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IT-enhanced peer-integrated collaborative care for US trauma care systems
Investigator (PI): Zatzick, Douglas
Performing Organization (PO): (Current): University of Washington, School of Medicine, Department of Psychiatry and Behavioral Sciences / (206) 543-3750
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2024
Record Source/Award ID: PCORI/IHS-2017C1-6151
Funding: Total Award Amount: $4,942,552
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background and significance: Each year in the United States, over 30 million individuals present to acute care medical emergency department and trauma center settings for the treatment of traumatic injury; annually 1.5-2.5 million Americans are so severely injured that they require inpatient hospitalization. Injured trauma survivors constitute a high-need patient population with multiple complex mental health and medical comorbidities. A series of PCORI position statements, Institute of Medicine reports, and Agency for Healthcare Research and Quality reviews provide support for the development and widespread implementation of health care system interventions targeting injured trauma survivors at risk for the development of mental and physical health comorbidities and fragmented care transitions. Peer interventionists are becoming a mainstay of treatment delivery for multiple health conditions across diverse US health care systems. However, unlike other areas of clinical medicine, acute post-injury interventions have yet to comprehensively integrate patient peer interventionists. Collaborative care interventions hold promise for the widespread implementation of integrated post-injury medical and psychiatric care throughout US trauma care systems. A critical gap in the evidence exists for high-need injured patient populations with multiple complex mental health and medical comorbidities; to date, few scalable, peer-integrated multidisciplinary team interventions exist that target improvements in key post-injury outcomes, including patient post-injury concerns, posttraumatic stress disorder symptoms, functional impairments, and fragmented health service utilization. The study team, which includes patients, clinical researchers, front-line provider and policy maker stakeholders, has been working together for over a decade to develop and implement interventions that target improvements in outcomes of relevance to injured patients and their caregivers for US trauma care systems nationally. We began this work by asking large groups of injured patients the key patient-centered outcome question, "Of everything that has happened to you since your injury, what concerns you the most?" The team developed scientifically sound assessment tools that allowed us to follow these patient concern narratives after injury hospitalization. Our team has now successfully completed a PCORI-funded comparative effectiveness trial that suggests that a social work-led care transition intervention can reduce the severity of patient post-injury concerns. This completed PCORI trial provides study team engagement momentum, preliminary data, and methods that inform the approach proposed for the current comparative effectiveness trial. The study team has an established track record of using evidence derived from comparative effectiveness trials to inform American College of Surgeons Committee on Trauma regulatory policy. Over the past decade, the study team has convened a series of American College of Surgeons policy summits that have successfully integrated patient voices in the development and roll-out of national trauma center policy. The most recent policy summit was convened in September of 2016. At this summit, led by patient co-principal investigator Peter Thomas, patient study team stakeholders strongly voiced the need for peer-integrated, multidisciplinary team, trauma care system interventions. The impetus for the current comparative effectiveness trial derives directly from our patient stakeholders' input, while also integrating other key national policy and trauma care system stakeholder perspectives. The study team is committed to working ongoing with patient, provider, and policy stakeholders to reduce barriers to and facilitate implementation of evidence-based screening and intervention procedures derived from the proposed comparative effectiveness trial. Study aims: Specific aims. This randomized comparative effectiveness trial aims to evaluate two readily implementable approaches to the delivery of transitional care for injured patients treated emergently in US trauma care systems. The two approaches to be compared are a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists, versus trauma surgical team notification of patient emotional distress with mental health consultation. The collaborative care intervention will be supported by a novel emergency department exchange health information technology platform. The primary aim of the investigation is to compare emergency department health service use, patient concerns, PTSD symptoms, and physical function for patients randomized to the two conditions. The study hypothesizes that patients receiving the peer-integrated collaborative care intervention will demonstrate significant reductions in post-injury emergency department utilization as documented by novel emergency department exchange data on the intent-to-treat sample. The investigation also hypothesizes the peer-integrated collaborative care intervention will be associated with significant reductions in the severity of post-injury concerns as well as reductions in PTSD symptom levels when compared to the surgical team notification condition. Improvements in physical function are also hypothesized for patients receiving the peer-integrated collaborative care intervention. Secondary analyses will assess the impact of traumatic brain injury, ethnic/racial diversity, and gender subgroup status on hypothesized treatment effects. A secondary aim of the study is to understand the care processes involved with the delivery of the peer-integrated collaborative care intervention. A final aim of the investigation is for study team members to work with the American College of Surgeons' Committee on Trauma, board members of the American Trauma Society, and the PCORI Transitional Care Evidence to Action Network