NCT02396576

Brief Summary

In partnership with a multi-site, Los Angeles-area community clinic consortium, North East Valley Health Corporation (NEVHC), the investigators will use telehealth to integrate pediatric developmental, behavioral and mental health (DB/MH) services into primary care for low-income, publicly insured children. During Project Year 1, the investigators used qualitative methods to conduct and analyze interviews with parents, clinicians, and staff at NEVHC to assess their perspectives on the delivery of child DB/MH services and on a potential telehealth-based patient visit, coordination, and clinician education system for the provision of DB/MH specialty care in primary care settings to children ages 5-12. This data was used in a stakeholder-engaged process to customize a telehealth-based delivery system for pediatric DB/MH services that can be integrated into primary care settings. During Project Years 2-3, the investigators will conduct a cluster randomized controlled trial (RCT) to compare the customized telehealth-based patient visit, coordination, and clinician education system to the usual in-person, community- based referral system at NEVHC. This study will examine whether a telehealth developmental, behavioral and mental health delivery model can be an effective, efficient, and family-centered way to provide integrated DB/MH services to children in low-income communities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
359

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

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

First Submitted

Initial submission to the registry

March 4, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

April 7, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

March 4, 2015

Last Update Submit

August 8, 2017

Conditions

Outcome Measures

Primary Outcomes (5)

  • Access to specialty services- Referral time

    Referral process from baseline to 6 month post-enrollment. Parent reported time from initial referral to first specialty visit as reported by parents on 6 month post-enrollment survey.

    6 month post-enrollment

  • Access to specialty services- Travel

    Parent reported number of miles traveled and commute time to initial visit as reported by parents on 6 month post-enrollment survey.

    6 month post-enrollment

  • Access to specialty services- Missed school/work

    Parent reported number of days missed from school/work as reported by parents on 6 month post-enrollment survey.

    6 month post enrollment

  • Access to specialty services- Out of pocket cost

    Parent reported amount of money spent for daycare and specialty services as reported by parents on 6 month post-enrollment survey.

    6 month post-enrollment

  • Access to specialty services- Visits

    Number of specialty visits attended as reported by parents on 6 month post-enrollment survey.

    6 month post-enrollment

Secondary Outcomes (4)

  • Quality of care measures

    6 month post-enrollment

  • Child Behavior measures

    6 month post-enrollment

  • Provider coordination- Communication

    6 month post-enrollment

  • Provider coordination- Comfort level

    6 month post-enrollment

Study Arms (2)

Usual Care

NO INTERVENTION

NEVHC has two main Department of Mental Health (DMH) contracted clinical partners where the majority of the patients are referred to -these are Child and Family Guidance Center (CFGC) in the San Fernando Valley and Child and Family Center (CFC) in the Santa Clarita Valley.

Telehealth Intervention

EXPERIMENTAL

The telehealth model will enhance patient coordination as well as clinician communication via live videoconferencing. Developmental behavioral services will be provided by a Developmental Behavioral Pediatrician (DBP) housed at UCLA from Children's Hospital Los Angeles (CHLA). Mental Health services will be provided by Child Family Center (CFC) and Child Family Guidance Center (CFGC). The location of the telehealth visit will be at the same clinic location as the index PCP visit with a telehealth coordinator facilitating the encounter between patient and clinicians.The clinician communication will be enhanced through monthly telehealth topic-based educational sessions as well as case-based educational sessions for the transfer cases.

Behavioral: Telehealth Intervention

Interventions

The telehealth model will integrate developmental, behavioral, (DB) and mental health services (MH) into pediatric primary care using videoconferencing that will be tested with children in low-income, urban communities.

Telehealth Intervention

Eligibility Criteria

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

You may qualify if:

  • Parent or guardian with child between the ages of 5 to 12
  • Must speak English or Spanish
  • Child has been referred by primary care doctor for mental health or developmental behavioral services

You may not qualify if:

  • Parent /Guardian under 18 years of age
  • Parent employed by Northeast Valley Health Corporation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Northeast Valley Health Corporation- Canoga Park

Canoga Park, California, 91303, United States

Location

Northeast Valley Health Corporation- Pacoima

Pacoima, California, 91331, United States

Location

Northeast Valley Health Corporation- San Fernando

San Fernando, California, 91340, United States

Location

Northeast Valley Health Corporation- Santa Clarita

Santa Clarita, California, 91351, United States

Location

Northeast Valley Health Corporation- Valencia

Valencia, California, 91355, United States

Location

Northeast Valley Health Corporation- Van Nuys

Van Nuys, California, 91405, United States

Location

Related Publications (1)

  • Coker TR, Porras-Javier L, Zhang L, Soares N, Park C, Patel A, Tang L, Chung PJ, Zima BT. A Telehealth-Enhanced Referral Process in Pediatric Primary Care: A Cluster Randomized Trial. Pediatrics. 2019 Mar;143(3):e20182738. doi: 10.1542/peds.2018-2738. Epub 2019 Feb 15.

MeSH Terms

Conditions

BehaviorPsychological Well-BeingAttention Deficit Disorder with HyperactivityDepressionAnxiety DisordersLearning DisabilitiesAutistic DisorderProblem Behavior

Condition Hierarchy (Ancestors)

Personal SatisfactionAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehavioral SymptomsCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAutism Spectrum DisorderChild Development Disorders, PervasiveChild Behavior

Study Officials

  • Tumaini Coker, MD

    University of California, Los Angeles

    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

March 4, 2015

First Posted

March 24, 2015

Study Start

April 7, 2015

Primary Completion

June 15, 2017

Study Completion

June 15, 2017

Last Updated

August 10, 2017

Record last verified: 2017-08

Locations