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In contrast to traditional randomized controlled trials, embedded pragmatic clinical trials (ePCTs) are conducted within healthcare settings with real-world patient populations. ePCTs are intentionally designed to align with health system priorities leveraging existing healthcare system infrastructure and resources to ease intervention implementation and increase the likelihood that effective interventions translate into routine practice following the trial. The NIH Pragmatic Trials Collaboratory, funded by the National Institutes of Health (NIH), supports the conduct of large-scale ePCT Demonstration Projects that address major public health issues within healthcare systems. The Collaboratory has a unique opportunity to draw on the Demonstration Project experiences to generate lessons learned related to ePCTs and the dissemination and implementation of interventions tested in ePCTs. In this article, we use case studies from six completed Demonstration Projects to summarize the Collaboratory's experience with post-trial interpretation of results, and implications for sustainment (or de-implementation) of tested interventions. We highlight three key lessons learned. First, ineffective interventions (i.e., ePCT is null for the primary outcome) may be sustained if they have other measured benefits (e.g., secondary outcome or subgroup) or even perceived benefits (e.g., staff like the intervention). Second, effective interventions-even those solicited by the health system and/or designed with significant health system partner buy-in-may not be sustained if they require significant resources. Third, alignment with policy incentives is essential for achieving sustainment and scale-up of effective interventions. Our experiences point to several recommendations to aid in considering post-trial sustainment or de-implementation of interventions tested in ePCTs: (1) include secondary outcome measures that are salient to health system partners; (2) collect all appropriate data to allow for post hoc analysis of subgroups; (3) collect experience data from clinicians and staff; (4) engage policy-makers before starting the trial.

Background: There is limited long-term data on the course of school-related problems and academic needs for youth with persistent post-concussive symptoms (PPCS). Methods: This was a randomized trial comparing collaborative care to usual care for 200 youth 11-18 years of age with PPCS. In this report, the main outcomes were academic functioning, GPA, school absences, date of return to school, and school days missed. Results: Youth were mean age of 14.7 (SD = 1.7), 62.0% female. New or worsening academic problems occurred in half of participants in both groups at 12 months after injury. Students were most concerned about grades and falling behind. There were no significant differences by study group on school problems or GPA, but number of days missed was lower in the collaborative care group compared at 3 months (12.5 [SD = 14.5] vs 16.1 days [20.4] adjusted relative risk [aRR] 0.67 [95% CI: 0.61, 0.74; p < 0.001]), 6 months (14.5 [22.1] vs 19.3 [26.6] aRR 0.77 [95% CI: 0.71, 0.84; p < 0.001]), and 12 months (16.9 [25.4] vs 19.6 [27.7], aRR 0.68 [95% CI: 0.62, 0.74; p < 0.001]). Conclusions: Youth with PPCS are at high risk of school problems in the year after injury.

ObjectiveThe Coronavirus disease (COVID-19) outbreak has evolved into a pandemic crisis, with King County in Washington State emerging as the early US epicenter. A literature review revealed few reports providing front-line clinical and research teams guidance related to multilevel, rapidly evolving COVID-19 directives.MethodThe Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) method was used to develop a clinical case series and conduct participant observation during an ongoing comparative effectiveness trial of peer-integrated, patient-centered interventions after traumatic injury. Participants were patients enrolled in the intervention arm of the ongoing trial, as well as front-line clinicians, patient peer interventionists, and clinical research team members implementing the trial. All participants were exposed to the Washington State COVID-19 outbreak.ResultsPrimary and secondary COVID-19 prevention strategies were feasibly integrated into ongoing care coordination and behavioral interventions for at-risk patients. Beyond the compilation of case studies, as an iterative method, RAPICE data collection naturalistically evolved to include observations of intervention team activity occurring within the larger pandemic epicenter context. A daily clinical research team huddle that flexibly accommodated virtual participation was also feasibly implemented.ConclusionsPrimary and secondary COVID-19 prevention strategies can be feasibly integrated into ongoing clinical interventions during the pandemic. Routine, proactive clinical and research team communication that transparently addresses ethical tensions and health-sustaining activities may promote well-being for providers grappling with rapidly evolving pandemic directives. Proactive assessments of individual provider vulnerabilities for severe COVID-19 related respiratory illness may also be a crucial element of the health care system pandemic responses.

