NCT02262962

Brief Summary

The purpose of this research is to design and test a new model for delivery of well-child care (WCC) for children ages 0-3 years in a sample of low-income parents. The investigators used an innovative expert panel and community advisory board process to develop this new model for the delivery of WCC to low-income families in partnership with our partner community pediatric practices. The new model of care utilizes a trained health educator, or "Parent Coach" at every well-visit from 0-3 years of age. The Parent Coach provides a range of services, including health education and guidance, developmental screening, and psychosocial screening and services. The Parent Coach works with the Primary Care Physician to ensure that the family's needs are met for that well-visit. As a part of this new model for well-child care, the parent also uses a web-based tool to help prioritize needs for the visit and complete any necessary pre-visit screening. Parents receive additional education and guidance from a text message service and have access to the Parent Coach outside of the visit. The randomized controlled trial (RCT) of this new model of care will include 250 families who will be enrolled at participating clinics if the child is under 1 year of age. Parents will receive the intervention for 12 months and will complete surveys to collect data on their experiences of care. Our hypothesis is that this new model of care will be more patient-centered and more effective in providing recommended preventive care services than usual care, and that it will be a sustainable and feasible model for the partner practices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
251

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2005

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

9.6 years

First QC Date

October 3, 2014

Last Update Submit

June 20, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Receipt of Recommended Preventive Care Services

    This is a composite measure

    At 12 months post enrollment

Secondary Outcomes (1)

  • Receipt of Recommended Preventive Care Services

    At 6 months post enrollment

Study Arms (2)

Usual Well-Child Care

NO INTERVENTION

No change in Well-Child Visits.

Redesigned Well-Child Care

EXPERIMENTAL

The Redesigned Well-Child Visits will be enhanced using a newly-designed model of care. Parents will have access to Parent Coach during child's routine well visits, Well Baby Help Line, Well-Visit Planner, and text messaging services (HealthyTxt).

Other: Redesigned Well-Child Care

Interventions

The Well-Child Visits will be enhanced using a newly-designed model of care. Parents will have access to Parent Coach during child's routine well visits, Well Baby Help Line, Well-Visit Planner, and HealthyTxt Messaging service.

Redesigned Well-Child Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parent or guardian of an infant who is 12 months of age or younger
  • Speaks English or Spanish
  • Is 18 years of age or older

You may not qualify if:

  • Has plans to move out of Los Angeles county within the next 12 months
  • Has plans to change the primary care location for the index child within the next 12 months.
  • Parent or guardian is an employee of one of the primary care clinics that are part of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Children's Discovery and Innovation Institute

Los Angeles, California, 90024, United States

Location

Related Publications (2)

  • Coker TR, Moreno C, Shekelle PG, Schuster MA, Chung PJ. Well-child care clinical practice redesign for serving low-income children. Pediatrics. 2014 Jul;134(1):e229-39. doi: 10.1542/peds.2013-3775. Epub 2014 Jun 16.

    PMID: 24936004BACKGROUND
  • Coker TR, Chacon S, Elliott MN, Bruno Y, Chavis T, Biely C, Bethell CD, Contreras S, Mimila NA, Mercado J, Chung PJ. A Parent Coach Model for Well-Child Care Among Low-Income Children: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20153013. doi: 10.1542/peds.2015-3013. Epub 2016 Feb 10.

Study Officials

  • Tumaini Coker, MD/MBA

    UCLA Department of General Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 3, 2014

First Posted

October 13, 2014

Study Start

June 1, 2005

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 22, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations