Developmental, Behavioral and Mental HealthNCT02396576
Using Telehealth to Deliver Mental Health Services in Primary Care Settings for Children in Underserved Areas
A study testing Telehealth Intervention in people with Developmental, Behavioral and Mental Health and Adhd, run by University of California, Los Angeles at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Developmental, Behavioral and Mental Health, Adhd, Depression
- What is being tested?
- Telehealth Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 359 participants
- Where
- 6 sitesUnited States
- Study dates
- 7 Apr 2015to 15 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Parent /Guardian under 18 years of age
- Parent employed by Northeast Valley Health Corporation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Northeast Valley Health Corporation- Canoga Park
Canoga Park, California, 91303
Northeast Valley Health Corporation- Pacoima
Pacoima, California, 91331
Northeast Valley Health Corporation- San Fernando
San Fernando, California, 91340
Northeast Valley Health Corporation- Santa Clarita
Santa Clarita, California, 91351
Northeast Valley Health Corporation- Valencia
Valencia, California, 91355
Northeast Valley Health Corporation- Van Nuys
Van Nuys, California, 91405
About this study
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.
Read the detailed description
There are three main parts to the basic template of this telehealth intervention:
- Real-time videoconference patient visits. Patients who need a specialty visit with a developmental/behavioral pediatrician will be scheduled for a telehealth visit (with the patient at the primary care clinical site and the subspecialists located at a University of California, Los Angeles (UCLA) telehealth site). Patients who need a psych/MH referral will initially connect with the mental health clinic (MHC) via telehealth. Therapy visits and the initial psychiatric assessment for medications are in person. Follow up psychiatric visits are via telehealth.
- Enhanced clinician communication and patient coordination. Providers will use telehealth capabilities to communicate with each other about patient care and coordination issues, including diagnostic decisions, management strategies, and other patient care coordination activities.
- Clinical educational sessions for clinicians. The telehealth equipment will also be used for real-time videoconference educational sessions to help primary care clinicians and specialty care clinicians share knowledge and experience that can translate into greater improvements for patient care.
The investigators will compare the new customized telehealth-based patient visit, coordination, and clinician education system to the usual in-person, community based referral system at NEVHC. Patients scheduled for a telehealth visit will receive a phone reminder 2 days before the visit. The location of the telehealth visit will be at the same clinic location as the index primary care provider (PCP) visit. Upon arrival for their telehealth visit, parents will be sent to a typical patient encounter room at the clinical site. The room will be set up for a telehealth visit with telehealth equipment, two chairs for the parent(s) and a small table with chairs and toys for the child and any siblings that arrive with the family. The camera will be set up to allow the specialty provider to have full view of the examination room. The system uses a multifunctional camera with zoom and pan (side to side) capabilities; the investigators will utilize a high-speed internet connection at NEVHC for optimal connection speed.
A bilingual (Spanish and English) telehealth coordinator will greet the parents and coordinate the visit at the NEVHC end. The telehealth coordinator is present at the NEVHC end of the telehealth visit for the duration of the visit. The telehealth coordinator ensures that the camera and microphones are operating correctly, positions the camera as necessary, conducts a volume and vision check, and as the exam proceeds, provides Spanish language interpretation if necessary.
The clinical encounter proceeds as a typical "in-person" encounter.
The developmental behavioral services in the telehealth-based patient visit will be provided by a developmental behavioral pediatrician (DBP) housed at UCLA from Children's Hospital Los Angeles (CHLA). The telehealth coordinator will call parent to inform parents of their DBP appointment date/time and will explain the telehealth visit.
The mental health services will be performed by psychiatrists at CFGC and CFC. The telehealth specialty physician will conduct the typical history, review of information brought by the parent to the visit, focused behavioral observations, and a general visual inspection, with assistance from the telehealth coordinator on the distal end. At the end of the visit, the telehealth coordinator will assist the physician in setting up any follow-up plans with the family. The telehealth coordinator will then prepare for the next scheduled patient.
