Improving Access to Early Psychosis Coordinated Specialty Care

NCT04277585 | Completed

• 2 other identifiers: 19-00483B09SM010032-19S3
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the feasibility of developing an Early Psychosis CSC service delivery model suitable for rural settings in NC. Major challenges to delivery of specialized health care services for persons in the early stages of psychosis include the high level of provider expertise and the frequency and intensity of services. These challenges limit the feasibility of brick-and-mortar programs to serve individuals living in rural settings. This study proposes to expand service delivery methods to include telehealth as a potential solution.

Conditions

Psychosis

Keywords

Telehealth; Specialty Care; Rural Initiative

Outcome Measures

Primary Outcomes (2)

• Mean Telehealth Healthcare Service Satisfaction and Usability Score (Month 3)

  The UNC OASIS Telehealth Satisfaction and Usability Survey is a self-report measure with 8 items assessing satisfaction with aspects of telehealth service delivery. Items using 5-item likert scale ranged from Strongly agree to Strongly disagree. Items include: 1) sessions ran smoothly, 2) preference for in-person or telehealth service or no preference, 3) comfortable using telehealth technology, 4) technical difficulties encountered (5-item likert ranging from Never to Often), 5) privacy/confidentiality of telehealth as either better than/same as/not as good as in-person visits and any comments, 6) comfort level communicating to staff using telehealth, 7) whether telehealth made attending appointments easier/same as/more difficult than in person visits, 8) whether would use telehealth services again. Lower scores reflect higher satisfaction.

  3 months

• Mean Telehealth Healthcare Service Satisfaction and Usability Score (Month 6)

  The UNC OASIS Telehealth Satisfaction and Usability Survey is a self-report measure with 8 items assessing satisfaction with aspects of telehealth service delivery. Items using 5-item likert scale ranged from Strongly agree to Strongly disagree. Items include: 1) sessions ran smoothly, 2) preference for in-person or telehealth service or no preference, 3) comfortable using telehealth technology, 4) technical difficulties encountered (5-item likert ranging from Never to Often), 5) privacy/confidentiality of telehealth as either better than/same as/not as good as in-person visits and any comments, 6) comfort level communicating to staff using telehealth, 7) whether telehealth made attending appointments easier/same as/more difficult than in person visits, 8) whether would use telehealth services again. Lower scores reflect higher satisfaction.

  6 months

Study Arms (1)

OASIS Clients

EXPERIMENTAL

Clients of the OASIS Program who live at least 45 minutes away from an Early Psychosis Coordinated Specialty Care Program and are willing to engage in some of their services through telehealth.

Other: Telehealth

Interventions

Telehealth OTHER

Early Psychosis Coordinated Specialty Care Services via telehealth.

Also known as: Video visits

OASIS Clients

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-36
• Reside in NC
• Live more than a 45 minute drive from UNC OASIS or UNC Encompass CSC programs.
• Accepted into the OASIS program.
• Have access to a computer or other device with broadband internet sufficient to support the EPIC-delivered telehealth services.
• Willing to receive some services via telehealth. A family member of a patient who is participating in this research study.

You may not qualify if:

• Not age 18-36
• Does not reside in NC
• Live within a 45 minute drive from UNC OASIS or UNC Encompass CSC programs.
• Not accepted into the OASIS program.
• No access to a computer or other device with broadband internet sufficient to support the EPIC-delivered telehealth services.
• Not willing to receive any services via telehealth

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Department of Health and Human Services: collaborator
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator

Study Sites (1)

OASIS Clinic

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Diana Perkins, MD, MPH

  University of North Carolina, School of Medicine, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open feasibility trial of addition of telehealth to an Early Psychosis Coordinated Specialty Service

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 20, 2020
• Study Start: September 27, 2019
• Primary Completion: September 27, 2020
• Study Completion: September 27, 2020
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 9-36 months following publication
• Access Criteria: IRB/IEC/REB approval and executed data use/sharing agreement with UNC.

Locations

US (1)