Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285812
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-02-01
Brief Title:
Otitis Treatment With OtoSight - Modification of Antibiotic Treatment Intervention in Children
Sponsor:
PhotoniCare Inc
Organization:
PhotoniCare Inc
Study Overview
Official Title:
OTO-MATIC Otitis Treatment With OtoSight - Modification of Antibiotic Treatment Intervention in Children
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OTO-MATIC
Brief Summary:
A pragmatic mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs
Detailed Description:
Mixed method multi-center pragmatic cluster-randomized effectiveness-implementation investigation focused on pediatric subjects presenting with ear complaints at the office setting
For the prospective randomized component eligible clinicians at a given site will be randomized to one of two groups the OtoSight intervention group or the usual care control group There will be three 3 periods of post-intervention assessment 10 days optional 6 months and 12 months
Eligible subjects will be automatically enrolled or invited to enroll in the clinical trial and will receive information Because this is a non-interference design frontline care clinicians randomized to either arm will be asked to 1 assess the presence or absence of fluid in the middle ear 2 record a diagnosis and 3 treat the patient as they would according to the information available to them
A separate retrospective historical matched control arm will also be conducted to analyze potential Hawthorne effect at a subset of collaborating practices or healthcare systems Randomization of clinicians and not children will decrease contamination in the usual practice group ie so clinicians are not asked to flip between intervention and usual care practices
For the prospective randomized component eligible clinicians at a given site will be randomized to one of two groups the OtoSight intervention group or the usual care control group There will be three 3 periods of post-intervention assessment 10 days optional 6 months and 12 months
Eligible subjects will be automatically enrolled or invited to enroll in the clinical trial and will receive information Because this is a non-interference design frontline care clinicians randomized to either arm will be asked to 1 assess the presence or absence of fluid in the middle ear 2 record a diagnosis and 3 treat the patient as they would according to the information available to them
A separate retrospective historical matched control arm will also be conducted to analyze potential Hawthorne effect at a subset of collaborating practices or healthcare systems Randomization of clinicians and not children will decrease contamination in the usual practice group ie so clinicians are not asked to flip between intervention and usual care practices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None