TSOS

February 6, 2024: Racial and Ethnic Minority Injury Survivors See Greater Improvements in PTSD Symptoms in the TSOS Study

Posted on by Damon Seils

Cover of the journal Trauma Surgery & Acute Care OpenInjury survivors from racial and ethnic minority groups experienced greater improvements than White injury survivors in their posttraumatic stress disorder (PTSD) symptoms after receiving a stepped collaborative care intervention. This was the finding of a secondary analysis of data from the Trauma Survivors Outcomes and Support (TSOS) study, an NIH Pragmatic Trials Collaboratory Trial led by principal investigator Doug Zatzick of the University of Washington.

The report was published online in Trauma Surgery & Acute Care Open.

In the TSOS study's main analysis, which was published in JAMA Surgery in 2021, the researchers saw a significant reduction in PTSD symptoms at 6 months in the intervention group compared with the control group. In the new secondary analysis, they saw that reduction in symptoms among racial and ethnic minority patients but not among White, non-Hispanic patients.

The findings "suggest that the previously reported 6-month treatment effects derive predominantly from intervention-related PTSD symptom improvements in non-white/Hispanic patients," wrote author Khadija Abu and colleagues from the University of Washington and the University of California, Los Angeles.

The TSOS study, an NIH Collaboratory Trial, was a stepped-wedge, cluster randomized pragmatic clinical trial testing the delivery of a stepped collaborative care intervention vs usual care for injured patients with PTSD symptoms and comorbid conditions. The study was conducted at 25 level I trauma centers in the United States. Of the 635 patients in the trial, 350 were from racial backgrounds other than White—including 218 patients who identified as African American, 15 as American Indian or Alaska Native, 8 as Asian or Pacific Islander, and 109 as multiple or other races. One-hundred two patients were Hispanic.

Patients in the control group received usual care plus nurse notification about their high level of distress. Patients in the intervention group received collaborative care consisting of evidence-based medication, cognitive behavioral therapy, and case management.

The study team proposed a few possible explanations for their findings:

  • In addition to its universal components, the TSOS intervention and referral elements consisted of tailored components designed to address the needs of a multicultural patient population by incorporating social determinants of health.
  • Collaborative care models include shared decision-making approaches, which are thought to enhance patients' engagement in care in racial and ethnic minority populations and other underserved groups.
  • In the year before their injury, almost half of the white, non-Hispanic patients in the study had accessed mental health services, compared with only about a quarter of the non-White and Hispanic patients, suggesting that participation in the study improved access to mental health care for patients in racial and ethnic minority groups.

A commentary accompanying the article praised the TSOS research team for "taking important steps to care for adverse sequelae associated with traumatic injury," and noted that "these first steps represent giant leaps for health equity" for underserved populations.

The TSOS study was supported within the NIH Pragmatic Trials Collaboratory by a cooperative agreement from the National Institute of Mental Health and by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. Learn more about the NIH Collaboratory Trials.

April 11, 2022: TSOS Implements Suicide Assessment and Monitoring Method in Pragmatic Clinical Trial

Posted on by terren.green@duke.edu

The Trauma Survivors Outcomes and Support (TSOS) trial, an NIH Pragmatic Trials Collaboratory Trial, successfully implemented a large-scale suicide assessment and monitoring method in a pragmatic clinical trial focused on collaborative mental healthcare for traumatic injury survivors. Study intervention and monitoring methods are detailed in a recent publication in Psychiatry.

TSOS researchers analyzed data collected at 25 trauma centers from 635 patients experiencing posttraumatic stress disorder (PTSD) as the result of a traumatic injury. The study used a randomized stepped-wedge design and assigned 370 patients to a control group and 265 to an intervention group.

Patients in the intervention group received proactive injury care management, psychopharmacology, and psychotherapy for PTSD and depression. All patients in both groups were evaluated at 4 timepoints: baseline and 3, 6, and 12 months after injury.

Study personnel interacting with patients participated in a 1-day training workshop to learn study methods and skills for the management of acute suicidal ideation or suicidal intent. Among other measures to assess PTSD symptoms, alcohol use, and physical function, the study team administered the Patient Health Questionnaire (PHQ-9) to screen for suicidal ideation and depression.

Source: Psychiatry. 2022; Spring. doi:10.1080/00332747.2021.1991200.

Patients from both the intervention and control groups who indicated suicidal ideation on the PHQ-9 received calls, texts, and voice messages from study personnel and referral for additional care from a clinician. Study personnel reached out to 161 control and 107 intervention group patients.

The intervention group showed a small but not significant reduction in suicidal ideation compared to the control group.

Lack of a significant treatment effect may be due to the outreach and additional care received by patients in the control group. This level of additional care could be considered a minor intervention for the control group.

Future studies may learn more about treatment differences between control and intervention groups by incorporating implementation process assessments into the design of pragmatic trials.

