PsychosisCSCPIINCT03465371
CSC OnDemand: An Innovative Online Learning Platform for Implementing Coordinated Specialty Care
A study testing CSC OnDemand Training Intervention, InPerson Intervention and Virtual InPerson Intervention in people with Psychosis, run by Center for Social Innovation, Massachusetts at 1 site in United States.
Trial summary
In response to the growing need for training on interventions to address first episode psychosis, the Center for Social Innovation (C4) partnered with experts in Coordinated Specialty Care (CSC) to develop and test CSC OnDemand: An Innovative Online Learning Platform for Implementing Coordinated Specialty Care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychosis
- What is being tested?
- CSC OnDemand Training Intervention, InPerson Intervention and Virtual InPerson Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 31 Jan 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agencies will need to provide:
- direct care to individuals with early psychosis;
- administrative-level support for training and use of the CSC model;
- an entire treatment team that is willing to participate in this team-based intervention;
- contact information for direct service staff;
- support for the study, including a staff person to serve as a liaison to work with the research team;
- access to the Internet during the intervention period; and
- a willingness to provide data and participate in the evaluation.
Who cannot join
- Teams should not have previously received CSC training.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Social Innovation
Needham, Massachusetts, 02494
About this study
In response to the growing need for training on interventions to address first episode psychosis, the Center for Social Innovation (C4) partnered with experts in Coordinated Specialty Care (CSC) to develop and test CSC OnDemand: An Innovative Online Learning Platform for Implementing Coordinated Specialty Care. The product builds on the findings of the Recovery After an Initial Schizophrenia Episode (RAISE) studies, funded by the National Institute of Mental Health (NIMH). RAISE examined team-based models of care for people early in the course of schizophrenia. Through a Fast Track Small Business Innovation Research (SBIR) grant, investigators will prototype, test, refine, and evaluate the impact of CSC OnDemand.
Read the detailed description
Building on existing resources and the expertise of our faculty and advisors, the investigators developed CSC OnDemand, a multifaceted online learning product that includes four levels: 1) an online readiness tool and CSC Learning Hub; 2) dynamic multimedia core curriculum on first episode psychosis and CSC; 3) live faculty-led online courses; and 4) ongoing support, including an online community of practice to support peer-to-peer learning.
During Phases I and II of this Fast Track SBIR, the investigators prototyped, pilot tested, built out, and evaluated the product through a cluster randomized study comparing it with InPerson training (and due to the global pandemic, a "virtual" in person training, using Zoom to train with the same curriculum as in-person, creating (unexpectedly) three study arms).
Phase I built a robust prototype of the online platform and tested it with 16 providers from three sites. This phase explored feasibility, acceptability, and preliminary effectiveness of the product, and examined which components of the online platform providers found most useful.
Based on our findings from Phase I, the investigators refined and fully built out the product to test in a larger randomized trial. Phase II used a cluster randomized non-inferiority design to assess if OnDemand training (n = 20 sites) was comparable to InPerson training (n = 10 sites). Using a mixed-methods approach, the investigators examined provider (n enrolled was 239; after attrition 206) outcomes (satisfaction; knowledge gains/retention; attitudes toward shared decision making) and client (n = 110) outcomes (work/school participation; engagement in CSC services; inpatient psychiatric hospitalizations).
The study was guided by the following specific aims:
Phase II AIM 1: To refine, expand, and finalize CSC OnDemand based on Phase I findings.
AIM 2: To examine the differences in outcomes of OnDemand training intervention as compared to the InPerson and Virtual In Person interventions as it related to CSC providers knowledge and shared decision making (SDM). Hypothesis: Providers in the OnDemand condition will achieve increases in knowledge, SDM and satisfaction at post training and nine months that will be no more than .5 standard deviations less than the InPerson or Virtual InPerson condition.
AIM 3: To determine if the OnDemand training intervention is as successful as the InPerson or Virtual InPerson training in increasing participation in work or school, improving engagement in treatment, and decreasing relapse rates for participating clients. Hypothesis: Clients being served by the providers in the OnDemand condition will have work/school participation rates, levels of engagement and rates of hospitalization nine months after admission that are no more than 10 percent higher (hospitalization) or lower (work/school, engagement) than clients served by providers in the InPerson or Virtual InPerson condition.
