Clinical trial NCT04635475: 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
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Mild
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2020-11-19
Enrollment: 62
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Testing RISE bundle to improve RTL care after concussion
Primary purpose: SUPPORTIVE_CARE

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.

Given return to school, we have reverted to the stepped wedge study design in WA state.

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.

Primary outcomes:
measure: RTL OUTCOMES - Symptom
timeFrame: 5 week
Secondary outcomes:
measure: RTL OUTCOMES - Academic Success
timeFrame: 5 week
Other outcomes:
Locations:
city: Seattle
country: United States
facility: HIPRC
state: Washington
Study officials:
affiliation: University of Washington
name: Monica S Vavilala, MD
role: PRINCIPAL_INVESTIGATOR
References: