Stepped Collaborative Care versus American College of Surgeons Committee on Trauma Required Screening and Referral for Posttraumatic Stress Disorder: Clinical Trial Protocol

Abstract

Background:

Each year in the US, approximately 1.5–2.5 million individuals are so severely injured that they require inpatient hospital admissions. The American College of Surgeons Committee on Trauma (College) now requires that trauma centers have in place protocols to identify and refer hospitalized patients at risk for injury psychological sequelae. Literature review revealed no investigations that have identified optimal screening, intervention, and referral procedures in the wake of the College requirement.

Methods:

The single-site pragmatic trial investigation will individually randomize 424 patients (212 intervention and 212 control) to a brief stepped care intervention versus College required mental health screening and referral control conditions. Blinded follow-up interviews at 1-, 3-, 6,- and 12-months post-injury will assess the symptoms of PTSD and related comorbidity for all patients. The emergency department information exchange (EDIE) will be used to capture population-level automated emergency department and inpatient utilization data for the intent-to-treat sample. The investigation aims to test the primary hypotheses that intervention patients will demonstrate significant reductions in PTSD symptoms and emergency department/inpatient utilization when compared to control patients. The study incorporates a Rapid Assessment Procedure-Informed Clinical Ethnography (RAPICE) implementation process assessment.

Conclusions:

The overarching goal of the investigation is to advance the sustainable delivery of high-quality trauma center mental health screening, intervention, and referral procedures for diverse injury survivors. An end-of-study policy summit will harness pragmatic trial data to inform the capacity for US trauma centers to implement high-quality acute care mental health screening, intervention and referral services for diverse injured patient populations.

1. BACKGROUND

Life-threatening traumatic exposures are endemic in the US and constitute a substantial source of individual suffering and a significant public health burden; national US events, including the COVID-19 pandemic and associated firearm proliferation are associated with individual and mass traumatic exposures that risk the development of posttraumatic stress disorder (PTSD) and associated comorbidity.^1–6 The impact of these developments on patients reinforces the need to improve mental health screening, intervention, and referral procedures for trauma survivors presenting to acute care medical settings.^1,2 Nationwide, acute care medical settings provide initial health services and care linkages for patients in the wake of life-threatening traumatic injury exposures.^7–9 Trauma centers are hospitals that meet national standards established by the American College of Surgeons Committee on Trauma (College) for the optimal care of the most severely injured patients.^7–9

Each year in the US, over 30 million individuals present to acute care medical settings after injury, and approximately 1.5–2.5 million individuals are so severely injured that they require inpatient hospital admissions.^10–12 Between 20–40% of hospitalized injury survivors go on to develop symptoms consistent with PTSD and related comorbidity.^13–16 PTSD appears to be endemic among injured trauma survivors, occurring acutely after a single injury and chronically after a cumulative burden of multiple recurrent traumatic exposures.^17,18 In traumatically injured patients, multiple disorders are comorbid with PTSD, including depression and associated suicidal ideation, as well as co-occurring alcohol, opioid, and stimulant use problems.^14,19–21 After injury, PTSD and related comorbidity are associated with a broad profile of functional impairments and costs.^{11,12,22–24}

Trauma center patients often receive fragmented, uncoordinated services in the transition from acute care to primary care and community settings.^25–27 Quality of care improvements in trauma care systems could address issues of care coordination between hospitalization and primary care/community services.^25–27

Stepped care approaches that combine effective intervention elements and incorporate information technology (IT) innovations have the potential to enhance screening, intervention, and referral services for patients presenting to acute care medical settings after life-threatening exposures (Figure 1). Acute care stepped approaches derive from collaborative care intervention models.^28–31 Stepped measurement-based care interventions for injured patients with PTSD repeatedly measure PTSD symptoms and make available higher-intensity care for patients who do not respond to initial lower-intensity treatments. Collaborative care is a comprehensive disease management strategy that combines proactive care management, pharmacotherapy, and behavioral intervention elements embedded within care management. A large body of literature has established the effectiveness of collaborative care interventions in primary care settings for patients with anxiety and depression.^28,29

Figure 1.

