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Integrating WIC With Early Childhood Systems of Developmental Care (CDC-WIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159038
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : March 5, 2020
Sponsor:
Collaborators:
Oregon WIC Program
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Katharine Zuckerman, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE November 7, 2019
First Posted Date  ICMJE November 12, 2019
Last Update Posted Date March 5, 2020
Actual Study Start Date  ICMJE January 10, 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
  • % of Women, Infants, & Children (WIC) participant visits with Early Intervention/Early Childhood Special Education (EI/ECSE) referral. [ Time Frame: Start of intervention for 6 months ]
    in immediate versus delayed intervention arms, to understand if the intervention boosted EI/ECSE referral rates.
  • % EI/ECSE referrals evaluated by EI/ECSE [ Time Frame: Start of intervention for 6 months ]
    by 6 months after referral, in both arms, to see if increased referral actually results in increased EI/ECSE evaluation.
  • Time from referral to evaluation [ Time Frame: Start of intervention for 6 months ]
    in both arms, to see if the intervention accelerated EI/ECSE evaluation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
  • % of those found eligible on EI/ECSE treatment, 6-months post referral [ Time Frame: Start of intervention for 6 months ]
    to see if the intervention increased the number of children receiving treatment services in EI/ECSE.
  • % of public-health identified children referred to EI/ECSE by WIC [ Time Frame: Start of intervention for 6 months ]
    to see if WIC can identify and refer children who are high-risk but not otherwise accessing developmental care.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Integrating WIC With Early Childhood Systems of Developmental Care
Official Title  ICMJE Integrating WIC With Early Childhood Systems of Developmental Care
Brief Summary This study's goals are to improve connections between Oregon Women, Infants, & Children (WIC) clinics, primary care providers, and Early Intervention/Early Childhood Special Education programs (EI/ECSE), in order to help children with suspected developmental delays get the services they need.
Detailed Description Disparities exist in early identification of developmental disabilities, particularly for families from low-income and/or racial ethnic minority backgrounds. As WIC has frequent contact with children and families in the first five years of life, it is optimally positioned to play a unique role in early identification of developmental disabilities. However, WIC staff are not formally trained in child development outside of program's primary focus on nutrition and supporting the feeding relationship nor is formal screening for potential developmental delays an allowable WIC expense. In our prior research Oregon WIC staff reported being frequently asked by parents about potential concerns yet they also reported not being well connected to pediatric primary care, Part C Early Intervention (EI), or other resources who could further assess these concerns. In this study the investigators propose to design and pilot test a 2-part intervention to enhance the link between WIC and early childhood resources. The 2-part intervention includes: (1) WIC staff training delivered at the Local Agency which will: build staff confidence in discussing developmental concerns with families, familiarize staff with the CDC Learn the Signs Act Early (LTSAE) material which may be used to support those conversations, provide easy tips for encouraging early language and literacy development with parents, and study procedures (2) the creation of a standardized, direct, closed-loop referral process from WIC to EI for families with an identified concern who agree to the referral. EI will notify the child's primary care provider of the referral as per usual EI protocol. A referral form has been approved by the Oregon Department of Education (ODE) to support the direct referral from WIC to EI, meeting all ODE FERPA requirements. In addition, a data use agreement has been approved by ODE to allow the study team to access data on referred children to determine if they completed further assessment and the given diagnosis (if any). While our primary quantitative outcomes of interest are the number of children with a potential developmental concern who are referred directly from WIC to EI, the timing of follow-up assessment by EI from that referral, services plan & start of services; the project really centers on improving processes between organizations who are key stakeholders in referral, assessment, and treatment. Therefore, secondary outcomes include feasibility and acceptability of the intervention amongst WIC staff, EI staff and primary care providers Upon completion of the study the investigators hope to apply our findings to scale up the WIC staff training and closed-loop referral process to take it Statewide. If successful the investigators will disseminate findings through the National WIC Association to encourage other State and Tribal WIC Authorities to adopt our procedures as best practices.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Parents in the immediate intervention arm sign a study consent that is integrated into the Women, Infants, & Children (WIC) Referral Form. They also complete a brief demographic survey. No consent is necessary in the delayed intervention arm as only aggregate information will be reported to the study team by Early Intervention/Early Childhood Special Education. EI/ECSE referrals are tracked from clinics in both arms for 6 months in ecWeb. At the end of the data collection period, the study team will meet to refine the intervention based on the experience with the immediate intervention group. Qualitative Interviews will take place with WIC staff, parents who indicate interest, EI/ECSE staff, and primary care providers during and after the post-intervention data collection period.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Developmental Disability
  • Food Assistance
  • Health Care Disparity
Intervention  ICMJE
  • Other: Immediate Intervention Group
    The immediate intervention group will receive training on how to properly refer and record EI/ECSE referrals.
  • Other: Delayed Intervention Group
    Delayed group will receive training 6 months after the immediate intervention group does.
Study Arms  ICMJE
  • Experimental: Immediate Intervention Group
    Parents in the immediate intervention arm sign a study consent that is integrated into the WIC Referral Form. They also complete a brief demographic survey. No consent is necessary in the delayed intervention arm as only aggregate information will be reported to the study team by EI/ECSE. EI/ECSE referrals are tracked from clinics in both arms for 6 months in ecWeb. At the end of the data collection period, the study team will meet to refine the intervention based on the experience with the immediate intervention group. Qualitative Interviews will take place with WIC staff, parents who indicate interest, EI/ECSE staff, and primary care providers during and after the post-intervention data collection period.
    Intervention: Other: Immediate Intervention Group
  • Delayed Intervention Group
    6 months after the immediate intervention group receives their training, the delayed intervention group will receive the training. Prior to implementation of the training in the delayed intervention group, the study team will meet with the Stakeholder Advisory Board. It will review interim results and consider the efficacy of the intervention as a whole. Based on actual use patterns and stakeholder feedback, the investigators will make improvements to the intervention prior to implementing it in the delayed intervention group.
    Intervention: Other: Delayed Intervention Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2019)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The primary subject population of interest are Women, Infants, & Children families who in the course of a WIC visit identify a potential developmental concern and agree to a direct referral from WIC to Early Intervention to further assess that concern. To be eligible for the study, the parent/guardian must speak English or Spanish. The child with the identified concern must be under 54 months of age as the investigators will need to follow the child for 6 months to determine initial outcomes and children are no longer eligible for WIC after their 5th birthday.

WIC staff at the 4 intervention agencies, EI staff in the 4 communities in which the 4 intervention WIC Local Agencies are located, and primary care providers (PCPs) who have had a patient referred to EI directly from WIC will all be invited to participate in a telephone interview to give their perspective on the process. The only staff inclusion requirement is that these staff are currently working in their professional role in the county studied.

Exclusion Criteria:

  • Family speaks language that isn't English or Spanish. Child is older than 54 months.

Staff does not work in their professional role in the county studied.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 54 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mauricio A Gomez, B.S. 5034949738 gomema@ohsu.edu
Contact: Katharine E Zuckerman, M.D., M.P.H. 503-494-6726 zuckerma@ohsu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04159038
Other Study ID Numbers  ICMJE STUDY00019833
19-3773 PO# 2000043062 ( Other Grant/Funding Number: Centers for Disease Control and Prevention )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Katharine Zuckerman, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE
  • Oregon WIC Program
  • Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Katharine Zuckerman, M.D., M.P.H. Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP