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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Hypertension; Obesity; Diabetes; Chronic Disease; Hypercholesterolemia; Mental Illness Persistent
• Intervention / Treatment: Behavioral: Reverse Colocated Integrated Care; Behavioral: Usual Care

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; The intervention group received a reverse colocated integrated behavioral health intervention or usual care	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.
ACTIVE_COMPARATOR: Control Group; The control group received behavioral health services only (usual care)	Behavioral: Usual Care; Behavioral health services without primary care or integrated care services

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg).	One year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Health Resources in Action, Inc.
• Collaborators: Methodist Healthcare Ministries of South Texas, Inc.; Social Innovation Fund

Publications and helpful links

General Publications

• Errichetti KS, Flynn A, Gaitan E, Ramirez MM, Baker M, Xuan Z. Randomized Trial of Reverse Colocated Integrated Care on Persons with Severe, Persistent Mental Illness in Southern Texas. J Gen Intern Med. 2020 Jul;35(7):2035-2042. doi: 10.1007/s11606-020-05778-2. Epub 2020 Apr 20.
• Sautter Errichetti K, Ramirez MM, Flynn A, Xuan Z. A reverse colocated integrated care model intervention among persons with severe persistent mental illness at the U.S.-Mexico border: A randomized controlled trial protocol. Contemp Clin Trials Commun. 2019 Nov 12;16:100490. doi: 10.1016/j.conctc.2019.100490. eCollection 2019 Dec.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 24, 2015
• Primary Completion (ACTUAL): August 22, 2017
• Study Completion (ACTUAL): August 22, 2017

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (ACTUAL): March 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Integrated Care; Integrated Behavioral Health; Reverse Colocation
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease Attributes; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Mental Disorders; Chronic Disease; Hypercholesterolemia
• Other Study ID Numbers: 100001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No