Stepped Care Pragmatic Trial Elements and Outcomes.

A series of investigations now document that brief stepped care interventions that derive from the collaborative care model to combine proactive care management, psychotherapeutic elements, and evidence-based medications can effectively target PTSD and related comorbidity for injured trauma survivors presenting to acute care settings (Figure 1).^30–33 Recent commentary encourages the broad uptake of brief stepped care interventions targeting PTSD and comorbidity for US trauma care systems.³⁴ Technological innovations, such as the EDIE, have the potential to enhance trauma care system clinical trial follow-up by replacing self-report outcomes with population-based automated data.^35,36

Over the past two decades, the study team has established a deployment-focused stakeholder partnership with the College, allowing the results of single and multisite pragmatic trials to be directly disseminated through College policy for US acute care trauma centers.^{7–9,33,37,38} The College oversees the development of national policy requirements and clinical best practice guidelines that inform the integrated operation of US trauma centers and affiliated trauma care systems. The College maintains/updates a Resources Guide with specific criterion for trauma center operation; every three years, the College performs trauma center verification site visits to ensure sites are delivering care that is concordant with Resources Guide quality specifications.

In the wake of the study team’s 25-site UH3 trial, the College is requiring that trauma centers implement protocols to identify patients at high risk for psychological sequelae after traumatic injury, as well as a referral process for patients who have been identified as high-risk; this includes protocols that screen and refer patients for PTSD and related comorbid conditions (e.g., depression).^9,33 While this requirement constitutes a landmark policy decision for patients with injury-related PTSD and comorbidity, additional pragmatic trial data has the potential to inform expanded College requirements, guidelines, and verification site visit criteria.

The investigation’s primary aim is to determine if injured patients receiving the stepped care intervention demonstrate significant reductions in PTSD symptoms and emergency department/inpatient visits compared to control patients receiving College required screening and referral. A secondary aim of the investigation is to explore mediators and moderators of intervention treatment effects that will highlight key College policy targets. A RAPICE-informed implementation process assessment will embed participant observation within frontline study team members rolling out clinical trial procedures, combined with regular data review with the study team’s mixed methods expert consultant. An end-of-study College policy summit will harness pragmatic trial data to inform the capacity for US trauma centers to implement high-quality mental health screening, intervention, and referral services for diverse injured patient populations.

2. METHODS

2a. Design Overview

Over the past two decades, a series of studies have been conducted that inform the design and roll-out of the current investigation.^33,36–39

The TSOS investigation tests optimal stepped care intervention strategies for diverse survivors of intentional (e.g., gunshots, physical assaults) and unintentional (e.g., motor vehicle crashes, falls) injuries presenting to acute care medical settings in the wake of the new College requirement. The single-site pragmatic trial will individually randomize 424 adult patients (212 intervention and 212 control) at risk for the development of PTSD to a brief stepped care intervention versus College required psychological distress screening and referral usual care control conditions (Figure 2).

Figure 2.

Flow through TSOS Protocol.

Patients with high baseline PTSD Checklist scores will be randomized and followed in the longitudinal portion of the investigation. Patients in the control condition will receive the EHR/EDIE and PTSD Checklist screens with trauma team notification of high PTSD symptom levels suggesting the need for referral. Patients in the intervention condition will receive a brief stepped care intervention targeting PTSD and related comorbidities that will be delivered over the course of the first six months post-injury. The primary intent-to-treat outcome analyses will use PTSD Checklist data from the 1-, 3-, 6-, and 12-month post-injury patient interviews, as well as automated emergency department/inpatient visit EDIE data that accrues over the course of the 12 months post-injury. All study procedures have been approved by the University of Washington Institutional Review Board and recruitment for the trial has begun.

2b. Patient Subject Eligibility, Recruitment, and Follow-up (Figure 2).

