Please select the eligibility criteria that correspond to the clinical trial below.
Title: Care Management Technology to Facilitate Depression Care in Safety Net Diabetes Clinics
Brief Summary: The specific aims of the proposed study are to:

1. Develop the innovative depression care management technology, including the speech recognition technology for automated monitoring and patient prompts over time, automatic integration of the responses into the patient registry, and evidence-based decision-support algorithms for care actions;
2. Conduct the quasi-experiment in eight Los Angeles County Department of Health Services (LAC-DHS) clinics to test the interventions;
3. Use mixed-method evaluation to assess the extent of the implementation of the interventions, the acceptance to the providers and to the patients, and the impact on adoption of depression screening and treatment management over time, utilization, and cost of healthcare services, and patient health outcomes; and
4. Conduct a cost-effectiveness analysis of the three study arms. Successful completion of the study will demonstrate which Comparative Effectiveness Research (CER) adoption strategies are successful and why, their comparative cost-effectiveness, as well as which strategies are successful under which circumstances to inform system-wide implementation of same.

Hypotheses of the Proposed Study

The following are the main hypotheses of the study:

1. There will be statistically significant difference in the adoption of depression care screening and management over time among the three study groups.

   1.1. The adoption rate will be Technology-supported care (TC) \> Supported Care (SC) \> Usual Care (UC).
2. There will be statistically significant difference in the depression symptom reduction, and better functional status, and quality of life among the three study groups.

   2.1. The difference between the TC and the SC will not be statistically significant, but both will be greater than the UC group.
3. There will be statistically significant difference in the diabetes care process and outcomes among the three study groups.

   3.1. The difference between the TC and the SC will not be statistically significant, but both will be greater than the UC group.
4. There will also be statistically significant differences in healthcare utilization among the three study groups, with least utilization in the TC group where the greatest level of technology is applied.
5. Of the three groups compared, the TC group will be the most cost-effective approach for accelerating adoption of the CER depression care results.


Options:
A: Inclusion Criteria:

* Cigarette smoker (daily smoker when smoking in usual way during the month before hospital admission)
* Counseled by hospital smoking counselor during hospital stay
* Plans to stop smoking tobacco products after hospital discharge
* Appropriate for use of smoking cessation medication after discharge

Exclusion Criteria:

* Expected hospital length of stay \<24 hours
* Not expected to be discharged to home
* No access to a telephone
* Unable to communicate by telephone
* Severe psychiatric or neurologic disease precluding ability to be counseled
* Pregnant, nursing, or planning to become pregnant in next 3 months
* Active substance abuse other than tobacco
* Unable to speak English
B: Inclusion Criteria:

* age equal to or greater than 18 years
* receiving primary care at DHS safety net clinics
* having a current diagnosis of type 2 diabetes mellitus (non-gestational).
* have a working telephone or cellular phone.

Exclusion Criteria:

* current suicidal ideation;
* inability to speak either English or Spanish;
* a score of 2 or greater on the CAGE (4M) alcohol assessment;
* having schizophrenia, schizoaffective disorder, manic-depressive, or needing lithium;
* and cognitive impairment precluding ability to give informed consent or participating in the intervention, i.e., Short Portable Mental Status Questionnaire(SPMSQ) score of 6 or more errors.

Provider and administrator inclusion criteria are: practicing or managing at one of the eight study sites; involved with diabetes or depression care

No specific exclusion criteria will be applied to providers and administrators.
C: Inclusion Criteria:

* Members of the Harvard Pilgrim Health Plan

Exclusion Criteria:

* Individuals who are not members of the Harvard Pilgrim Health Plan
D: Inclusion Criteria:

* Age ≥ 21 years

  * BMI 30-50 kg/m2 and weight ≤ 400 lbs.
  * At least 2 of 5 criteria for metabolic syndrome

    * Elevated waist circumference (\> 102 cm for men, \> 88 cm for women)
    * Elevated blood pressure (≥ 130/85 mmHg)
    * Impaired fasting glucose (≥ 100 mg/dl)
    * Elevated triglycerides (≥ 150 mg/dl)
    * Low HDL cholesterol (\< 40 for men, \< 50 mg/dl for women)
  * Willing to change diet, physical activity and weight
  * Willing to accept randomization to each group
  * Able to give informed consent
  * Patient of participating PCP

Persons with the following conditions are eligible with PCP approval:

* Diabetes mellitus
* Prior CVD event \> 6 months before randomization
* Stable CVD or peripheral vascular disease

Exclusion Criteria:

* Serious medical condition likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss (e.g., end-stage renal disease on dialysis, cancer diagnosis or treatment within 2 yrs)
* Prior or planned bariatric surgery
* Chronic use (at least past 6 months) of medications likely to cause weight gain or prevent weight loss (e.g. corticosteroids, lithium, olanzapine, risperidone, clozapine)
* Unintentional weight loss within 6 months of enrollment (≥ 5% of body weight)
* Intentional weight loss within 6 months of enrollment (≥ 5% of body weight)
* Pregnant or nursing within past 6 months
* Plans to relocate from the area within 2 years
* Another member of household is a study participant or staff in the trial
* Consumes \> 14 alcoholic drinks per week
* Current use of illicit substances
* Psychiatric hospitalization in last year
* Psychiatric condition likely to impair adherence to treatment (e.g., schizophrenia)
* Blood pressure ≥ 160/100 mmHg; patient may be re-screened in 1 month
* Principal Investigator or PCP discretion

Answer: B