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Pilot Study of Asynchronous and Synchronous Telepsychiatry for Skilled Nursing Facilities

Primary Purpose

Dementia, Depression, Mood Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychiatric Consultation
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Norwood Pines Care Center
  • Cottonwood Post-Acute Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Synchronous telepsychiatry (STP)

Asynchronous telepsychiatry (ATP)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 25, 2015
Last Updated
July 7, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT02537093
Brief Title
Pilot Study of Asynchronous and Synchronous Telepsychiatry for Skilled Nursing Facilities
Official Title
A Pilot Study Examining Use of Asynchronous and Synchronous Telepsychiatry Consultation for Skilled Nursing Facility Residents
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Depression, Mood Disorder, Anxiety Disorder, Substance Use Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Synchronous telepsychiatry (STP)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Asynchronous telepsychiatry (ATP)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychiatric Consultation
Primary Outcome Measure Information:
Title
Clinical Global Impression
Description
Change in CGI will be measured from baseline to study endpoint of 12-month follow-up
Time Frame
12 months
Title
Brief Interview for Mental Status (BIMS)
Description
Change in BIMS will be measured from baseline to 12-month
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Norwood Pines Care Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95838
Country
United States
Facility Name
Cottonwood Post-Acute Rehabilitation Center
City
Woodland
State/Province
California
ZIP/Postal Code
95695
Country
United States

12. IPD Sharing Statement

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Pilot Study of Asynchronous and Synchronous Telepsychiatry for Skilled Nursing Facilities

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