A Controlled Trial of Patient Centered Telepsychiatry Interventions

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.

Study Overview

• Status: Completed
• Conditions: Substance Use Disorder; Anxiety Disorder; Mood Disorder
• Intervention / Treatment: Behavioral: telepsychiatry evaluation

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.

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Auburn, California, United States, 95603
      • UC Davis Primary Care Network
    • Sacramento, California, United States, 95816
      • UC Davis Primary Care Network Midtown
    • West Sacramento, California, United States, 95605
      • Communicare Health Centers Salud Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Asynchronous telepsychiatry; Experimental Arm: Asynchronous telepsychiatry evaluation and consultation	Behavioral: telepsychiatry evaluation; telepsychiatry evaluation and consultation to primary care
Active Comparator: Synchronous telepsychiatry; Control Arm: Synchronous telepsychiatry evaluation and consultation	Behavioral: telepsychiatry evaluation; telepsychiatry evaluation and consultation to primary care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Alcohol Use Disorders Identification Test (AUDIT)	developed by for the World Health Organization to identify persons whose alcohol consumption has become hazardous or harmful to their health and has been widely used in many studies. The AUDIT takes under 2 minutes to administer and is commonly used in primary care. Based on our previous research we have found a great deal of substance abuse comorbid with other disorders.	Every 6 months- 2 year follow-up period
The Patient Telemedicine Satisfaction Questionnaire	This measure is a modified version of the Parent Telemedicine Satisfaction Survey. : 1) technical functioning (items 2, 3, 5, 10); 2) comfort of patient and provider with the technology and perceived privacy (items 1, 4, 6); and 3) timely and geographic access to care (items 7, 8, 9). Items 11 and 12 assess global satisfaction with the telemedicine visit.	every 6 months- 2 year follow-up period
PHQ-9	The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire to assist clinicians with diagnosing depression and monitoring treatment response. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV (Diagnostic and Statistical Manual Fourth Edition). This can help track a patients overall depression severity as well as the specific symptoms that are improving or not with treatment. The PHQ-9 was developed by Robert L. Spitzer, MD, Janet B.W. Williams, DSW, and Kurt Kroenke, MD, and colleagues at Columbia University	every 6 months for a 2 year follow-up period
The Generalized Anxiety Disorder 7 item (GAD-7)	The Generalized Anxiety Disorder 7 item (GAD-7) was developed to diagnose generalized anxiety disorders and has been validated in 2740 primary-care patients. It has a sensitivity of 89% and a specificity of 82%. It is moderately good at screening 3 other common anxiety disorders: panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%), and posttraumatic stress disorder (sensitivity 66%, specificity 81%). The GAD-7 was developed by Robert L. Spitzer, MD, and colleagues.	every 6 months for a 2 year follow-up period
Provider Telepsychiatry Satisfaction Questionnaire	The provider questionnaire was used in our preliminary studies. It reflects three domains of satisfaction reported to be highly correlated with global satisfaction for telemedicine: 1) technical functioning (items 2, 3, 5, 10); 2) comfort of patient and provider with the technology and perceived privacy (items 1, 4, 6); and 3) timely and geographic access to care (items 7, 8, 9). Items 11 and 12 assess global satisfaction with the telemedicine visit.	every 6 months for a 2 year follow-up period
PCL	PTSD Check List	every 6 months for a 2 year follow-up period
SF12	A widely validated and used self-report health survey consisting of 12 questions that produces a functional health, well-being, physical and mental health summary.	every 6 months for a 2 year follow-up period
Manual for WHO Disability Assessment Schedule - WHODAS 2.0	This instrument was developed by the WHO Classification, Terminology and Standards team, within the framework of the WHO/National Institutes of Health (NIH) Joint Project on Assessment and Classification of Disability.	every 6 months for a 2 year follow-up period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Log	Patient Health Log- will be administered to collect health utilization data for economic data collection	every 6 months for a 2 year follow-up period

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Peter Yellowlees, MD, Professor UC Davis

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): April 29, 2019

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: March 10, 2014
• First Posted (Estimate): March 12, 2014

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Primary care mental health consultation; Telepsychiatry; Asynchronous telepsychiatry
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease; Anxiety Disorders; Mood Disorders
• Other Study ID Numbers: 522696; 1R01HS021477-01A1 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No