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

NCT04635475 | Completed

• 2 other identifiers: STUDY000081811R49CE003087-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Mild

Outcome Measures

Primary Outcomes (1)

• 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.

  5 week

Secondary Outcomes (1)

• RTL OUTCOMES - Academic Success

  5 week

Study Arms (2)

Control Group

NO INTERVENTION

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

Intervention Group

EXPERIMENTAL

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.

Behavioral: RISE Bundle

Interventions

RISE Bundle BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

HIPRC

Seattle, Washington, 98122, United States

Location

Related Links

• Consolidated Framework

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Monica S Vavilala, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine

Model Details: Testing RISE bundle to improve RTL care after concussion

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 19, 2020
• Study Start: August 30, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)