Exploratory Study Providing Telepsychiatry in the Home With a Clinician Present

Sponsor
Wayne State University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03854045
Collaborator
(none)
160
1
2
22
7.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Telepsychiatry
N/A

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.

Study Design

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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. PHQ-9 [6 months]

    depressiive symptoms

Secondary Outcome Measures

  1. GAD7 [6 months]

    anxiety symptoms

  2. Home checklist [6 months]

    Problems detected in the home

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patient at FQHC

  • referred for psychiatric services

  • 50 or older

Exclusion Criteria:
  • does not speak English

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wayne State University Detroit Michigan United States 48201

Sponsors and Collaborators

  • Wayne State University

Investigators

  • Principal Investigator: Cynthia L Arfken, PhD, Wayne State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cynthia L. Arfken, PhD, Professor, Wayne State University
ClinicalTrials.gov Identifier:
NCT03854045
Other Study ID Numbers:
  • MHEF 2018
First Posted:
Feb 26, 2019
Last Update Posted:
Feb 26, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Professor, Wayne State University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 26, 2019