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

Not Applicable

Completed

• Conditions: Diabetes; Mental Illness Persistent; Hypercholesterolemia; Depression; Obesity; Chronic Disease; Hypertension
• Interventions: Behavioral: Usual Care; Behavioral: Reverse Colocated Integrated Care

• Registration Number: NCT03881657
• Lead Sponsor: Health Resources in Action, Inc.

Brief 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.

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 Timeline

• Study Start: 2015-11-24
• Primary Completion: 2017-08-22
• Study Completion: 2017-08-22
• Status Verified: 2019-03
• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-18
• Last Update Submitted: 2019-03-18
• Study First Posted: 2019-03-19
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Usual Care	The control group received behavioral health services only (usual care)
Intervention Group	Reverse Colocated Integrated Care	The intervention group received a reverse colocated integrated behavioral health intervention or usual care

Primary Outcome Measures

Name	Time	Method
Blood pressure	One year	Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg).

Secondary Outcome Measures

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