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Enrolling by invitation NCT06674616

Reducing Disparities in Cardiovascular Health in Community Mental Health Settings: Optimizing Implementation Strategies

No phase Interventional Cardiovascular Risk Factors Serious Mental Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Replicating Effective Programs, Coaching, Facilitation.
Who it may be relevant to
Registry conditions: Cardiovascular Risk Factors, Serious Mental Illness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

In this trial, the investigators will examine the uptake of the evidenced-based IDEAL Goals program, a heart disease risk reduction program, while testing different implementation strategies with our partners in Michigan and Maryland who serve persons with serious mental illness (SMI).

Detailed description

In this trial, the investigators will work with Michigan and Maryland mental health programs to improve the uptake of the 18-month heart disease risk reduction program, IDEAL Goals, to be delivered to persons with SMI enrolled in their behavioral health homes.

Interventions

  • Other Replicating Effective Programs
    Replicating Effective Programs (REP), based on Social Learning Theory and Rogers' Diffusion of Innovations, incorporates program packaging, training, and technical support
  • Other Coaching
    Coaching is based on the Positive Behavior Interventions and Supports model, addresses staff barriers by building implementers' evidence-based practice (EBP) knowledge, self-efficacy, and skills through clinical support and feedback.
  • Other Facilitation
    Facilitation addresses potential organizational barriers to delivery, including leadership support and acceptance among other staff.

Primary outcome measures

  • Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health program [Time frame: baseline to 18 months]
Secondary outcome measures (1)
  • Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health program [Time frame: baseline to 18 months]

Eligibility criteria

Community Mental Health Program site staff participants:

Inclusion criteria

  • Ages 18 and Older
  • English Speaking
  • Agree to complete applicable data collection
  • Agree to engage with the program according to their role (e.g., training, IDEAL Goals program delivery).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Factorial
Masking
Double blind
Primary purpose
Health services research

Study locations

United States · 2 centers
  • Johns Hopkins University — Baltimore
  • University of Michigan — Ann Arbor

Publications

  • Yuan CT, Wang NY, Fink T, Almirall D, Appel LJ, Cook C, Cooper LA, Dalcin AT, Gennusa J, Goldsholl S, Kirley E, Liebrecht C, McGinty EE, Smith SN, Terry A, Kilbourne AM, Daumit GL. Achieving cardiovascular health equity in community mental health: study protocol for a cluster-randomized hybrid Type 3 effectiveness-implementation trial. Implement Sci. 2025 Oct 23;20(1):46. doi: 10.1186/s13012-025-0 PMID 41131632

Identifiers

NCT: NCT06674616 · IRB00410086 · UH3HL154280

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