NCT03881657

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

March 15, 2019

Last Update Submit

March 18, 2019

Conditions

Keywords

Integrated Behavioral HealthReverse ColocationIntegrated Care

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

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

    One year

Secondary Outcomes (5)

  • Blood glucose concentration

    One year

  • Body mass index

    One year

  • Total cholesterol

    One year

  • Depressive symptoms

    One year

  • Life functioning

    One year

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Reverse Colocated Integrated Care

Control Group

ACTIVE COMPARATOR

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

Behavioral: Usual Care

Interventions

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

Intervention Group
Usual CareBEHAVIORAL

Behavioral health services without primary care or integrated care services

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Not actively suicidal at time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Chronic DiseaseHypertensionDiabetes MellitusHypercholesterolemiaDepressionObesity

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersBehavioral SymptomsBehaviorOverweightOvernutritionNutrition DisordersBody WeightSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Research and Evaluation

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 19, 2019

Study Start

November 24, 2015

Primary Completion

August 22, 2017

Study Completion

August 22, 2017

Last Updated

March 19, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share