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| ID | Type | Description | Link |
|---|---|---|---|
| UH3HL154280 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Replicating Effective Programs (REP) | Active Comparator |
| |
| Replicating Effective Programs (REP) plus coaching | Experimental |
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| Replicating Effective Programs (REP) plus facilitation | Experimental |
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| Replicating Effective Programs (REP) plus coaching and facilitation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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) |
Community Mental Health Program site staff participants:
Inclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Gail Daumit, MD, MHS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41131632 | Derived | 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. |
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We will follow NHLBI guidelines.
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| 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. |
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| Facilitation | Other | Facilitation addresses potential organizational barriers to delivery, including leadership support and acceptance among other staff. |
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| 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 |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |