Factors Affecting Post-trial Sustainment or De-implementation of Study Interventions: A Narrative Review.

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.

Impact of posttraumatic stress disorder and depressive symptoms on quality of life in adolescents after general traumatic injury.

Posttraumatic stress disorder (PTSD) and depressive symptoms have been associated with poorer health-related quality of life in adolescents after general traumatic injuries; few studies have examined the broader construct of postinjury quality of life (QOL). We evaluated the impact of traumatic injury on adolescent QOL and examined factors that potentially contribute to poorer outcomes, using the Youth Quality of Life Instrument-Research Version as the outcome measure. Data were collected within 30 days postinjury and 2, 5, and 12 months postinjury. Mixed-model regression (MMR) was used for the main analyses. Participants (N = 204) were drawn from a prospective cohort study of 12-18-year-olds admitted to a Level 1 trauma center (n = 108) and healthy participants from a local cross-sectional study (n = 116); study group participants were significantly older. The initial MMR indicated that female adolescents had significantly lower QOL, B = -2.69, 95% CI [-4.68, -0.70], and were more likely to score above the cutoffs for PTSD (19.1% vs. 2.0%), χ2 (1, N = 381) = 34.6, p < .001, or depression (32.8% vs. 14.0%), χ2 (1, N = 381) = 18.7, p < .001, on post hoc analyses. Adolescents with mental health conditions in the year postinjury had significant QOL deficits without predicted improvements toward baseline, PTSD: B = -10.05, 95% CI [-15.29, -4.81]; depression: B = -18.00, 95% CI [-21.69, -14.31]. These findings highlight the importance of ongoing mental health monitoring and care for adolescents, particularly female adolescents, following traumatic injury even when physical recovery appears complete.

A Rapid Ethnographic Assessment of the Impact of the COVID-19 Pandemic on Mental Health Services Delivery in an Acute Care Medical Emergency Department and Trauma Center.

A rapid ethnographic assessment of delivery of mental health services to patients at a Level I trauma center in a major metropolitan hospital undergoing a COVID-19 surge was conducted to assess the challenges involved in services delivery and to compare the experience of delivering services across time. Study participants were patients and providers who interacted with or otherwise were observed by three clinicians engaged in the delivery of care within the Emergency Department (ED) and Trauma Center at Harborview Medical Center from the COVID-19-related "surge" in April to the end of July 2020. Data were collected and analyzed in accordance with the Rapid Assessment Procedures-Informed Clinical Ethnography (RAPICE) protocol. Community and institutional efforts to control the spread of the coronavirus created several challenges to providing mental health services in an acute care setting during the April surge. Most of these challenges were successfully addressed by standardization of infection control protocols, but new challenges emerged including an increase in expenses for infection control and reduction in clinical revenues due to fewer patients, furloughs of mental health services providers and peer specialists in the ED, services not provided or delayed, increased stress due to fear of furloughs or increased workload of those not furloughed, and increases in patients seen with injuries due to risky behavior, violence, and substance use. These findings illustrate the rapidly shifting nature of the pandemic, its impacts on mental health services, and the mitigation efforts of communities and healthcare systems.

A Prospective US National Trauma Center Study of Firearm Injury Survivors Weapon Carriage and Posttraumatic Stress Disorder Symptoms.

