Sickle Cell Disease
Conditions
Keywords
Transition, Emerging Adults, Peer Mentoring
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
Interventions
OTHERPeer Mentoring [PM]
Virtual Peer Mentoring
OTHERStructured Education Based Transition Program STE
Education-based program
Sponsors
Patient-Centered Outcomes Research Institute
Atrium Health Levine Cancer Institute
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Cluster Randomized Parallel group study
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Care Visits (Visits Per Year) | Duration of time on study, on average 23 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Quality of Life - Sickle Cell Module (PedsQL-SCD Module) for Health-related Quality of Life | At 6 and 12 months post-enrollment | 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) Overall Social Support | At 6 and 12 months post-enrollment. | 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). |
| Transition Intervention Program Readiness for Transition (TIP-RFT) Scale | At 6 and 12 months post-enrollment. | 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. |
| Health Care Transition Feedback Survey Item: How Often Does Your Health Care Provider Explain Things in a Way That is Easy to Understand? | 12 months post-enrollment. | 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. |
| Health Care Transition Feedback Survey: How Often do You Schedule Your Own Appointments With Your Health Care Provider? | 12 months post-enrollment. | 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. |
| Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC) | 6 and 12 months post-enrollment. | 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. |
| Number of Ambulatory Visits Per Year | Duration of time on study up, on average 23 months | 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). |
| Number of Visits With Adult Provider | Adult duration of time on study, on average 16.5 months | 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. |
| Number of Hospitalization Days | Duration of time on study, on average 23 months | 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). |
| Number of 14-day Readmissions | Duration of time on study, on average 23 months. | 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. |
| Number of 30-day Readmissions | Duration of time on study, on average 23 months | 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. |
| Health Care Transition Feedback Survey: Does Your Health Care Provider Update and Share a Medical Summary With You? | 12 months post-enrollment. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Program Structured Education Based Transition Program Program Structured Education Based Transition Program \[STE\]
Structured Education Based Transition Program STE: Education-based program | 196 |
| Structured Education Based Transition Program + Peer Mentoring Structured Education Based Transition Program \[STE\] + Peer Mentoring \[PM\]
Peer Mentoring \[PM\]: Virtual Peer Mentoring
Structured Education Based Transition Program STE: Education-based program | 95 |
| Total | 291 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 3 |
| Overall Study | Lost to Follow-up | 48 | 3 |
| Overall Study | No Information | 1 | 7 |
| Overall Study | Participant Relocated | 19 | 3 |
| Overall Study | Physician Decision | 0 | 6 |
| Overall Study | Withdrawal by Subject | 5 | 24 |
Baseline characteristics
| Characteristic | Program Structured Education Based Transition Program | Total | Structured Education Based Transition Program + Peer Mentoring |
|---|---|---|---|
| Acute Care Visits per Year (Historical) | 4.0 visits per year STANDARD_DEVIATION 5.2 | 3.6 visits per year STANDARD_DEVIATION 4.9 | 2.6 visits per year STANDARD_DEVIATION 4.3 |
| Age, Continuous | 18.9 years STANDARD_DEVIATION 1.4 | 18.8 years STANDARD_DEVIATION 1.5 | 18.7 years STANDARD_DEVIATION 1.7 |
| Ambulatory Care Visits per Year (Historical) | 5.9 visits per year STANDARD_DEVIATION 7.3 | 6.3 visits per year STANDARD_DEVIATION 6.8 | 7.0 visits per year STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 13 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 182 Participants | 272 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 6 Participants | 0 Participants |
| Overall MOS-SSS Score (0-100%) | 75.3 units on a scale STANDARD_DEVIATION 22.8 | 74.0 units on a scale STANDARD_DEVIATION 23.2 | 70.7 units on a scale STANDARD_DEVIATION 24.1 |
| Overall PedsQL SCD Score (0-100) | 63.2 units on a scale STANDARD_DEVIATION 18.4 | 62.6 units on a scale STANDARD_DEVIATION 18.7 | 61.3 units on a scale STANDARD_DEVIATION 19.6 |
| Overall TIP-RFT Score (0-88) | 14.8 units on a scale STANDARD_DEVIATION 11 | 14.2 units on a scale STANDARD_DEVIATION 10.6 | 12.9 units on a scale STANDARD_DEVIATION 9.6 |
| Race/Ethnicity, Customized Race African American | 188 Participants | 278 Participants | 90 Participants |
| Race/Ethnicity, Customized Race Other | 6 Participants | 11 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Unknown | 2 Participants | 2 Participants | 0 Participants |
| SCD Phenotype Other | 17 Participants | 34 Participants | 17 Participants |
| SCD Phenotype SC Disease | 45 Participants | 63 Participants | 18 Participants |
| SCD Phenotype SS Disease | 134 Participants | 194 Participants | 60 Participants |
| Sex: Female, Male Female | 100 Participants | 151 Participants | 51 Participants |
| Sex: Female, Male Male | 96 Participants | 140 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 196 | 3 / 95 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Acute Care Visits (Visits Per Year)
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.
