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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03881657
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
Methodist Healthcare Ministries of South Texas, Inc.
Social Innovation Fund
Information provided by (Responsible Party):
Karen Errichetti, 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.

Condition or disease Intervention/treatment Phase
Mental Illness Persistent Chronic Disease Hypertension Diabetes Hypercholesterolemia Depression Obesity Behavioral: Reverse Colocated Integrated Care Behavioral: Usual Care Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Sí Texas: Improving Access to Integrated Care for Rio Grande Valley Residents With Severe & Persistent Mental Illness
Actual Study Start Date : November 24, 2015
Actual Primary Completion Date : August 22, 2017
Actual Study Completion Date : August 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

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




Primary Outcome Measures :
  1. Blood pressure [ Time Frame: One year ]
    Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg).


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Karen Errichetti, Director, Research and Evaluation, Health Resources in Action, Inc.
ClinicalTrials.gov Identifier: NCT03881657    
Other Study ID Numbers: 100001
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Errichetti, Health Resources in Action, Inc.:
Integrated Behavioral Health
Reverse Colocation
Integrated Care
Additional relevant MeSH terms:
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Hypercholesterolemia
Chronic Disease
Mental Disorders
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Disease Attributes
Pathologic Processes