Exploratory Study Providing Telepsychiatry in the Home With a Clinician Present

Mental Disorder Clinical Trial

Official title:

Team-based Telemedicine

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03854045
• Other study ID #: MHEF 2018
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 2020

Study information

• Verified date: February 2019
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• patient at FQHC

• referred for psychiatric services

• 50 or older

Exclusion Criteria:

• does not speak English

Related Conditions & MeSH terms

• Mental Disorder
• Mental Disorders
• Psychotic Disorders

Intervention

Other:
• Telepsychiatry
Receive telepsychiatry with clinician obtaining initial data and presenting it to the psychiatrist

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PHQ-9	depressiive symptoms	6 months
Secondary	GAD7	anxiety symptoms	6 months
Secondary	Home checklist	Problems detected in the home	6 months