OBJECTIVE: To describe the demographic, injury-related, and mental health characteristics of firearm injury patients and trace firearm weapon carriage and PTSD symptoms over the year after injury. SUMMARY AND BACKGROUND DATA: Based on the increasing incidence of firearm injury and need for novel injury prevention strategies, hospital-based violence intervention programs are being implemented in US trauma centers. There is limited data on the long-term outcomes and risk behaviors of firearm injury survivors to guide this work. METHODS: We conducted a secondary analysis of a pragmatic 25-trauma center randomized trial (N = 635). Baseline characteristics of firearm-injured patients (N = 128) were compared with other trauma patients. Mixed model regression was used to identify risk factors for postinjury firearm weapon carriage and PTSD symptoms. RESULTS: Firearm injury patients were younger and more likely to be black, male and of lower socioeconomic status, and more likely to carry a firearm in the year before injury. Relative to preinjury, there was a significant drop in firearm weapon carriage at 3- and 6-months postinjury, followed by a return to preinjury levels at 12-months. Firearm injury was significantly and independently associated with an increased risk of postinjury firearm weapon carriage [relative risk = 2.08, 95% confidence interval (1.34, 3.22), P < 0.01] and higher PTSD symptom levels [Beta = 3.82, 95% confidence interval (1.29, 6.35), P < 0.01]. CONCLUSIONS: Firearm injury survivors are at risk for firearm carriage and high PTSD symptom levels postinjury. The significant decrease in the high-risk behavior of firearm weapon carriage at 3-6 months postinjury suggests that there is an important postinjury "teachable moment" that should be targeted with preventive interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT02655354.

Catalyzing the Translation of Patient-Centered Research Into United States Trauma Care Systems: A Case Example.

BACKGROUND: The expedient translation of research findings into sustainable intervention procedures is a longstanding health care system priority. The Patient-Centered Outcomes Research Institute (PCORI) has facilitated the development of "research done differently," with a central tenet that key stakeholders can be productively engaged throughout the research process. Literature review revealed few examples of whether, as originally posited, PCORI's innovative stakeholder-driven approach could catalyze the expedient translation of research results into practice. OBJECTIVES: This narrative review traces the historical development of an American College of Surgeons Committee on Trauma (ACS/COT) policy guidance, facilitated by evidence supplied by the PCORI-funded studies evaluating the delivery of patient-centered care transitions. Key elements catalyzing the guidance are reviewed, including the sustained engagement of ACS/COT policy stakeholders who have the capacity to invoke system-level implementation strategies, such as regulatory mandates linked to verification site visits. Other key elements, including the encouragement of patient stakeholder voice in policy decisions and the incorporation of end-of-study policy summits in pragmatic comparative effectiveness trial design, are discussed. CONCLUSIONS: Informed by comparative effectiveness trials, ACS/COT policy has expedited introduction of the patient-centered care construct into US trauma care systems. A comparative health care systems conceptual framework for transitional care which incorporates Research Lifecycle, pragmatic clinical trial and implementation science models is articulated. When combined with Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE), employed as a targeted implementation strategy, this approach may accelerate the sustainable delivery of high-quality patient-centered care transitions for US trauma care systems.

Parent Traumatic Events and Adolescent Internalizing Symptoms: The Mediating Role of Parental Depression Among Youth with Persistent Post-concussive Symptoms.

OBJECTIVE: Research has demonstrated associations between parental depression (PD) and negative psychological outcomes among their children. However, little is known about the pathways through which lifetime parent traumatic events (PTEs) influence their adolescents' internalizing symptoms. Our study examined whether PD mediates the association between PTE and adolescent depressive and anxious symptoms among youth with persistent postconcussive symptoms (PPCS). METHODS: We used baseline data from a randomized effectiveness trial of collaborative care for treatment of persistent postconcussive symptoms among sports-injured adolescents aged 11-18 years. Parent-adolescent dyads were recruited from pediatric clinics throughout western Washington. Eligible adolescents had three or more PPCS that lasted for at least 1 month but <9 months and spoke English. Of 1,870 potentially eligible adolescents, 1,480 (79%) were excluded for not meeting the inclusion criteria. Of the eligible 390 adolescents, 189 (49%) declined to participate/consent. Participants included 200 parent-adolescent dyads (adolescent Mage = 14.7 years, SD = 1.7). Parent respondents were mostly female (83%) and mothers (81%). Adolescents reported on their depressive (Patient Health Questionnaire-9; PHQ-9) and anxious symptoms (Revised Child Anxiety and Depression Scale-Short Version [anxiety subscale]) and parents reported on their depressive symptoms (M = 3.7, SD = 3.7; PHQ-9). RESULTS: Mediation analyses revealed two (out of four) significant indirect effects of PTE on both adolescent and parent report of depressive symptoms, but not anxiety. CONCLUSIONS: This study elucidates one pathway (PD) through which PTE history influences adolescent depressive symptoms, supporting a two-generation approach to pediatric patient care for youth experiencing PPCS.

