Sí Texas Hope Family Health Center

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916016
• Other study ID #: 100002
• Status: Completed
• Phase: N/A
• Start date: December 9, 2015
• Est. completion date: March 29, 2018

Study information

• Verified date: April 2019
• Source: Health Resources in Action, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: March 29, 2018
• Est. primary completion date: March 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Depression
• Diabetes
• Hypercholesterolemia
• Hypertension
• Obesity

Intervention

Behavioral:
• Enhanced Integrated Behavioral Health Care
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.
• Usual Care
A collaborative model where medical and behavioral providers worked with each other episodically

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Health Resources in Action, Inc.	Methodist Healthcare Ministries of South Texas, Inc., Social Innovation Fund

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg).	One year
Secondary	Body mass index	Height and weight were measured at baseline, and body mass index was calculated.	One year
Secondary	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
Secondary	Blood glucose concentration	Blood glucose concentration was measured via blood test for HbA1c as a continuous variable	One year