NCT03264560

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2022

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

5 years

First QC Date

August 23, 2017

Last Update Submit

December 22, 2022

Conditions

Keywords

TelepsychiatrySynchronousAsynchronousSNF

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impression (CGI)- severity scale

    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 Outcomes (1)

  • Patient Satisfaction Rating

    Change from baseline measure at 1-, 2-, 3-, 6- and 12-months

Study Arms (2)

Synchronous Telepsychiatry (STP) group

ACTIVE COMPARATOR
Behavioral: Telepsychiatry

Asynchronous Telepsychiatry (ATP) group

EXPERIMENTAL
Behavioral: Telepsychiatry

Interventions

TelepsychiatryBEHAVIORAL

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.

Asynchronous Telepsychiatry (ATP) groupSynchronous Telepsychiatry (STP) group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis Medical Center

Sacramento, California, 95816, United States

Location

Related Links

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 29, 2017

Study Start

June 27, 2017

Primary Completion

June 24, 2022

Study Completion

June 24, 2022

Last Updated

December 27, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations