Trauma-informed Collaborative Care for Low-income African Americans With Posttraumatic Stress Disorder (PTSD)
Phase: NA
Conditions: PTSD
Sponsor: RAND

 
1 
Trauma-Informed Collaborative Care for African American Primary Care Patients in 
Federally Qualified Health Centers: A Pilot Randomized Trial 
 
Study Protocol and Statistical Analysis Plan 
 
Trial registration: (Clinicaltrials.gov NCT03591107) 
September 15, 2017 
 

 
2 
 
 
 
 

 
3 
METHODS 
Design 
ViStA-NOLA was a pragmatic pilot patient-level randomized controlled trial to 
compare the effectiveness of our adapted and tailored TICC intervention with enhanced 
usual care (EUC).24 The RAND Institutional Review Board approved the study protocol. 
Adaptation and Tailoring. We used a two-step approach in developing the 
study intervention to increase engagement in and adherence with collaborative care. 
First, we addressed both the challenges that the research team identified in 
implementing ViStA and the recommendations from selected patients and clinic staff 
interviewed at the end of that study to elicit practical feedback about how to make our 
collaborative care intervention more pragmatic, feasible, and acceptable. We hired and 
incentivized a CM from the clinic rather than hiring a CM from outside the clinic to better 
integrate into the clinic’s flow. We also connected intervention patients with the CM on 
the same day or within two days using a warm handoff (e.g., in-person if available or 
using a handout with the CM’s picture and contact information). To reduce patient 
burden and because a more frequent CM contact schedule was not feasible in the 
previous ViStA study, we shortened the duration of the intervention from 12 to nine 
months. Accordingly, we cut the number of CM contacts with patients from 15 to eight 
contacts. Because patients reported undue burden of being reassessed so often with 
many items, we used a briefer symptom assessment for measurement-based care. We 
provided 1.5 days of formal training on motivational interviewing (compared with just a 
brief 2-hour module previously). And we involved representatives from a local social 

 
4 
service organization to facilitate CM referrals to address social determinants of health 
needs rather than simply providing the patient with a list of resources. 
We also used a community-partnered approach for tailoring the intervention to 
the local context and population. We formed a study workgroup comprised of multiple 
stakeholders (primary care providers (PCPs), behavioral health providers (BHPs), clinic 
managers, the CM, patient representatives, public health and community service 
representatives). Our goal was to target barriers that disproportionately impact African 
Americans, including financial hardship, chronic exposure to violence, negative beliefs 
about psychotropic medication,4 trust in health care providers and institutions,25-31 and 
the community-wide trauma experienced in this Hurricane ravaged area and associated 
flooding.32 
Some of the suggestions from the community stakeholder workgroup were to use 
images reflective of the population, to gear intervention materials toward a 7th-grade 
reading level, and for the CM to use text messaging to communicate with providers. The 
group emphasized the importance of trust in providers and of providing hope and 
meaning given the suffering for many years since Hurricane Katrina. We incorporated 
all of these lessons and feedback to optimize the intervention protocol (training 
materials, guides, manuals, etc.) and to make it less burdensome. 
Enhanced Usual Care (EUC). The EUC arm of the randomized study consisted 
of educating all primary care clinic staff about PTSD and trauma-informed care. Prior to 
implementing the intervention, we delivered a 2-hour training onsite at the FQHC. We 
also trained FQHC physicians on evidence-based medication for PTSD based on the 
National Institute for Clinical Excellence guidelines33 and provided them with a 