- Conditions
- Psychosis
- Being tested
- CSC OnDemand Training Intervention, InPerson Intervention, Virtual InPerson Intervention
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSC OnDemand Training InterventionOther
Level 1: Readiness
Online readiness tool
Level 2: Core Knowledge
Week 1-self-paced core curriculum, totaling 8 hours of instruction
Level 3: Going Deeper
Week 2-instructor-led, role-specific, and advanced topics, totaling 12 hours of instruction
Level 4: Sustainability
9 months of online community of practice support; a discussion forum; open office hours with experts; multisite case conferencing; access to online materials
InPerson InterventionOther
Level 1: Readiness
Telephone conversations with program leaders to determine structures, roles, staffing, recruitment
Level 2: Core Knowledge
1 day of in-person training on FEP basics and CSC components
Level 3: Going Deeper
1.5 days of in-person training on how the team works, followed by breakout sessions by role
Level 4: Sustainability
9 months of monthly implementation coaching calls with team leads; monthly telephone case conferences; monthly care coordination calls split out by role
Virtual InPerson InterventionOther
Level 1: Readiness
Telephone conversations with program leaders to determine structures, roles, staffing, recruitment
Level 2: Core Knowledge
1 day of virtual (via Zoom) in-person training on FEP basics and CSC components
Level 3: Going Deeper
1.5 days of virtual (via Zoom) in-person training on how the team works, followed by breakout sessions by role
Level 4: Sustainability
9 months of monthly implementation coaching calls with team leads; monthly telephone case conferences; monthly care coordination calls split out by role
| Study group | Role | What they receive |
|---|---|---|
| OnDemand Training Intervention | Experimental | Participants receiving the OnDemand Training Intervention Receives: Other: CSC OnDemand Training Intervention |
| InPerson Intervention | Active comparator | Participants receiving the InPerson Intervention Receives: Other: InPerson Intervention |
| Virtual InPerson Intervention | Active comparator | Participants receiving the Virtual InPerson Intervention (the InPerson training via Zoom) Receives: Other: Virtual InPerson Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider-level: Success in increasing CSC providers knowledge of CSC
CSC knowledge will be assessed with a 50-item, complex, multiple-choice test (25 common across disciplines, 25 discipline-specific), which will be created in conjunction with the intervention modules and will be piloted in Phase I. The outcome will be the percentage of correct responses.
Measured: Up to 9 months
Provider-level: Success in increasing CSC providers shared decision making
Shared Decision Making Questionnaire-physician version (SDM-Q-Doc) is a standardized brief instrument (9 items) for assessing SDM in clinical encounters. SDM-Q-Doc was developed for physicians, but has been adapted to all healthcare professionals. The instrument consists of 9 statements rated on a 6-point scale from "completely disagree" (0) to "completely agree" (5). The items are summed to create a total score.
Measured: Up to 9 months
Secondary outcomes (3)
Client-level: Work/School Participation
Work/school participation (any work or school participation in the prior three months) will be assessed by the team at baseline, three months, six months, and nine months.
Measured: Up to 9 months
Client-level: Engagement
The time to last mental health visit will be truncated at the nine-month point, so the investigators will use a binary indicator (yes/no) of continued treatment participation at nine months.
Measured: Up to 9 months
Client-level: Psychiatric Hospitalization
The investigators will use a binary indicator of whether the client has been hospitalized in the first nine months of treatment.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start1 Oct 2018
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 3-arm randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Social Innovation, Massachusetts
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College, University of Maryland, New York State Psychiatric Institute
- Responsible party
- Sponsor
- Investigators
- Kathleen Ferreira, PhD, Principal investigator, C4 Innovations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465371
- Sponsor's protocol ID
- 4R44MH111283-02
- Acronym
- CSCPII
- Status last verified
- Apr 2022
- First submitted
- 20 Feb 2018
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSC OnDemand: An Innovative Online Learning Platform for Implementing Coordinated Specialty Care
- ClinicalTrials.gov ID
- NCT03465371
- Acronym / sponsor ID
- CSCPII / 4R44MH111283-02
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Center for Social Innovation, MassachusettsUniversity, hospital or other
- Collaborators
- Dartmouth College, University of Maryland, New York State Psychiatric Institute
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 14 Mar 2018 (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.
In response to the growing need for training on interventions to address first episode psychosis, the Center for Social Innovation (C4) partnered with experts in Coordinated Specialty Care (CSC) to develop and test CSC OnDemand: An Innovative Online Learning Platform for Implementing Coordinated Specialty Care. The product builds on the findings of the Recovery After an Initial Schizophrenia Episode (RAISE) studies, funded by the National Institute of Mental Health (NIMH). RAISE examined team-based models of care for people early in the course of schizophrenia. Through a Fast Track Small Business Innovation Research (SBIR) grant, investigators will prototype, test, refine, and evaluate the impact of CSC OnDemand.
Detailed description
Building on existing resources and the expertise of our faculty and advisors, the investigators developed CSC OnDemand, a multifaceted online learning product that includes four levels: 1) an online readiness tool and CSC Learning Hub; 2) dynamic multimedia core curriculum on first episode psychosis and CSC; 3) live faculty-led online courses; and 4) ongoing support, including an online community of practice to support peer-to-peer learning.
During Phases I and II of this Fast Track SBIR, the investigators prototyped, pilot tested, built out, and evaluated the product through a cluster randomized study comparing it with InPerson training (and due to the global pandemic, a "virtual" in person training, using Zoom to train with the same curriculum as in-person, creating (unexpectedly) three study arms).
Phase I built a robust prototype of the online platform and tested it with 16 providers from three sites. This phase explored feasibility, acceptability, and preliminary effectiveness of the product, and examined which components of the online platform providers found most useful.
