Return to Learn Implementation Bundle for Schools (RISE) After Youth Concussion

NCT ID: NCT04635475

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-30
• Study Completion Date: 2022-06-30

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.

Conditions

Concussion, Mild

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group

Consented parents of a concussed high school student who will receive CDC Head's UP Concussion Guidelines during a five week program. 75 Participants.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

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.

Group Type: EXPERIMENTAL

RISE Bundle

Intervention Type: BEHAVIORAL

Toolkit to build capacity where students receive education and provide symptom based and tailored accommodations after concussion

Interventions

RISE Bundle

Toolkit to build capacity where students receive education and provide symptom based and tailored accommodations after concussion

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Monica Vavilala

Professor, School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monica S Vavilala, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

HIPRC

Seattle, Washington, United States

Countries

United States

Related Links

https://implementationscience.biomedcentral.com/articles/10.1186/1748-5908-4-50

Consolidated Framework

Other Identifiers

1R49CE003087-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00008181

Identifier Type: -

Identifier Source: org_study_id