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Completed

NCT Number: NCT03881657

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reverse Colocated Integrated Care

Behavioral

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

Behavioral health services without primary care or integrated care services

Primary outcomes

  1. Blood pressure

    Time frame: One year

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

Secondary outcomes

  1. Blood glucose concentration

    Time frame: One year

    Blood glucose concentration was measured via blood test for HbA1c as a continuous variable

  2. Body mass index

    Time frame: One year

    Height and weight were measured at baseline, and body mass index was calculated

  3. Total cholesterol

    Time frame: One year

    Measured as a continuous variable in milligrams per deciliter

  4. Depressive symptoms

    Time frame: One year

    Measured as a score on the Patient Health Questionnaire-9 tool

  5. Life functioning

    Time frame: One year

    Measured as a score composite of the Adult Needs and Strengths Assessment Tool

Sponsors and collaborators

Lead sponsor

Health Resources in Action, Inc.

Other

Collaborators

  • Methodist Healthcare Ministries of South Texas, Inc.
  • Social Innovation Fund

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 19, 2019
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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