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OpenTrials
Completed

NCT Number: NCT03264560

Comparison of Asynchronous Telepsychiatry vs. Synchronous Telepsychiatry in Skilled Nursing Facilities

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis Medical Center

Sacramento, California, 95816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Residents with imminent suicidal and/or violence risks that require emergency psychiatric referrals or patients who cannot wait until the next ATP/STP evaluation,
  • 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.

Treatment and study plan

Telepsychiatry

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Comparison of Asynchronous Telepsychiatry vs. Synchronous Telepsychiatry in Skilled Nursing Facilities: A Randomized, Controlled, Non-inferiority Trial (CATeleST)

Acronym: CATeleST

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Aug 29, 2017
Registry last updated
Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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