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

Primary Purpose

Psychosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CSC OnDemand Training Intervention
InPerson Intervention
Virtual InPerson Intervention
Sponsored by
Center for Social Innovation, Massachusetts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Center for Social Innovation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

OnDemand Training Intervention

InPerson Intervention

Virtual InPerson Intervention

Arm Description

Participants receiving the OnDemand Training Intervention

Participants receiving the InPerson Intervention

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Client-level: Work/School Participation
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.
Client-level: Engagement
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.
Client-level: Psychiatric Hospitalization
The investigators will use a binary indicator of whether the client has been hospitalized in the first nine months of treatment.

Full Information

First Posted
February 20, 2018
Last Updated
April 25, 2022
Sponsor
Center for Social Innovation, Massachusetts
Collaborators
Dartmouth College, University of Maryland, New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03465371
Brief Title
CSC OnDemand: An Innovative Online Learning Platform for Implementing Coordinated Specialty Care
Acronym
CSCPII
Official Title
CSC OnDemand: An Innovative Online Learning Platform for Implementing Coordinated Specialty Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Social Innovation, Massachusetts
Collaborators
Dartmouth College, University of Maryland, New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A 3-arm randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
349 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OnDemand Training Intervention
Arm Type
Experimental
Arm Description
Participants receiving the OnDemand Training Intervention
Arm Title
InPerson Intervention
Arm Type
Active Comparator
Arm Description
Participants receiving the InPerson Intervention
Arm Title
Virtual InPerson Intervention
Arm Type
Active Comparator
Arm Description
Participants receiving the Virtual InPerson Intervention (the InPerson training via Zoom)
Intervention Type
Other
Intervention Name(s)
CSC OnDemand Training Intervention
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
InPerson Intervention
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Virtual InPerson Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Provider-level: Success in increasing CSC providers knowledge of CSC
Description
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.
Time Frame
Up to 9 months
Title
Provider-level: Success in increasing CSC providers shared decision making
Description
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.
Time Frame
Up to 9 months
Secondary Outcome Measure Information:
Title
Client-level: Work/School Participation
Description
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.
Time Frame
Up to 9 months
Title
Client-level: Engagement
Description
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.
Time Frame
Up to 9 months
Title
Client-level: Psychiatric Hospitalization
Description
The investigators will use a binary indicator of whether the client has been hospitalized in the first nine months of treatment.
Time Frame
Up to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Ferreira, PhD
Organizational Affiliation
C4 Innovations
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Social Innovation
City
Needham
State/Province
Massachusetts
ZIP/Postal Code
02494
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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