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

NCT03591107 | Completed Results DMC

• 1 other identifier: 1R34MH111860
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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, Louisiana. We will randomize 40 patients to either a Posttraumatic Stress Disorder (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.

Conditions

PTSD

Outcome Measures

Primary Outcomes (4)

• PCL-5 Symptom Score

  total count of 20 PTSD symptom ratings on the 0-4 PTSD Checklist for DSM-5 (PCL-5), range = 0=80, higher scores mean a worse outcome

  0 months

• Provisional PTSD Diagnosis

  count/percent of patients with a provisional diagnosis of PTSD (exceeded a cutoff of 32 and endorsed the required symptoms in each cluster as "Moderately" or higher in frequency following the DSM-5 diagnostic rule)

  0 months

• PCL-5 Symptom Score

  total count of PTSD symptom scores on the 0-4 PTSD Checklist for DSM-5 (PCL-5), range = 0=80, higher scores mean a worse outcome

  approximately 9 months

• Provisional PTSD Diagnosis

  count/percent of patients with a provisional diagnosis of PTSD (exceeded a cutoff of 32 and endorsed the required symptoms in each cluster as "Moderately" or higher in frequency following the DSM-5 diagnostic rule)

  approximately 9 months

Study Arms (2)

PTSD Care Management (PCM)

EXPERIMENTAL

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)

Minimally Enhanced Usual Care (MEU)

ACTIVE COMPARATOR

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)

Interventions

PTSD Care Management (PCM) OTHER

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

PTSD Care Management (PCM)

Minimally Enhanced Usual Care (MEU) OTHER

Education and feedback alone

Minimally Enhanced Usual Care (MEU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• RAND: lead
• Louisiana Public Health Institute: collaborator

Study Sites (1)

EXCELth Family Health and Dental 70127New Orleans East

New Orleans, Louisiana, 70127, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

This pilot study was limited to a single clinic and may only generalize to settings that serve African Americans in New Orleans. The small sample size limits statistical conclusion validity, but patients were randomized to each arm so that internal validity was retained.

Results Point of Contact

• Title: Lisa Meredith, Senior Behavioral Scientist
• Organization: RAND

seidel@rand.org

310.393.0411

Study Officials

• Lisa S Meredith, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Behavioral Scientist

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 18, 2018
• Study Start: October 12, 2018
• Primary Completion: July 2, 2019
• Study Completion: March 30, 2020
• Last Updated: December 2, 2022
• Results First Posted: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)