
Health Care Transition Feedback Survey: How Often do You Schedule Your Own Appointments With Your Health Care Provider?
Outcome Description
Specific item from the Health Care Transition Feedback Survey, created by Got Transition. The survey evaluated patients' experience with changing from a pediatric to an adult approach to care. This question evaluated if the health care provider updated and shared a medical summary with the patient. Answer categories for this item were Yes or No.
Outcome Time Frame
12 months post-enrollment.
Outcome Measure
Health Care Transition Feedback Survey: Does Your Health Care Provider Update and Share a Medical Summary With You?
Outcome Description
Ambulatory visits was calculated for each patient as the average number of ambulatory visits per year. Ambulatory visits were identified by manual chart reviews and included primary care visits, visits with the hematology/SCD provider, and other outpatient specialty visits. Ambulatory visits per year was calculated as the total number of ambulatory visits reported over the duration of time on study (from enrollment to discontinuation of study participation).
Outcome Time Frame
Duration of time on study up, on average 23 months
Outcome Measure
Number of Ambulatory Visits Per Year
Outcome Description
Adult provider visits was calculated for each patient as the average number of ambulatory visits that occurred with adult providers. These visits were identified by manual chart reviews. Adult provider visits per year was calculated as the total number of adult provider visits reported on study over the time from first visit with adult provider to end of study participation.
Outcome Time Frame
Adult duration of time on study, on average 16.5 months
Outcome Measure
Number of Visits With Adult Provider
Outcome Description
Hospitalization days was calculated for each patient as the average number of days spent inpatient for hospitalization per year. Inpatient dates were identified by manual chart reviews. Hospitalization days per year was calculated as the total number of hospitalization days reported on study over the total duration on study (from enrollment to discontinuation of study participation).
Outcome Time Frame
Duration of time on study, on average 23 months
Outcome Measure
Number of Hospitalization Days
Outcome Description
14-day readmissions was calculated for each patient as the number of hospital admissions that occur within 14 days after discharge from a previous admission, per year. Hospital admissions were identified by manual chart reviews and total number of readmissions within 14 days were counted over the duration of time on study.
Outcome Time Frame
Duration of time on study, on average 23 months.
Outcome Measure
Number of 14-day Readmissions
Outcome Description
30-day readmissions will be calculated for each patient as the number of hospital admissions that occur within 30 days after discharge from a previous admission, per year. Hospital admissions were identified by manual chart reviews and total number of readmissions within 30 days were counted over the duration of time on study.
Outcome Time Frame
Duration of time on study, on average 23 months
Outcome Measure
Number of 30-day Readmissions
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
16
Investigators
Investigator Type
Principal Investigator
Investigator Name
Deepa Manwani
Investigator Email
dmanwani@montefiore.org
Investigator Phone
718-741-2342