Sí Texas Hope Family Health Center

NCT ID: NCT03916016

Last Updated: 2019-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 585 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-09
• Study Completion Date: 2018-03-29

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

The intervention group received enhanced integrated behavioral health care.

Group Type: EXPERIMENTAL

Enhanced Integrated Behavioral Health Care

Intervention Type: 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.

Control Group

The control group received care as usual only.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Usual Care

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Methodist Healthcare Ministries of South Texas, Inc.

UNKNOWN

Sponsor Role: collaborator

Social Innovation Fund

UNKNOWN

Sponsor Role: collaborator

Health Resources in Action, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Karen Errichetti

Director, Research and Evaluation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

100002

Identifier Type: -

Identifier Source: org_study_id