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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Risk Factors; Serious Mental Illness
• Intervention / Treatment: Other: Replicating Effective Programs; Other: Coaching; Other: Facilitation

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Replicating Effective Programs (REP)	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
Experimental: Replicating Effective Programs (REP) plus coaching	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.
Experimental: Replicating Effective Programs (REP) plus facilitation	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: Facilitation; Facilitation addresses potential organizational barriers to delivery, including leadership support and acceptance among other staff.
Experimental: Replicating Effective Programs (REP) plus coaching and facilitation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health program	Marginal 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.	baseline to 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of IDEAL Goals sessions received by persons with SMI at the community mental health program at 30 Months (Exploratory)	Number of sessions received at 30 months	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
Proportion of visits with recommended diabetes activities (e.g. screening, monitoring if have diabetes, screening exams if have diabetes, medication modification as appropriate) (Exploratory)		baseline to 18 months, 30 months
Proportion of visits with recommended dyslipidemia activities (e.g. screening, monitoring if have dyslipidemia, medication modification as appropriate ) (Exploratory)		baseline to 18 months, 30 months
Proportion of visits with recommended weight management activities (e.g. counseling) (Exploratory)		baseline to 18 months, 30 months
Self-reported tobacco use among persons with SMI at the community mental health program (Exploratory)	proportion with self-reported tobacco use recorded by staff in electronic health record	baseline to 18 months, 30 months
Blood pressure (systolic and diastolic) in mmHG among persons with SMI at the community mental health program (Exploratory)		baseline to 18 months, 30 months
HgbA1c level among persons with SMI at the community mental health program. (Exploratory)		baseline to 18 months, 30 months
Lipid values among persons with SMI at the community mental health program (Exploratory)	low density lipoprotein (LDL) mg/dl, high density lipoprotein (HDL) mg/dl,, triglycerides mg/dl, and total cholesterol mg/dl,	baseline to 18 months, 30 months
BMI (kg/m^2) among persons with SMI at the community mental health program pre and post implementation. (Exploratory)	BMI in kg/m^2 based on measured weight in kg and height in meters	baseline to 18 months, 30 months
Cardiovascular risk in persons with SMI at community mental health programs (Exploratory)	American Heart Association (AHA) American College of Cardiology Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score, percent risk, higher scores convey more risk	baseline to 18 months, 30 months
Estimated cost of delivering the IDEAL Goals program and implementation strategies (Exploratory)		baseline to 18 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Gail Daumit, MD, MHS, Johns Hopkins University

Publications and helpful links

General 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/s13012-025-01461-4.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: IRB00410086; UH3HL154280 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will follow NHLBI guidelines.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No