 
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medication decision aid. In addition, we informed PCPs about patient’s study eligibility 
and enrollment which indicated that the patient met criteria for having probable PTSD. 
We provided patients who were identified as having probable PTSD an information 
sheet adapted from patient education resources from the National Institute of Mental 
Health and the International Society for Traumatic Stress Studies. 
Trauma-Informed collaborative care (TICC). The TICC intervention included all 
of the EUC components plus components facilitated by the study-trained CM, initially a 
medical assistant, replaced by a nurse care manager over the last several months of 
the study. These additional components involved active patient education and 
engagement using the PTSD handout and motivational interviewing techniques.4 CMs 
also facilitated linkages to community resources with locally tailored information. CMs 
had structured cross-disciplinary communication with PCPs and mental health providers 
(if relevant), plus monthly meetings with the study behavioral health consultant to guide 
clinical care decisions. CMs facilitated measurement-based care (using the Short PTSD 
Rating Interview/SPRINT)34, 35 through an initial in-person visit complemented by a 
series of seven follow-up contacts by telephone to monitor care over nine months. CMs 
also received ongoing phone supervision as needed (~once/month).  
Setting and Participants 
Researchers from RAND and the Louisiana Public Health Institute (LPHI) 
partnered with a large FQHC in New Orleans, Louisiana. Primary care patients 
participated in an intervention and interviews, and clinic staff in primary care participated 
in stakeholder meetings and exit interviews as described in the following sections. 

 
6 
Recruitment Procedures. We completed patient recruitment across 70 days 
over the course of nine months from October 12, 2018 to July 2, 2019. Patients were 
approached in the primary care waiting area and if they met inclusion criteria (age 18 or 
older, self-identified as African American, considered the clinic their usual source of 
care). They were asked to complete a brief PTSD symptom checklist (the PC-PTSD-
5),36 followed by a longer PTSD assessment with the PTSD checklist for version five of 
the Diagnostic Statistical Manual (PCL-537). If patients were at-risk for PTSD, they were 
invited to enroll in the study and asked for informed consent. Study staff completed a 
baseline assessment either in the clinic or by telephone prior to randomization to study 
condition. A total of 42 adult patients were enrolled in the study. 
Assessments. Patients were evaluated at baseline and nine months via in-
person or telephone by interviewers blinded to the study assignment. Our primary 
outcome was PSTD symptoms based on the PCL-5. 
We also examined three types of potential mediating variables to determine 
whether they might explain the relationship between the intervention and PTSD 
symptom reduction. We assessed outcome expectancy with a single question, “My 
PTSD symptoms can be successfully treated?” using a 5-point Likert rating scale.38 We 
assessed coping efficacy with a single item also adapted from CALM – “I will be able to 
do what is necessary to make treatment of my PTSD symptoms successful?” using a 5-
point Likert rating scale.38 We assessed trust in health care provider with the 8-item trust 
subscale of the Primary Care Assessment Survey.39 This measure uses a 5-point Likert 
scale to rate trust domains of integrity, agency, and competence and is correlated with 
measures of physician communication (r=.75) and interpersonal care (r=.73), and has 

 
7 
strong internal consistency reliability (α=.86). Sample items include, “I trust my doctor’s 
judgments about my medical care” and “I trust my doctor to tell me if a mistake was 
made about my treatment.” 
Statistical Analysis. This pilot trial had planned a modest sample size of 40 and 
assumed a 20% attrition (n=32), which was powered to detect a large effect size of 1.0 
standard deviation for a continuous outcome and about 45 percentage points difference 
in the mean of a binary outcome. The initial sample size at baseline was 42 when the 
recruitment was finished. However, one patient was double counted in both arms and 
subsequentially excluded from the analysis, and one patient dropped out before 
completing the baseline, leaving a sample size of 40 at baseline (21 in EUC and 19 in 
TICC). Attrition from study enrollment to baseline interview completion was 10%, 
yielding a sample of 36 completers at 9-month follow-up (20 in EUC and 16 in TICC).  
Per the study protocol, we ran an intent-to-treat (ITT) analysis based on initial 
randomization and ignoring the actual treatment exposure. The primary outcome and all 
mediators were tested at both waves separately. We applied nonparametric Wilcoxon 
two-sample tests for numerical outcomes and Fisher’s exact test for categorical 
outcomes as our main approach. The usual two-sample t-tests and chi-square tests 
were also performed as sensitivity checks. Difference-in-differences analysis were 
performed for outcomes which had significant differences in the follow-up wave. Since 
no mediators showed a significant difference at follow-up, we did not perform further 
structural equation modeling analysis for potential moderation pathways. All analyses 
were performed in SAS 9. 
 

