Taking POSNA's OrthoKids to the People

August 23, 2024 updated by: Louisiana State University Health Sciences Center in New Orleans

Taking POSNA's OrthoKids to the People: Overcoming Knowledge Disparities in Pediatric Orthopaedic Trauma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This project aims to reduce knowledge disparity amongst caregivers of patients presenting for pediatric fracture care. At our institution, many patients presenting with fractures do not have easy access to either technology or the internet, preventing caregivers from benefiting from educational tools such as POSNA's OrthoKids®. We are planning to increase access and improve health literacy through a simple intervention of providing tablet-based access to POSNA's Orthokids while families are waiting for their physician. Families will be randomized to either standard waiting room experience vs. tablet-based educational intervention to limit selection bias. A brief pre-visit questionnaire will be completed by all caregivers to assess fracture and cast care knowledge as well as the highest educational degree obtained by the caregiver.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Children's Hospital of New Orleans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (RCT and observational arms):

  • 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.

Exclusion Criteria (RCT and observational arms):

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
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
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.
No Intervention: Control Group

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Knowledge questionnaire scores
Time Frame: up to the second clinic followup visit (Average 6 weeks)
up to the second clinic followup visit (Average 6 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in caregiver satisfaction scores
Time Frame: up to the second clinic followup visit (Average 6 weeks)
up to the second clinic followup visit (Average 6 weeks)
Feedback about the OrthoKids website
Time Frame: up to the second clinic followup visit (Average 6 weeks)
up to the second clinic followup visit (Average 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Louisiana State University Health Sciences Center in New Orleans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • POSNA's OrthoKids

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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