- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02933567
CSC OnDemand: An Innovative Online Learning Platform for Implementing Coordinated Specialty Care (CSCOnDemand)
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Needham, Massachusetts, United States, 02494
- Center for Social Innovation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: (providers in agencies)
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.
Exclusion criteria:
1. Teams should not have previously received CSC training.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CSC OnDemand Pilo
Pilot Intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Participants will respond to satisfaction and acceptability questionnaires.
|
2 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R44MH111283-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psychosis
-
Columbia UniversityNational Institute of Mental Health (NIMH); University of California, Davis; University... and other collaboratorsRecruitingClinical High Risk | First Episode Psychosis | Early PsychosisUnited States
-
University of OxfordWellcome Trust; Jazz PharmaceuticalsNot yet recruitingClinical High Risk for Psychosis | Clinical High Risk for Psychosis (CHR) | Clinical High Risk for Developing PsychosisUnited Kingdom, Italy, Greece, Finland, Germany, Netherlands, Austria, Canada, Spain, Switzerland
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)Enrolling by invitationFirst Episode Psychosis (FEP) | Clinical High Risk for Psychosis (CHR)United States
-
University of New MexicoNational Institute of Mental Health (NIMH)CompletedPsychosis | Clinical High Risk for Psychosis | First Episode PsychosisUnited States
-
Elazığ Mental Health and Diseases HospitalRecruitingMethamphetamine Induced PsychosisTurkey (Türkiye)
-
Columbia UniversityNational Institute of Mental Health (NIMH)RecruitingClinical High Risk | First Episode Psychosis | Early PsychosisUnited States
-
Shanghai Jiao Tong University School of MedicineGuangzhou Psychiatric Hospital; Suzhou Psychiatric Hospital; Tianjin Anding Hospital and other collaboratorsRecruitingSchizophrenia; Psychosis | Clinical High Risk | First Episode PsychosisChina
-
Stephanie MehlGerman Research Foundation; Charite University, Berlin, Germany; Ludwig-Maximilians... and other collaboratorsRecruitingPsychosis | Psychosis NOS | First-episode Psychosis | Schizophrenia Spectrum Disorders (SSD) | Randomized Controlled Trial (RCT) | Early Onset Psychosis | First Psychotic Episode Within the Last 5 YearsGermany
-
University of OxfordHospital General Universitario Gregorio Marañon; Charite University, Berlin... and other collaboratorsNot yet recruitingPsychosis | Treatment Resistant PsychosisSpain, United Kingdom, Germany, Israel, Greece, Italy, Netherlands, Switzerland
-
Chulalongkorn UniversityNational Research Council of Thailand; Thanyarak InstituteCompletedMethamphetamine-induced PsychosisThailand
Clinical Trials on CSC OnDemand
-
Center for Social Innovation, MassachusettsUniversity of Maryland; Dartmouth College; New York State Psychiatric InstituteCompleted
-
NYU Langone HealthNational Institute of Mental Health (NIMH)WithdrawnFirst Episode Psychosis (FEP)
-
Indiana UniversityNational Institute of Mental Health (NIMH); Yale University; University of Michigan and other collaboratorsCompletedSchizophrenia | Schizoaffective Disorder | Major Depression With Psychotic Features | Schizophreniform Disorders | Bipolar Disorder With Psychotic FeaturesUnited States
-
Northwell HealthNational Institute of Mental Health (NIMH)RecruitingFirst Episode PsychosisUnited States
-
Northwell HealthNational Institute of Mental Health (NIMH)RecruitingFirst Episode PsychosisUnited States
-
Hams Hamed AbdelrahmanCompletedAccuracy of Digital Dental ModelEgypt
-
Zhujiang HospitalRecruiting
-
Fuda Cancer Hospital, GuangzhouUniversity of MichiganCompletedNeoplasms,OvarianChina
-
Indiana UniversityNational Cancer Institute (NCI)CompletedColorectal Cancer | Breast Cancer Female
-
University of California, IrvineBeckman Laser Institute University of California IrvineCompleted