 
8 
REFERENCES 
 
24. Liebschutz J, Saitz R, Brower V, et al. PTSD in urban primary care: High prevalence 
and low physician recognition. Journal of general internal medicine. Jun 
2007;22(6):719-726. doi:10.1007/s11606-007-0161-0 
25. Boulware LE, Cooper LA, Ratner LE, LaVeist TA, Powe NR. Race and trust in the 
health care system. Public Health Rep. Jul-Aug 2003;118(4):358-365. doi:Doi 
10.1016/S0033-3549(04)50262-5 
26. Brandon DT, Isaac LA, LaVeist TA. The legacy of Tuskegee and trust in medical 
care: is Tuskegee responsible for race differences in mistrust of medical care? 
Journal of the National Medical Association. 2005;97(7):951.  
27. Doescher MP, Saver BG, Franks P, Fiscella K. Racial and ethnic disparities in 
perceptions of physician style and trust. Arch Fam Med. Nov-Dec 2000;9(10):1156-
1163. doi:DOI 10.1001/archfami.9.10.1156 
28. Guffey T, Yang PQ. Trust in Doctors. SAGE Open. 2012;2(4):2158244012466092.  
29. Jacobs EA, Rolle I, Ferrans CE, Whitaker EE, Warnecke RB. Understanding African 
Americans' views of the trustworthiness of physicians. Journal of general internal 
medicine. 2006;21(6):642-647.  
30. King WD. Examining African Americans' mistrust of the health care system: 
expanding the research question. Commentary on "Race and trust in the health care 
system". Public Health Rep. Jul-Aug 2003;118(4):366-7.  

 
9 
31. Kennedy BR, Mathis CC, Woods AK. African Americans and their distrust of the 
health care system: healthcare for diverse populations. Journal of cultural diversity. 
2007;14(2) 
32. Galea S, Brewin CR, Gruber M, et al. Exposure to hurricane-related stressors and 
mental illness after Hurricane Katrina. Archives of general psychiatry. 
2007;64(12):1427-1434.  
33. National Institute for Clinical Excellence. Post-traumatic stress disorder (PTSD): The 
management of PTSD in adults and children in primary and secondary care. Clinical 
Guidelines, 26, from http://wwwniceorguk/guidance/cg26. 2005; 
34. Connor KM, Davidson JR. SPRINT: a brief global assessment of post-traumatic 
stress disorder. Int Clin Psychopharmacol. Sep 2001;16(5):279-84.  
35. Vaishnavi S, Payne V, Connor K, Davidson JRT. A comparison of the SPRINT and 
CAPS assessment scales for posttraumatic stress disorder. Depression and Anxiety. 
2006;23(7):437-440. doi:https://doi.org/10.1002/da.20202 
36. Prins A, Bovin MJ, Smolenski DJ, et al. The Primary Care PTSD Screen for DSM-5 
(PC-PTSD-5): Development and Evaluation Within a Veteran Primary Care Sample. 
Journal of general internal medicine. Oct 2016;31(10):1206-1211. 
doi:10.1007/s11606-016-3703-5 
37. Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP. The PTSD 
Checklist for DSM-5 (PCL-5). PTSD: National Center for PTSD. Available at: 
https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp; 2013. 
38. Jakubovski E, Bloch MH. Anxiety Disorder-Specific Predictors of Treatment 
Outcome in the Coordinated Anxiety Learning and Management (CALM) Trial. The 

