A Controlled Trial of Patient Centered Telepsychiatry Interventions

NCT ID: NCT02084979

Last Updated: 2019-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2019-04-29

Brief Summary

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This two-year randomized controlled trial of clinical outcomes seeks to evaluate the superiority of the asynchronous telepsychiatry (ATP) consultation model on access, quality, cost and outcomes of care over the usual care for adults referred from primary care clinics for psychiatric evaluation and treatment.

Detailed Description

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This project addresses a critical public mental health problem: the need to improve access to high quality, mental health services for diverse populations through improving the flow of clinical work across care settings (primary care and specialty care) by implementing an efficient, provider compatible, administratively simple health IT solution: Asynchronous Telepsychiatry. To assess the impact of this novel approach, this two-year randomized controlled trial of clinical outcomes seeks to evaluate the superiority of the asynchronous telepsychiatry (ATP) consultation model on access, quality, cost and outcomes of care over the usual care for adults referred from primary care clinics for psychiatric evaluation and treatment.

Aim 1: To assess whether the ATP delivery model improves clinical OUTCOMES in adult patients referred for psychiatric treatment by their PCPs; Hypotheses: Compared to the participants in the 'usual care" arm, participants in the ATP arm will show:

H1: Higher scores over the course of treatment (better clinical trajectory) on the Short-Form-12 Health Survey (SF12- the primary outcome measure), the Clinical Global Impressions scale (CGI), the Who Disability Schedule (WHODAS) and the Global Assessment of Functioning (GAF) score.

H2 (Exploratory): Improved clinical trajectories on specific disorder scales, such as the PSQ9, the Hamilton Anxiety Scale (HAMA), the GAD7 and the AUDIT substance abuse scale over the those in the "usual care" arm.

Aim 2: To assess whether ATP improves the QUALITY of care for adult patients referred for psychiatric treatment by their PCPs and for PCP providers; Hypotheses: Compared to the participants in the 'usual care" arm, participants in the ATP arm will show:

H1: higher levels of satisfaction (as measured by the patient rated Patient Telemedicine Satisfaction Survey which includes a general care satisfaction measure to be used across TAU and ATP groups and by the provider rated Telemedicine Provider Satisfaction Questionnaire) H2 (Exploratory- Spanish only speaking participants): will report more positive ratings of their provider on the Interpersonal Processes of Care Survey short form. Hypothesis: PCP's will be highly satisfied with the quality of ATP H3: PCPs with patients referred to the ATP arm will report high satisfaction ratings on the Telemedicine Provider Satisfaction Questionnaire. Aim 3: To assess whether ATP improves EFFICIENCY and REACH through reducing COSTS and increasing ACCESS for adult patients referred for psychiatric treatment by their PCPs; Hypotheses: Compared to care in the 'usual care" arm, care in the ATP arm will: H1: be more cost effective than "usual care" arm as measured by comprehensive economic data that will be collected from patient, provider, and payor perspectives.

H2: produce shorter wait-times for appointment and consultation feedback as measured by comprehensive efficiency data that will be collected from patient, provider, and payor perspectives.

Conditions

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Mood Disorder Anxiety Disorder Substance Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Asynchronous telepsychiatry

Experimental Arm: Asynchronous telepsychiatry evaluation and consultation

Group Type EXPERIMENTAL

telepsychiatry evaluation

Intervention Type BEHAVIORAL

telepsychiatry evaluation and consultation to primary care

Synchronous telepsychiatry

Control Arm: Synchronous telepsychiatry evaluation and consultation

Group Type ACTIVE_COMPARATOR

telepsychiatry evaluation

Intervention Type BEHAVIORAL

telepsychiatry evaluation and consultation to primary care

Interventions

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telepsychiatry evaluation

telepsychiatry evaluation and consultation to primary care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* aged 18 or older
* diagnosis of a mood disorder, anxiety disorder, or substance/alcohol abuse disorder(s)
* referred by PCP at participating site.

Exclusion Criteria

* less than 18 years
* imminent suicidal ideation and/or plans
* immediate violent intentions or plans
* incarceration
* significant cognitive deficits
* patient who's PCP recommends not participating.
* PCP not at participating site
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Yellowlees, MD

Role: PRINCIPAL_INVESTIGATOR

Professor UC Davis

Locations

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UC Davis Primary Care Network

Auburn, California, United States

Site Status

UC Davis Primary Care Network Midtown

Sacramento, California, United States

Site Status

Communicare Health Centers Salud Clinic

West Sacramento, California, United States

Site Status

Countries

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United States

References

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Yellowlees PM, Burke MM, Gonzalez AD, Fisher A, Chan SR, Hilty DM, McCarron RM, Scher LM, Sciolla AF, Shore J, Xiong G, Fine J, Bannister J, Iosif AM. Patient and Provider Satisfaction with Asynchronous Versus Synchronous Telepsychiatry in Primary Care: A Secondary Mixed-Methods Analysis of a Randomized Controlled Trial. Telemed J E Health. 2024 Apr;30(4):e1049-e1063. doi: 10.1089/tmj.2023.0238. Epub 2023 Nov 22.

Reference Type DERIVED
PMID: 38011623 (View on PubMed)

Lieng MK, Aurora MS, Kang Y, Kim JM, Marcin JP, Chan SR, Mouzoon JL, Tancredi DJ, Parish M, Gonzalez AD, Scher L, Xiong G, McCarron RM, Yellowlees P. Primary Care Physician Adherence to Telepsychiatry Recommendations: Intermediate Outcomes from a Randomized Clinical Trial. Telemed J E Health. 2022 Jun;28(6):838-846. doi: 10.1089/tmj.2021.0389. Epub 2021 Nov 2.

Reference Type DERIVED
PMID: 34726542 (View on PubMed)

Yellowlees PM, Parish MB, Gonzalez AD, Chan SR, Hilty DM, Yoo BK, Leigh JP, McCarron RM, Scher LM, Sciolla AF, Shore J, Xiong G, Soltero KM, Fisher A, Fine JR, Bannister J, Iosif AM. Clinical Outcomes of Asynchronous Versus Synchronous Telepsychiatry in Primary Care: Randomized Controlled Trial. J Med Internet Res. 2021 Jul 20;23(7):e24047. doi: 10.2196/24047.

Reference Type DERIVED
PMID: 33993104 (View on PubMed)

Other Identifiers

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1R01HS021477-01A1

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

522696

Identifier Type: -

Identifier Source: org_study_id

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