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Enrolling by Invitation

NCT Number: NCT06674616

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).

Enrolling by Invitation

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Key information

Conditions

Cardiovascular Risk Factors Serious Mental Illness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Replicating Effective Programs

Other

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

Coaching

Other

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

Other

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

Primary outcomes

  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

    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.

Secondary outcomes

  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

    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.

Other outcomes

  1. Number of IDEAL Goals sessions received by persons with SMI at the community mental health program at 30 Months (Exploratory)

    Time frame: baseline to 30 months

    Number of sessions received at 30 months

  2. Proportion of visits with recommended tobacco smoking activities (e.g. assessment, counseling if smoker, pharmacotherapy offered if smoker) (Exploratory)

    Time frame: baseline to 18 months, 30 months

  3. Proportion of visits with recommended hypertension activities (e.g. screening, monitoring if have hypertension, medication modification as appropriate) (Exploratory)

    Time frame: baseline to 18 months, 30 months

  4. Proportion of visits with recommended diabetes activities (e.g. screening, monitoring if have diabetes, screening exams if have diabetes, medication modification as appropriate) (Exploratory)

    Time frame: baseline to 18 months, 30 months

  5. Proportion of visits with recommended dyslipidemia activities (e.g. screening, monitoring if have dyslipidemia, medication modification as appropriate ) (Exploratory)

    Time frame: baseline to 18 months, 30 months

  6. Proportion of visits with recommended weight management activities (e.g. counseling) (Exploratory)

    Time frame: baseline to 18 months, 30 months

  7. Self-reported tobacco use among persons with SMI at the community mental health program (Exploratory)

    Time frame: baseline to 18 months, 30 months

    proportion with self-reported tobacco use recorded by staff in electronic health record

  8. Blood pressure (systolic and diastolic) in mmHG among persons with SMI at the community mental health program (Exploratory)

    Time frame: baseline to 18 months, 30 months

  9. HgbA1c level among persons with SMI at the community mental health program. (Exploratory)

    Time frame: baseline to 18 months, 30 months

  10. Lipid values among persons with SMI at the community mental health program (Exploratory)

    Time frame: baseline to 18 months, 30 months

    low density lipoprotein (LDL) mg/dl, high density lipoprotein (HDL) mg/dl,, triglycerides mg/dl, and total cholesterol mg/dl,

  11. BMI (kg/m^2) among persons with SMI at the community mental health program pre and post implementation. (Exploratory)

    Time frame: baseline to 18 months, 30 months

    BMI in kg/m^2 based on measured weight in kg and height in meters

  12. Cardiovascular risk in persons with SMI at community mental health programs (Exploratory)

    Time frame: baseline to 18 months, 30 months

    American Heart Association (AHA) American College of Cardiology Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score, percent risk, higher scores convey more risk

  13. Estimated cost of delivering the IDEAL Goals program and implementation strategies (Exploratory)

    Time frame: baseline to 18 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 5, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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