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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02537093
Other study ID # 741223
Secondary ID
Status Completed
Phase N/A
First received August 25, 2015
Last updated July 7, 2017
Start date August 2015
Est. completion date May 2017

Study information

Verified date July 2017
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Psychiatric Consultation


Locations

Country Name City State
United States Norwood Pines Care Center Sacramento California
United States Cottonwood Post-Acute Rehabilitation Center Woodland California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

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