English and Spanish-speaking survivors of intentional and unintentional injury, ages ≥ 18, will be assessed for study participation. The investigation will recruit injured patients who have been admitted to the hospital and who are being evaluated in the emergency department. Patients included in the investigation will be individuals residing in the Western United States of Washington, Oregon, Alaska, California, Nevada, Montana, Idaho, Utah, and New Mexico. Patient identification and recruitment procedures described below have been successfully implemented in prior study team investigations. Research study staff will identify potential patient subjects who meet the criteria of having ≥ 3 PTSD risk factor domains positive.⁴⁰ The 10 PTSD risk factors derived from EHR domains are female gender, non-White race and/or Hispanic ethnicity, public insurance, any ICU stay, blood alcohol positive, or any substance disorder, any psychiatric disorder, diagnosed PTSD, tobacco use, intentional injury, and any prior hospitalization. Consenting patients will be screened with a blended version of the PTSD Checklist that allows for a comprehensive assessment of both the DSM-IV and DSM-5 PTSD symptomatic criteria.^40–45 Patients scoring either ≥ 30 on the DSM-5 version or ≥ 35 on the DSM-IV version of the PTSD Checklist will be randomized into the longitudinal portion of the study.

2c. Exclusion Criteria

Injured patients will be excluded if they require immediate psychiatric intervention (e.g., self-inflicted injury, active psychosis, altered mental status) or are currently incarcerated. Once a patient is approached for the investigation, the research study staff will inform the potential patient that in order to maximize the likelihood of interview follow-up, they must be able to provide at least two pieces of contact information that consist of at least one phone number and a second alternate contact (e.g., another phone number, email address).

Patients who do not speak either English-and/or Spanish will be excluded from the protocol. The rationale for exclusion of non-English speaking patients is that prior study team investigation has previously documented over 40 different languages, with only approximately 20% speaking Spanish, at Harborview, making the translation of study documentation impractical for this remarkably diverse target population.^46,47

2d. Randomization

Randomization will occur in a 1:1 ratio. A study biostatistician (Dr. Wang) will use a computer-generated algorithm to randomize patients in blocks of either 4 or 6.

2e. Enhanced College Required Screening and Referral Usual Care Control Condition.

The control patients will receive requirement as usual trauma center care. The College is requiring that trauma centers nationally have in place protocols to screen and refer patients at high risk for the psychological sequelae of traumatic injury, which often includes PTSD.^7–9 The study will contribute to this usual care with the 10-domain EHR/EDIE screen and the PTSD Checklist evaluation. The study team will also inform the trauma surgical team covering the patient’s care of distress they are experiencing as identified by PTSD Checklist scores of either ≥ 30 (DSM-5) or ≥ 35 (DSM-IV). Control patients in the study may receive both an inpatient and outpatient mental health referral.

The study team’s prior investigations suggest that usual post-injury care includes routine surgical, primary care, and emergency department visits, as well as the occasional use of specialty mental health services.^30–33 Population-level emergency department/inpatient utilization for the control group will be assessed ongoing using EDIE.³⁵ Of note, College guidelines allow trauma centers to select from multiple potential evidence-based screening and referral procedures.⁴⁸ A limitation of the investigation is that the selected stepped collaborative care intervention procedure and comparator condition may be different than other procedures being employed by trauma centers nationally in the wake of the College mandate.

2f. Stepped Care Intervention Procedures.

