- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03264560
Comparison of Asynchronous Telepsychiatry vs. Synchronous Telepsychiatry in Skilled Nursing Facilities (CATeleST)
Comparison of Asynchronous Telepsychiatry vs. Synchronous Telepsychiatry in Skilled Nursing Facilities: A Randomized, Controlled, Non-inferiority Trial (CATeleST)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95816
- University of California, Davis Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Synchronous Telepsychiatry (STP) group
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline measure at 1-, 2-, 3-, 6- and 12-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from baseline measure at 1-, 2-, 3-, 6- and 12-months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1078220
- 1R01HS025395 (U.S. AHRQ Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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