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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06674616
Enrollment
72
Registered
2024-11-05
Start date
2024-11-07
Completion date
2027-06-30
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factors, Serious Mental Illness

Brief summary

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

Replicating Effective Programs (REP), based on Social Learning Theory and Rogers' Diffusion of Innovations, incorporates program packaging, training, and technical support

OTHERCoaching

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.

Facilitation addresses potential organizational barriers to delivery, including leadership support and acceptance among other staff.

Sponsors

Johns Hopkins University
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Community Mental Health Program site staff participants: Inclusion Criteria 1. Ages 18 and Older 2. English Speaking 3. Agree to complete applicable data collection 4. Agree to engage with the program according to their role (e.g., training, IDEAL Goals program delivery).

Design outcomes

Primary

MeasureTime frameDescription
Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health programbaseline to 18 monthsMain effects of implementation strategies defined as those who attend sessions that are assigned to the most intensive strategies (Replicating Effective Programs (REP), Coaching, and Facilitation) compared to the least intensive (REP only). The investigators will use electronic health record data on all clients enrolled in the behavioral health home at a participating organization to assess sessions attended. These individuals are not formally enrolled into the trial; their data, obtained under a waiver of informed consent, comprise this outcome.

Secondary

MeasureTime frameDescription
Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health programbaseline to 18 monthsMarginal effects of implementation strategies defined as those who attend sessions that are assigned to Coaching or Facilitation compared to those not assigned to that same strategy.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGail Daumit, MD, MHS

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026