NCT05597449

Brief Summary

Randomized study to assess the impact of supplemental educational YouTube videos on postoperative healthcare utilization following ambulatory pediatric urologic surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 21, 2022

Last Update Submit

October 27, 2022

Conditions

Health Care Utilization

Outcome Measures

Primary Outcomes (1)

  • Total number of episodes (Postoperative healthcare utilization)

    Episodes of postoperative calls, messages, add-on clinic visits, Urgent Care or Emergency Department visits. Each caregiver-initiated call, message, or visit will count as an individual episode. Multiple calls, messages, and visits will each be counted toward a total number of episodes.

    30 days following surgery

Study Arms (2)

Video group

EXPERIMENTAL

Access to YouTube videos and written postoperative instructions

Behavioral: YouTube videos on care after urologic surgery

Control group

NO INTERVENTION

Access to written instructions only

Interventions

YouTube videos on care after urologic surgeryBEHAVIORAL

Supplemental educational videos regarding care following pediatric urologic surgery

Video group

Eligibility Criteria

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

You may qualify if:

  • Caregivers of patients age \<18 years old undergoing ambulatory pediatric urologic surgery

You may not qualify if:

  • Caregivers that decline participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants (caregivers) blinded to the intervention and outcomes and care providers blinded to the study group assignments
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Families randomized by urologic surgery type to receive access to YouTube video link
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Urology acting instructor

Study Record Dates

First Submitted

October 21, 2022

First Posted

October 28, 2022

Study Start

July 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

October 28, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)