NCT04996745

Brief Summary

The objective of this project is to determine the efficacy of a tablet-based educational intervention at improving orthopaedic health literacy amongst families of pediatric patients treated for fractures in an outpatient setting.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

July 27, 2021

Last Update Submit

August 23, 2024

Conditions

Keywords

health literacypediatric fracturesOrthoKids

Outcome Measures

Primary Outcomes (1)

  • Change in Knowledge questionnaire scores

    up to the second clinic followup visit (Average 6 weeks)

Secondary Outcomes (2)

  • Change in caregiver satisfaction scores

    up to the second clinic followup visit (Average 6 weeks)

  • Feedback about the OrthoKids website

    up to the second clinic followup visit (Average 6 weeks)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients randomized to the intervention group of the RCT will be given tablet-based education. The first clinic follow-up visit will consist of screening for consent, providing a QR code for Orthokids, and conducting the pre-intervention questionnaire. The pre-intervention questionnaire has two sections with questions pertaining to demographics and orthopedic knowledge. The second clinic follow-up visit will be provided with the tablet for repeat education, with Orthokids and the post-intervention questionnaire will be distributed. The post-intervention questionnaire has two sections with questions pertaining to orthopedic knowledge and satisfaction with care.

Behavioral: Tablet-based educational intervention

Control Group

NO INTERVENTION

Patients randomized to the control group of the RCT will receive the standard clinic experience. This group will not be exposed to any education enrichment about their child's fracture except for the physician's explanation within the exam room. The first clinic follow-up visit will consist of screening for consent and conducting the pre-intervention questionnaire. The pre-intervention questionnaire has two sections with questions pertaining to demographics and orthopedic knowledge. The second clinic follow-up visit will consist of conducting the post-intervention questionnaire. The post-intervention questionnaire has two sections with questions pertaining to orthopedic knowledge and satisfaction with care.

Interventions

POSNA's Orthokids website and the article on pediatric forearm fracture will be provided on a tablet. The article provided has two separate tabs, labeled "Condition" and "FAQs", that caregivers will be able to read through. Those who speak Spanish will have the Spanish translated version of Orthokids.

Intervention Group

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with forearm fractures who presented to the CHNOLA ED. "Children" are defined as persons under the age of 18 years for this study. "Forearm fracture" is defined as a radial and or ulnar shaft fracture for this study.
  • Documented radiographs must show an injury in which the fracture line is wholly located within the diaphysis of the radius or ulna.

You may not qualify if:

  • Fractures that require internal or external fixation
  • Fractures associated with multi-system trauma
  • Caregivers that do not speak English or Spanish as their first language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of New Orleans

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 9, 2021

Study Start

October 1, 2021

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

August 26, 2024

Record last verified: 2024-08

Locations