Achieving Cardiovascular Health Equity in Community Mental Health: Optimizing Implementation Strategies
2 other identifiers
interventional
72
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2024
Typical duration for not_applicable
2 active sites
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
November 1, 2024
CompletedFirst Posted
Study publicly available on registry
November 5, 2024
CompletedStudy Start
First participant enrolled
November 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
September 4, 2025
September 1, 2025
2.6 years
November 1, 2024
September 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health program
Main 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.
baseline to 18 months
Secondary Outcomes (1)
Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health program
baseline to 18 months
Other Outcomes (13)
Number of IDEAL Goals sessions received by persons with SMI at the community mental health program at 30 Months (Exploratory)
baseline to 30 months
Proportion of visits with recommended tobacco smoking activities (e.g. assessment, counseling if smoker, pharmacotherapy offered if smoker) (Exploratory)
baseline to 18 months, 30 months
Proportion of visits with recommended hypertension activities (e.g. screening, monitoring if have hypertension, medication modification as appropriate) (Exploratory)
baseline to 18 months, 30 months
- +10 more other outcomes
Study Arms (4)
Replicating Effective Programs (REP)
ACTIVE COMPARATORReplicating Effective Programs (REP) plus coaching
EXPERIMENTALReplicating Effective Programs (REP) plus facilitation
EXPERIMENTALReplicating Effective Programs (REP) plus coaching and facilitation
EXPERIMENTALInterventions
Replicating Effective Programs (REP), based on Social Learning Theory and Rogers' Diffusion of Innovations, incorporates program packaging, training, and technical support
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.
Eligibility Criteria
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Johns Hopkins University
Baltimore, Maryland, 21287, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
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/s13012-025-01461-4.
PMID: 41131632DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Gail Daumit, MD, MHS
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2024
First Posted
November 5, 2024
Study Start
November 7, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
September 4, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
We will follow NHLBI guidelines.