NCT03465371

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

3.3 years

First QC Date

February 20, 2018

Last Update Submit

April 25, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Provider-level: Success in increasing CSC providers knowledge of CSC

    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

    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 Outcomes (3)

  • Client-level: Work/School Participation

    Up to 9 months

  • Client-level: Engagement

    Up to 9 months

  • Client-level: Psychiatric Hospitalization

    Up to 9 months

Study Arms (3)

OnDemand Training Intervention

EXPERIMENTAL

Participants receiving the OnDemand Training Intervention

Other: CSC OnDemand Training Intervention

InPerson Intervention

ACTIVE COMPARATOR

Participants receiving the InPerson Intervention

Other: InPerson Intervention

Virtual InPerson Intervention

ACTIVE COMPARATOR

Participants receiving the Virtual InPerson Intervention (the InPerson training via Zoom)

Other: Virtual InPerson Intervention

Interventions

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

OnDemand Training 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

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

Virtual InPerson Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Teams should not have previously received CSC training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Social Innovation

Needham, Massachusetts, 02494, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Kathleen Ferreira, PhD

    C4 Innovations

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A 3-arm randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2018

First Posted

March 14, 2018

Study Start

October 1, 2018

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

May 2, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Locations