Child- compared with parent-report ratings on psychosocial measures following a mild traumatic brain injury among youth with persistent post-concussion symptoms.

Primary Objective: To compare child- and parent-report ratings on the Health Behavior Inventory, Revised Child Anxiety and Depression Scale-Short Version (anxiety subscale), Patient Health Questionnaire-9, and Pediatric Quality of Life InventoryTM among children with persistent post-concussive symptoms following a sports- or recreation-related concussion, overall and by child age and gender.Research Design: Cross-sectional study examining baseline data from a randomized, comparative effectiveness trial.Methods and Procedures: Inter-rater reliability was assessed using two-way random effects model (absolute agreement) intraclass correlations, correlations were examined using Spearman's rho, mean differences were determined using paired t-tests, and agreement was examined using Bland-Altman plots.Main Outcomes and Results: The final analytic sample was 200 parent-child dyads [child Mage = 14.7 (95% CI: 14.5, 15.0)]. Reliability and correlations were modest overall. When considering child age and gender, reliability ranged from poor to excellent (-1.01-0.95) and correlations ranged from weak to strong (-0.64-0.94). Overall, children reported more symptoms but better functioning than parents, and mean differences in scores were greater among females (versus males) and ages 16-18 (versus younger groups).Conclusions: Findings should inform the use and interpretation of psychosocial measures when developing appropriate youth concussion treatment plans.

Prevalence and risk factors for depression, anxiety and suicidal ideation in youth with persistent post-concussive symptoms (PPCS).

Objectives: To assess the prevalence and risk factors for emotional distress in youth with persistent post-concussive symptoms (PPCS) greater than one month.Methods: We used baseline data from an intervention study for youth with PPCS, utilizing Poisson regression to examine factors associated with exceeding clinical cut-points on measures of depression, anxiety, self-harm and suicidal ideation. Predictors included: age, sex, socioeconomic status, mental health history, duration of concussion symptoms, history of prior concussion, trauma history and sleep quality.Results: The sample included 200 youth with PPCS, (mean 14.7 SD 1.7 years, 82% white, 62% female). Forty percent reported clinically significant depressive symptoms, 25% anxiety, 14% thoughts of self-harm and 8% thoughts of suicide. History of depression was associated with 3-fold higher risk for thoughts of self-harm (95% CI:1.82-6.99) and 6-fold higher risk for suicidal ideation (95% CI:1.74-24.46). Better sleep quality was associated with lower risk for all outcomes. History of prior concussion and duration of PPCS were not significantly associated with any outcomes.Conclusions: Suicidal thoughts are common post-concussion, and history of depression is a strong risk factor. Tailored interventions may be needed to address mental health in this population.

Traumatic Brain Injury and the Risk for Subsequent Crime Perpetration.

