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Working towards true representation: Increasing Hispanic participation in a clinical research trial for depression. Vivianne R. Aponte Rivera, MD Emory University Department of Psychiatry and Behavioral Sciences. Objectives.
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Working towards true representation: Increasing Hispanic participation in a clinical research trial for depression Vivianne R. Aponte Rivera, MD Emory University Department of Psychiatry and Behavioral Sciences
Objectives • Understand the demographic characteristics of patients attending an exclusively Hispanic psychiatric (depression) research clinic • Understand how clinical research studies can help decrease health disparities
The Emory PReDICT study • 600 patient, NIH-funded study of Major Depressive Disorder • Aim: identify predictors of response to treatment in treatment naïve patients • 12 week study • Random assignment • Medication (Escitalopram or Duloxetine) • Cognitive Behavioral Therapy (CBT) • Extension study • Treatment up to 2 years from date of randomization • Evaluate factors leading to relapse or sustained remission/response
The Emory PReDICT Study • Predictive factors assessed • Demographic and clinical factors • Functional Magnetic resonance imaging (fMRI) • Genetics • Hypothalamus-Pituitary-Adrenal Axis (HPA axis) activity • Immune and inflammatory markers • Personality • Early life trauma • Primary site is located in a specialized clinical research unit at Emory University in the suburbs of Atlanta, and is solely for English speaking patients
Clínica Latina para el Tratamiento de la Depresión (CLTD) • Satellite research clinic for the Emory PReDICT study • Located within the International Medical Center (IMC) at Grady Memorial Hospital in Atlanta, GA • One of the largest public health hospitals in the US • IMC: health clinic for limited English proficient patients • Most patients are Spanish speaking • Bilingual and bicultural staff
Clínica Latina para el Tratamiento de la Depresión • Fully established 18 months ago • Part-time clinic • 1,291 Hispanics have called expressing interest in the study • Psychoeducation and referrals provided for those who do not qualify • 146 screening evaluations performed • 42 patients randomized
Clínica Latina para el Tratamiento de la Depresión • Research staff works at primary research site when CLTD is closed • Greater staff to patient ratio • Patient navigators • Offices in IMC exclusively reserved for the research team when CLTD is open • Patients first sign a consent to undergo a clinical interview/evaluation • If eligible, they are then offered the PReDICT study specific consent
Informed consent process questions • Concerns about documentation/legal aspects • Concerns about confidentiality • Requests for further clarification of protocol and study related procedures • Concerns about medications and study procedures • “Guinea pig”, medication side effects
CLTD Demographics:146 patients evaluated • Average age (years old): • 37.75 ± 9.65 (SD) • Ages ranged from 18-66 y/o • Average number of years in the USA: • 11.22 ± 7.65 (SD) • Ranged from 1 to 40 years
Show and Retention Rates • No show rates for screening visit • CLTD: 50/239 (20.9%) • Main clinic: 420/1475 (28.5%) • Retention Rates • CLTD: 29/42 (69%) • Main clinic: 122/163 (74.8%)
Final remarks • Adding bilingual and bicultural research clinics to ongoing or new depression research studies • Increases diversity in the study population • Leads to treatment recommendations that take ethnicity into account • Biologically • Socioculturally • Leads to more specific and effective interventions • Provides treatment to an underserved population • Increases awareness about mental health and depression within the Hispanic community and helps decrease stigma