BackgroundThe clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped.MethodsTo strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design.ResultsIn this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs.ConclusionA planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.

OBJECTIVE:This investigation comprehensively assessed the technology use, preferences, and capacity of diverse injured trauma survivors with posttraumatic stress disorder (PTSD) symptoms. METHOD:A total of 121 patients participating in a randomized clinical trial (RCT) of stepped collaborative care targeting PTSD symptoms were administered baseline one-, three-, and six-month interviews that assessed technology use. Longitudinal data about the instability of patient cell phone ownership and phone numbers were collected from follow-up interviews. PTSD symptoms were also assessed over the course of the six months after injury. Regression analyses explored the associations between cell phone instability and PTSD symptoms. RESULTS:At baseline, 71.9% (n = 87) of patients reported current cell phone ownership, and over half (58.2%, n = 46) of these patients possessed basic cell phones. Only 19.0% (n = 23) of patients had no change in cell phone number or physical phone over the course of the six months postinjury. In regression models that adjusted for relevant clinical and demographic characteristics, cell phone instability was associated with higher six-month postinjury PTSD symptom levels (p

To examine feasibility and acceptability of providing stepped collaborative care case management targeting posttraumatic stress disorder (PTSD) and pain symptoms after major traumatic injury. Participants were major trauma survivors in Victoria, Australia, at risk of persistent pain or PTSD with high baseline symptoms. Participants were block-randomized, stratified by compensation-status, to the usual care (n = 15) or intervention (n = 17) group (46% of eligible patients). The intervention was adapted from existing stepped collaborative care interventions with input from interdisciplinary experts and people with lived experience in trauma and disability. The proactive case management intervention targeted PTSD and pain management for 6-months using motivational interviewing, cognitive behavioral therapy strategies, and collaborative care. Qualitative interviews explored intervention acceptability. Intervention participants received a median of 7 h case manager contact and reported that they valued the supportive and non-judgmental listening, and timely access to effective strategies, resources, and treatments post-injury from the case manager. Participants reported few disadvantages from participation, and positive impacts on symptoms and recovery outcomes consistent with the reduction in PTSD and pain symptoms measured at 1-, 3- and 6-months. Stepped collaborative care was low-cost, feasible, and acceptable to people at risk of PTSD or pain after major trauma. After hospitalization for injury, people can experience difficulty accessing timely support to manage posttraumatic stress, pain and other concerns. Stepped case management-based interventions that provide individualized support and collaborative care have reduced posttraumatic stress symptom severity for patients admitted to American trauma centers. We showed that this model of care could be adapted to target pain and mental health in the trauma system in Victoria, Australia. The intervention was low cost, acceptable and highly valued by most participants who perceived that it helped them use strategies to better manage post-traumatic symptoms, and to access clinicians and treatments relevant to their needs. [ABSTRACT FROM AUTHOR]

ObjectivesAdherence to pediatric traumatic brain injury guidelines has been associated with improved survival and better functional outcome. However, the relationship between guideline adherence and hospitalization costs has not been examined. To evaluate the relationship between adherence to pediatric severe traumatic brain injury guidelines, measured by acute care clinical indicators, and the total costs of hospitalization associated with severe traumatic brain injury.DesignRetrospective cohort study.SettingFive regional pediatric trauma centers affiliated with academic medical centers.PatientsDemographic, injury, treatment, and charge data were included for pediatric patients (17 yr) with severe traumatic brain injury.InterventionsPercent adherence to clinical indicators was determined for each patient. Cost-to-charge ratios were used to estimate ICU and total hospital costs for each patient. Generalized linear models evaluated the association between healthcare costs and adherence rate.Measurements and main resultsCost data for 235 patients were examined. Estimated mean adjusted hospital costs were $103,485 (95% CI, 98,553-108,416); adjusted ICU costs were $82,071 (95% CI, 78,559-85,582). No association was found between adherence to guidelines and total hospital or ICU costs, after adjusting for patient and injury characteristics. Adjusted regression model results provided cost ratio equal to 1.01 for hospital and ICU costs (95% CI, 0.99-1.03 and 0.99-1.02, respectively).ConclusionsAdherence to severe pediatric traumatic brain injury guidelines at these five leading pediatric trauma centers was not associated with increased hospitalization and ICU costs. Therefore, cost should not be a factor as institutions and providers strive to provide evidence-based guideline driven care of children with severe traumatic brain injury.