As with control patients, intervention patients will receive EHR/EDIE screening and PTSD Checklist evaluations. Patients in the intervention condition will receive a brief stepped care intervention that includes posttraumatic concern elicitation, proactive care management, medication, and cognitive behavioral psychotherapy elements targeting PTSD and related comorbidity. The psychotherapy elements include problem-solving, psychoeducation, anxiety reduction techniques such as training in progressive muscle relaxation and breathing, attention to experience, and behavioral activation embedded within care management. The intervention components are distilled from manualized procedures derived from the study team’s previous intervention trials and are briefly described below.³³

The care manager will attempt to meet all intervention patients during their trauma center or emergency department stay. During this meeting, the care manager will begin to elicit and target each patient’s posttraumatic concerns for improvement. The care manager will give the patients the study team’s 24-hours per day/7-days per week telephone and text message contact number and encourage texts/calls for spontaneous questions, needs, and concerns. The care coordination component will include a series of intervention elements that have previously improved acute care to primary care and community transitions, with a particular focus on multicultural patient populations.⁴⁹ The care manager will also elicit treatment preferences (e.g., psychotherapy elements only, medication only, combined treatment) for PTSD and comorbidity and may schedule ongoing times to meet/call the patients during the initial days and weeks post-injury. Patients who demonstrate enduring symptoms of PTSD or related comorbidity (e.g., depression) after initial treatment receive “stepped up” care that can include medication adjustments or the addition of new psychotherapeutic elements. Whenever possible, patients’ family members will be integrated into treatment planning and longitudinal care. The delivery of specific elements will be dependent on care manager time allocation and patient intensity of symptoms. In the protocol, care management will occur up to six months after the injury. A final intervention case review will summarize intervention element delivery, timing, and duration.

2g. EDIE Alerts and 24/7 Study Team Cell Phone Coverage.

EDIE connects emergency department care settings by providing historical emergency department utilization information from a large database managed by Collective Medical (CM). EDIE enables emergency department care networks to share information and provides real-time, workflow-integrated electronic alerts by text and/or email that allow team providers to be notified 24 hours a day/7-days per week when patients make recurrent visits to any emergency department in Washington and approximately 30 other states including Oregon, Alaska, California, Nevada, Montana, Idaho, Utah, and New Mexico. As in previous effective care transition interventions conducted by the study team, intervention patients will have 24 hours a day/7-days per week, study team phone and text access.

Before trial recruitment was initiated, study team members received a one-day intervention workshop training delivered by Dr. Zatzick and others. The workshop provided an overview of the key elements of the PTSD and comorbidity intervention that includes core stepped care elements such as population-based registry tracking of patients and stepped measurement-based care targeting PTSD and related comorbidity. After the training, the study team psychiatrist will oversee weekly supervisory “coaching” meetings for the duration of the intervention. Coaching will be facilitated by the study Research Electronic Data Capture (REDCap) hosted intervention data management tool. This computerized data management system will be password protected and accessible to intervention team members on a 24 hours a day/7-days per week basis. Care managers will enter all assessments and treatment contacts into web-based forms. Because information is available in real time, the system can be used by care management supervisors to monitor and support the standardized implementation of the patient-centered care management procedure. These regular meetings are anticipated to occupy 1 hour weekly with some variability that will depend on the number of patients and symptomatic intensity of caseloads. These sessions will include coaching in posttraumatic concern elicitation and psychotherapeutic element delivery, as well as problem-solving surrounding organizational obstacles to PTSD and related comorbidity screening, intervention, and referral. These calls will also include coaching on evidence-based medication prescriptions for PTSD and comorbidity. The timing and duration of intervention activities will be tracked.

While final patient subject follow-up interviews take place approximately 12 months post-consent, activities with intervention patients are anticipated to conclude approximately six months after patients consent into the trial. It is anticipated that the majority of intervention activity will occur in the first six months after the injury, with booster sessions occurring for patients with crises (e.g., EDIE emergency department alerts) intermittently after the 6-month time point.

2h. Blinded Patient Follow-up Interviews.

Patients will be recontacted for blinded follow-up interviews at 1-, 3-, 6-, and 12-months post-injury (Table 1). The study team has developed specific methods to obtain high follow-up rates with this patient population and attained between 75–80% 3–12-month follow-up in the 25-site UH3 trial.³³ In order to enhance follow-up, the study team asks patient subjects for at least two pieces of contact information. In the event that the subject’s contact information changes (a common event after injury admission), the follow-up team may reach out to these alternate contacts in an effort to get back in touch with the subject. Over the 12 months after the injury, the follow-up team may perform scheduling or check-in phone calls with subjects to ensure that the contact information on file is up to date. Senior study investigators will, prior to the initiation of recruitment and follow-up, train research study staff in recruitment and follow-up procedures that derive from prior study team single and multisite pragmatic trial protocols.^30–33

Table 1.

