Sí Texas Hope Family Health Center

NCT03916016 | Completed

• 1 other identifier: 100002
• Study Type: interventional
• Target: 585
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Disease; Hypertension; Diabetes; Hypercholesterolemia; Depression; Obesity

Keywords

Integrated Behavioral Health; Integrated Care; Volunteer Clinic

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg).

  One year

Secondary Outcomes (3)

• Body mass index

  One year

• Depressive Symptoms

  One year

• Blood glucose concentration

  One year

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group received enhanced integrated behavioral health care.

Behavioral: Enhanced Integrated Behavioral Health Care

Control Group

ACTIVE COMPARATOR

The control group received care as usual only.

Behavioral: Usual Care

Interventions

Enhanced Integrated Behavioral Health Care BEHAVIORAL

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 Group

Usual Care BEHAVIORAL

A collaborative model where medical and behavioral providers worked with each other episodically

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Not actively suicidal at time of enrollment

Sponsors & Collaborators

• Health Resources in Action, Inc.: lead
• Methodist Healthcare Ministries of South Texas, Inc.: collaborator
• Social Innovation Fund: collaborator

MeSH Terms

Conditions

Chronic Disease; Hypertension; Diabetes Mellitus; Hypercholesterolemia; Depression; Obesity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Behavioral Symptoms; Behavior; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Research and Evaluation

Model Details: Treatment group participants were randomized to receive enhanced integrated behavioral health care. Control group participants received care as usual.

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: December 9, 2015
• Primary Completion: March 29, 2018
• Study Completion: March 29, 2018
• Last Updated: April 22, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share