Return to Learn Implementation Bundle for Schools (RISE) After Youth Concussion
Primary Purpose
Concussion, Mild
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RISE Bundle
Sponsored by
About this trial
This is an interventional supportive care trial for Concussion, Mild
Eligibility Criteria
Inclusion Criteria: Public high school student, grade 9th - 12th who has sustained a concussion.
- High School Student between the age of 14-19, who attends in person, online, or a hybrid academic platform, and the concussion did not include an acute care hospital course greater than 48 hours.
Sites / Locations
- HIPRC
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Intervention Group
Arm Description
Consented parents of a concussed high school student who will receive CDC Head's UP Concussion Guidelines during a five week program. 75 Participants.
Consented parents of a concussed high school student who will receive the CDC Head's Up Concussion Guidelines and intervention RTL Student Protocol during a five week program. 75 Participants.
Outcomes
Primary Outcome Measures
RTL OUTCOMES - Symptom
Tracking children's symptoms over a five-week period of time. Parental completion of 4 - week symptom checklist 100% completion of weekly symptom checklist resulting in 20% fewer symptoms for the intervention group.
Secondary Outcome Measures
RTL OUTCOMES - Academic Success
Outcome measures to assess academic success. Parental completion of CLASS survey weeks 2 and 4 resulting in a 20 % less decline Intervention group.
Full Information
NCT ID
NCT04635475
First Posted
November 5, 2020
Last Updated
November 13, 2020
Sponsor
University of Washington
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT04635475
Brief Title
Return to Learn Implementation Bundle for Schools (RISE) After Youth Concussion
Official Title
Return to Learn Implementation Bundle for Schools (RISE) After Youth Concussion
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Using the Consolidated Framework for Implementation Research, as our overarching conceptual framework, this translational 2 ½ year pragmatic RCT uses a clustered, stepped wedge design to test the effectiveness of a school-based (unit of analysis) implementation strategy (project intervention) called RISE (Return to Learn Implementation bundle for schools) on evidence-based practice (RTL protocol implementation; main outcome) and student outcomes (i.e., days to RTL start after diagnosis) after youth concussion. The central hypothesis is that schools in the intervention condition receiving the RISE implementation bundle (toolkit plus school support) will have more complete and sustainable RTL protocols, and better student outcomes compared to schools in control condition who receive only written RTL protocol information. As rural and low SES schools are particularly likely to struggle to implement RTL protocols,19,25 we specifically examine RISE implementation and barriers to implementation related to school demographic characteristics related to health equity. The school characteristics we examine are rurality, primary language, racial and ethnic mix, and free/reduced-cost lunch.
Detailed Description
As you are aware, COVID caused us to consider how to complete this project and answer the scientific questions posed in the Specific Aims. The investigators considered shifting the RTL project to a later time and switching with another project but this would not have worked for the other project.
To solve this challenge of impact of school changes, the investigators convened with the project advisory board for consultation, consulted the research core at HIPRC and contacted the participants who were to have been participants in the randomized controlled trial. 19 of the 24 schools responded. From this work, the investigators agreed that since the school context has changed to either home online or hybrid mode, that students with concussion who are the recipients of the intervention should not be deprived of an intervention that is potentially beneficial.
The investigators have therefore made the following adaptations that retained the specific aims and central hypothesis that school context capacity can be strengthened to provide tailored student-centered RTL care and improve outcomes for students with a concussion.
To this end, the investigators are considering "school" wherever students are receiving an education. The investigators will recruit subjects who are currently largely coordinating education due to COVID, work with their schools, and recruit nationally. These adaptations will require a sample size of a total of 150 high school students with recent concussion (75 intervention [Group A: RISE bundle + CDC information], 75 controls [Group B: CDC information only]) who will be recruited using social media and other platforms.
There are some advantages to this design: 1) The investigator's intervention materials will now be able to be translated to Spanish due to adaptations, 2) This project will reach more particpants in rural and from disadvantaged backgrounds, 3) Communications between particpants and schools will be enhanced.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Testing RISE bundle to improve RTL care after concussion
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Consented parents of a concussed high school student who will receive CDC Head's UP Concussion Guidelines during a five week program. 75 Participants.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Consented parents of a concussed high school student who will receive the CDC Head's Up Concussion Guidelines and intervention RTL Student Protocol during a five week program. 75 Participants.
Intervention Type
Behavioral
Intervention Name(s)
RISE Bundle
Intervention Description
Toolkit to build capacity where students receive education and provide symptom based and tailored accommodations after concussion
Primary Outcome Measure Information:
Title
RTL OUTCOMES - Symptom
Description
Tracking children's symptoms over a five-week period of time. Parental completion of 4 - week symptom checklist 100% completion of weekly symptom checklist resulting in 20% fewer symptoms for the intervention group.
Time Frame
5 week
Secondary Outcome Measure Information:
Title
RTL OUTCOMES - Academic Success
Description
Outcome measures to assess academic success. Parental completion of CLASS survey weeks 2 and 4 resulting in a 20 % less decline Intervention group.
Time Frame
5 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Public high school student, grade 9th - 12th who has sustained a concussion.
High School Student between the age of 14-19, who attends in person, online, or a hybrid academic platform, and the concussion did not include an acute care hospital course greater than 48 hours.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica S Vavilala, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
HIPRC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will not share individual participant data
Links:
URL
https://implementationscience.biomedcentral.com/articles/10.1186/1748-5908-4-50
Description
Consolidated Framework
Learn more about this trial
Return to Learn Implementation Bundle for Schools (RISE) After Youth Concussion
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