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

April 5, 2024 updated by: Wake Forest University Health Sciences

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)

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
291

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
      • Mobile, Alabama, United States, 36617
        • University of South Alabama Health System
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Saint Petersburg, Florida, United States, 33701
        • Johns Hopkins All Children's Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta/Emory University
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
      • Charlotte, North Carolina, United States, 28204
        • Novant Health
      • Durham, North Carolina, United States, 27705
        • Duke University
      • Greenville, North Carolina, United States, 27834
        • East Carolina University
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University (VCU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Program Structured Education Based Transition Program
Program Structured Education Based Transition Program [STE]
Other: Structured Education Based Transition Program STE
Education-based program
Experimental: Structured Education Based Transition Program + Peer Mentoring
Structured Education Based Transition Program [STE] + Peer Mentoring [PM]
Other: Structured Education Based Transition Program STE
Education-based program
Other: Peer Mentoring [PM]
Virtual Peer Mentoring

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acute Care Visits (Visits Per Year)
Time Frame: 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.
Duration of time on study, on average 23 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC)
Time Frame: 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.
6 and 12 months post-enrollment.
Pediatric Quality of Life - Sickle Cell Module (PedsQL-SCD Module) for Health-related Quality of Life
Time Frame: 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.
At 6 and 12 months post-enrollment
Medical Outcomes Study Social Support Survey (MOS-SSS) Overall Social Support
Time Frame: 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).
At 6 and 12 months post-enrollment.
Transition Intervention Program Readiness for Transition (TIP-RFT) Scale
Time Frame: 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.
At 6 and 12 months post-enrollment.
Health Care Transition Feedback Survey Item: How Often Does Your Health Care Provider Explain Things in a Way That is Easy to Understand?
Time Frame: 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.
12 months post-enrollment.
Health Care Transition Feedback Survey: How Often do You Schedule Your Own Appointments With Your Health Care Provider?
Time Frame: 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.
12 months post-enrollment.
Health Care Transition Feedback Survey: Does Your Health Care Provider Update and Share a Medical Summary With You?
Time Frame: 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.
12 months post-enrollment.
Number of Ambulatory Visits Per Year
Time Frame: 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).
Duration of time on study up, on average 23 months
Number of Visits With Adult Provider
Time Frame: 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.
Adult duration of time on study, on average 16.5 months
Number of Hospitalization Days
Time Frame: 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).
Duration of time on study, on average 23 months
Number of 14-day Readmissions
Time Frame: 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.
Duration of time on study, on average 23 months.
Number of 30-day Readmissions
Time Frame: 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.
Duration of time on study, on average 23 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health Care Transition Process Measurement Tool Score
Time Frame: At baseline, 6, 12, 18, 24, 30, 36, 42, 48, and 54 months post study initiation
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.
At baseline, 6, 12, 18, 24, 30, 36, 42, 48, and 54 months post study initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute
Atrium Health Levine Cancer Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Payal Desai, MD, Wake Forest University Health Sciences
  • Principal Investigator: Raymona Lawrence, DRPH, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LCI-HEM-SCD-ST3P-UP-001
  • 00027706 (Other Grant/Funding Number: PCORI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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