Cardiovascular Risk Factors, Serious Mental Illness
Conditions
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.
OTHERFacilitation
Facilitation addresses potential organizational barriers to delivery, including leadership support and acceptance among other staff.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins University
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
| Measure | Time frame | Description |
|---|---|---|
| Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health program | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health program | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | baseline to 18 months, 30 months | proportion with self-reported tobacco use recorded by staff in electronic health record |
| Number of IDEAL Goals sessions received by persons with SMI at the community mental health program at 30 Months (Exploratory) | baseline to 30 months | Number of sessions received at 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) | 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, |
| BMI (kg/m^2) among persons with SMI at the community mental health program pre and post implementation. (Exploratory) | baseline to 18 months, 30 months | BMI in kg/m\^2 based on measured weight in kg and height in meters |
| Cardiovascular risk in persons with SMI at community mental health programs (Exploratory) | 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 |
| Estimated cost of delivering the IDEAL Goals program and implementation strategies (Exploratory) | baseline to 18 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 | — |
| 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 | — |
Countries
United States
Outcome results
None listed