Clinical trial NCT06674616: Achieving Cardiovascular Health Equity in Community Mental Health: Optimizing Implementation Strategies
Official title: Achieving Cardiovascular Health Equity in Community Mental Health: Optimizing Implementation Strategies: An Implementation Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Risk Factors
Serious Mental Illness
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-11-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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).

Primary outcomes:
measure: Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health program
timeFrame: baseline to 18 months
Secondary outcomes:
measure: Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health program
timeFrame: baseline to 18 months
Other outcomes:
measure: Number of IDEAL Goals sessions received by persons with SMI at the community mental health program at 30 Months (Exploratory)
timeFrame: baseline to 30 months
measure: Proportion of visits with recommended tobacco smoking activities (e.g. assessment, counseling if smoker, pharmacotherapy offered if smoker) (Exploratory)
timeFrame: baseline to 18 months, 30 months
measure: Proportion of visits with recommended hypertension activities (e.g. screening, monitoring if have hypertension, medication modification as appropriate) (Exploratory)
timeFrame: baseline to 18 months, 30 months
measure: Proportion of visits with recommended diabetes activities (e.g. screening, monitoring if have diabetes, screening exams if have diabetes, medication modification as appropriate) (Exploratory)
timeFrame: baseline to 18 months, 30 months
measure: Proportion of visits with recommended dyslipidemia activities (e.g. screening, monitoring if have dyslipidemia, medication modification as appropriate ) (Exploratory)
timeFrame: baseline to 18 months, 30 months
measure: Proportion of visits with recommended weight management activities (e.g. counseling) (Exploratory)
timeFrame: baseline to 18 months, 30 months
measure: Self-reported tobacco use among persons with SMI at the community mental health program (Exploratory)
timeFrame: baseline to 18 months, 30 months
measure: Blood pressure (systolic and diastolic) in mmHG among persons with SMI at the community mental health program (Exploratory)
timeFrame: baseline to 18 months, 30 months
measure: HgbA1c level among persons with SMI at the community mental health program. (Exploratory)
timeFrame: baseline to 18 months, 30 months
measure: Lipid values among persons with SMI at the community mental health program (Exploratory)
timeFrame: baseline to 18 months, 30 months
measure: BMI (kg/m^2) among persons with SMI at the community mental health program pre and post implementation. (Exploratory)
timeFrame: baseline to 18 months, 30 months
measure: Cardiovascular risk in persons with SMI at community mental health programs (Exploratory)
timeFrame: baseline to 18 months, 30 months
measure: Estimated cost of delivering the IDEAL Goals program and implementation strategies (Exploratory)
timeFrame: baseline to 18 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Johns Hopkins University
name: Gail Daumit, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: