Pilot Study of Asynchronous and Synchronous Telepsychiatry for Skilled Nursing Facilities

July 7, 2017 updated by: University of California, Davis

A Pilot Study Examining Use of Asynchronous and Synchronous Telepsychiatry Consultation for Skilled Nursing Facility Residents

Specific Aims: This study aims to assess the acceptability of asynchronous

telepsychiatry (ATP) and synchronous (STP) in rural Skilled Nursing Facility (SNF)

population, in a 12-month randomized controlled trial. ATP relies on video recording of a

psychiatric interview, where the video is later reviewed by a psychiatrist to make a

psychiatric diagnosis and treatment recommendation to the primary treatment team.

STP is real-time, face-to-face psychiatric assessment using video conferencing to come

up with a psychiatric recommendation. People residing in SNFs generally rely on primary

and consultant physicians to visit them and rarely have outpatient psychiatrist follow-up.

SNFs offer more services than what is available to primary care office, and include 24-

hours skilled nursing services, physical therapy, nutritional consultation, occupational

therapy, social services, wound care, and psychiatric consultation when available. SNF

residents are unable to live independently due to their multiple medical comorbidities

and are therefore more medically ill than patients who are typically seen in primary care

settings. The present study aims to demonstrate feasibility and to collect pilot data in

SNFs. This study is funded by the UC Davis Behavior Health Center of Excellence grant

via the California Mental Health Services Act (Prop 63). In a larger, future study, the investigators

intend to demonstrate that ATP will be no different than STP in clinical outcomes but will

be more accessible and cost effective.

Study Overview

Detailed Description

Specific Aims: This study aims to assess the acceptability of asynchronous

telepsychiatry (ATP) and synchronous (STP) in rural Skilled Nursing Facility

(SNF) population, in a 12-month randomized controlled trial. ATP relies on

video recording of a psychiatric interview, where the video is later reviewed by

a psychiatrist to make a psychiatric diagnosis and treatment recommendation

to the primary treatment team.

STP is real-time, face-to-face psychiatric assessment using video conferencing

to come up with a psychiatric recommendation. People residing in SNFs

generally rely on primary and consultant physicians to visit them and rarely

have outpatient psychiatrist follow-up. SNFs offer more services than what is

available to primary care office, and include 24-hours skilled nursing services,

physical therapy, nutritional consultation, occupational therapy, social services,

wound care, and psychiatric consultation when available. SNF residents are

unable to live independently due to their multiple medical comorbidities and are

therefore more medically ill than patients who are typically seen in primary care

settings. The present study aims to demonstrate feasibility and to collect pilot

data in SNFs. This study is funded by the University of California (UC Davis)

Behavior Health Center of Excellence grant via the California Mental Health

Services Act (Prop 63). In a larger, future study, we intend to demonstrate that

ATP will be no different than STP in clinical outcomes but will be more

accessible and cost effective.

Aim 1: To assess whether ATP and STP models improve clinical outcomes:

Hypotheses: Compared to STP, the ATP arm will: H1: show similar clinical

outcome trajectory, reflected in improvement from baseline, as measured by

Clinical Global Impression (CGI), Patient Health Questionaire-9 (PHQ-9), Brief

Interview for Mental Status (BIMS), and overall behavioral symptoms; H2: have

similar use of health care resources: psychiatric medications, additional interval

psychiatric visits, number of emergency room visits and hospitalizations

(medical, psychiatric, and overall); And H3: produce shorter waiting times for

psychiatric consultation.

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: Telemedicine Satisfaction Survey as completed by

participants.

Aim 3: To conduct preliminary healthcare economics analysis and feasibility of

producing estimates of cost-effectiveness of ATP vs. STP in SNFs. Hypotheses:

ATP, compared to STP, will: H1: be more cost effective as measured by cost

savings from reduced need for face-to-face psychiatrist time and similar use of

other medical and psychiatric services.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Sacramento, California, United States, 95838
        • Norwood Pines Care Center
      • Woodland, California, United States, 95695
        • Cottonwood Post-Acute Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged ≥18, with non-emergent psychiatric symptoms: depression, schizophrenia, bipolar disorder, Post-Traumatic Stress Disorder (PTSD), dementia-related behavioral problems, management of psychiatric medications, and other mental health problems that the Skilled Nursing Facility (SNF) Primary Care Provider (PCP) and team deems necessary to obtain psychiatric consultation.
  • referred by SNF staff and PCP at participating site

Exclusion Criteria:

  • Residents with imminent suicide and/or violence risks that require emergency psychiatric referrals or residents who cannot wait until the next ATP/STP evaluation
  • Residents with other psychiatric emergencies will be referred to the local emergency department as is the current practice at both SNFs.
  • less than 18 years
  • immediate violent intentions or plans
  • incarceration
  • patient whose PCP recommends not participating.
  • PCP not at participating site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Synchronous telepsychiatry (STP)
Control Arm/Synchronous telepsychiatry (STP): After baseline assessment, subjects will be assessed by a psychiatrist using live interactive videoconferencing every 6 months for a 1 year follow up (3 STP assessments: baseline plus 2 assessments). A report with treatment recommendations following American Psychiatric Association guidelines will be sent to the PCP who will be able to have adlib telephone or email consultations with the telepsychiatrist. The telepsychiatrist will have access to all previous clinical information about the patients.
Experimental: Asynchronous telepsychiatry (ATP)
Intervention Arm (ATP): All ATP assessments at 6 monthly intervals post baseline will be conducted by an ATP trained clinician. This interview will be video recorded.The ATP clinicians will then fill out a standardized medical template that will be reviewed by a psychiatrist who will provide a written assessment and psychiatric treatment plan. He will have access to any previous assessments and the PCP will also have continuing access to this psychiatrist by phone or email between the 3 consultations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression
Time Frame: 12 months
Change in CGI will be measured from baseline to study endpoint of 12-month follow-up
12 months
Brief Interview for Mental Status (BIMS)
Time Frame: 12 months
Change in BIMS will be measured from baseline to 12-month
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

July 7, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

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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