A Controlled Trial of Patient Centered Telepsychiatry Interventions

Anxiety Disorder Clinical Trial

Official title:

A Controlled Trial of Patient Centered Telepsychiatry Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084979
• Other study ID #: 522696
• Secondary ID: 1R01HS021477-01A
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: April 29, 2019

Study information

• Verified date: June 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: April 29, 2019
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Disease
• Mood Disorder
• Mood Disorders
• Substance Use Disorder
• Substance-Related Disorders

Intervention

Behavioral:
• telepsychiatry evaluation
telepsychiatry evaluation and consultation to primary care

Locations

Country	Name	City	State
United States	UC Davis Primary Care Network	Auburn	California
United States	UC Davis Primary Care Network Midtown	Sacramento	California
United States	Communicare Health Centers Salud Clinic	West Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	PCL	PTSD Check List	every 6 months for a 2 year follow-up period
Secondary	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
Secondary	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