PsychosisCSCOnDemandNCT02933567
CSC OnDemand: An Innovative Online Learning Platform for Implementing Coordinated Specialty Care
A study testing CSC OnDemand 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) has 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 15 Aug 2017
- 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
- To be eligible, 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
- 1. 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) has 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, we will develop 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, we will prototype, pilot test, build out, and evaluate the product through a cluster randomized non-inferiority study comparing it with InPerson training.
Phase I will build a robust prototype of the online platform and test it with 15-20 providers from three sites. This Phase will explore feasibility, acceptability, and preliminary effectiveness of the product, and will examine which components of the online platform providers find most useful.
Based on our findings from Phase I, we will refine and fully build out the product to test in a larger randomized trial. Phase II will use a cluster randomized non-inferiority design to assess if OnDemand training (n = 20 sites) is comparable to InPerson training (n = 10 sites). Using a mixed-methods approach, we will examine provider (n = 150) outcomes (satisfaction; knowledge gains/retention; attitudes toward shared decision making) and client (n = 600) outcomes (work/school participation; engagement in CSC services; inpatient psychiatric hospitalizations).
The study is guided by the following specific aims:
Phase I AIM 1: To develop a prototype version of CSC OnDemand. AIM 2: To test the prototype online platform with a small sample of sites/providers to determine feasibility, acceptability, and preliminary effectiveness of the product.
Hypothesis: CSC OnDemand will show positive learning and satisfaction outcomes among providers, and findings will suggest the need for and feasibility of conducting a Phase II effectiveness trial.
Phase II AIM 1: To refine, expand, and finalize CSC OnDemand based on Phase I findings. AIM 2: To determine if the OnDemand training intervention is as successful as the InPerson intervention in increasing 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 condition.
AIM 3: To determine if the OnDemand training intervention is as successful as the 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 condition.
- Conditions
- Psychosis
- Being tested
- CSC OnDemand
- 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 OnDemandOther
CSC OnDemand is 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.
| Study group | Role | What they receive |
|---|---|---|
| CSC OnDemand Pilo | Experimental | Pilot Intervention Receives: Other: CSC OnDemand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Test: Percentage of correct responses on a 50-item, complex multiple choice knowledge (effectiveness) test that is both discipline-specific and inclusive of all disciplines.
Participants will be tested on preliminary effectiveness of the CSC OnDemand tool.
Measured: 2 weeks
Secondary outcomes (1)
Satisfaction and Acceptability Survey: Level of satisfaction and acceptability with the CSC OnDemand tool as measured by quantitative and qualitative measures.
Participants will respond to satisfaction and acceptability questionnaires.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startNov 2016
- Primary completion15 Aug 2017
- Study completion15 Aug 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Social Innovation, Massachusetts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Olivet, MA, Principal investigator, Center for Social Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933567
- Sponsor's protocol ID
- 1R44MH111283-01
- Acronym
- CSCOnDemand
- Status last verified
- Oct 2017
- First submitted
- 24 Sep 2016
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. 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
- NCT02933567
- Acronym / sponsor ID
- CSCOnDemand / 1R44MH111283-01
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Center for Social Innovation, MassachusettsUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 14 Oct 2016 (estimated)
- 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) has 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, we will develop 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, we will prototype, pilot test, build out, and evaluate the product through a cluster randomized non-inferiority study comparing it with InPerson training.
Phase I will build a robust prototype of the online platform and test it with 15-20 providers from three sites. This Phase will explore feasibility, acceptability, and preliminary effectiveness of the product, and will examine which components of the online platform providers find most useful.
Based on our findings from Phase I, we will refine and fully build out the product to test in a larger randomized trial. Phase II will use a cluster randomized non-inferiority design to assess if OnDemand training (n = 20 sites) is comparable to InPerson training (n = 10 sites). Using a mixed-methods approach, we will examine provider (n = 150) outcomes (satisfaction; knowledge gains/retention; attitudes toward shared decision making) and client (n = 600) outcomes (work/school participation; engagement in CSC services; inpatient psychiatric hospitalizations).
The study is guided by the following specific aims:
Phase I AIM 1: To develop a prototype version of CSC OnDemand. AIM 2: To test the prototype online platform with a small sample of sites/providers to determine feasibility, acceptability, and preliminary effectiveness of the product.
Hypothesis: CSC OnDemand will show positive learning and satisfaction outcomes among providers, and findings will suggest the need for and feasibility of conducting a Phase II effectiveness trial.
Phase II AIM 1: To refine, expand, and finalize CSC OnDemand based on Phase I findings. AIM 2: To determine if the OnDemand training intervention is as successful as the InPerson intervention in increasing 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 condition.
AIM 3: To determine if the OnDemand training intervention is as successful as the 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 condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CSC OnDemand Pilo | Experimental | Other: CSC OnDemandPilot Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- To be eligible, agencies will need to provide:
Key exclusion criteria (1 listed)
- 1. 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 OnDemandCSC OnDemand is 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. | Other | CSC OnDemand Pilo |
Primary outcome
Knowledge Test: Percentage of correct responses on a 50-item, complex multiple choice knowledge (effectiveness) test that is both discipline-specific and inclusive of all disciplines.
Time frame: 2 weeks
Participants will be tested on preliminary effectiveness of the CSC OnDemand tool.
1 secondary outcome
Satisfaction and Acceptability Survey: Level of satisfaction and acceptability with the CSC OnDemand tool as measured by quantitative and qualitative measures.
Time frame: 2 weeks
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 16 Oct 2017.
- 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.
Jeffrey Olivet, MA principal investigator
Center for Social Innovation
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 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 16 Oct 2017. 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?
Knowledge Test: Percentage of correct responses on a 50-item, complex multiple choice knowledge (effectiveness) test that is both discipline-specific and inclusive of all disciplines. (time frame: 2 weeks). 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 16 Oct 2017.