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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 28
- 主要终点
- Acute Care Visits (Visits Per Year)
研究概览
简要总结
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)
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Acute Care Visits (Visits Per Year)
时间窗: 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.
次要结局
- 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.)
- Pediatric Quality of Life - Sickle Cell Module (PedsQL-SCD Module) for Health-related Quality of Life(At 6 and 12 months post-enrollment)
- Medical Outcomes Study Social Support Survey (MOS-SSS) Overall Social Support(At 6 and 12 months post-enrollment.)
- Transition Intervention Program Readiness for Transition (TIP-RFT) Scale(At 6 and 12 months post-enrollment.)
- Number of Hospitalization Days(Duration of time on study, on average 23 months)
- 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.)
- Number of 14-day Readmissions(Duration of time on study, on average 23 months.)
- Number of 30-day Readmissions(Duration of time on study, on average 23 months)
- Health Care Transition Feedback Survey: How Often do You Schedule Your Own Appointments With Your Health Care Provider?(12 months post-enrollment.)
- Health Care Transition Feedback Survey: Does Your Health Care Provider Update and Share a Medical Summary With You?(12 months post-enrollment.)
- Number of Visits With Adult Provider(Adult duration of time on study, on average 16.5 months)
- Number of Ambulatory Visits Per Year(Duration of time on study up, on average 23 months)