 
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Psychiatric quarterly. Nov 12 2015;(November 2015):1-20. doi:10.1007/s11126-015-
9399-6 
39. Safran DG, Kosinski M, Tarlov AR, et al. The primary care assessment surrey - 
Tests of data quality and measurement performance. Medical care. May 
1998;36(5):728-739. doi:Doi 10.1097/00005650-199805000-00012 
40. Fortney JC, Heagerty PJ, Bauer AM, et al. Study to promote innovation in rural 
integrated telepsychiatry (SPIRIT): Rationale and design of a randomized 
comparative effectiveness trial of managing complex psychiatric disorders in rural 
primary care clinics. Contemporary Clinical Trials. 2020/03/01/ 2020;90:105873. 
doi:https://doi.org/10.1016/j.cct.2019.105873 
 
 
 

 
11 
 
Table 1. Baseline Patient Demographic Characteristics and Primary Outcomes 
 
No. (%) of patients 
Characteristics 
Full Sample 
(N = 40) 
EUC 
(N = 21) 
TICC  
(N = 19) 
Demographics 
  
  
  
Women 
32 (80.0) 
16 (76.2) 
16 (84.2) 
Education* 
 
 
 
< high school  
12 (30.0) 
10 (47.6) 
2 (10.5) 
High school graduate/ GED 
17 (42.5) 
9 (42.9) 
8 (42.1) 
College degree or graduate 
11 (27.5) 
2 (9.5) 
9 (47.4) 
Marital status 
  
 
 
Single 
23 (57.5) 
10 (47.6) 
13 (68.4) 
Married 
3 (7.5) 
2 (9.5) 
1 (5.3) 
Unmarried couple 
1 (2.5) 
1 (4.8) 
0 (0) 
Separated/divorced/ widowed 
13 (32.5) 
8 (38.1) 
5 (26.3) 
Type of medical insurance 
  
 
 
Medicaid 
33 (82.5) 
18 (85.7) 
15 (78.9) 
Medicare 
3 (7.5) 
1 ( 4.8) 
2 (10.5) 
Employer/private 
2 (5.0) 
1 (4.8) 
1 (5.3) 
Other (Medicaid and Medicare) 
1 (2.5) 
1 (4.8) 
0 (0) 
No insurance 
1 (2.5) 
0 (0) 
1 (5.3) 
Born in the US 
39 (97.5) 
21 (100) 
18 (94.7) 
Years lived in the US 
42.75 (12.3) 
45.38 (12.5) 
39.84 (11.6) 
Outcomes 
  
  
  
PCL-5 score, mean (SD) (primary) 
73.12 (13.9) 
72.95 (14.3) 
73.32 (13.7) 
PHQ-9 score, mean (SD) (secondary) 
17.35 (4.8) 
16.76 (5.0) 
18.00 (4.7) 
*p<.05 
 
 
 

 
12 
Table 2. Baseline Target Mechanisms, Health Comorbidity, and Health Care 
Characteristics  
 
No. (%) of patients 
Characteristics 
Full Sample 
(N = 40) 
EUC 
(N = 21) 
TICC  
(N = 19) 
Target Mechanisms 
  
  
  
Outcome expectancy, mean (SD) 
3.83 (1.1) 
3.86 (1.1) 
3.79 (1.0) 
Coping Efficacy, mean (SD) 
4.42 (0.8) 
4.29 (0.9) 
4.58 (0.6) 
Trust in health care provider, mean (SD) 
19.12 (1.4) 
19.24 (1.2) 
19.00 (1.6) 
Health Comorbidity* 
Depression 
11 (26) 
5 (24) 
6 (29) 
Psychoses* 
4 (10) 
4 (19) 
0 (0) 
Drug use 
0 (0) 
0 (0) 
0 (0) 
Alcohol use 
1 (2) 
1 (5) 
0 (0) 
Heart conditions 
1 (2) 
1 (5) 
0 (0) 
Diabetes 
12 (29) 
6 (29) 
6 (29) 
Hypertension 
3 (7) 
1 (5) 
2 (10) 
Cancer 
0 (0) 
0 (0) 
0 (0) 
Neurological disorders 
1 (2) 
0 (0) 
0 (0) 
Health Care 
  
