Clinical trial NCT03881657: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness Persistent
Chronic Disease
Hypertension
Diabetes
Hypercholesterolemia
Depression
Obesity
Keywords: Integrated Behavioral Health
Reverse Colocation
Integrated Care
Lead sponsor: Health Resources in Action, Inc.
Sponsor class: OTHER
Collaborators: name: Methodist Healthcare Ministries of South Texas, Inc.
name: Social Innovation Fund
First posted: 2019-03-19
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Blood pressure
timeFrame: One year
Secondary outcomes:
measure: Blood glucose concentration
timeFrame: One year
measure: Body mass index
timeFrame: One year
measure: Total cholesterol
timeFrame: One year
measure: Depressive symptoms
timeFrame: One year
measure: Life functioning
timeFrame: One year
Other outcomes:
Locations:
Study officials:
References:
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.
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.