The other two components of the telehealth system include clinical educational sessions and clinician communication and patient coordination sessions. As part of our ongoing stakeholder engagement process, the investigators will hold a telehealth primary care-mental health educational session via videoconference monthly. These sessions are topic-based webinars and case-based educational sessions for the transfer cases. Sessions will alternate between webinars and case-based educational sessions. The session will include the child psychiatrist(s), and the NEVHC PCPs; each session will be held during the clinic's lunch hour for about 45 minutes, based on the NEVHC PCP availability. There will be 9 topic-based webinar sessions during the intervention period. The first 4 sessions will focus on referral indications and recommendations for the most common child MH symptoms. Topics include: guidelines for referral to CFGC/CFC (e.g., when not to refer), diagnosis and management of attention deficit hyperactivity disorder, anxiety, and depression, and diagnostic criteria for Oppositional Defiant Disorder and PTSD. the investigators will also conduct some sessions on primary care topics (e.g., anorexia nervosa) for mental health providers.
- Conditions
- Developmental, Behavioral and Mental Health, Adhd, Depression, Anxiety, Developmental Delay, Autism
- Being tested
- Telehealth Intervention
- Medical subject headings
- Behavior, Psychological Well-Being, Attention Deficit Disorder with Hyperactivity, Depression, Anxiety Disorders, Learning Disabilities, Autistic Disorder, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Telehealth Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 month post-enrollment
Access to specialty services- Visits
Number of specialty visits attended as reported by parents on 6 month post-enrollment survey.
Measured: 6 month post-enrollment
Secondary outcomes (4)
Quality of care measures
Parent reported quality of care measures as measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician and Group Survey. Three measures will be utilized from CAHPS; 1.Timely Appointment, Care and Information, 2. Providers Communication with Patients, and 3. Patients' Rating of Providers.
Measured: 6 month post-enrollment
Child Behavior measures
Parent reported child behavior as measured by Pediatric Quality of Life (PedsQL), and Pediatric Symptom Checklist.
Measured: 6 month post-enrollment
Provider coordination- Communication
Provider reported level of communication between PCP and specialists as measured by the communication measure from the California Mental Health Services Authority Integrated Behavior Health Care (IBHC).
Measured: 6 month post-enrollment
Provider coordination- Comfort level
Provider reported comfort level of diagnosis, medication initiation, medication management, and patient monitoring as reported by providers on 6 month post-enrollment survey.
Measured: 6 month post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study start7 Apr 2015
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental, Behavioral and Mental HealthStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Tumaini R Coker, University of California, Los Angeles
- Investigators
- Tumaini Coker, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396576
- Sponsor's protocol ID
- IH-12-11-4168
- Status last verified
- Aug 2017
- First submitted
- 4 Mar 2015
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30770523
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Telehealth to Deliver Mental Health Services in Primary Care Settings for Children in Underserved Areas
- ClinicalTrials.gov ID
- NCT02396576
- Acronym / sponsor ID
- IH-12-11-4168
- Conditions
- Developmental, Behavioral and Mental Health, Adhd, Depression, Anxiety, Developmental Delay, Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 7 Apr 2015 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are three main parts to the basic template of this telehealth intervention:
- Real-time videoconference patient visits. Patients who need a specialty visit with a developmental/behavioral pediatrician will be scheduled for a telehealth visit (with the patient at the primary care clinical site and the subspecialists located at a University of California, Los Angeles (UCLA) telehealth site). Patients who need a psych/MH referral will initially connect with the mental health clinic (MHC) via telehealth. Therapy visits and the initial psychiatric assessment for medications are in person. Follow up psychiatric visits are via telehealth.
- Enhanced clinician communication and patient coordination. Providers will use telehealth capabilities to communicate with each other about patient care and coordination issues, including diagnostic decisions, management strategies, and other patient care coordination activities.
- Clinical educational sessions for clinicians. The telehealth equipment will also be used for real-time videoconference educational sessions to help primary care clinicians and specialty care clinicians share knowledge and experience that can translate into greater improvements for patient care.
