NCT02537093

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

August 25, 2015

Last Update Submit

July 7, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Clinical Global Impression

    Change in CGI will be measured from baseline to study endpoint of 12-month follow-up

    12 months

  • Brief Interview for Mental Status (BIMS)

    Change in BIMS will be measured from baseline to 12-month

    12 months

Study Arms (2)

Synchronous telepsychiatry (STP)

ACTIVE COMPARATOR

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.

Behavioral: Psychiatric Consultation

Asynchronous telepsychiatry (ATP)

EXPERIMENTAL

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.

Behavioral: Psychiatric Consultation

Interventions

Asynchronous telepsychiatry (ATP)Synchronous telepsychiatry (STP)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Norwood Pines Care Center

Sacramento, California, 95838, United States

Location

Cottonwood Post-Acute Rehabilitation Center

Woodland, California, 95695, United States

Location

MeSH Terms

Conditions

DementiaDepressionMood DisordersAnxiety DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavioral SymptomsBehaviorChemically-Induced Disorders

Study Design

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

Study Record Dates

First Submitted

August 25, 2015

First Posted

September 1, 2015

Study Start

August 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations