Reverse Colocated Integrated Care Intervention Among Persons With Severe Persistent Mental Illness at US-Mexico Border

Obesity Clinical Trial

Official title:

Sí Texas: Improving Access to Integrated Care for Rio Grande Valley Residents With Severe & Persistent Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03881657
• Other study ID #: 100001
• Status: Completed
• Phase: N/A
• Start date: November 24, 2015
• Est. completion date: August 22, 2017

Study information

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

Clinical Trial Summary

This study evaluated whether patients with severe and persistent mental illness (SPMI) who received coordinated co-located behavioral health and primary care services were more likely to improve health outcomes after 12 months compared to SPMI patients who receive only behavioral health services from the local mental health authority (LMHA) Tropical Texas Behavioral Health (TTBH).The study employed a randomized control trial (RCT) design where intervention participants receiving integrated behavioral health were compared to control participants receiving the usual care provided within an LMHA for SPMI patients. Patients were placed in each group using a randomized number process. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data was subsequently collected at 6-month and 12-month follow-up points.

Description:

This study evaluated whether patients with severe and persistent mental illness (SPMI) who received coordinated co-located behavioral health and primary care services were more likely to improve health outcomes after 12 months compared to SPMI patients who receive only behavioral health services from the local mental health authority (LMHA) Tropical Texas Behavioral Health (TTBH).The study employed a randomized control trial (RCT) design where intervention participants receiving integrated behavioral health were compared to control participants receiving the usual care provided within an LMHA for SPMI patients. Patients were placed in each group using a randomized number process. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data was subsequently collected at 6-month and 12-month follow-up points. The primary outcome of interest was systolic blood pressure. Additional secondary outcomes of interest were diastolic blood pressure, HbA1c, BMI, total cholesterol, depressive symptoms, and life functioning. 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 intervention and control groups were patients with an SPMI diagnosis over 18 years of age who were not receiving primary care services prior to enrollment and were eligible to receive behavioral health services from TTBH. The participants resided in Cameron or Hidalgo County and had one or more chronic conditions: hypertension (blood pressure of 140/90 mmHg or higher), poorly controlled diabetes (HbA1c over 8.5%), obesity (body mass index of 30.0 or higher), or hypercholesterolemia (total cholesterol level above 200).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: August 22, 2017
• Est. primary completion date: August 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Reside in Cameron, Hidalgo, or Willacy County

• Have a severe, persistent mental illness as diagnosed by a licensed behavioral health care provider

• Be eligible to receive behavioral health services from TTBH

• Must not be receiving any primary care outside of TTBH (as ascertained via patient self-report)

• 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 8.5%)

• Hypercholesterolemia (Total cholesterol level above 200)

Exclusion Criteria:

• Not actively suicidal at time of enrollment

Related Conditions & MeSH terms

• Chronic Disease
• Depression
• Diabetes
• Hypercholesterolemia
• Hypertension
• Mental Disorders
• Mental Illness Persistent
• Obesity

Intervention

Behavioral:
• Reverse Colocated Integrated Care
A reverse colocated integrated care model is one where primary care and preventive services are embedded within a behavioral health service setting.
• Usual Care
Behavioral health services without primary care or integrated care services

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	Blood glucose concentration	Blood glucose concentration was measured via blood test for HbA1c as a continuous variable	One year
Secondary	Body mass index	Height and weight were measured at baseline, and body mass index was calculated	One year
Secondary	Total cholesterol	Measured as a continuous variable in milligrams per deciliter	One year
Secondary	Depressive symptoms	Measured as a score on the Patient Health Questionnaire-9 tool	One year
Secondary	Life functioning	Measured as a score composite of the Adult Needs and Strengths Assessment Tool	One year