Trauma Survivors Outcomes & Support 8 Study Assessments.

Patient-reported outcome measures
Measures delivered during specified interview time points
Scale	Interviews
	Baseline	1-month	3-month	6-month	12-month
Electronic Medical Record 10 Item PTSD Evaluation40	✓	-	-	-	-
Self-reported demographics33	✓	-	-	-	-
Consciousness/Glasgow Coma Scale50	✓	-	-	-	-
PTSD Symptoms (PTSD Checklist DSM IV/5)51,52	✓	✓	✓	✓	✓
Depressive Symptoms (PHQ-9)53	✓	✓	✓	✓	✓
Suicidal Ideation (CSSRS) 54	✓	✓	✓	✓	✓
Posttraumatic Concerns55	✓	✓	✓	✓	✓
Alcohol (AUDIT)56	✓	✓	✓	✓	✓
Illegal and Prescription Drug Use (Single items)33,57	✓	✓	✓	✓	✓
Pain (McGill Pain Short Form)58	✓	✓	✓	✓	✓
Post-concussive/Somatic Symptoms (NSCOT)59	✓	✓	✓	✓	✓
Functioning (MOS SF12)60	✓	✓	✓	✓	✓
Work, Disability & Legal ADL/IADL (NSCOT)24	✓	✓	✓	✓	✓
Medication, & Psychotherapy Utilization (UH3)24	✓	✓	✓	✓	✓
Satisfaction with Care (NSCOT)31	✓	✓	✓	✓	✓
Medical Comorbidity	-	-	✓	-	-
Pre-Injury Trauma (National Comorbidity Survey)17,61	-	✓	-	-	-
Recurrent Traumatic Events (National Co. Surv.)17,61	-	-	-	-	✓
Reactions to Research Participation (RRPQ)62	✓	✓	✓	✓	✓
WHODAS63	-	-	-	✓	✓
GAD-764	-	-	-	✓	✓
Cross-cutting DSM 5 Symptoms65	-	-	-	✓	✓
EDIE Emergency Department & Inpatient Use35			Ongoing - Automated Data

2i. Data Sources, Instruments, and Assessments.

Table 1 outlines the timing of the EHR, EDIE, and patient-reported outcome assessments that will be utilized during the investigation. All measures listed in Table 3 have established psychometric properties and have been used in prior team acute care medical investigations.⁶⁶ The primary outcome assessments are detailed in Table 1.

2j. Data for Primary Outcome Analyses (Aim 1).

1) PTSD Checklist (PCL-C). A blended version of the PTSD Checklist that comprehensively includes all elements of the DSM IV and DSM-5 PTSD symptomatic criteria will be used to assess PTSD symptoms.^43,51,52 Prior study team investigations have detailed the rationale for the use of the blended DSM IV/DSM 5 PTSD Checklist.⁴³ Briefly, a series of investigations have established the relative psychometric equivalence of the DSM IV and DSM 5 versions of the PTSD Checklists across military and civilian patient populations.^41–44 In acute care medical settings, seminal investigations establishing the PTSD psychometric properties of the PTSD Checklist were conducted using DSM-IV PTSD criteria; this included investigations documenting the reliability and validity of the PTSD Checklist compared to the gold standard Clinician Administered PTSD Scale as well investigation documenting the psychometric properties of the EHR PTSD screen relative to the DSM-IV PTSD checklist.^40–45 Employing the blended version of the PTSD Checklist allows the study team to continue to conduct investigations that establish the psychometric utility of the DSM 5 PTSD criteria in the acute care settings while also having available the “gold standard” DSM IV assessments. 2) Emergency Department/ Inpatient Health Service Utilization. Emergency department/inpatient health service utilization will be assessed using EDIE, developed by Collective Medical.³⁵ Recent study team investigations document the reliability and validity of EDIE emergency department/inpatient assessments.^35,36