  
  
Nervous, emotional, drug or alcohol problem in 
past 6 months 
20 (50.0) 
11 (52.4) 
9 (47.4) 
Think need to talk to professional about problems 
33 (82.5) 
17 (81.0) 
16 (84.2) 
Number of visits to general physician, mean (SD) 
5.36 (4.5) 
5.81 (4.7) 
4.83 (4.3) 
Number of visits mental health issues were 
discussed, mean (SD) 
4.23 (4.0) 
4.48 (3.7) 
3.94 (4.5) 
Received prescription medication for mental 
health 
28 (71.8) 
15 (71.4) 
13 (72.2) 
Received referral for mental health problem 
28 (71.8) 
16 (76.2) 
12 (66.7) 
Number of visits with mental health/substance 
use provider, mean (SD) 
4.82 (8.0) 
3.57 (4.8) 
6.21 (10.5) 
Number of visits where advice about medication, 
mean (SD) 
2.88 (2.9) 
3.69 (3.5) 
1.91 (1.6) 
Number of visits with counseling/ talk therapy, 
mean (SD) 
7.42 (8.6) 
5.15 (4.7) 
10.09 (11.3) 
Number of counseling visits, mean (SD) 
7.40 (8.6) 
5.15 (4.7) 
10.09 (11.3) 
Number of visits with psychiatrist, mean (SD) 
3.12 (5.9) 
3.23 (4.8) 
3.00   (7.2) 
Received prescription from psychiatrist 
16 (69.6) 
8 (61.5) 
8 (80.0) 
Attended self-help/ family support groups for 
mental health 
4 (10.3) 
2 (10.0) 
2 (10.5) 
Number of days in self-help/ family support group 
for mental health, mean (SD) 
6.25 (9.2) 
1.50 (0.7) 
11 (12.73) 
*p<.05; Comorbidity measures were derived from ICD-9 codes. 
 

 
13 
Figure 1. Study Flow Diagram 
 
555 Patients approached 
6 referred from providers 
184 (33%) Met inclusion 
criteria 
433 (77%) Excluded 
36 Not 18-65 years old 
18 Not African American 
82 Not usual source of care 
85 No traumatic event 
198 Refused to participate 
10 Called in to see PCP 
(Incomplete) 
4 Incomplete 
7 (4%) Excluded 
7 Called in to see PCP 
177 (96%) Took brief 5-
item PTSD screener 
104 (59%) Screened 
positive for PTSD 
73 (41%) Excluded 
73 Screened negative for PTSD 
symptoms 
15 (14%) Excluded 
13 Called in to see PCP 
(incomplete) 
2 Refused full PCL-5 
89 (86%) Took longer PCL-
5 assessment 
42 (47%) Screened positive 
for provisional PTSD 
diagnosis and consented 
for study participation 
21 (50%) Randomized to 
Trauma-Informed 
Collaborative Care (TICC) 
Intervention condition 
and completed baseline 
interview 
21 (50%) Randomized to  
Enhanced Usual Care 
(EUC) condition 
and completed baseline 
interview 
47 (53%) Excluded 
23 Screened negative for 
provisional PTSD diagnosis 
9 Called in to see PCP 
15 Refused consent 
5 (24%) Withdrawn 
1 Discharged from clinic  
2 Sought care at other clinics 
1 Same patient in both arms 
1 Dropped out from study 
1 (5%) Withdrawn 
1 Same patient in 
both arms 
20 (95%) Completed 
 9-month Follow up  
16 (76%) Completed  
9-month Follow up  
42 
Randomized 

 
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Figure 2. PCL-5 Scores at Baseline and 9-Month Follow-Up 
  
 
73
47.3
73.3
37.1
0
10
20
30
40
50
60
70
80
Baseline
9-Month Follow-up
PCL-5 Scores
EUC
TICC