OBJECTIVE: To examine whether patients with traumatic brain injury (TBI) are at higher risk for subsequent crime perpetration compared with injured patients without TBI and those hospitalized for reasons other than injury. SETTING AND PARTICIPANTS: Patients hospitalized in Washington State from 2006-2007. DESIGN: A retrospective cohort study using linked statewide datasets. MAIN MEASURES: Primary outcomes were arrest for any violent or nonviolent crime within 5 years of discharge. Adjusted subhazard ratios were calculated using regression models incorporating death as a competing risk. RESULTS: Compared with uninjured patients (n = 158 247), the adjusted rate of arrest for any crime was greater among injured patients with TBI (n = 6894; subdistribution hazard ratios [sHR], 1.57; 95% confidence interval [CI], 1.49-1.62) and without TBI (n = 40 035; sHR, 1.55; 95% CI, 1.49-1.62). When patients with TBI were directly compared with injured patients without TBI, no effect of TBI on subsequent arrests was found (sHR, 1.02; 95% CI, 0.94-1.11). TBI did not increase the likelihood of either violent or nonviolent crime when these outcomes were examined separately. CONCLUSIONS: TBI survivors do not appear to be at increased risk for criminality compared with injured individuals without TBI. However, injured persons with or without TBI may be at elevated risk of crime perpetration compared with those who are uninjured.

Task-shifting to improve the reach of mental health interventions for trauma patients: findings from a pilot study of trauma nurse training in patient-centered activity scheduling for PTSD and depression.

Despite high rates of posttraumatic stress disorder (PTSD) and depression among traumatically injured patients, engagement in session-based psychotherapy early after trauma is limited due to various service utilization and readiness barriers. Task-shifting brief mental health interventions to routine trauma center providers is an understudied but potentially critical part of the continuum of care. This pilot study assessed the feasibility of training trauma nurses to engage patients in patient-centered activity scheduling based on a Behavioral Activation paradigm, which is designed to counteract dysfunctional avoidance/withdrawal behavior common among patients after injury. Nurses (N = 4) and patients (N = 40) were recruited from two level II trauma centers. A portion of a one day in-person workshop included didactics, demonstrations, and experiential activities to teach brief intervention delivery. Nurses completed pre- and posttraining standardized patient role-plays prior to and two months after training, which were coded for adherence to the intervention. Nurses also completed exit interviews to assess their perspectives on the training and addressing patient mental health concerns. Findings support the feasibility of training trauma nurses in a brief mental health intervention. Task-shifting brief interventions holds promise for reaching more of the population in need of posttrauma mental health care.

Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) in Pragmatic Clinical Trials of Mental Health Services Implementation: Methods and Applied Case Study.

Pragmatic clinical trials of mental health services are increasingly being developed to establish comparative effectiveness, influence sustainable implementation, and address real world policy decisions. However, use of time and resource intensive qualitative methods in pragmatic trials may be inconsistent with the aims of efficiency and cost minimization. This paper introduces a qualitative method known as Rapid Assessment Procedure-Informed Clinical Ethnography (RAPICE) that combines the techniques of Rapid Assessment Procedures with clinical ethnography. A case study is presented to illustrate how RAPICE can be used to efficiently understand pragmatic trial implementation processes and associated real world policy implications.

Timely Hemodynamic Resuscitation and Outcomes in Severe Pediatric Traumatic Brain Injury: Preliminary Findings.

OBJECTIVES: Early resuscitation may improve outcomes in pediatric traumatic brain injury (TBI). We examined the association between timely treatment of hypotension and hypoxia during early care (prehospital or emergency department locations) and discharge outcomes in children with severe TBI. METHODS: Hypotension was defined as systolic blood pressure less than 70 + 2 (age in years), and hypoxia was defined as PaO2 less than 60 mm Hg or oxygen saturation less than 90% in accordance with the 2003 Brain Trauma Foundation guidelines. Timely treatment of hypotension and hypoxia during early care was defined as the treatment within 30 minutes of a documented respective episode. Two hundred thirty-six medical records of children younger than 18 years with severe TBI from 5 regional pediatric trauma centers were examined. Main outcomes were in-hospital mortality and discharge Glasgow Outcome Scale (GOS) score. RESULTS: Hypotension occurred in 26% (60/234) during early care and was associated with in-hospital mortality (23.3% vs 8.6%; P = 0.01). Timely treatment of hypotension during early care occurred in 92% (55/60) by use of intravenous fluids, blood products, or vasopressors and was associated with reduced in-hospital mortality [adjusted relative risk (aRR), 0.46; 95% confidence interval, 0.24-0.90] and less likelihood of poor discharge GOS (aRR, 0.54; 95% confidence interval, 0.39-0.76) when compared to children with hypotension who were not treated in a timely manner. Early hypoxia occurred in 17% (41/236) and all patients received timely oxygen treatment. CONCLUSIONS: Timely resuscitation during early care was common and associated with lower in-hospital mortality and favorable discharge GOS in severe pediatric TBI.

