Clinical trial NCT02084979: A Controlled Trial of Patient Centered Telepsychiatry Interventions
Official title: A Controlled Trial of Patient Centered Telepsychiatry Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Disorder
Anxiety Disorder
Substance Use Disorder
Keywords: Primary care mental health consultation
Telepsychiatry
Asynchronous telepsychiatry
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: This project addresses a critical public mental health problem: the need to improve access to high quality, mental health services for diverse populations through improving the flow of clinical work across care settings (primary care and specialty care) by implementing an efficient, provider compatible, administratively simple health IT solution: Asynchronous Telepsychiatry. To assess the impact of this novel approach, 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.

Aim 1: To assess whether the ATP delivery model improves clinical OUTCOMES in adult patients referred for psychiatric treatment by their PCPs; Hypotheses: Compared to the participants in the 'usual care" arm, participants in the ATP arm will show:

H1: Higher scores over the course of treatment (better clinical trajectory) on the Short-Form-12 Health Survey (SF12- the primary outcome measure), the Clinical Global Impressions scale (CGI), the Who Disability Schedule (WHODAS) and the Global Assessment of Functioning (GAF) score.

H2 (Exploratory): Improved clinical trajectories on specific disorder scales, such as the PSQ9, the Hamilton Anxiety Scale (HAMA), the GAD7 and the AUDIT substance abuse scale over the those in the "usual care" arm.

Aim 2: To assess whether ATP improves the QUALITY of care for adult patients referred for psychiatric treatment by their PCPs and for PCP providers; Hypotheses: Compared to the participants in the 'usual care" arm, participants in the ATP arm will show:

H1: higher levels of satisfaction (as measured by the patient rated Patient Telemedicine Satisfaction Survey which includes a general care satisfaction measure to be used across TAU and ATP groups and by the provider rated Telemedicine Provider Satisfaction Questionnaire) H2 (Exploratory- Spanish only speaking participants): will report more positive ratings of their provider on the Interpersonal Processes of Care Survey short form. Hypothesis: PCP's will be highly satisfied with the quality of ATP H3: PCPs with patients referred to the ATP arm will report high satisfaction ratings on the Telemedicine Provider Satisfaction Questionnaire. Aim 3: To assess whether ATP improves EFFICIENCY and REACH through reducing COSTS and increasing ACCESS for adult patients referred for psychiatric treatment by their PCPs; Hypotheses: Compared to care in the 'usual care" arm, care in the ATP arm will: H1: be more cost effective than "usual care" arm as measured by comprehensive economic data that will be collected from patient, provider, and payor perspectives.

H2: produce shorter wait-times for appointment and consultation feedback as measured by comprehensive efficiency data that will be collected from patient, provider, and payor perspectives.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Global Assessment of Functioning (GAF)
timeFrame: every 6 months for a 2 year follow-up period
measure: The Clinical Global Impression (CGI)
timeFrame: every 6 months for a 2 year follow-up period
Secondary outcomes:
measure: The Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Every 6 months- 2 year follow-up period
measure: The Patient Telemedicine Satisfaction Questionnaire
timeFrame: every 6 months- 2 year follow-up period
measure: PHQ-9
timeFrame: every 6 months for a 2 year follow-up period
measure: The Generalized Anxiety Disorder 7 item (GAD-7)
timeFrame: every 6 months for a 2 year follow-up period
measure: Provider Telepsychiatry Satisfaction Questionnaire
timeFrame: every 6 months for a 2 year follow-up period
measure: PCL
timeFrame: every 6 months for a 2 year follow-up period
measure: SF12
timeFrame: every 6 months for a 2 year follow-up period
measure: Manual for WHO Disability Assessment Schedule - WHODAS 2.0
timeFrame: every 6 months for a 2 year follow-up period
Other outcomes:
measure: Patient Health Log
timeFrame: every 6 months for a 2 year follow-up period
Locations:
city: Auburn
country: United States
facility: UC Davis Primary Care Network
state: California
city: Sacramento
country: United States
facility: UC Davis Primary Care Network Midtown
state: California
city: West Sacramento
country: United States
facility: Communicare Health Centers Salud Clinic
state: California
Study officials:
affiliation: Professor UC Davis
name: Peter Yellowlees, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.