- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05939570
DOSC and Association With Neighborhood Opportunity: Phase II
April 2, 2026 updated by: Brittany Willer, Nationwide Children's Hospital
Pediatric Day-of-Surgery Cancellations and the Association With Neighborhood Opportunity and Indices of Vulnerability : Phase II
Prospective, qualitative interview study to explore factors associated with pediatric day of surgery cancellations (DOSC) from the prospective of parents with hopes the interviews will reveal additional vulnerabilities not included in COI 2.0 that predispose to DOSC.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
We plan to prospectively study vulnerability factors that contribute to day of surgery cancellations (DOSC) by conducting a qualitative study using semi-structured interviews with families cancelled the day of surgery.
We plan to enroll between 20-30 families using convenience sampling.
Based on preliminary data, we anticipate that most families will come from minority racial and ethnic groups and parents of non-English primary language (NEPL) - these interviews will be conducted via an interpreter.
Interviews will be structured to explore surgical care utilization themes based on the Gelberg-Anderson Behavioral Model for Vulnerable Populations including 1) Parental knowledge and attitudes regarding surgical services, 2) family and community resources, 3) Perceived surgical conditions and perceived need for surgical services, and 4) use of surgical services and difficulties accessing them.
Family recruitment will be ongoing and will continue until we have reached saturation of themes.
The data generated from this study will lay the foundation for a multi-layered intervention at the hospital level to allow patients to be triaged according to COI 2.0, race/ethnicity, NEPL status, and other vulnerabilities.
This will enable adaptation of hospital pre-operative procedures (i.e.
NPO preoperative calls) to reduce DOSC.
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Catherine Roth, MPH
- Phone Number: 614-722-2997
- Email: Catherine.Roth@nationwidechildrens.org
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Recruiting
- Nationwide Children's Hospital
-
Contact:
- Catherine Roth, MPH
- Phone Number: 614-722-2997
- Email: Catherine.Roth@nationwidechildrens.org
-
Principal Investigator:
- Brittany Willer, MD
-
-
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
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Parents/guardians of children <18 who had a day of surgery cancellation
Description
Inclusion Criteria:
- Parents/guardians of children <18 who had a day of surgery cancellation
- Parents/guardians speak English, Spanish, Somali, Nepali or Arabic.
Exclusion Criteria:
- Parents/guardians speak a different language other than above listed.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Factors associated with DOSC
Time Frame: Identified during interview.
|
Identified during interview.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Additional vulnerabilities not included in COI 2.0 that predispose to DOSC
Time Frame: Identified during interview.
|
Identified during interview.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
July 25, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
July 3, 2023
First Submitted That Met QC Criteria
July 3, 2023
First Posted (Actual)
July 11, 2023
Study Record Updates
Last Update Posted (Actual)
April 3, 2026
Last Update Submitted That Met QC Criteria
April 2, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003198
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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