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Exploratory Study Providing Telepsychiatry in the Home With a Clinician Present

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ClinicalTrials.gov Identifier: NCT03854045
Recruitment Status : Enrolling by invitation
First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Cynthia L. Arfken, PhD, Wayne State University

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.

Condition or disease Intervention/treatment Phase
Mental Disorder Other: Telepsychiatry Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Nonequivalent pre-post
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Team-based Telemedicine
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Home-based
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.
Other: Telepsychiatry
Receive telepsychiatry with clinician obtaining initial data and presenting it to the psychiatrist

Active Comparator: Clinic-based
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.
Other: Telepsychiatry
Receive telepsychiatry with clinician obtaining initial data and presenting it to the psychiatrist




Primary Outcome Measures :
  1. PHQ-9 [ Time Frame: 6 months ]
    depressiive symptoms


Secondary Outcome Measures :
  1. GAD7 [ Time Frame: 6 months ]
    anxiety symptoms

  2. Home checklist [ Time Frame: 6 months ]
    Problems detected in the home



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • does not speak English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03854045


Locations
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United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Cynthia L Arfken, PhD Wayne State University

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Responsible Party: Cynthia L. Arfken, PhD, Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT03854045     History of Changes
Other Study ID Numbers: MHEF 2018
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cynthia L. Arfken, PhD, Wayne State University:
telepsychiatry
telemedicine
home-based care
Additional relevant MeSH terms:
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Mental Disorders