Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT02537093
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2015-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Asynchronous and Synchronous Telepsychiatry for Skilled Nursing Facilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-07', 'studyFirstSubmitDate': '2015-08-25', 'studyFirstSubmitQcDate': '2015-08-28', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Global Impression', 'timeFrame': '12 months', 'description': 'Change in CGI will be measured from baseline to study endpoint of 12-month follow-up'}, {'measure': 'Brief Interview for Mental Status (BIMS)', 'timeFrame': '12 months', 'description': 'Change in BIMS will be measured from baseline to 12-month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dementia', 'Depression', 'Mood Disorder', 'Anxiety Disorder', 'Substance Use Disorder']}, 'descriptionModule': {'briefSummary': 'Specific Aims: This study aims to assess the acceptability of asynchronous\n\ntelepsychiatry (ATP) and synchronous (STP) in rural Skilled Nursing Facility (SNF)\n\npopulation, in a 12-month randomized controlled trial. ATP relies on video recording of a\n\npsychiatric interview, where the video is later reviewed by a psychiatrist to make a\n\npsychiatric diagnosis and treatment recommendation to the primary treatment team.\n\nSTP is real-time, face-to-face psychiatric assessment using video conferencing to come\n\nup with a psychiatric recommendation. People residing in SNFs generally rely on primary\n\nand consultant physicians to visit them and rarely have outpatient psychiatrist follow-up.\n\nSNFs offer more services than what is available to primary care office, and include 24-\n\nhours skilled nursing services, physical therapy, nutritional consultation, occupational\n\ntherapy, social services, wound care, and psychiatric consultation when available. SNF\n\nresidents are unable to live independently due to their multiple medical comorbidities\n\nand are therefore more medically ill than patients who are typically seen in primary care\n\nsettings. The present study aims to demonstrate feasibility and to collect pilot data in\n\nSNFs. This study is funded by the UC Davis Behavior Health Center of Excellence grant\n\nvia the California Mental Health Services Act (Prop 63). In a larger, future study, the investigators\n\nintend to demonstrate that ATP will be no different than STP in clinical outcomes but will\n\nbe more accessible and cost effective.', 'detailedDescription': 'Specific Aims: This study aims to assess the acceptability of asynchronous\n\ntelepsychiatry (ATP) and synchronous (STP) in rural Skilled Nursing Facility\n\n(SNF) population, in a 12-month randomized controlled trial. ATP relies on\n\nvideo recording of a psychiatric interview, where the video is later reviewed by\n\na psychiatrist to make a psychiatric diagnosis and treatment recommendation\n\nto the primary treatment team.\n\nSTP is real-time, face-to-face psychiatric assessment using video conferencing\n\nto come up with a psychiatric recommendation. People residing in SNFs\n\ngenerally rely on primary and consultant physicians to visit them and rarely\n\nhave outpatient psychiatrist follow-up. SNFs offer more services than what is\n\navailable to primary care office, and include 24-hours skilled nursing services,\n\nphysical therapy, nutritional consultation, occupational therapy, social services,\n\nwound care, and psychiatric consultation when available. SNF residents are\n\nunable to live independently due to their multiple medical comorbidities and are\n\ntherefore more medically ill than patients who are typically seen in primary care\n\nsettings. The present study aims to demonstrate feasibility and to collect pilot\n\ndata in SNFs. This study is funded by the University of California (UC Davis)\n\nBehavior Health Center of Excellence grant via the California Mental Health\n\nServices Act (Prop 63). In a larger, future study, we intend to demonstrate that\n\nATP will be no different than STP in clinical outcomes but will be more\n\naccessible and cost effective.\n\nAim 1: To assess whether ATP and STP models improve clinical outcomes:\n\nHypotheses: Compared to STP, the ATP arm will: H1: show similar clinical\n\noutcome trajectory, reflected in improvement from baseline, as measured by\n\nClinical Global Impression (CGI), Patient Health Questionaire-9 (PHQ-9), Brief\n\nInterview for Mental Status (BIMS), and overall behavioral symptoms; H2: have\n\nsimilar use of health care resources: psychiatric medications, additional interval\n\npsychiatric visits, number of emergency room visits and hospitalizations\n\n(medical, psychiatric, and overall); And H3: produce shorter waiting times for\n\npsychiatric consultation.\n\nAim 2: To assess the acceptability of ATP and STP by examining satisfaction\n\nsurveys from SNF residents (who are able to complete the surveys).\n\nHypothesis:\n\nCompared to STP, ATP participants will show: H1: Similar levels of satisfaction\n\nas measured by: Telemedicine Satisfaction Survey as completed by\n\nparticipants.\n\nAim 3: To conduct preliminary healthcare economics analysis and feasibility of\n\nproducing estimates of cost-effectiveness of ATP vs. STP in SNFs. Hypotheses:\n\nATP, compared to STP, will: H1: be more cost effective as measured by cost\n\nsavings from reduced need for face-to-face psychiatrist time and similar use of\n\nother medical and psychiatric services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* referred by SNF staff and PCP at participating site\n\nExclusion Criteria:\n\n* Residents with imminent suicide and/or violence risks that require emergency psychiatric referrals or residents who cannot wait until the next ATP/STP evaluation\n* Residents with other psychiatric emergencies will be referred to the local emergency department as is the current practice at both SNFs.\n* less than 18 years\n* immediate violent intentions or plans\n* incarceration\n* patient whose PCP recommends not participating.\n* PCP not at participating site'}, 'identificationModule': {'nctId': 'NCT02537093', 'briefTitle': 'Pilot Study of Asynchronous and Synchronous Telepsychiatry for Skilled Nursing Facilities', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'A Pilot Study Examining Use of Asynchronous and Synchronous Telepsychiatry Consultation for Skilled Nursing Facility Residents', 'orgStudyIdInfo': {'id': '741223'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Synchronous telepsychiatry (STP)', '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.', 'interventionNames': ['Behavioral: Psychiatric Consultation']}, {'type': 'EXPERIMENTAL', 'label': 'Asynchronous telepsychiatry (ATP)', '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.', 'interventionNames': ['Behavioral: Psychiatric Consultation']}], 'interventions': [{'name': 'Psychiatric Consultation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Asynchronous telepsychiatry (ATP)', 'Synchronous telepsychiatry (STP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95838', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Norwood Pines Care Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95695', 'city': 'Woodland', 'state': 'California', 'country': 'United States', 'facility': 'Cottonwood Post-Acute Rehabilitation Center', 'geoPoint': {'lat': 38.67852, 'lon': -121.7733}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}