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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

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.

Condition or disease Intervention/treatment Phase
Psychiatric Disorder Behavioral: Telepsychiatry Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Asynchronous Telepsychiatry vs. Synchronous Telepsychiatry in Skilled Nursing Facilities: A Randomized, Controlled, Non-inferiority Trial (CATeleST)
Actual Study Start Date : June 27, 2017
Estimated Primary Completion Date : August 28, 2022
Estimated Study Completion Date : August 28, 2023

Arm Intervention/treatment
Active Comparator: Synchronous Telepsychiatry (STP) group 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.

Experimental: Asynchronous Telepsychiatry (ATP) group 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03264560


Locations
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United States, California
University of California, Davis Medical Center Recruiting
Sacramento, California, United States, 95816
Contact: Glen Xiong, MD    916-712-5078    gxiong@ucdavis.edu   
Contact    9167105078    gxiong@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Agency for Healthcare Research and Quality (AHRQ)

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03264560     History of Changes
Other Study ID Numbers: 1078220
1R01HS025395 ( U.S. AHRQ Grant/Contract )
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Telepsychiatry
Synchronous
Asynchronous
SNF
Additional relevant MeSH terms:
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Mental Disorders
Problem Behavior
Behavioral Symptoms