- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03465371
CSC OnDemand: An Innovative Online Learning Platform for Implementing Coordinated Specialty Care (CSCPII)
Study Overview
Status
Conditions
Intervention / Treatment
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 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:
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:
- Teams should not have previously received CSC training.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: OnDemand Training Intervention
Participants receiving the OnDemand Training Intervention
|
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 |
|
Active Comparator: InPerson Intervention
Participants receiving the InPerson Intervention
|
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 |
|
Active Comparator: Virtual InPerson Intervention
Participants receiving the Virtual InPerson Intervention (the InPerson training via Zoom)
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to 9 months
|
|
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.
|
Up to 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Client-level: Work/School Participation
Time Frame: Up to 9 months
|
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.
|
Up to 9 months
|
|
Client-level: Engagement
Time Frame: Up to 9 months
|
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.
|
Up to 9 months
|
|
Client-level: Psychiatric Hospitalization
Time Frame: Up to 9 months
|
The investigators will use a binary indicator of whether the client has been hospitalized in the first nine months of treatment.
|
Up to 9 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kathleen Ferreira, PhD, C4 Innovations
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 (Actual)
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
- 4R44MH111283-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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