CSC OnDemand: An Innovative Online Learning Platform for Implementing Coordinated Specialty Care (CSCPII)

April 25, 2022 updated by: Center for Social Innovation, Massachusetts
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
349

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Needham, Massachusetts, United States, 02494
        • Center for Social Innovation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OnDemand Training Intervention
Participants receiving the OnDemand Training Intervention
Other: CSC 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
Other: 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)
Other: Virtual InPerson Intervention

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Center for Social Innovation, Massachusetts

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Maryland
Dartmouth College
New York State Psychiatric Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kathleen Ferreira, PhD, C4 Innovations

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4R44MH111283-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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