METRIC: Measurement, Education and Tracking in Integrated Care

May 17, 2023 updated by: The University of Texas at Arlington

METRIC: Measurement, Education and Tracking in Integrated Care: Strategies to Increase Patient Engagement and Reduce Mental Health Disparities Among Hispanics

The proposed study seeks to establish the feasibility of universal screening for depression in an adult primary care safety net setting, measure the effectiveness of a culturally appropriate depression education intervention to reduce stigma and increase uptake in depression treatment among Hispanics, and implement a Measurement-Based Integrated Care (MBIC) model with collaborative, multi-disciplinary treatment and culturally tailored care management strategies.

Study Overview

Detailed Description

Specific Aim 1: Examine the specific effects of a Depression Education Fotonovela (DEF) to increase knowledge of depression, reduce stigma and increase engagement in depression treatment among Hispanic patients.

Specific Aim 2: Evaluate the impact of Measurement-Based Integrated Care (MBIC) for the treatment of depression in one community-based Federally Qualified Health Centers (FQHC) in North Texas whose patient population is majority Hispanic.

Specific Aim 3: Examine the feasibility of universal screening and accurate detection of depression among adult primary care patients utilizing innovative iPad Depression Screening technology.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult primary care patients
  • Hispanic
  • Meets diagnostic criteria for depression

Exclusion Criteria:

  • currently in treatment for depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MBIC + DEF
Measurement-Based Integrated Care with Depression Education Fotonovela
Measurement-Based Integrated Care (MBIC) synthesizes the science of integrated health care and incorporates the strategies of measurement-based care. concept of MBIC for the treatment of depression includes: systematic assessment of symptoms, antidepressant treatment side effects and medication adherence and incorporation of a Depression Care Manager (DCM) to track patients and keep them engaged in care using behavioral interventions
Depression education that uses a unique, culturally adapted depression fotonovela titled "Secret Feelings" developed by Cabassa, Molina and Baron (2012). The fotonovela is a popular comic-book style pamphlet that portrays a dramatic story using photographs and dialogue bubbles, which has become an effective tool for engaging Hispanic audiences and increasing knowledge about specific health issues
Experimental: MBIC + SE
Measurement-Based Integrated Care + Standard Education
Measurement-Based Integrated Care (MBIC) synthesizes the science of integrated health care and incorporates the strategies of measurement-based care. concept of MBIC for the treatment of depression includes: systematic assessment of symptoms, antidepressant treatment side effects and medication adherence and incorporation of a Depression Care Manager (DCM) to track patients and keep them engaged in care using behavioral interventions
The the use of a pamphlet to educate people about depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants who engage in depression treatment
Time Frame: baseline to one month post education session
baseline to one month post education session
Change in PHQ-9 (depressive symptoms) scores
Time Frame: baseline compared to one year post enrollment
baseline compared to one year post enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of primary care patients screened for depression using the iPad technology
Time Frame: two year participant enrollment period
two year participant enrollment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Katherine Sanchez, PhD, University of Texas at Arlington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

January 15, 2019

Study Completion (Actual)

January 15, 2019

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R15MD010220-01 (U.S. NIH Grant/Contract)
  • R15MD010220 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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