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Exploratory Study Providing Telepsychiatry in the Home With a Clinician Present

Primary Purpose

Mental Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telepsychiatry
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mental Disorder focused on measuring telepsychiatry, telemedicine, home-based care

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient at FQHC
  • referred for psychiatric services
  • 50 or older

Exclusion Criteria:

  • does not speak English

Sites / Locations

  • Wayne State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home-based

Clinic-based

Arm Description

Clinicians at the FQHC will identify and offer the opportunity to receive telepsychiatry in the home with 2 clinicians present. The patients are not required to agree to the evaluation to receive the services. The services are entered into their EHR but are not eligible for Medicaid reimbursement.

Clinicians at the FQHC will identify and offer the opportunity to receive telepsychiatry in the clinic with 1 clinican present. The patients are not required to agree to the evaluation to receive the services. The services are entered into their EHR and eligible for Medicaid reimbursement.

Outcomes

Primary Outcome Measures

PHQ-9
depressiive symptoms

Secondary Outcome Measures

GAD7
anxiety symptoms
Home checklist
Problems detected in the home

Full Information

First Posted
February 20, 2019
Last Updated
February 21, 2019
Sponsor
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT03854045
Brief Title
Exploratory Study Providing Telepsychiatry in the Home With a Clinician Present
Official Title
Team-based Telemedicine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Telemedicine can expand access to behavioral health services for people who have difficulty traveling to clinics. Travel can be especially challenging for older adults with mobility issues or access to reliable transportation. Assessment in the home can uncover factors impacting patient's physical and behavioral health. The goals of this project to document benefits and barriers to expanding reimbursement for telemedicine to older patient's home as the originating site.
Detailed Description
The goal of this project is to document the benefits and barriers to expanding reimbursement for telemedicine to older patient's home as the originating site. The objectives are: Develop training module for midlevel clinicians to be ready for dissemination Improved patient outcomes measures on satisfaction with care; functioning and symptoms (anxiety, depression, traumatic stress, sleep apnea, alcohol use and problems) Reductions in emergency healthcare utilization and medications prescribed as obtained from electronic health record (EHR) at the Federally Qualified Health Center (FQHC) and self-reports Summarize activities and barriers, including communication with primary care provider, identification and improvement of home environmental risks, and assistance to support system This is an observational study of team-based telepsychiatry in the home for one group and team-based psychiatry in the clinic for the comparison group. The initial assessment will include information and informed consent for treatment, biopsychosocial assessment, summary for the psychiatrist, psychiatric evaluation and recommendations (all standard of care). To that the investigators are adding informed consent for program evaluation with 6 month follow-up with information for re-contacting (3 sources, addresses, email-telephone numbers), and brief administration of selected instruments before informed consent for treatment. If an eligible patient does not want to participate in the research study, the patient would still receive services. Additional telemedicine sessions and/or therapy sessions will be conducted as medically needed in accordance with quality care. At six months (with one month window on either side) the evaluation packet will be re-administered by the clinician if convenient or by the research assistant either in person or by phone. The sample size was selected to provide robust indicators of barriers to home based assessments. The comparison group was included to provide a context for the findings. It is anticipated that the home group will have greater problems at baseline than the clinic based comparison group but both will show improvements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder
Keywords
telepsychiatry, telemedicine, home-based care

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Nonequivalent pre-post
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based
Arm Type
Experimental
Arm Description
Clinicians at the FQHC will identify and offer the opportunity to receive telepsychiatry in the home with 2 clinicians present. The patients are not required to agree to the evaluation to receive the services. The services are entered into their EHR but are not eligible for Medicaid reimbursement.
Arm Title
Clinic-based
Arm Type
Active Comparator
Arm Description
Clinicians at the FQHC will identify and offer the opportunity to receive telepsychiatry in the clinic with 1 clinican present. The patients are not required to agree to the evaluation to receive the services. The services are entered into their EHR and eligible for Medicaid reimbursement.
Intervention Type
Other
Intervention Name(s)
Telepsychiatry
Intervention Description
Receive telepsychiatry with clinician obtaining initial data and presenting it to the psychiatrist
Primary Outcome Measure Information:
Title
PHQ-9
Description
depressiive symptoms
Time Frame
6 months
Secondary Outcome Measure Information:
Title
GAD7
Description
anxiety symptoms
Time Frame
6 months
Title
Home checklist
Description
Problems detected in the home
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient at FQHC referred for psychiatric services 50 or older Exclusion Criteria: does not speak English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia L Arfken, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Exploratory Study Providing Telepsychiatry in the Home With a Clinician Present

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