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

Primary Purpose

Mental Illness Persistent, Chronic Disease, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reverse Colocated Integrated Care
Usual Care
Sponsored by
Health Resources in Action, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Illness Persistent focused on measuring Integrated Behavioral Health, Reverse Colocation, Integrated Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    The intervention group received a reverse colocated integrated behavioral health intervention or usual care

    The control group received behavioral health services only (usual care)

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 15, 2019
    Last Updated
    March 18, 2019
    Sponsor
    Health Resources in Action, Inc.
    Collaborators
    Methodist Healthcare Ministries of South Texas, Inc., Social Innovation Fund
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03881657
    Brief Title
    Reverse Colocated Integrated Care Intervention Among Persons With Severe Persistent Mental Illness at US-Mexico Border
    Official Title
    Sí Texas: Improving Access to Integrated Care for Rio Grande Valley Residents With Severe & Persistent Mental Illness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 24, 2015 (Actual)
    Primary Completion Date
    August 22, 2017 (Actual)
    Study Completion Date
    August 22, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Health Resources in Action, Inc.
    Collaborators
    Methodist Healthcare Ministries of South Texas, Inc., Social Innovation Fund

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Illness Persistent, Chronic Disease, Hypertension, Diabetes, Hypercholesterolemia, Depression, Obesity
    Keywords
    Integrated Behavioral Health, Reverse Colocation, Integrated Care

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Treatment group participants were randomized to receive primary care in addition to behavioral health services within a behavioral health setting. Control group participants received behavioral health care services as usual.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    416 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    The intervention group received a reverse colocated integrated behavioral health intervention or usual care
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    The control group received behavioral health services only (usual care)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Reverse Colocated Integrated Care
    Intervention Description
    A reverse colocated integrated care model is one where primary care and preventive services are embedded within a behavioral health service setting.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual Care
    Intervention Description
    Behavioral health services without primary care or integrated care services
    Primary Outcome Measure Information:
    Title
    Blood pressure
    Description
    Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg).
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    Blood glucose concentration
    Description
    Blood glucose concentration was measured via blood test for HbA1c as a continuous variable
    Time Frame
    One year
    Title
    Body mass index
    Description
    Height and weight were measured at baseline, and body mass index was calculated
    Time Frame
    One year
    Title
    Total cholesterol
    Description
    Measured as a continuous variable in milligrams per deciliter
    Time Frame
    One year
    Title
    Depressive symptoms
    Description
    Measured as a score on the Patient Health Questionnaire-9 tool
    Time Frame
    One year
    Title
    Life functioning
    Description
    Measured as a score composite of the Adult Needs and Strengths Assessment Tool
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32314132
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    31872157
    Citation
    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.
    Results Reference
    derived

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

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