2k. Analytic Plan Primary Analyses (Aim 1):

All primary statistical analyses will be conducted with the intent-to-treat sample. The primary purpose of the statistical analyses is to examine and compare trends in 1) patient-reported PTSD symptoms on the PTSD Checklist and 2) EDIE-documented emergency department/inpatient utilization for patients randomized to the brief stepped care intervention versus requirement as usual care control group conditions longitudinally over the course of the year after injury. The investigation hypothesizes that patients randomized to the TSOS stepped care intervention and referral procedure will demonstrate significant reductions in PTSD symptoms and in emergency department/inpatient utilization when compared to patients randomized to the requirement as usual care control condition. For the PTSD Checklist, the major test of the intervention effect will be an examination of the treatment group by time interaction over the course of the 12 months post-injury. The PTSD outcome analyses will also examine changes in PTSD Checklist scores from baseline to the 1-, 3-, 6-, and 12-month study time points. For emergency department/inpatient utilization, the study team will examine the treatment group by time interaction effect over the course of the 12 months post-injury, as well as compare monthly emergency department/inpatient utilization rates for patients randomized to the intervention and control group conditions.

The study team will use mixed model regression for the primary and secondary analyses of continuous and discrete outcomes.⁶⁷ Mixed model regression permits the inclusion of subjects with missing data and allows for individual varying slopes and intercepts over time. In addition, mixed model regression allows for the use of covariates to model potential sources of nonresponse bias and time-dependent covariates.

The outcome analyses incorporate two types of data, EDIE automated health service utilization data that accrues on the intent-to-treat sample and patient-reported outcome data that will be collected at the baseline assessment and 1-, 3-, 6-, and 12-month follow-up interviews. For the EDIE data, prior investigations document follow-up rates of ≥ 95%. Greater attrition is expected for outcomes that require patient self-report, including the PTSD Checklist. In randomized clinical trials, including the nationwide 25-site UH3 investigation, the investigators have achieved 3–12-month follow-up completion rates of 75–80%.^31–33 Estimates derived from these rates are incorporated into descriptions of subject flow and power analyses.

Moderational and mediational analyses will be conducted (Table 2). Mediational analyses will be performed that account for the temporal associations between treatment group assignment, hypothesized mediators, and PTSD treatment outcomes.^68,69 Mediational analyses will assess whether greater treatment effects are observed for patients who report receiving greater intensity of evidence-based service delivery (i.e., psychotropic medications and psychotherapy elements).

Table 2.

Trauma Survivors Outcomes & Support 8 Stepped Care Elements & Associated Outcomes/Secondary Analyses.

Step	Elements	Outcomes/Secondary Analyses
Step I	EHR/EDIE PTSD Checklist Screen	EDIE moderation
Step II	Brief Intervention (care management, therapy, meds) & EDIE Alerts	↓PTSD, ↓ Utilization; Mediation
Step III	Coaching, Stepped Up Care & Tailored Referral	↓PTSD, ↓ Utilization; Mediation & Moderation

Moderational analysis will assess whether non-White and/or Hispanic patients, when compared to White, non-Hispanic patients demonstrate greater, statistically significant PTSD treatment effects. A prior study team 25 site investigation suggested greater 6-month PTSD treatment effects in non-White/Hispanic patients compared to White/non-Hispanic patients^33,49 This prior investigation also documented that 13 of the 25 sites achieved good/excellent implementation. A broad spectrum of social work, nursing, physician, and other front-line trauma center providers implemented the approximately 2-hour intervention across the 25 sites.

2l. Sample Size and Power for Primary Hypotheses.

Power analyses were conducted using the PASS program.⁷⁰ For the primary analyses, three follow-up time points were used. Other parameters used in ascertaining power, including effect sizes, were derived from prior study team investigations.