TSOS was supported within the NIH Collaboratory by a cooperative agreement from the National Institute of Mental Health and by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. Learn more about the NIH Collaboratory Trials.

December 14, 2021: A Year of New Insights From the NIH Collaboratory

Posted on by Damon Seils

Collage of journal coversNIH Collaboratory researchers in 2021 shared study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced 3 dozen articles in the peer-reviewed literature, including the primary results of the PPACT and TSOS trials, the study design of the Nudge and OPTIMUM studies, insights into the COVID-19 pandemic from the EMBED and ACP PEACE studies, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ACP PEACE NIH Collaboratory Trial

BackInAction NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

GRACE NIH Collaboratory Trial

HiLo NIH Collaboratory Trial

LIRE NIH Collaboratory Trial

Nudge NIH Collaboratory Trial

OPTIMUM NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

TSOS NIH Collaboratory Trials

August 4, 2021: PCT Grand Rounds Presents Results of the TSOS NIH Collaboratory Trial

Posted on by Damon Seils

Photo of Dr. Doug Zatzick
Dr. Doug Zatzick

A recent PCT Grand Rounds webinar and slides presenting the results from TSOS, an NIH Collaboratory Trial, are now available. TSOS was a stepped-wedge, cluster randomized pragmatic clinical trial testing the delivery of a stepped collaborative care intervention vs usual care for 635 injured patients with PTSD symptoms and comorbid conditions at 25 level I trauma centers in the United States. The results of the study were published in March in JAMA Surgery.

The TSOS Closeout Study Snapshot is also available.

TSOS is supported within the NIH Collaboratory by a cooperative agreement from the National Institute of Mental Health.

June 11, 2021: The TSOS Effectiveness-Implementation Hybrid Study: Health Care System Level Theoretical Considerations & Pragmatic Trial Results (Douglas Zatzick, MD)

Posted on by terren.green@duke.edu

Speaker

Douglas Zatzick, MD
Professor of Psychiatry & Behavioral Sciences
Harborview Level I Trauma Center
University of Washington School of Medicine, Seattle

Topic

The TSOS Effectiveness-Implementation Hybrid Study: Health Care System Level Theoretical Considerations & Pragmatic Trial Results

Keywords

Pragmatic clinical trials; Implementation Science; Healthcare policy; TSOS; Effectiveness research; Longitudinal health care

Key Points

  • Combining Implementation Science theories with results from pragmatic clinical trials may be useful to target changes in healthcare policy and reduce the 17 year lag on translation from research to practice.
  • TSOS is a hybrid pragmatic clinical trial studying the effect of PTSD screening and implementation of screening procedures in healthcare systems.
  • TSOS study sites that implemented the study interventions better showed significant positive results in the experimental group as compared to the control group.
  • The results of the TSOS study have prompted the American College of Surgeons to require psychological sequelae screening in trauma centers nationally.

Discussion Themes

Healthcare systems want to see beneficial changes from pragmatic clinical trials implemented more quickly. 

To quickly implement procedures from a pragmatic clinical trial, we need a trial design that is feasible and easy to implement into clinical care and easy to incorporate into health care systems.

The focus should be on implementing the possible changes that you know you can get done in order to start a cascade of changes going forward.

Read more about TSOS.

Tags

#pctGR, @Collaboratory1

March 11, 2021: TSOS Study Intervention Reduces PTSD Symptoms in Injured Patients at Level I Trauma Centers

Posted on by Damon Seils

Photo of Dr. Doug Zatzick
Dr. Doug Zatzick

A collaborative care intervention for injured patients at trauma centers can reduce symptoms of posttraumatic stress disorder (PTSD), according to the results of the Trauma Survivors Outcomes and Support (TSOS) study. The results were published online this week in JAMA Surgery.

The TSOS study, an NIH Collaboratory Demonstration Project, was a stepped-wedge, cluster randomized pragmatic clinical trial testing the delivery of a stepped collaborative care intervention vs usual care for 635 injured patients with PTSD symptoms and comorbid conditions at 25 level I trauma centers in the United States.

Patients in the control group received usual care plus nurse notification about the patient’s high level of distress. Patients in the intervention group received collaborative care consisting of evidence-based medication, cognitive behavioral therapy, and case management. Patients in the intervention group whose PTSD symptoms persisted after initial treatment received stepped-up care, such as medication adjustments or additional psychotherapeutic elements.

After 6 months, the intervention group experienced a significant reduction in PTSD symptoms as compared with the control group. The treatment effect was greater for patients with higher baseline PTSD risk.

“Our study shows that a brief, approximately 2-hour collaborative care intervention delivered by frontline trauma center providers can significantly reduce PTSD symptoms in diverse injury survivors, including survivors of firearm injuries,” said Dr. Doug Zatzick of the University of Washington School of Medicine, the TSOS study’s principal investigator. “Collaborative care may therefore be an optimal treatment approach for trauma-exposed patients treated in acute care medical settings,” he said.

