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Clinical Trials/NCT03881657
NCT03881657
Completed
Not Applicable

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

Health Resources in Action, Inc.0 sites416 target enrollmentNovember 24, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Illness Persistent
Sponsor
Health Resources in Action, Inc.
Enrollment
416
Primary Endpoint
Blood pressure
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 24, 2015
End Date
August 22, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Health Resources in Action, Inc.
Responsible Party
Principal Investigator
Principal Investigator

Karen Errichetti

Director, Research and Evaluation

Health Resources in Action, Inc.

Eligibility Criteria

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

Outcomes

Primary Outcomes

Blood pressure

Time Frame: One year

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

Secondary Outcomes

  • Blood glucose concentration(One year)
  • Body mass index(One year)
  • Total cholesterol(One year)
  • Depressive symptoms(One year)
  • Life functioning(One year)

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