Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04635475 |
| Other study ID # |
STUDY00008181 |
| Secondary ID |
1R49CE003087-01 |
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 13, 2020 |
| Est. completion date |
March 2022 |
Study information
| Verified date |
November 2020 |
| Source |
University of Washington |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