Based on our findings from Phase I, the investigators refined and fully built out the product to test in a larger randomized trial. Phase II used a cluster randomized non-inferiority design to assess if OnDemand training (n = 20 sites) was comparable to InPerson training (n = 10 sites). Using a mixed-methods approach, the investigators examined provider (n enrolled was 239; after attrition 206) outcomes (satisfaction; knowledge gains/retention; attitudes toward shared decision making) and client (n = 110) outcomes (work/school participation; engagement in CSC services; inpatient psychiatric hospitalizations).
The study was guided by the following specific aims:
Phase II AIM 1: To refine, expand, and finalize CSC OnDemand based on Phase I findings.
AIM 2: To examine the differences in outcomes of OnDemand training intervention as compared to the InPerson and Virtual In Person interventions as it related to CSC providers knowledge and shared decision making (SDM). Hypothesis: Providers in the OnDemand condition will achieve increases in knowledge, SDM and satisfaction at post training and nine months that will be no more than .5 standard deviations less than the InPerson or Virtual InPerson condition.
AIM 3: To determine if the OnDemand training intervention is as successful as the InPerson or Virtual InPerson training in increasing participation in work or school, improving engagement in treatment, and decreasing relapse rates for participating clients. Hypothesis: Clients being served by the providers in the OnDemand condition will have work/school participation rates, levels of engagement and rates of hospitalization nine months after admission that are no more than 10 percent higher (hospitalization) or lower (work/school, engagement) than clients served by providers in the InPerson or Virtual InPerson condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A 3-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| OnDemand Training Intervention | Experimental | Other: CSC OnDemand Training InterventionParticipants receiving the OnDemand Training Intervention |
| InPerson Intervention | Active comparator | Other: InPerson InterventionParticipants receiving the InPerson Intervention |
| Virtual InPerson Intervention | Active comparator | Other: Virtual InPerson InterventionParticipants receiving the Virtual InPerson Intervention (the InPerson training via Zoom) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- direct care to individuals with early psychosis;
- administrative-level support for training and use of the CSC model;
- an entire treatment team that is willing to participate in this team-based intervention;
- contact information for direct service staff;
- support for the study, including a staff person to serve as a liaison to work with the research team;
Key exclusion criteria (1 listed)
- Teams should not have previously received CSC training.
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 |
|---|---|---|
| CSC OnDemand Training InterventionLevel 1: Readiness Online readiness tool Level 2: Core Knowledge Week 1-self-paced core curriculum, totaling 8 hours of instruction Level 3: Going Deeper Week 2-instructor-led, role-specific, and advanced topics, totaling 12 hours of instruction Level 4: Sustainability 9 months of online community of practice support; a discussion forum; open office hours with experts; multisite case conferencing; access to online materials | Other | OnDemand Training Intervention |
| InPerson InterventionLevel 1: Readiness Telephone conversations with program leaders to determine structures, roles, staffing, recruitment Level 2: Core Knowledge 1 day of in-person training on FEP basics and CSC components Level 3: Going Deeper 1.5 days of in-person training on how the team works, followed by breakout sessions by role Level 4: Sustainability 9 months of monthly implementation coaching calls with team leads; monthly telephone case conferences; monthly care coordination calls split out by role | Other | InPerson Intervention |
| Virtual InPerson InterventionLevel 1: Readiness Telephone conversations with program leaders to determine structures, roles, staffing, recruitment Level 2: Core Knowledge 1 day of virtual (via Zoom) in-person training on FEP basics and CSC components Level 3: Going Deeper 1.5 days of virtual (via Zoom) in-person training on how the team works, followed by breakout sessions by role Level 4: Sustainability 9 months of monthly implementation coaching calls with team leads; monthly telephone case conferences; monthly care coordination calls split out by role | Other | Virtual InPerson Intervention |
Primary outcome
Provider-level: Success in increasing CSC providers knowledge of CSC
Time frame: Up to 9 months
CSC knowledge will be assessed with a 50-item, complex, multiple-choice test (25 common across disciplines, 25 discipline-specific), which will be created in conjunction with the intervention modules and will be piloted in Phase I. The outcome will be the percentage of correct responses.
Provider-level: Success in increasing CSC providers shared decision making
Time frame: Up to 9 months
Shared Decision Making Questionnaire-physician version (SDM-Q-Doc) is a standardized brief instrument (9 items) for assessing SDM in clinical encounters. SDM-Q-Doc was developed for physicians, but has been adapted to all healthcare professionals. The instrument consists of 9 statements rated on a 6-point scale from "completely disagree" (0) to "completely agree" (5). The items are summed to create a total score.
3 secondary outcomes
Client-level: Work/School Participation
Time frame: Up to 9 months
Client-level: Engagement
Time frame: Up to 9 months
Client-level: Psychiatric Hospitalization
Time frame: Up to 9 months
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 2 May 2022.
- Individual participant dataSharing planned: Yes
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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.
Kathleen Ferreira, PhD principal investigator
C4 Innovations
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSC OnDemand Training Intervention, InPerson Intervention and Virtual InPerson Intervention in people with Psychosis, run by Center for Social Innovation, Massachusetts 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 8 inclusion and 1 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 2 May 2022. 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?
Provider-level: Success in increasing CSC providers knowledge of CSC (time frame: Up to 9 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 2 May 2022.