Fracture ForearmNCT04996745
Taking POSNA's OrthoKids to the People
A study testing Tablet-based educational intervention in people with Fracture Forearm and Pediatric ALL, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Fracture Forearm, Pediatric ALL
- What is being tested?
- Tablet-based educational intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2021to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of New Orleans
New Orleans, Louisiana, 70112
About this study
Official title: 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.
Read the 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.
- Conditions
- Fracture Forearm, Pediatric ALL
- Being tested
- Tablet-based educational intervention
- Keywords
- health literacy, pediatric fractures, OrthoKids
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet-based educational interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knowledge questionnaire scores
Measured: up to the second clinic followup visit (Average 6 weeks)
Secondary outcomes (2)
Change in caregiver satisfaction scores
Measured: up to the second clinic followup visit (Average 6 weeks)
Feedback about the OrthoKids website
Measured: up to the second clinic followup visit (Average 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study startOct 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: Submitted in error
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture ForearmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996745
- Sponsor's protocol ID
- POSNA's OrthoKids
- Status last verified
- Aug 2024
- First submitted
- 27 Jul 2021
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taking POSNA's OrthoKids to the People: Overcoming Knowledge Disparities in Pediatric Orthopaedic Trauma
- ClinicalTrials.gov ID
- NCT04996745
- Acronym / sponsor ID
- POSNA's OrthoKids
- Conditions
- Fracture Forearm, Pediatric ALL
- Keywords
- health literacy, pediatric fractures, OrthoKids
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Submitted in error
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Tablet-based educational interventionPatients 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. |
| 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. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablet-based educational interventionPOSNA'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. | Behavioural | Intervention Group |
Primary outcome
Change in Knowledge questionnaire scores
Time frame: up to the second clinic followup visit (Average 6 weeks)
2 secondary outcomes
Change in caregiver satisfaction scores
Time frame: 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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet-based educational intervention in people with Fracture Forearm and Pediatric ALL, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knowledge questionnaire scores (time frame: up to the second clinic followup visit (Average 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.