<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03264560</url>
  </required_header>
  <id_info>
    <org_study_id>1078220</org_study_id>
    <secondary_id>1R01HS025395</secondary_id>
    <nct_id>NCT03264560</nct_id>
  </id_info>
  <brief_title>Comparison of Asynchronous Telepsychiatry vs. Synchronous Telepsychiatry in Skilled Nursing Facilities</brief_title>
  <acronym>CATeleST</acronym>
  <official_title>Comparison of Asynchronous Telepsychiatry vs. Synchronous Telepsychiatry in Skilled Nursing Facilities: A Randomized, Controlled, Non-inferiority Trial (CATeleST)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a critical shortage of psychiatric services to people with mental illness who live&#xD;
      in Skilled Nursing Facilities (SNFs), especially those in rural settings. Although real-time&#xD;
      video conferencing psychiatric consultation, termed Synchronous Telepsychiatry (STP), has&#xD;
      been around for almost 3 decades, its adaptation is met with logistic and other challenges.&#xD;
      In this context, the investigators investigate a novel method of psychiatric consultation&#xD;
      termed Asynchronous Telepsychiatry (ATP). The main hypotheses are that that ATP will be as&#xD;
      clinically effective as STP, and that it will be acceptable to patients. This study aims to&#xD;
      evaluate the comparative clinical effectiveness of ATP vs. STP in SNF population, in a&#xD;
      12-month non-inferiority, randomized, controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to assess the acceptability of asynchronous telepsychiatry (ATP) and&#xD;
      synchronous (STP) in rural, Northern California Skilled Nursing Facility (SNF) population, in&#xD;
      a 12-month randomized controlled trial.&#xD;
&#xD;
      The study will be conducted at 5 SNFs in Northern California. SNF staff will place a formal&#xD;
      order for psychiatric consultation to the study so that the participants can receive&#xD;
      psychiatric care via ATP or STP. Research assistants will screen each referral by reviewing&#xD;
      inclusion and exclusion criteria based on the psychiatric referral question. To closely match&#xD;
      real-world practice settings, STP &quot;clinic&quot; will be pre-scheduled for 4 hours once per month&#xD;
      for each site. ATP participants will be interviewed by SNF staff (and videotaped with&#xD;
      assistance from research assistant within 5 days). The video will then by reviewed by&#xD;
      research psychiatrist and a consultation report will be send to the PCP in &lt;5 days. Follow-up&#xD;
      will occur at 1-, 2-, 3-, 6- and 12-month time periods, in addition to the baseline (0-month)&#xD;
      visit for a total of 6 consults.&#xD;
&#xD;
      Aim 1: To assess whether ATP and STP models improve clinical outcomes: Hypotheses: Compared&#xD;
      to STP, the ATP arm will: H1: show non-inferior clinical outcome trajectory, reflected in&#xD;
      improvement from baseline, as measured by Clinical Global Impression (CGI).&#xD;
&#xD;
      Aim 2: To assess the acceptability of ATP and STP by examining satisfaction surveys from SNF&#xD;
      residents (who are able to complete the surveys). Hypothesis: Compared to STP, ATP&#xD;
      participants will show: H1: Similar levels of satisfaction as measured by the Telemedicine&#xD;
      Satisfaction Survey as completed by participants.&#xD;
&#xD;
      Aim 3: To conduct healthcare economics and net benefit analysis of cost-effectiveness of ATP&#xD;
      vs. STP in SNFs. H3: ATP, compared to STP, will be more cost effective with respect to SNF&#xD;
      resident satisfaction and reduced wait times.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2017</start_date>
  <completion_date type="Actual">June 24, 2022</completion_date>
  <primary_completion_date type="Actual">June 24, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Global Impression (CGI)- severity scale</measure>
    <time_frame>Change from baseline measure at 1-, 2-, 3-, 6- and 12-months</time_frame>
    <description>Clinical outcomes from MDS 3.0 form to be collected at each consult. The primary endpoint is improvement from baseline at the 6-month visit. We will also assess long term effects of ATP, by examining 12-month outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction Rating</measure>
    <time_frame>Change from baseline measure at 1-, 2-, 3-, 6- and 12-months</time_frame>
    <description>Satisfaction survey results to be collected at each consult</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">235</enrollment>
  <condition>Psychiatric Disorder</condition>
  <arm_group>
    <arm_group_label>Synchronous Telepsychiatry (STP) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Asynchronous Telepsychiatry (ATP) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telepsychiatry</intervention_name>
    <description>A total of 6 synchronous or asynchronous telepsychiatry interventions conducted via telecommunications done at baseline, 1 month, 2 months, 3 months, 6 months, and 12 months.</description>
    <arm_group_label>Asynchronous Telepsychiatry (ATP) group</arm_group_label>
    <arm_group_label>Synchronous Telepsychiatry (STP) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants must be residents of SNF that has been approved by University of California,&#xD;
        Davis IRB, and adults aged ≥18, with non-emergent psychiatric issues, including:&#xD;
&#xD;
        depression, schizophrenia, bipolar disorder, PTSD, dementia behavioral problems, management&#xD;
        of psychiatric medications, and others mental health problems. Chronic medical disorders&#xD;
        are not excluded. Study PI or co-PI will be available by phone to help with screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Residents with imminent suicidal and/or violence risks that require emergency&#xD;
             psychiatric referrals or patients who cannot wait until the next ATP/STP evaluation,&#xD;
&#xD;
          2. Residents with imminent risks will be referred to the local emergency department as is&#xD;
             the current practice at both SNFs, and 3) Residents who are unable to consent to the&#xD;
             study and who do not have surrogate decisional makers to provide informed consent will&#xD;
             not be able to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://studypages.com/s/is-viewing-videotaped-interviews-with-patients-as-effective-as-psychiatric-evaluation-via-live-teleconference-in-snfs-140164/</url>
    <description>Learn more or sign up for the study here!</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>December 22, 2022</last_update_submitted>
  <last_update_submitted_qc>December 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Telepsychiatry</keyword>
  <keyword>Synchronous</keyword>
  <keyword>Asynchronous</keyword>
  <keyword>SNF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03264560
org study id: 1078220
secondary id: 1R01HS025395
nct id: NCT03264560
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is a critical shortage of psychiatric services to people with mental illness who live
      in Skilled Nursing Facilities (SNFs), especially those in rural settings. Although real-time
      video conferencing psychiatric consultation, termed Synchronous Telepsychiatry (STP), has
      been around for almost 3 decades, its adaptation is met with logistic and other challenges.
      In this context, the investigators investigate a novel method of psychiatric consultation
      termed Asynchronous Telepsychiatry (ATP). The main hypotheses are that that ATP will be as
      clinically effective as STP, and that it will be acceptable to patients. This study aims to
      evaluate the comparative clinical effectiveness of ATP vs. STP in SNF population, in a
      12-month non-inferiority, randomized, controlled trial.
This study aims to assess the acceptability of asynchronous telepsychiatry (ATP) and
      synchronous (STP) in rural, Northern California Skilled Nursing Facility (SNF) population, in
      a 12-month randomized controlled trial.