Hypothesis 1. Patient-reported PTSD Symptoms: In prior study team single-site pragmatic trials, the study team observed 6–12-month PTSD treatment effects ranging between 0.34–0.65. In the prior UH3 multisite pragmatic trial, good/excellent sites demonstrated 6–12-month treatment effects ranging from 0.26–0.31. For the current investigation, with on average 25% 1-, 3-, 6-, and 12-month attrition, 424 patients, the probability of a 2-tailed type I error set at 5%, a correlation between observations of 0.6 and a conservatively estimated effect size = 0.26, the power to detect differences in PTSD symptoms will be = 0.80.

Hypothesis 2. EDIE Documented Emergency Department/Inpatient Utilization. In a prior study team single-site pragmatic trial investigation, at 3–6 months post-injury, 30% of control patients versus 17% of intervention patients had one or more emergency department visits, at 6–9 months post-injury, the difference was 31% control versus 21% intervention), and at 12 months post-injury, the difference was 30% control versus 22% intervention. With the ≥ 95% follow-up rate provided by EDIE, the probability of a 2-tailed type I error set at 5%, a correlation between observations of 0.4, and a similar pattern of emergency department visits as seen in the prior investigation with 424 total patients (n = 212 in each arm), the power to detect a conservatively estimated 9% difference between groups (control 30% versus intervention 21%) is ≥ 0.80.

2m. RAPICE Mixed Method Implementation Process Assessment^1,2,71

The project will incorporate a sequential mixed quantitative and quantitative design. This sequential mixed method design is being employed to augment the initial quantitative results of the pragmatic trial. The RAPICE approach incorporates a review of multiple data sources, including patient questionnaires, study team field logs, and final intervention case reviews, while also harnessing frontline clinician-investigator participant observation combined with regular data review/analyses from an expert implementation science consultant). The RAPICE implementation process assessment will document any intervention modifications that occur in the wake of COVID-19-related acute care medical surges, extreme weather events, and other mass trauma exposures (e.g., mass firearm violence injury presentations).^72,73

The RAPICE data analyses will follow procedures previously articulated by Drs. Palinkas and Zatzick.^1,2,71 Logs and field jottings derived from weekly staffing meetings, as well as other field observation contexts (e.g., COVID-19 surges), will be brought to the monthly mixed method consultant rounds for coding. Results of the analyses will be presented through a number of modalities that may include tabular representation of themes with illustrative quotes and thematic counts.^55,74

3. CONCLUSIONS

The end-of-study policy summit is an essential component of the project’s deployment-focused approach and will be directly informed by pragmatic trial findings and the RAPICE implementation process assessment (Figure 3).^37,75 The summit will be modeled along prior study team experiences with College policy summits in the wake of successfully implemented pragmatic trials.^31,32,38,66 From a dissemination and implementation science perspective, US trauma care systems are distinct from other health care systems in that the College has the capacity to develop regulatory policy derived from the results of pragmatic clinical trials.^7–9,37,71 Over the past two decades, the Trauma Survivors Outcomes and Support (TSOS) team, which includes research scientists, trauma surgical policymakers, patients, and frontline clinicians, has established a track record of using evidence derived from NIH pragmatic trials to target College regulatory policy directly.^{7–9,33,37,71} This makes the development, refinement, dissemination, and sustained implementation of early acute care medical interventions an excellent example of a deployment-focused mental health services research approach.

Figure 3.

Two Decades of American College of Surgeons (ACS) Policy Dissemination of Study Team NIH Funded Pragmatic Trial Results.

Highlights:

1. The trial randomizes patients to collaborative care intervention and control conditions.

2. The TSOS intervention targets PTSD and emergency department utilization reductions.

3. The trial aims to inform American College of Surgeons mental health policy.

Data Availability:

The data sets generated and/or analyzed during the current study are not publicly available but are available from the corresponding on reasonable request.