- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02537093
Pilot Study of Asynchronous and Synchronous Telepsychiatry for Skilled Nursing Facilities
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
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95838
- Norwood Pines Care Center
-
Woodland, California, United States, 95695
- Cottonwood Post-Acute Rehabilitation Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 741223
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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