      The study will be conducted at 5 SNFs in Northern California. SNF staff will place a formal
      order for psychiatric consultation to the study so that the participants can receive
      psychiatric care via ATP or STP. Research assistants will screen each referral by reviewing
      inclusion and exclusion criteria based on the psychiatric referral question. To closely match
      real-world practice settings, STP "clinic" will be pre-scheduled for 4 hours once per month
      for each site. ATP participants will be interviewed by SNF staff (and videotaped with
      assistance from research assistant within 5 days). The video will then by reviewed by
      research psychiatrist and a consultation report will be send to the PCP in <5 days. Follow-up
      will occur at 1-, 2-, 3-, 6- and 12-month time periods, in addition to the baseline (0-month)
      visit for a total of 6 consults.

      Aim 1: To assess whether ATP and STP models improve clinical outcomes: Hypotheses: Compared
      to STP, the ATP arm will: H1: show non-inferior clinical outcome trajectory, reflected in
      improvement from baseline, as measured by Clinical Global Impression (CGI).

      Aim 2: To assess the acceptability of ATP and STP by examining satisfaction surveys from SNF
      residents (who are able to complete the surveys). Hypothesis: Compared to STP, ATP
      participants will show: H1: Similar levels of satisfaction as measured by the Telemedicine
      Satisfaction Survey as completed by participants.

      Aim 3: To conduct healthcare economics and net benefit analysis of cost-effectiveness of ATP
      vs. STP in SNFs. H3: ATP, compared to STP, will be more cost effective with respect to SNF
      resident satisfaction and reduced wait times.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical Global Impression (CGI)- severity scale
time frame: Change from baseline measure at 1-, 2-, 3-, 6- and 12-months
description: Clinical outcomes from MDS 3.0 form to be collected at each consult. The primary endpoint is improvement from baseline at the 6-month visit. We will also assess long term effects of ATP, by examining 12-month outcomes.
measure: Patient Satisfaction Rating
time frame: Change from baseline measure at 1-, 2-, 3-, 6- and 12-months
description: Satisfaction survey results to be collected at each consult
arm group label: Synchronous Telepsychiatry (STP) group
arm group type: Active Comparator
arm group label: Asynchronous Telepsychiatry (ATP) group
arm group type: Experimental
intervention type: Behavioral
intervention name: Telepsychiatry
description: A total of 6 synchronous or asynchronous telepsychiatry interventions conducted via telecommunications done at baseline, 1 month, 2 months, 3 months, 6 months, and 12 months.
arm group label: Asynchronous Telepsychiatry (ATP) group
arm group label: Synchronous Telepsychiatry (STP) group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
url: https://studypages.com/s/is-viewing-videotaped-interviews-with-patients-as-effective-as-psychiatric-evaluation-via-live-teleconference-in-snfs-140164/
description: Learn more or sign up for the study here!
responsible party type: Sponsor
mesh term: Mental Disorders
mesh term: Problem Behavior
sharing ipd: No