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
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
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
NCT ID
NCT03881657
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
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
Learn more about this trial
Reverse Colocated Integrated Care Intervention Among Persons With Severe Persistent Mental Illness at US-Mexico Border
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