to better understand barriers to widespread implementation of study results. To facilitate this aim, the study team will convene an American College of Surgeons policy summit in the final year of the contract. Study description: Overall study design. Injured trauma survivors ages 18 or older years of age will undergo electronic health record screening for high levels of emotional distress. Patients determined to be at risk on the EHR screen will be approached for informed consent. After informed consent is obtained, patients' posttraumatic concerns will be assessed and patients will be screened for emotional distress with the PTSD checklist; patients with >= 1 severe posttraumatic concerns and scores of >= 35 on the PTSD checklist will be randomized. A total of 424 patients will be randomized to peer-integrated collaborative care (n = 212) and surgical team notification (n =212) conditions. Intervention activity will continue for up to six months after the injury hospitalization, while follow-up continues until 12 months after the index hospitalization. Emergency department health service use, patient concerns, posttraumatic stress disorder symptoms, physical function, and other outcomes will be followed up at 1, 3, 6, 9, and 12 months after injury for all patients. Main components: A. Peer-integrated multidisciplinary collaborative care intervention. The peer-integrated collaborative care intervention includes front-line trauma center staff (e.g., nursing and master's in social work), joined by injured peer interventionists and supervised by an MD psychiatrist. The collaborative care team will provide case management, behavioral intervention elements, psychopharmacologic medication recommendations, as well as 24/7 cell phone coverage for 6 months post-injury. The intervention will be supported by a novel emergency department health information technology platform. B. Trauma surgery notification. Trauma surgery team notification of patient emotional distress, with plan for mental health inpatient consultation (e.g., MD, PhD, or master's level provider) will be the comparator condition. Prior investigation documents that nationally between 50-80% of US acute care centers routinely provide mental health consultation for emotional distress and/or substance use. Study population: The demographic and clinical characteristics of patients included in the proposed study are anticipated to be similar to the characteristics of injured patients recruited into the prior PCORI-funded comparative effectiveness trials. For the 424 randomized patients, the mean age is anticipated to be 42.4 years and 56.7% of patients are anticipated to be female. The study team anticipates that 56% of patients will identify as white, 16% of patients will identify as African American, 13% of subjects will identify as American Indian, 7.0% will identify as Hispanic, 5% will identify as Asian, and 3% will identify as Pacific Islanders. Over 90% of patients are anticipated to endorse a public insurance source and approximately 50% of patients will be working at the time of their injury. Approximately 30-40% of patients are anticipated to have incurred a mild, moderate, or severe TBI and 60% of patients will have at least one pre-injury chronic medical condition. As in the previous trial, 100% of patients randomized are anticipated to have one or more severe post-injury concerns. All patients recruited into the trial are anticipated to have early high levels of posttraumatic stress disorder symptom levels. Primary and secondary outcomes: A. Primary outcomes are 1) population-level emergency department health service utilization, 2) patient posttraumatic concern severity, 3) posttraumatic stress disorder symptoms, and 4) physical function. B. Secondary outcomes are measures of care processes of care and treatment fidelity. Analytic methods: All primary statistical analyses will be conducted with the intent-to-treat sample. The primary statistical analyses will test the hypothesis that patients randomized to the peer-integrated collaborative care intervention will demonstrate reductions in emergency department health service use when compared to patients randomized to the trauma surgery notification condition, over the course of the 12 months after injury. Primary analyses will also assess whether collaborative care intervention patients demonstrate longitudinal reductions in posttraumatic concern severity and PTSD symptoms and improvements in physical function when compared to trauma surgery notification patients. The study team will use mixed effects regression models to test these hypotheses for both continuous and discrete outcomes. The effect of major interest will be the time by treatment group interaction term. For these models, repeated measurements of the baseline, 1-, 3-, 6-, 9-, and 12-month outcome will be the dependent variables. Secondary, heterogeneity of treatment effect analyses will also assess whether the intervention is equally effective in subgroups of patients with and without traumatic brain injury, for male and female patients and for ethnoculturally diverse patients. As in prior study team investigation, sensitivity analyses will be used to assess the impact of key assumptions. The study team will use logistic regression models to determine which, if any, demographic or clinical characteristics, including treatment group membership, are predictive of subject attrition; the study team will also perform a sensitivity analysis for the data using multiple imputation.
MeSH Terms:
  • Comorbidity
  • Comparative Effectiveness Research
  • Emergency Medicine /methods
  • Emergency Service, Hospital /organization & administration
  • Evidence-Based Medicine
  • Female
  • Health Policy
  • Health Services Research
  • Hospitalization
  • Humans
  • Inpatients
  • Male
  • Medical Informatics /*methods
  • Mental Disorders /therapy
  • Outcome Assessment, Health Care
  • Patient-Centered Care
  • Peer Group
  • Randomized Controlled Trials as Topic
  • Regression Analysis
  • Social Work
  • Stress Disorders, Post-Traumatic /therapy
  • Stress, Psychological
  • Trauma Centers /*organization & administration
  • United States
  • United States Agency for Healthcare Research and Quality
  • Wounds and Injuries /*therapy
Country: United States
State: Washington
Zip Code: 98195
UI: 20183350
Project Status: Ongoing