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory.

BACKGROUND: The 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. METHODS: To 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. RESULTS: In 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. CONCLUSION: A 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.

Violence Perpetration Among Patients Hospitalized for Unintentional and Assault-Related Firearm Injury: A Case-Control Study and a Cohort Study.

BACKGROUND: Hospital-based violence intervention programs typically focus on patients whose firearm injury occurred through interpersonal violence (assault). Knowledge of violence perpetration by victims of unintentional (accidental) firearm injury is limited. OBJECTIVE: To examine violence perpetration before and after a patient becomes hospitalized for firearm injury according to injury intent (intentional [assault] or unintentional [accidental]). DESIGN: A case-control study and a retrospective cohort study. SETTING: Hospitals in Washington. PATIENTS: Persons aged 15 years or older hospitalized for a firearm injury, other injuries, or a noninjury reason from 2006 to 2007. MEASUREMENTS: In the case-control study, the odds of violence-related arrest from 2001 through hospitalization by injury intent among 3 groups were compared. In the cohort study, the rates of violence-related arrest from hospitalization through 2011 by injury intent among 3 groups were compared. RESULTS: Patients with unintentional firearm injuries (n = 180) were more likely than those with other unintentional injuries (n = 62 795; odds ratio [OR], 2.01 [95% CI, 1.31 to 3.09]) and no injuries (n = 172 830; OR, 3.43 [CI, 2.22 to 5.32]) to have been arrested for a violent crime before hospitalization. Prior violence-related arrest did not differ between patients with assault-related firearm injuries (n = 339) and those with other assault-related injuries (n = 2342; OR, 1.10 [CI, 0.84 to 1.46]). During follow-up, the cumulative incidence of violence-related arrest for patients with unintentional and assault-related firearm injuries was 10% and 15% (subhazard ratio, 1.88 [CI, 1.11 to 3.17] and 1.61 [CI, 1.08 to 2.44]), respectively, compared with 1% for those without injuries. LIMITATION: Exclusion of self-inflicted injuries, misclassification of intent, and ascertainment bias. CONCLUSION: Some firearm injuries classified as accidental may indicate involvement in the cycle of violence and present an opportunity for intervention. PRIMARY FUNDING SOURCE: City of Seattle and the University of Washington Royalty Research Fund.

Longitudinal trajectories of post-concussive and depressive symptoms in adolescents with prolonged recovery from concussion.

PRIMARY OBJECTIVE: To investigate the symptom trajectories of depressive and post-concussive symptoms (PCS) in slow-to-recover adolescents to understand how the two sets of symptoms are related. RESEARCH DESIGN: We used data from a randomized clinical trial of a collaborative care intervention for post-concussive symptoms to better understand how these two sets of symptoms change in parallel over 6 months. METHODS AND PROCEDURE: PCS and depressive symptom scores for 49 adolescents (ages 11-17) were measured at enrolment and after 1, 3, and 6 months. Latent growth curve modelling for parallel processes was used to simultaneously examine change in PCS and depressive symptoms over time and to evaluate the influence of one change process on the other. MAIN OUTCOMES AND RESULTS: On average, patients enrolled 66 days following injury (Interquartile range (IQR) 43.5, 88.5). PCS and depressive symptoms were significantly associated at enrolment and over time, and both decreased over the course of 6 months. Higher PCS at enrolment predicted a greater decrease in depressive symptoms over time. CONCLUSIONS: Our results suggest that clinicians should screen for and treat depressive symptoms in patients with high post-concussive symptoms one month following injury.

