Targeting Infant Development With Early Screening

Development, Child Clinical Trial

— TIDES  

Official title:

Targeting Infant Development With Early Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326179
• Other study ID #: Pro00103604
• Status: Completed
• Start date: November 4, 2019
• Est. completion date: August 6, 2021

Study information

• Verified date: April 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess feasibility and acceptability of parent-completed screeners of child social/emotional development, social determinants of health, and adverse childhood experiences in the setting of a pediatrics primary care clinic.

Description:

Local pediatric primary care practices are beginning to implement universal screening. The investigators plan to assess feasibility and acceptability of screening by querying parents of children in order to determine their expectations, perceptions, and opinions about the screeners. The investigators will also use data from electronic health records to examine the impact of screeners on referrals and healthcare utilization. The investigators will be examining screening rates and outcomes, and correlations with demographics and changes over time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7720
• Est. completion date: August 6, 2021
• Est. primary completion date: August 6, 2021
• Gender: All
• Age group: N/A to 3 Years

Eligibility

Inclusion for general practice retrospective reviews:

• Seen for a well child check at Duke Children's Primary Care Roxboro Road.

• Age 0 to 4 at day of visit

Inclusion for targeted retro reviews:

• Seen for well check at Duke Children's Primary Care Roxboro Road

• Determined by HealthySteps to require Tier 2 or Tier 3 behavioral support services

• Age 0 to 4 at day of visit

Related Conditions & MeSH terms

• Development, Child

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening results	We will use data extracts from the electronic health system to examine rates of meeting positive/negative thresholds on screening tools used as part of clinical care.	18 months
Secondary	Screening compliance	We will use data extracts from the electronic health system to examine screening compliance rate	18 months
Secondary	Rate of attending scheduled appointments (show rate)	We will use data extracts from the electronic health system to examine rate of families attending their scheduled appointments and no-show rate	18 months
Secondary	Healthcare utilization	Data extracts from Epic and/or from DEDUCE will be used to evaluate healthcare utilization. For the targeted chart review, we will look specifically at families who are enrolled in or who qualify for Healthy Steps Tier 2 and Tier 3, subsets of the whole practice who are receiving additional co-located behavioral supports during standard well child care.	18 months
Secondary	Referral rates	Data extracts from Epic and/or from DEDUCE will be used to evaluate rates of referrals to other services. For the targeted chart review, we will look specifically at families who are enrolled in or who qualify for Healthy Steps Tier 2 and Tier 3, subsets of the whole practice who are receiving additional co-located behavioral supports during standard well child care.	18 months