Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Learning Collaborative to Implement Health Promotion in Mental Health
Brief Summary: Healthcare organizations have increasingly formed quality-improvement Learning Collaboratives to improve care for specific populations; however, there are few data on the effectiveness of this strategy compared to conventional training approaches. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to typical implementation consisting of site training and one-on-one individual technical assistance (TA). The investigators hypothesize that VLC compared to TA will be associated with greater Program Participation, Program Fidelity, and a greater proportion of participants achieving clinically significant weight loss.


Options:
A: Inclusion Criteria:

* Reside in Cameron, Hidalgo, or Willacy County
* Have a severe, persistent mental illness as diagnosed by a licensed behavioral health care provider
* Be eligible to receive behavioral health services from TTBH
* Must not be receiving any primary care outside of TTBH (as ascertained via patient self-report)
* Have a diagnosis of one or more chronic conditions:
* Hypertension (blood pressure of 140/90 mmHg or higher)
* Obesity (body mass index of 30.0 or higher)
* Poorly controlled diabetes (HbA1c over 8.5%)
* Hypercholesterolemia (Total cholesterol level above 200)

Exclusion Criteria:

* Not actively suicidal at time of enrollment
B: Inclusion Criteria:

* Major depression or dysthymia as diagnosed by a structured diagnostic interview.
* Patient plans to receive primary care at the study clinic for the next year.

Exclusion Criteria:

* Age under 60.
* Current symptoms or history of psychosis or mania as determined by structured diagnostic interview.
* Cognitive impairment as defined by a score less than 23 on a Mini Mental Status Examination.
* Terminal illness - defined as having a life expectancy of less than 6 months.
* Active alcohol abuse as determined by a screening interview.
* High suicide risk as determined by current plan for suicide or a history of more than 3 prior suicide attempts in the past 10 years.
C: Mental Health Provider Organizations Inclusion Criteria:

* Provide outpatient behavioral health services to people with SMI as defined by primary DSM-V Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder or any other state-certified serious mental illness diagnosis (e.g., post-traumatic stress disorder)
* Agree to study procedures including a commitment by CEO or designee to: (a) participate over the full program, including randomization to VLC or TA; (b) engage (if randomized to VLC) in monthly web-based meetings with other VLC members, including sharing implementation outcome data and performance evaluations; (c) collect and submit aggregate participant-level data, including demographics, weight/BMI, physical fitness as measured by a 6-minute walk test, waist circumference, frequency of physical activity, and self-reported changes in nutrition; and (d) participate in phone-based organizational change and implementation assessments, including organization leadership, middle management, and InSHAPE staff.

InSHAPE Participant Inclusion Criteria:

* Age 18 or older
* SMI as defined by primary DSM-V Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder or any other state-certified SMI diagnosis (e.g., post-traumatic stress disorder)
* Verbal permission from participant to share de-identified data with the research team
* Overweight or obesity as indicated by BMI of 25 kg/m2 or greater
* Medical clearance for participation in an exercise and dietary medication program by a physician, physician assistant, or nurse practitioner.

Exclusion Criteria:

• None
D: Inclusion Criteria:

* Diagnosis of serious mental illness (schizophrenia, bipolar disorder, other psychosis, major depressive disorder, or other recurrent depression or affective disorder)
* Have at least one of the following risk factors for CVD (cardiovascular disease):

Body mass index (BMI) \>28 or waist circumference of \>35 (women) or \>40 (men) inches OR Self-reported diagnosis of hypertension ("high blood pressure"), dyslipidemia ("high cholesterol") or diabetes or high blood sugar OR Documentation in the medical record of a diagnosis of or treatment for hypertension (defined as documented diagnosis or blood pressure of \>140/90 on 2 occasions or prescription for an antihypertensive medication), dyslipidemia (documented diagnosis or LDL\>160 or prescription for a lipid-lowering medication) or diabetes mellitus (documented diagnosis or HbA1C \>7% or current prescription for oral hypoglycemic therapy)

Exclusion Criteria:

* Have unresolved substance intoxication or withdrawal, such as appearing to be intoxicated (e.g., incoherent, slurred speech), or experiencing withdrawal symptoms from substance abuse at the time of enrollment.
* Are unwilling or unable to provide informed consent or comply with study requirements at the time of enrollment (e.g., unable to complete forms or attend sessions due to substantial functional limitations).
* Active suicidal ideation at time of enrollment (focused interventions are more appropriate for this group)

Answer: C