PsychosisNCT04277585
Improving Access to Early Psychosis Coordinated Specialty Care
A study testing Telehealth in people with Psychosis, run by University of North Carolina, Chapel Hill at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 36 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Telehealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2019to 27 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Access to Early Psychosis Coordinated Specialty Care Services
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.
Read the detailed 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.
- Conditions
- Psychosis
- Being tested
- Telehealth
- Keywords
- Telehealth, Specialty Care, Rural Initiative
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelehealthOther
Also called Video visits
Early Psychosis Coordinated Specialty Care Services via telehealth.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start27 Sep 2019
- Primary completion27 Sep 2020
- Study completion27 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open feasibility trial of addition of telehealth to an Early Psychosis Coordinated Specialty Service
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA)
- Responsible party
- Sponsor
- Investigators
- Diana Perkins, MD, MPH, Principal investigator, University of North Carolina, School of Medicine, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277585
- Sponsor's protocol ID
- 19-0048
- Other IDs
- 3B09SM010032-19S3
- Status last verified
- Jun 2021
- First submitted
- 17 Feb 2020
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to Early Psychosis Coordinated Specialty Care Services
- ClinicalTrials.gov ID
- NCT04277585
- Acronym / sponsor ID
- 19-0048
- Conditions
- Psychosis
- Keywords
- Telehealth, Specialty Care, Rural Initiative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 27 Sep 2020 (actual)
- Study completion
- 27 Sep 2020 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open feasibility trial of addition of telehealth to an Early Psychosis Coordinated Specialty Service
| Arm | Type | Receives |
|---|---|---|
| OASIS Clients | Experimental | Other: TelehealthClients 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. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelehealthAlso: Video visitsEarly Psychosis Coordinated Specialty Care Services via telehealth. | Other | OASIS Clients |
Primary outcome
Mean Telehealth Healthcare Service Satisfaction and Usability Score (Month 3)
Time frame: 3 months
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.
Mean Telehealth Healthcare Service Satisfaction and Usability Score (Month 6)
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Perkins, MD, MPH principal investigator
University of North Carolina, School of Medicine, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth in people with Psychosis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Telehealth Healthcare Service Satisfaction and Usability Score (Month 3) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.