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

NCT ID: NCT03881657

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 416 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-24
• Study Completion Date: 2017-08-22

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).

Conditions

Mental Illness Persistent; Chronic Disease; Hypertension; Diabetes; Hypercholesterolemia; Depression; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

Reverse Colocated Integrated Care

Intervention Type: BEHAVIORAL

A reverse colocated integrated care model is one where primary care and preventive services are embedded within a behavioral health service setting.

Control Group

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Behavioral health services without primary care or integrated care services

Interventions

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.

Intervention Type: BEHAVIORAL

Usual Care

Behavioral health services without primary care or integrated care services

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Methodist Healthcare Ministries of South Texas, Inc.

UNKNOWN

Sponsor Role: collaborator

Social Innovation Fund

UNKNOWN

Sponsor Role: collaborator

Health Resources in Action, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Karen Errichetti

Director, Research and Evaluation

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 32314132 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31872157 (View on PubMed)

Other Identifiers

100001

Identifier Type: -

Identifier Source: org_study_id