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Trauma-informed Collaborative Care for Low-income African Americans With PTSD

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ClinicalTrials.gov Identifier: NCT03591107
Recruitment Status : Completed
First Posted : July 18, 2018
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Louisiana Public Health Institute
Information provided by (Responsible Party):
Lisa Meredith, RAND

Brief Summary:
The purpose of this study is to optimize, culturally adapt, implement, and pilot test a trauma-informed collaborative care intervention for low-income African Americans who receive care in Federally Qualified Health Centers (FQHCs) in New Orleans, LA. We will randomize 40 patients to either a PTSD collaborative care intervention or to an enhanced usual care control and will evaluate the effectiveness of the intervention (including whether outcome expectancy, coping efficacy, and trust mediate the impact of the intervention) as well as its feasibility, tolerability, and acceptability.

Condition or disease Intervention/treatment Phase
PTSD Other: PTSD Care Management (PCM) Other: Minimally Enhanced Usual Care (MEU) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Recruitment Coordinators/Data Collectors will only recruit at one of the two sites. The baseline assessment will be conducted prior to random assignment. After the assessment, they will be aware of study assignment which is necessary for connecting patients assigned to the PCM arm to connect patients to the Care Manager. However, they will only conduct 6-month assessments with patients from the "other" site and therefore will not be aware of the assignments for those patients.
Primary Purpose: Health Services Research
Official Title: Trauma-informed Collaborative Care for Low-income African Americans With PTSD
Actual Study Start Date : October 12, 2018
Actual Primary Completion Date : July 2, 2019
Actual Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PTSD Care Management (PCM)
In addition to the education and feedback components for both conditions the PCM intervention provides access to a trained Care Manager (CM) who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist.
Other: PTSD Care Management (PCM)
Collaborative care for PTSD facilitated by a trained CM who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist in addition to education and feedback

Active Comparator: Minimally Enhanced Usual Care (MEU)
The MEU condition will consist of only clinician education, patient education (Information Sheet) and feedback about having a probably diagnosis of PTSD to both the clinician and patient.
Other: Minimally Enhanced Usual Care (MEU)
Education and feedback alone




Primary Outcome Measures :
  1. PTSD Checklist for DSM5 [ Time Frame: 0 months ]
    Probable current diagnosis and symptoms of PTSD

  2. PTSD Checklist for DSM5 [ Time Frame: 6 months ]
    Probable current diagnosis an symptoms of PTSD



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a scheduled or walk-in appointment with a primary care provider at the clinic
  • Age 18 or over
  • Self-identify as African American
  • Consider clinic their usual source of care
  • No physical or cognitive disabilities that would preclude completing assessments

Exclusion Criteria:

  • Does not screen positive for probable PTSD on the PCL-5

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591107


Locations
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United States, Louisiana
EXCELth Family Health and Dental 70127New Orleans East
New Orleans, Louisiana, United States, 70127
Sponsors and Collaborators
RAND
Louisiana Public Health Institute
Investigators
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Principal Investigator: Lisa S Meredith, PhD RAND
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Responsible Party: Lisa Meredith, Senior Behavioral Scientist, RAND
ClinicalTrials.gov Identifier: NCT03591107    
Other Study ID Numbers: 1R34MH111860 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No