Time frame: Duration of time on study, on average 23 months
Population: All enrolled subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Program Structured Education Based Transition Program | Acute Care Visits (Visits Per Year) | 2.46 visits per year |
| Structured Education Based Transition Program + Peer Mentoring | Acute Care Visits (Visits Per Year) | 2.96 visits per year |
95% CI: [1.81, 3.34]
95% CI: [2.09, 4.19]
Secondary
Health Care Transition Feedback Survey: Does Your Health Care Provider Update and Share a Medical Summary With You?
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.
Time frame: 12 months post-enrollment.
Population: Participants with survey data at 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Program Structured Education Based Transition Program | Health Care Transition Feedback Survey: Does Your Health Care Provider Update and Share a Medical Summary With You? | Yes | 46 Participants |
| Program Structured Education Based Transition Program | Health Care Transition Feedback Survey: Does Your Health Care Provider Update and Share a Medical Summary With You? | No | 5 Participants |
| Structured Education Based Transition Program + Peer Mentoring | Health Care Transition Feedback Survey: Does Your Health Care Provider Update and Share a Medical Summary With You? | Yes | 25 Participants |
| Structured Education Based Transition Program + Peer Mentoring | Health Care Transition Feedback Survey: Does Your Health Care Provider Update and Share a Medical Summary With You? | No | 1 Participants |
Secondary
Health Care Transition Feedback Survey: How Often do You Schedule Your Own Appointments With Your Health Care Provider?
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.
Time frame: 12 months post-enrollment.
Population: Participants with survey data at 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Program Structured Education Based Transition Program | Health Care Transition Feedback Survey: How Often do You Schedule Your Own Appointments With Your Health Care Provider? | Always/Usually | 16 Participants |
| Program Structured Education Based Transition Program | Health Care Transition Feedback Survey: How Often do You Schedule Your Own Appointments With Your Health Care Provider? | Sometimes/Never | 35 Participants |
| Structured Education Based Transition Program + Peer Mentoring | Health Care Transition Feedback Survey: How Often do You Schedule Your Own Appointments With Your Health Care Provider? | Always/Usually | 8 Participants |
| Structured Education Based Transition Program + Peer Mentoring | Health Care Transition Feedback Survey: How Often do You Schedule Your Own Appointments With Your Health Care Provider? | Sometimes/Never | 18 Participants |
Secondary
Health Care Transition Feedback Survey Item: How Often Does Your Health Care Provider Explain Things in a Way That is Easy to Understand?
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.
Time frame: 12 months post-enrollment.
Population: Participants with survey data at 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Program Structured Education Based Transition Program | Health Care Transition Feedback Survey Item: How Often Does Your Health Care Provider Explain Things in a Way That is Easy to Understand? | Always/Usually | 48 Participants |
| Program Structured Education Based Transition Program | Health Care Transition Feedback Survey Item: How Often Does Your Health Care Provider Explain Things in a Way That is Easy to Understand? | Sometimes/Never | 3 Participants |
| Structured Education Based Transition Program + Peer Mentoring | Health Care Transition Feedback Survey Item: How Often Does Your Health Care Provider Explain Things in a Way That is Easy to Understand? | Always/Usually | 26 Participants |
| Structured Education Based Transition Program + Peer Mentoring | Health Care Transition Feedback Survey Item: How Often Does Your Health Care Provider Explain Things in a Way That is Easy to Understand? | Sometimes/Never | 0 Participants |
Secondary
Medical Outcomes Study Social Support Survey (MOS-SSS) Overall Social Support
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).
Time frame: At 6 and 12 months post-enrollment.
Population: Participants who completed the survey.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Program Structured Education Based Transition Program | Medical Outcomes Study Social Support Survey (MOS-SSS) Overall Social Support | 6 Months | 76.8 score on a scale |
| Program Structured Education Based Transition Program | Medical Outcomes Study Social Support Survey (MOS-SSS) Overall Social Support | 12 Months | 75.3 score on a scale |
| Structured Education Based Transition Program + Peer Mentoring | Medical Outcomes Study Social Support Survey (MOS-SSS) Overall Social Support | 6 Months | 77.8 score on a scale |
| Structured Education Based Transition Program + Peer Mentoring | Medical Outcomes Study Social Support Survey (MOS-SSS) Overall Social Support | 12 Months | 80.6 score on a scale |
Secondary
Number of 14-day Readmissions
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.
Time frame: Duration of time on study, on average 23 months.
