Sí Texas Hope Family Health Center

Study Overview
=================
Brief Summary
-----------------
This study evaluated whether uninsured patients living at or below 200% of the federal poverty level who received enhanced, culturally-relevant, integrated behavioral health services were more likely to improve health outcomes after 12 months compared to similar patients receiving usual care from Hope Family Health Center (HFHC), a charitable community clinic. The study employed a randomized control trial (RCT) design where intervention participants receiving integrated care at HFHC were compared to control participants receiving usual care at HFHC. Patients were placed in each group using simple random assignment. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data were subsequently collected at 6-month and 12-month follow-up points.

Detailed Description
-----------------
This study evaluated whether uninsured patients living at or below 200% of the federal poverty level who received enhanced, culturally-relevant, integrated behavioral health services were more likely to improve health outcomes after 12 months compared to similar patients receiving usual care from Hope Family Health Center (HFHC), a charitable community clinic. The study employed a randomized control trial (RCT) design where intervention participants receiving integrated care at HFHC were compared to control participants receiving usual care at HFHC. Patients were placed in each group using simple random assignment. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data were subsequently collected at 6-month and 12-month follow-up points. The primary outcomes of interest were systolic and diastolic blood pressure and depressive symptoms. Additional secondary outcomes of interest were HbA1c and BMI. These outcomes were analyzed as continuous variables using linear regression with backward model selection. Longitudinal analyses were also conducted using a likelihood-based approach to general linear mixed models. The participants (1) resided in Cameron, Hidalgo, Willacy, or Starr County, (2) were eligible to receive behavioral health services from HFHC (e.g., uninsured, living at or below 200% of the federal poverty level, residence in HFHC's service area), and (3) had a diagnosis of hypertension (blood pressure of 140/90 mm Hg or higher) and/or obesity (body mass index of 30.0 or higher) and/or poorly controlled diabetes (HbA1c over 6.8) and/or moderate depression (score of 10 or above on PHQ-9).

Official Title
-----------------
Sí Texas HOPE: Enhanced Integrated Behavioral Health Model for Uninsured Patients

Conditions
-----------------
Chronic Disease, Hypertension, Diabetes, Hypercholesterolemia, Depression, Obesity

Intervention / Treatment
-----------------
* Behavioral: Enhanced Integrated Behavioral Health Care
* Behavioral: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Reside in Cameron, Hidalgo, Starr, or Willacy County Were eligible to receive behavioral health services from HFHC (e.g., uninsured, living at or below 200% of the federal poverty level, residence in HFHC's service area) 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 6.8%) Moderate depression (score of 10 or above on PHQ-9) Exclusion Criteria: Not actively suicidal at time of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment group participants were randomized to receive enhanced integrated behavioral health care. Control group participants received care as usual.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>The intervention group received enhanced integrated behavioral health care. | Behavioral: Enhanced Integrated Behavioral Health Care<br>* The intervention involved moving from HFHC's previous collaborative model, where medical and behavioral providers worked with each other episodically, to a more fully integrated collaborative care model with care coordination, shared treatment plans, shared service provision, and shared record keeping. To achieve this enhanced level of integration, HFHC changed its current primary care workflow to include a behavioral health specialist who conducted assessments, provided initial counseling (individual or group), and coordinated referrals to care management and/or community-based health services.<br>|
| Active Comparator: Control Group<br>The control group received care as usual only. | Behavioral: Usual Care<br>* A collaborative model where medical and behavioral providers worked with each other episodically<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg). | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | Height and weight were measured at baseline, and body mass index was calculated. | One year | 
| Depressive Symptoms | Score calculated based on responses to the Patient Health Questionnaire-9. The PHQ-9 has a total possible score of 27. Each of the nine questions is assigned a value of 0, 1, 2, or 3. The total score is the sum of individual questions' scores. The PHQ-9 scoring criteria is categorized as minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27) depression. | One year | 
| Blood glucose concentration | Blood glucose concentration was measured via blood test for HbA1c as a continuous variable | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Integrated Behavioral Health, Integrated Care, Volunteer Clinic