DementiaNCT02537093
Pilot Study of Asynchronous and Synchronous Telepsychiatry for Skilled Nursing Facilities
A study testing Psychiatric Consultation in people with Dementia and Depression, run by University of California, Davis at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Depression, Mood Disorder
- What is being tested?
- Psychiatric Consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Norwood Pines Care Center
Sacramento, California, 95838
Cottonwood Post-Acute Rehabilitation Center
Woodland, California, 95695
About this study
Official title: 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)
Read more
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.
Read the 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.
- Conditions
- Dementia, Depression, Mood Disorder, Anxiety Disorder, Substance Use Disorder
- Being tested
- Psychiatric Consultation
- Medical subject headings
- Dementia, Depression, Mood Disorders, Anxiety Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric ConsultationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Psychiatric Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression
Change in CGI will be measured from baseline to study endpoint of 12-month follow-up
Measured: 12 months
Brief Interview for Mental Status (BIMS)
Change in BIMS will be measured from baseline to 12-month
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537093
- Sponsor's protocol ID
- 741223
- Status last verified
- Jul 2017
- First submitted
- 25 Aug 2015
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining Use of Asynchronous and Synchronous Telepsychiatry Consultation for Skilled Nursing Facility Residents
- ClinicalTrials.gov ID
- NCT02537093
- Acronym / sponsor ID
- 741223
- Conditions
- Dementia, Depression, Mood Disorder, Anxiety Disorder, Substance Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synchronous telepsychiatry (STP) | Active comparator | Behavioral: Psychiatric ConsultationControl 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. |
| Asynchronous telepsychiatry (ATP) | Experimental | Behavioral: Psychiatric ConsultationIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric Consultation | Behavioural | Asynchronous telepsychiatry (ATP), Synchronous telepsychiatry (STP) |
Primary outcome
Clinical Global Impression
Time frame: 12 months
Change in CGI will be measured from baseline to study endpoint of 12-month follow-up
Brief Interview for Mental Status (BIMS)
Time frame: 12 months
Change in BIMS will be measured from baseline to 12-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychiatric Consultation in people with Dementia and Depression, run by University of California, Davis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.