BACKGROUND: Each year in the USA, 1.5-2.5 million Americans are so severely injured that they require inpatient hospitalization. Multiple conditions including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression, and chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries. METHODS/DESIGN: The trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid trial is designed to test the delivery of high-quality screening and intervention for PTSD and comorbidities across 24 US level I trauma center sites. The pragmatic trial aims to recruit 960 patients. The TSOS investigation employs a stepped wedge cluster randomized design in which sites are randomized sequentially to initiate the intervention. Patients identified by a 10-domain electronic health record screen as high risk for PTSD are formally assessed with the PTSD Checklist for study entry. Patients randomized to the intervention condition will receive stepped collaborative care, while patients randomized to the control condition will receive enhanced usual care. The intervention training begins with a 1-day on-site workshop in the collaborative care intervention core elements that include care management, medication, cognitive behavioral therapy, and motivational-interviewing elements targeting PTSD and comorbidity. The training is followed by site supervision from the study team. The investigation aims to determine if intervention patients demonstrate significant reductions in PTSD and depressive symptoms, suicidal ideation, alcohol consumption, and improvements in physical function when compared to control patients. The study uses implementation science conceptual frameworks to evaluate the uptake of the intervention model. At the completion of the pragmatic trial, results will be presented at an American College of Surgeons policy summit. Twenty-four representative US level I trauma centers have been selected for the study, and the protocol is being rolled out nationally. DISCUSSION: The TSOS pragmatic trial simultaneously aims to establish the effectiveness of the collaborative care intervention targeting PTSD and comorbidity while also addressing sustainable implementation through American College of Surgeons regulatory policy. The TSOS effectiveness-implementation hybrid design highlights the importance of partnerships with professional societies that can provide regulatory mandates targeting enhanced health care system sustainability of pragmatic trial results. TRIAL REGISTRATION: ClinicalTrials.gov NCT02655354 . Registered 27 July 2015.

A growing evidence base supports stepped care interventions for the early treatment of posttraumatic stress disorder (PTSD) after physical injury. Few investigations have examined the characteristics of patients who do and do not respond to these interventions. This investigation was a secondary analysis that used previously collected data from three randomized clinical trials of stepped care interventions (patient N = 498). The study hypothesized that a subgroup of patients would manifest persistent PTSD symptoms regardless of randomization to intervention or control conditions, and that characteristics present at the time of baseline injury hospitalization could distinguish patients who would develop persistent symptoms from potential treatment responders. Regression analyses identified baseline patient clinical and demographic characteristics that were associated with persistent PTSD symptoms over the 6-months post-injury. Additional analyses identified treatment attributes of intervention patients who were and were not likely to demonstrate persistent symptoms. A substantial subgroup of patients (n = 222, 44.6%) demonstrated persistent PTSD symptoms over time. Greater numbers of pre-injury trauma, pre-injury PTSD symptoms, elevated early post-injury PTSD symptoms, unemployment, and non-White race identified patients with persistent symptoms. Patients with ≥3 of these baseline risk characteristics demonstrated diminished treatment responses when compared to patients with <3 characteristics. Intervention patients with ≥3 risk characteristics were less likely to engage in treatment and required greater amounts of interventionist time. Injured trauma survivors have readily identifiable characteristics at the time of hospitalization that can distinguish responders to PTSD stepped care interventions versus patients who may be treatment refractory. [ABSTRACT FROM AUTHOR]