The investigators will compare the new customized telehealth-based patient visit, coordination, and clinician education system to the usual in-person, community based referral system at NEVHC. Patients scheduled for a telehealth visit will receive a phone reminder 2 days before the visit. The location of the telehealth visit will be at the same clinic location as the index primary care provider (PCP) visit. Upon arrival for their telehealth visit, parents will be sent to a typical patient encounter room at the clinical site. The room will be set up for a telehealth visit with telehealth equipment, two chairs for the parent(s) and a small table with chairs and toys for the child and any siblings that arrive with the family. The camera will be set up to allow the specialty provider to have full view of the examination room. The system uses a multifunctional camera with zoom and pan (side to side) capabilities; the investigators will utilize a high-speed internet connection at NEVHC for optimal connection speed.
A bilingual (Spanish and English) telehealth coordinator will greet the parents and coordinate the visit at the NEVHC end. The telehealth coordinator is present at the NEVHC end of the telehealth visit for the duration of the visit. The telehealth coordinator ensures that the camera and microphones are operating correctly, positions the camera as necessary, conducts a volume and vision check, and as the exam proceeds, provides Spanish language interpretation if necessary.
The clinical encounter proceeds as a typical "in-person" encounter.
The developmental behavioral services in the telehealth-based patient visit will be provided by a developmental behavioral pediatrician (DBP) housed at UCLA from Children's Hospital Los Angeles (CHLA). The telehealth coordinator will call parent to inform parents of their DBP appointment date/time and will explain the telehealth visit.
The mental health services will be performed by psychiatrists at CFGC and CFC. The telehealth specialty physician will conduct the typical history, review of information brought by the parent to the visit, focused behavioral observations, and a general visual inspection, with assistance from the telehealth coordinator on the distal end. At the end of the visit, the telehealth coordinator will assist the physician in setting up any follow-up plans with the family. The telehealth coordinator will then prepare for the next scheduled patient.
The other two components of the telehealth system include clinical educational sessions and clinician communication and patient coordination sessions. As part of our ongoing stakeholder engagement process, the investigators will hold a telehealth primary care-mental health educational session via videoconference monthly. These sessions are topic-based webinars and case-based educational sessions for the transfer cases. Sessions will alternate between webinars and case-based educational sessions. The session will include the child psychiatrist(s), and the NEVHC PCPs; each session will be held during the clinic's lunch hour for about 45 minutes, based on the NEVHC PCP availability. There will be 9 topic-based webinar sessions during the intervention period. The first 4 sessions will focus on referral indications and recommendations for the most common child MH symptoms. Topics include: guidelines for referral to CFGC/CFC (e.g., when not to refer), diagnosis and management of attention deficit hyperactivity disorder, anxiety, and depression, and diagnostic criteria for Oppositional Defiant Disorder and PTSD. the investigators will also conduct some sessions on primary care topics (e.g., anorexia nervosa) for mental health providers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Telehealth InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Parent /Guardian under 18 years of age
- Parent employed by Northeast Valley Health Corporation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth InterventionThe 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. | Behavioural | Telehealth Intervention |
Primary outcome
Access to specialty services- Referral time
Time frame: 6 month post-enrollment
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.
Access to specialty services- Travel
Time frame: 6 month post-enrollment
Parent reported number of miles traveled and commute time to initial visit as reported by parents on 6 month post-enrollment survey.
Access to specialty services- Missed school/work
Time frame: 6 month post enrollment
Parent reported number of days missed from school/work as reported by parents on 6 month post-enrollment survey.
Access to specialty services- Out of pocket cost
Time frame: 6 month post-enrollment
Parent reported amount of money spent for daycare and specialty services as reported by parents on 6 month post-enrollment survey.
Access to specialty services- Visits
Time frame: 6 month post-enrollment
Number of specialty visits attended as reported by parents on 6 month post-enrollment survey.
4 secondary outcomes
Quality of care measures
Time frame: 6 month post-enrollment
Child Behavior measures
Time frame: 6 month post-enrollment
Provider coordination- Communication
Time frame: 6 month post-enrollment
Provider coordination- Comfort level
Time frame: 6 month post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Derived from this study: PubMed 30770523Coker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tumaini Coker, MD principal investigator
University of California, Los Angeles
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Intervention in people with Developmental, Behavioral and Mental Health and Adhd, run by University of California, Los Angeles at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Access to specialty services- Referral time (time frame: 6 month post-enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02396576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.