Frequency of and factors associated with emergency department intracranial pressure monitor placement in severe paediatric traumatic brain injury.

OBJECTIVE: To examine the frequency of and factors associated with emergency department (ED) intracranial pressure (ICP) monitor placement in severe paediatric traumatic brain injury (TBI). METHODS: Retrospective, multicentre cohort study of children <18 years admitted to the ED with severe TBI and intubated for >48 hours from 2007 to 2011. RESULTS: Two hundred and twenty-four children had severe TBI and 75% underwent either ED, operating room (OR) or paediatric intensive care unit (PICU) ICP monitor placement. Four out of five centres placed ICP monitors in the ED, mostly (83%) fibreoptic. Nearly 40% of the patients who received ICP monitors get it placed in the ED (29% overall). Factors associated with ED ICP monitor placement were as follows: age 13 to <18 year olds compared to infants (aRR 2.02; 95% CI 1.37, 2.98), longer ED length of stay (LOS) (aRR 1.15; 95% CI 1.08, 1.21), trauma centre designation paediatric only I/II compared to adult/paediatric I/II (aRR 1.71; 95% CI 1.48, 1.98) and higher mean paediatric TBI patient volume (aRR 1.88;95% CI 1.68, 2.11). Adjusted for centre, higher bedside ED staff was associated with longer ED LOS (aRR 2.10; 95% CI 1.06, 4.14). CONCLUSION: ICP monitors are frequently placed in the ED at paediatric trauma centres caring for children with severe TBI. Both patient and organizational level factors are associated with ED ICP monitor placement.

Mental Health Utilization Patterns During a Stepped, Collaborative Care Effectiveness Trial for PTSD and Depression in the Military Health System.

BACKGROUND: Integrated health care models aim to improve access and continuity of mental health services in general medical settings. STEPS-UP is a stepped, centrally assisted collaborative care model designed to improve posttraumatic stress disorder (PTSD) and depression care by providing the appropriate intensity and type of care based on patient characteristics and clinical complexity. STEPS-UP demonstrated improved PTSD and depression outcomes in a large effectiveness trial conducted in the Military Health System. The objective of this study was to examine differences in mental health utilization patterns between patients in the stepped, centrally assisted collaborative care model relative to patients in the collaborative care as usual-treatment arm. METHODS: Patients with probable PTSD and/or depression were recruited at 6 large military treatment facilities, and 666 patients were enrolled and randomized to STEPS-UP or usual collaborative care. Utilization data acquired from Military Health System administrative datasets were analyzed to determine mental health service use and patterns. Clinical complexity and patient characteristics were based on self-report questionnaires collected at baseline. RESULTS: Compared with the treatment as usual arm, STEPS-UP participants received significantly more mental health services and psychiatric medications across primary and specialty care settings during the year of their participation. Patterns of service use indicated that greater clinical complexity was associated with increased service use in the STEPS-UP group, but not in the usual-care group. CONCLUSIONS: Results suggest that stepped, centrally assisted collaborative care models may increase the quantity of mental health services patients receive, while efficiently matching care on the basis of the clinical complexity of patients.

Impact of Collaborative Care for Underserved Patients with PTSD in Primary Care: a Randomized Controlled Trial.

