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Comparison of Asynchronous Telepsychiatry vs. Synchronous Telepsychiatry in Skilled Nursing Facilities (CATeleST)

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ClinicalTrials.gov Identifier: NCT03264560
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE August 23, 2017
First Posted Date  ICMJE August 29, 2017
Last Update Posted Date June 13, 2019
Actual Study Start Date  ICMJE June 27, 2017
Estimated Primary Completion Date August 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
Clinical Global Impression (CGI)- severity scale [ Time Frame: Change from baseline measure at 1-, 2-, 3-, 6- and 12-months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03264560 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
Patient Satisfaction Rating [ Time Frame: Change from baseline measure at 1-, 2-, 3-, 6- and 12-months ]
Satisfaction survey results to be collected at each consult
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Asynchronous Telepsychiatry vs. Synchronous Telepsychiatry in Skilled Nursing Facilities
Official Title  ICMJE Comparison of Asynchronous Telepsychiatry vs. Synchronous Telepsychiatry in Skilled Nursing Facilities: A Randomized, Controlled, Non-inferiority Trial (CATeleST)
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psychiatric Disorder
Intervention  ICMJE Behavioral: Telepsychiatry
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.
Study Arms  ICMJE
  • Active Comparator: Synchronous Telepsychiatry (STP) group
    Intervention: Behavioral: Telepsychiatry
  • Experimental: Asynchronous Telepsychiatry (ATP) group
    Intervention: Behavioral: Telepsychiatry
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 25, 2017)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 28, 2023
Estimated Primary Completion Date August 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Participants must be residents of SNF that has been approved by University of California, Davis IRB, and adults aged ≥18, with non-emergent psychiatric issues, including:

depression, schizophrenia, bipolar disorder, PTSD, dementia behavioral problems, management of psychiatric medications, and others mental health problems. Chronic medical disorders are not excluded. Study PI or co-PI will be available by phone to help with screening.

Exclusion Criteria:

  1. Residents with imminent suicidal and/or violence risks that require emergency psychiatric referrals or patients who cannot wait until the next ATP/STP evaluation,
  2. Residents with imminent risks will be referred to the local emergency department as is the current practice at both SNFs, and 3) Residents who are unable to consent to the study and who do not have surrogate decisional makers to provide informed consent will not be able to participate.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03264560
Other Study ID Numbers  ICMJE 1078220
1R01HS025395 ( U.S. AHRQ Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE Not Provided
PRS Account University of California, Davis
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP