Sí Texas Hope Family Health Center
Primary Purpose
Chronic Disease, Hypertension, Diabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhanced Integrated Behavioral Health Care
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Disease focused on measuring Integrated Behavioral Health, Integrated Care, Volunteer Clinic
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Control Group
Arm Description
The intervention group received enhanced integrated behavioral health care.
The control group received care as usual only.
Outcomes
Primary Outcome Measures
Blood Pressure
Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg).
Secondary Outcome Measures
Body mass index
Height and weight were measured at baseline, and body mass index was calculated.
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.
Blood glucose concentration
Blood glucose concentration was measured via blood test for HbA1c as a continuous variable
Full Information
NCT ID
NCT03916016
First Posted
April 12, 2019
Last Updated
April 18, 2019
Sponsor
Health Resources in Action, Inc.
Collaborators
Methodist Healthcare Ministries of South Texas, Inc., Social Innovation Fund
1. Study Identification
Unique Protocol Identification Number
NCT03916016
Brief Title
Sí Texas Hope Family Health Center
Official Title
Sí Texas HOPE: Enhanced Integrated Behavioral Health Model for Uninsured Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 9, 2015 (Actual)
Primary Completion Date
March 29, 2018 (Actual)
Study Completion Date
March 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Resources in Action, Inc.
Collaborators
Methodist Healthcare Ministries of South Texas, Inc., Social Innovation Fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Hypertension, Diabetes, Hypercholesterolemia, Depression, Obesity
Keywords
Integrated Behavioral Health, Integrated Care, Volunteer Clinic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
585 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group received enhanced integrated behavioral health care.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group received care as usual only.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Integrated Behavioral Health Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
A collaborative model where medical and behavioral providers worked with each other episodically
Primary Outcome Measure Information:
Title
Blood Pressure
Description
Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg).
Time Frame
One year
Secondary Outcome Measure Information:
Title
Body mass index
Description
Height and weight were measured at baseline, and body mass index was calculated.
Time Frame
One year
Title
Depressive Symptoms
Description
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.
Time Frame
One year
Title
Blood glucose concentration
Description
Blood glucose concentration was measured via blood test for HbA1c as a continuous variable
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sí Texas Hope Family Health Center
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