BACKGROUND: The effectiveness of collaborative care of mental health problems is clear for depression and growing but mixed for anxiety disorders, including posttraumatic stress disorder (PTSD). We know little about whether collaborative care can be effective in settings that serve low-income patients such as Federally Qualified Health Centers (FQHCs). OBJECTIVE: We compared the effectiveness of minimally enhanced usual care (MEU) versus collaborative care for PTSD with a care manager (PCM). DESIGN: This was a multi-site patient randomized controlled trial of PTSD care improvement over 1 year. PARTICIPANTS: We recruited and enrolled 404 patients in six FQHCs from June 2010 to October 2012. Patients were eligible if they had a primary care appointment, no obvious physical or cognitive obstacles to participation, were age 18-65 years, planned to continue care at the study location for 1 year, and met criteria for a past month diagnosis of PTSD. MAIN MEASURES: The main outcomes were PTSD diagnosis and symptom severity (range, 0-136) based on the Clinician-Administered PTSD Scale (CAPS). Secondary outcomes were medication and counseling for mental health problems, and health-related quality of life assessed at baseline, 6 months, and 12 months. KEY RESULTS: Patients in both conditions improved similarly over the 1-year evaluation period. At 12 months, PTSD diagnoses had an absolute decrease of 56.7% for PCM patients and 60.6% for MEU patients. PTSD symptoms decreased by 26.8 and 24.2 points, respectively. MEU and PCM patients also did not differ in process of care outcomes or health-related quality of life. Patients who actually engaged in care management had mental health care visits that were 14% higher (p < 0.01) and mental health medication prescription rates that were 15.2% higher (p < 0.01) than patients with no engagement. CONCLUSIONS: A minimally enhanced usual care intervention was similarly effective as collaborative care for patients in FQHCs.

Guideline Adherence and Hospital Costs in Pediatric Severe Traumatic Brain Injury.

OBJECTIVES: Adherence 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. DESIGN: Retrospective cohort study. SETTING: Five regional pediatric trauma centers affiliated with academic medical centers. PATIENTS: Demographic, injury, treatment, and charge data were included for pediatric patients (17 yr) with severe traumatic brain injury. INTERVENTIONS: Percent 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 RESULTS: Cost 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). CONCLUSIONS: Adherence 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.

Firearm-related hospitalization and risk for subsequent violent injury, death, or crime perpetration: a cohort study.

BACKGROUND: Risk for violent victimization or crime perpetration after firearm-related hospitalization (FRH) must be determined to inform the need for future interventions. OBJECTIVE: To compare the risk for subsequent violent injury, death, or crime perpetration among patients with an FRH, those hospitalized for noninjury reasons, and the general population. DESIGN: Retrospective cohort study. SETTING: All hospitals in Washington. PATIENTS: Patients with an FRH and a random sample of those with a non-injury-related hospitalization in 2006 to 2007 (index hospitalization). MEASUREMENTS: Primary outcomes included subsequent FRH, firearm-related death, and the combined outcome of firearm- or violence-related arrest ascertained through 2011. RESULTS: Among patients with an index FRH (n = 613), rates of subsequent FRH, firearm-related death, and firearm- or violence-related arrest were 329 (95% CI, 142 to 649), 100 (CI, 21 to 293), and 4221 (CI, 3352 to 5246) per 100 000 person-years, respectively. Compared with the general population, standardized incidence ratios among patients with an index FRH were 30.1 (CI, 14.9 to 61.0) for a subsequent FRH and 7.3 (CI, 2.4 to 22.9) for firearm-related death. In survival analyses that accounted for competing risks, patients with an index FRH were at greater risk for subsequent FRH (subhazard ratio [sHR], 21.2 [CI, 7.0 to 64.0]), firearm-related death (sHR, 4.3 [CI, 1.3 to 14.1]), and firearm- or violence-related arrest (sHR, 2.7 [CI, 2.0 to 3.5]) than those with a non-injury-related index hospitalization. LIMITATION: Lack of information on whether patients continued to reside in Washington during follow-up may have introduced outcome misclassification. CONCLUSION: Hospitalization for a firearm-related injury is associated with a heightened risk for subsequent violent victimization or crime perpetration. Further research at the intersection of clinical care, the criminal justice system, and public health to evaluate the effectiveness of interventions delivered to survivors of firearm-related injury is warranted. PRIMARY FUNDING SOURCE: Seattle City Council and University of Washington Royalty Research Fund.