Improving Access to Early Psychosis Coordinated Specialty Care

Psychosis Clinical Trial

Official title:

Improving Access to Early Psychosis Coordinated Specialty Care Services

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04277585
• Other study ID #: 19-0048
• Secondary ID: 3B09SM010032-19S
• Status: Completed
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: September 27, 2020

Study information

• Verified date: June 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The UNC OASIS program currently provides evidenced-based outpatient coordinated specialty care services (CSC) to persons within the first five years of a psychotic disorder. Medical management and psychotherapy services are mainly provided in brick and mortar offices. Supported education, supported employment, and peer support services are provided in offices and also in the community. The service model is relatively intense, involving treatment sessions up to several times a week. Thus a barrier to persons in rural North Carolina receiving CSC services is the time taken to travel to office based appointments.

The purpose of this study is to determine feasibility and acceptability of providing some of the services provided by OASIS via telehealth.

Participants: Up to 10 patients who have been accepted by the OASIS program and who live 45-minutes or more from the UNC OASIS program or another CSC program. Participants must also have home internet bandwidth sufficient to support the telehealth platform and own a computer or other device (smart phone, tablet, etc.) compatible with the telehealth platform.

Procedures (methods): The OASIS program does not exclude patients based on where they live in North Carolina. Potential OASIS patients and their families participate in an initial psychosocial and medical evaluation. At this time the OASIS program director reviews the OASIS program expectations with the patient and family. If the OASIS program and the patient and the patient's family member agree that the OASIS program is a good fit, the patient is then accepted into the program. After acceptance into the OASIS program patients who live 45 minutes or more away from the UNC OASIS or another CSC program and who reside in North Carolina will be informed about the availability of the telehealth pilot project by the OASIS program director.

UNCH has developed a telehealth service that is provided via the UNC electronic medical record platform, EPIC. If interested, the OASIS patient and their family member will meet with a study staff person, who will evaluate whether their internet bandwidth is sufficient to support the EPIC telehealth platform and if they own a computer or other device that supports the EPIC telehealth platform. Patients who are interested and who meet these requirements will then participate in the oral and written informed consent process.

Participants who consent to participate in the study will receive some of their CSC services via telehealth, and will continue to receive some of their services in the OASIS offices. During this pilot phase the project will be flexible about the relative proportion of services delivered via telehealth and in-person. The main study participant is the patient, however since family therapy may be delivered via telehealth interested family members are also asked to consent to study participation.

The OASIS program routinely collects quality assurance data via self-report and clinician-administered assessments. The study will obtain consent from study participants to access this information. In addition to the Quality Assurance document patients who are subjects and their family members who also consent to participate in the the telehealth pilot project will also complete a self-report survey inquiring about their satisfaction with telehealth services.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: September 27, 2020
• Est. primary completion date: September 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 36 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Other:
• Telehealth
Early Psychosis Coordinated Specialty Care Services via telehealth.

Locations

Country	Name	City	State
United States	OASIS Clinic	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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