A Controlled Trial of Patient Centered Telepsychiatry Interventions
Primary Purpose
Mood Disorder, Anxiety Disorder, Substance Use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
telepsychiatry evaluation
Sponsored by
About this trial
This is an interventional health services research trial for Mood Disorder focused on measuring Primary care mental health consultation, Telepsychiatry, Asynchronous telepsychiatry
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
Sites / Locations
- UC Davis Primary Care Network
- UC Davis Primary Care Network Midtown
- Communicare Health Centers Salud Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Asynchronous telepsychiatry
Synchronous telepsychiatry
Arm Description
Experimental Arm: Asynchronous telepsychiatry evaluation and consultation
Control Arm: Synchronous telepsychiatry evaluation and consultation
Outcomes
Primary Outcome Measures
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)
The Clinical Global Impression (CGI)
The CGI is a widely used clinician rated scale that assesses a patient's response to mental health treatment.
Secondary Outcome Measures
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.
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.
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
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.
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.
PCL
PTSD Check List
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.
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.
Full Information
NCT ID
NCT02084979
First Posted
March 10, 2014
Last Updated
June 10, 2019
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT02084979
Brief Title
A Controlled Trial of Patient Centered Telepsychiatry Interventions
Official Title
A Controlled Trial of Patient Centered Telepsychiatry Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
April 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorder, Anxiety Disorder, Substance Use Disorder
Keywords
Primary care mental health consultation, Telepsychiatry, Asynchronous telepsychiatry
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asynchronous telepsychiatry
Arm Type
Experimental
Arm Description
Experimental Arm: Asynchronous telepsychiatry evaluation and consultation
Arm Title
Synchronous telepsychiatry
Arm Type
Active Comparator
Arm Description
Control Arm: Synchronous telepsychiatry evaluation and consultation
Intervention Type
Behavioral
Intervention Name(s)
telepsychiatry evaluation
Intervention Description
telepsychiatry evaluation and consultation to primary care
Primary Outcome Measure Information:
Title
Global Assessment of Functioning (GAF)
Description
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)
Time Frame
every 6 months for a 2 year follow-up period
Title
The Clinical Global Impression (CGI)
Description
The CGI is a widely used clinician rated scale that assesses a patient's response to mental health treatment.
Time Frame
every 6 months for a 2 year follow-up period
Secondary Outcome Measure Information:
Title
The Alcohol Use Disorders Identification Test (AUDIT)
Description
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.
Time Frame
Every 6 months- 2 year follow-up period
Title
The Patient Telemedicine Satisfaction Questionnaire
Description
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.
Time Frame
every 6 months- 2 year follow-up period
Title
PHQ-9
Description
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
Time Frame
every 6 months for a 2 year follow-up period
Title
The Generalized Anxiety Disorder 7 item (GAD-7)
Description
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.
Time Frame
every 6 months for a 2 year follow-up period
Title
Provider Telepsychiatry Satisfaction Questionnaire
Description
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.
Time Frame
every 6 months for a 2 year follow-up period
Title
PCL
Description
PTSD Check List
Time Frame
every 6 months for a 2 year follow-up period
Title
SF12
Description
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.
Time Frame
every 6 months for a 2 year follow-up period
Title
Manual for WHO Disability Assessment Schedule - WHODAS 2.0
Description
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.
Time Frame
every 6 months for a 2 year follow-up period
Other Pre-specified Outcome Measures:
Title
Patient Health Log
Description
Patient Health Log- will be administered to collect health utilization data for economic data collection
Time Frame
every 6 months for a 2 year follow-up period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Yellowlees, MD
Organizational Affiliation
Professor UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Primary Care Network
City
Auburn
State/Province
California
ZIP/Postal Code
95603
Country
United States
Facility Name
UC Davis Primary Care Network Midtown
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Communicare Health Centers Salud Clinic
City
West Sacramento
State/Province
California
ZIP/Postal Code
95605
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34726542
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.
Results Reference
derived
PubMed Identifier
33993104
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.
Results Reference
derived
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A Controlled Trial of Patient Centered Telepsychiatry Interventions
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