NCT02084979

Brief Summary

This two-year randomized controlled trial of clinical outcomes seeks to evaluate the superiority of the asynchronous telepsychiatry (ATP) consultation model on access, quality, cost and outcomes of care over the usual care for adults referred from primary care clinics for psychiatric evaluation and treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 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 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2019

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

3.8 years

First QC Date

March 10, 2014

Last Update Submit

June 10, 2019

Conditions

Keywords

Primary care mental health consultationTelepsychiatryAsynchronous telepsychiatry

Outcome Measures

Primary Outcomes (2)

  • Global Assessment of Functioning (GAF)

    The GAF is used by clinicians to rate patients' social, occupational and psychological functioning Scale from 0-100 with 100 being the superior functioning and 1 being poor functioning (0 not enough info)

    every 6 months for a 2 year follow-up period

  • The Clinical Global Impression (CGI)

    The CGI is a widely used clinician rated scale that assesses a patient's response to mental health treatment.

    every 6 months for a 2 year follow-up period

Secondary Outcomes (8)

  • The Alcohol Use Disorders Identification Test (AUDIT)

    Every 6 months- 2 year follow-up period

  • The Patient Telemedicine Satisfaction Questionnaire

    every 6 months- 2 year follow-up period

  • PHQ-9

    every 6 months for a 2 year follow-up period

  • The Generalized Anxiety Disorder 7 item (GAD-7)

    every 6 months for a 2 year follow-up period

  • Provider Telepsychiatry Satisfaction Questionnaire

    every 6 months for a 2 year follow-up period

  • +3 more secondary outcomes

Other Outcomes (1)

  • Patient Health Log

    every 6 months for a 2 year follow-up period

Study Arms (2)

Asynchronous telepsychiatry

EXPERIMENTAL

Experimental Arm: Asynchronous telepsychiatry evaluation and consultation

Behavioral: telepsychiatry evaluation

Synchronous telepsychiatry

ACTIVE COMPARATOR

Control Arm: Synchronous telepsychiatry evaluation and consultation

Behavioral: telepsychiatry evaluation

Interventions

telepsychiatry evaluation and consultation to primary care

Asynchronous telepsychiatrySynchronous telepsychiatry

Eligibility Criteria

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

You may qualify if:

  • aged 18 or older
  • diagnosis of a mood disorder, anxiety disorder, or substance/alcohol abuse disorder(s)
  • referred by PCP at participating site.

You may not qualify if:

  • less than 18 years
  • imminent suicidal ideation and/or plans
  • immediate violent intentions or plans
  • incarceration
  • significant cognitive deficits
  • patient who's PCP recommends not participating.
  • PCP not at participating site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UC Davis Primary Care Network

Auburn, California, 95603, United States

Location

UC Davis Primary Care Network Midtown

Sacramento, California, 95816, United States

Location

Communicare Health Centers Salud Clinic

West Sacramento, California, 95605, United States

Location

Related Publications (3)

  • Yellowlees PM, Burke MM, Gonzalez AD, Fisher A, Chan SR, Hilty DM, McCarron RM, Scher LM, Sciolla AF, Shore J, Xiong G, Fine J, Bannister J, Iosif AM. Patient and Provider Satisfaction with Asynchronous Versus Synchronous Telepsychiatry in Primary Care: A Secondary Mixed-Methods Analysis of a Randomized Controlled Trial. Telemed J E Health. 2024 Apr;30(4):e1049-e1063. doi: 10.1089/tmj.2023.0238. Epub 2023 Nov 22.

  • Lieng MK, Aurora MS, Kang Y, Kim JM, Marcin JP, Chan SR, Mouzoon JL, Tancredi DJ, Parish M, Gonzalez AD, Scher L, Xiong G, McCarron RM, Yellowlees P. Primary Care Physician Adherence to Telepsychiatry Recommendations: Intermediate Outcomes from a Randomized Clinical Trial. Telemed J E Health. 2022 Jun;28(6):838-846. doi: 10.1089/tmj.2021.0389. Epub 2021 Nov 2.

  • Yellowlees PM, Parish MB, Gonzalez AD, Chan SR, Hilty DM, Yoo BK, Leigh JP, McCarron RM, Scher LM, Sciolla AF, Shore J, Xiong G, Soltero KM, Fisher A, Fine JR, Bannister J, Iosif AM. Clinical Outcomes of Asynchronous Versus Synchronous Telepsychiatry in Primary Care: Randomized Controlled Trial. J Med Internet Res. 2021 Jul 20;23(7):e24047. doi: 10.2196/24047.

MeSH Terms

Conditions

Mood DisordersAnxiety DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Mental DisordersChemically-Induced Disorders

Study Officials

  • Peter Yellowlees, MD

    Professor UC Davis

    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
SPONSOR

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 12, 2014

Study Start

April 1, 2014

Primary Completion

December 31, 2017

Study Completion

April 29, 2019

Last Updated

June 11, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations