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

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

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

Interventional

Enrollment (Actual)

349

Phase

  • 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

    • 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

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
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

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

Investigators

  • 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)

October 1, 2018

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID 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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