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A Controlled Trial of Patient Centered Telepsychiatry Interventions

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ClinicalTrials.gov Identifier: NCT02084979
Recruitment Status : Active, not recruiting
First Posted : March 12, 2014
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Mood Disorder Anxiety Disorder Substance Use Disorder Behavioral: telepsychiatry evaluation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Controlled Trial of Patient Centered Telepsychiatry Interventions
Actual Study Start Date : April 2014
Actual Primary Completion Date : December 31, 2017
Estimated Study Completion Date : October 2018

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




Primary Outcome Measures :
  1. Global Assessment of Functioning (GAF) [ Time Frame: every 6 months for a 2 year follow-up period ]
    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)

  2. The Clinical Global Impression (CGI) [ Time Frame: every 6 months for a 2 year follow-up period ]
    The CGI is a widely used clinician rated scale that assesses a patient's response to mental health treatment.


Secondary Outcome Measures :
  1. The Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: Every 6 months- 2 year follow-up period ]
    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.

  2. The Patient Telemedicine Satisfaction Questionnaire [ Time Frame: every 6 months- 2 year follow-up period ]
    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.

  3. PHQ-9 [ Time Frame: every 6 months for a 2 year follow-up period ]
    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

  4. The Generalized Anxiety Disorder 7 item (GAD-7) [ Time Frame: every 6 months for a 2 year follow-up period ]
    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.

  5. Provider Telepsychiatry Satisfaction Questionnaire [ Time Frame: every 6 months for a 2 year follow-up period ]
    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.

  6. PCL [ Time Frame: every 6 months for a 2 year follow-up period ]
    PTSD Check List

  7. SF12 [ Time Frame: every 6 months for a 2 year follow-up period ]
    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.

  8. Manual for WHO Disability Assessment Schedule - WHODAS 2.0 [ Time Frame: every 6 months for a 2 year follow-up period ]
    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.


Other Outcome Measures:
  1. Patient Health Log [ Time Frame: every 6 months for a 2 year follow-up period ]
    Patient Health Log- will be administered to collect health utilization data for economic data collection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02084979


Locations
United States, California
UC Davis Primary Care Network
Auburn, California, United States, 95603
UC Davis Primary Care Network Midtown
Sacramento, California, United States, 95816
Communicare Health Centers Salud Clinic
West Sacramento, California, United States, 95605
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Peter Yellowlees, MD Professor UC Davis

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02084979     History of Changes
Other Study ID Numbers: 522696
1R01HS021477-01A1 ( U.S. AHRQ Grant/Contract )
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Davis:
Primary care mental health consultation
Telepsychiatry
Asynchronous telepsychiatry

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Mood Disorders
Substance-Related Disorders
Pathologic Processes
Mental Disorders
Chemically-Induced Disorders