Population: All enrolled subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Program Structured Education Based Transition Program | Number of 14-day Readmissions | 0.14 readmissions per year |
| Structured Education Based Transition Program + Peer Mentoring | Number of 14-day Readmissions | 0.16 readmissions per year |
Secondary
Number of 30-day Readmissions
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.
Time frame: Duration of time on study, on average 23 months
Population: All enrolled subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Program Structured Education Based Transition Program | Number of 30-day Readmissions | 0.25 readmissions per year |
| Structured Education Based Transition Program + Peer Mentoring | Number of 30-day Readmissions | 0.25 readmissions per year |
Secondary
Number of Ambulatory Visits Per Year
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).
Time frame: Duration of time on study up, on average 23 months
Population: All enrolled subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Program Structured Education Based Transition Program | Number of Ambulatory Visits Per Year | 5.31 visits per year |
| Structured Education Based Transition Program + Peer Mentoring | Number of Ambulatory Visits Per Year | 5.97 visits per year |
Secondary
Number of Hospitalization Days
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).
Time frame: Duration of time on study, on average 23 months
Population: All enrolled subjects
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Program Structured Education Based Transition Program | Number of Hospitalization Days | 4.38 days per year |
| Structured Education Based Transition Program + Peer Mentoring | Number of Hospitalization Days | 4.57 days per year |
Secondary
Number of Visits With Adult Provider
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.
Time frame: Adult duration of time on study, on average 16.5 months
Population: Among those with at least one visit with adult provider.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Program Structured Education Based Transition Program | Number of Visits With Adult Provider | 6.16 visits per year |
| Structured Education Based Transition Program + Peer Mentoring | Number of Visits With Adult Provider | 6.23 visits per year |
Secondary
Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC)
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.
Time frame: 6 and 12 months post-enrollment.
Population: Among participants with survey data available at relevant time points.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Program Structured Education Based Transition Program | Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC) | 6 months | 9-10 | 50 Participants |
| Program Structured Education Based Transition Program | Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC) | 12 months | 7-8 | 17 Participants |
| Program Structured Education Based Transition Program | Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC) | 12 months | 0-6 | 10 Participants |
| Program Structured Education Based Transition Program | Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC) | 6 months | 7-8 | 26 Participants |
| Program Structured Education Based Transition Program | Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC) | 12 months | 9-10 | 28 Participants |
| Program Structured Education Based Transition Program | Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC) | 6 months | 0-6 | 4 Participants |
| Structured Education Based Transition Program + Peer Mentoring | Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC) | 12 months | 9-10 | 17 Participants |
| Structured Education Based Transition Program + Peer Mentoring | Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC) | 6 months | 0-6 | 4 Participants |
| Structured Education Based Transition Program + Peer Mentoring | Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC) | 6 months | 7-8 | 5 Participants |
| Structured Education Based Transition Program + Peer Mentoring | Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC) | 6 months | 9-10 | 16 Participants |
| Structured Education Based Transition Program + Peer Mentoring | Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC) | 12 months | 7-8 | 6 Participants |
| Structured Education Based Transition Program + Peer Mentoring | Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC) | 12 months | 0-6 | 3 Participants |
Secondary
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.
Time frame: At 6 and 12 months post-enrollment
Population: Participants with data at 6 and 12 months.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Program Structured Education Based Transition Program | Pediatric Quality of Life - Sickle Cell Module (PedsQL-SCD Module) for Health-related Quality of Life | 6 months | 66.5 score on a scale |
| Program Structured Education Based Transition Program | Pediatric Quality of Life - Sickle Cell Module (PedsQL-SCD Module) for Health-related Quality of Life | 12 months | 68.7 score on a scale |
| Structured Education Based Transition Program + Peer Mentoring | Pediatric Quality of Life - Sickle Cell Module (PedsQL-SCD Module) for Health-related Quality of Life | 6 months | 63.4 score on a scale |
| Structured Education Based Transition Program + Peer Mentoring | Pediatric Quality of Life - Sickle Cell Module (PedsQL-SCD Module) for Health-related Quality of Life | 12 months | 62.4 score on a scale |
Secondary
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. If any items were missing, the scores were not computed.
Time frame: At 6 and 12 months post-enrollment.
Population: Participants who completed the survey.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Program Structured Education Based Transition Program | Transition Intervention Program Readiness for Transition (TIP-RFT) Scale | 6 Months | 10.4 score on a scale |
| Program Structured Education Based Transition Program | Transition Intervention Program Readiness for Transition (TIP-RFT) Scale | 12 Months | 9.4 score on a scale |
| Structured Education Based Transition Program + Peer Mentoring | Transition Intervention Program Readiness for Transition (TIP-RFT) Scale | 6 Months | 8.5 score on a scale |
| Structured Education Based Transition Program + Peer Mentoring | Transition Intervention Program Readiness for Transition (TIP-RFT) Scale | 12 Months | 8.0 score on a scale |