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

Psychosis Clinical Trial

— CSCPII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465371
• Other study ID #: 4R44MH111283-02
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2022
• Source: Center for Social Innovation, Massachusetts
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psychosis
• Psychotic Disorders

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
• 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
• 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

Locations

Country	Name	City	State
United States	Center for Social Innovation	Needham	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Center for Social Innovation, Massachusetts	Dartmouth College, New York State Psychiatric Institute, University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Up to 9 months
Secondary	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.	Up to 9 months
Secondary	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.	Up to 9 months