Figure from the TSOS main outcomes paper
Source: JAMA Surg. 2021 Mar 10. doi: 10.1001/jamasurg.2021.0131.

The study also included an implementation process assessment to allow the investigators to examine how the quality of each site’s implementation of the protocol affected study outcomes. The effect of the intervention on PTSD symptoms was greater at trauma centers with good or excellent protocol implementation.

“The upfront integration of an implementation process assessment into the TSOS pragmatic trial design allowed us to identify sites with good/excellent versus fair/poor protocol implementation, a key characteristic in discriminating patient-level PTSD treatment effects,” Zatzick said.

Overall, reduction in PTSD symptoms did not differ significantly between the study arms at 3 and 12 months, and there was no effect on secondary outcomes. However, the subgroup of patients who had firearm injuries and who were treated at sites with good or excellent implementation had among the largest 6-month treatment effects and demonstrated significant treatment effects at 12 months.

TSOS was supported within the NIH Collaboratory by a cooperative agreement from the National Institute of Mental Health and by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. Learn more about the NIH Collaboratory Demonstration Projects.

January 5, 2021: New Video Collection Highlights Advances in Electronic Health Records for Pragmatic Research

Posted on by Damon Seils

We are pleased to announce our new collection of short educational videos that highlight advances in the use of electronic health records (EHRs) in pragmatic clinical trials.

The videos are drawn from our 2020 EHR Workshop Grand Rounds Series, “Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials.” The series highlighted advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic trials. Experts discuss the evolving regulatory context for EHRs, national policy priorities, and innovative uses of EHRs in several NIH Collaboratory Trials.

Video topics include:

Visit the EHR Workshop Video Modules page for access to all of the new videos.

December 15, 2020: A Year of Results and New Insights From the NIH Collaboratory

Posted on by Damon Seils

Collection of Journal CoversNIH Collaboratory researchers in 2020 reported study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced more than 3 dozen articles in the peer-reviewed literature, including the primary results of the PROVEN and LIRE trials, the study design of ACP PEACE, insights into the COVID-19 pandemic from TSOS and EMBED, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ACP PEACE NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

HiLo NIH Collaboratory Trial

LIRE NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

STOP CRC NIH Collaboratory Trial

TSOS NIH Collaboratory Trial

October 22, 2020: TSOS Study Team Describes Impacts of a COVID-19 Surge on Delivery of Acute Care and Emergency Services

Posted on by Damon Seils

Photo of Dr. Doug Zatzick
Dr. Doug Zatzick, principal investigator of TSOS

A team of frontline healthcare workers in a level I trauma center recorded observations and summaries of conversations with other healthcare workers and patients about the impacts of a local surge in COVID-19 cases on care delivery.

The ethnographic study at Seattle’s Harborview Medical Center identified impacts in 4 thematic areas, including impacts on procedures, providers, patients, and quality of care. The study also identified strategies healthcare workers used to cope with the physical and mental health demands associated with the pandemic.

The article, published this week in BMJ Open, offers lessons for healthcare systems responding to the COVID-19 pandemic in other settings.

Team members recorded their observations in the context of an ongoing comparative effectiveness trial of multidisciplinary, peer-integrated care coordination for patients with severe injury, and of the ongoing Trauma Survivors Outcomes and Support (TSOS) study. TSOS, an NIH Collaboratory Trial, is a stepped-wedge, cluster randomized pragmatic trial testing the delivery of screening and intervention strategies for patients with posttraumatic stress disorder and comorbid conditions at 24 level I trauma centers in the United States.

This work was supported in part by the Patient-Centered Outcomes Research Institute (PCORI). TSOS is supported within the NIH Collaboratory by a cooperative agreement from the National Institute of Mental Health and by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.

For more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

September 22, 2020: New Article Highlights Ethical and Regulatory Challenges of Conducting PCTs

Posted on by Gina Uhlenbrauck

Cover of Ethics & Human ResearchA recent article in Ethics & Human Research describes the experience and management of regulatory noncompliance during the conduct of a large, multisite embedded pragmatic clinical trial (ePCT). The Trauma Survivors Outcomes and Support (TSOS), an NIH Collaboratory Trial, was a stepped-wedge, cluster-randomized clinical trial of a collaborative care intervention for injured patients with symptoms of posttraumatic stress disorder in 25 level 1 trauma centers in the United States. The article, Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight, was coauthored by members of the TSOS study team, the Collaboratory’s Ethics and Regulatory Core, and colleagues.

The authors describe how the study encountered variabilities in participant tracking across sites, which led to a study-wide internal audit and corrective action. The study team implemented a revision of the participant tracking system and retrained site staff in new procedures. Based on the lessons learned, the authors offer recommendations for future PCTs and relevant stakeholders, including institutional review boards, data safety and monitoring boards, institutions, and trial sponsors.

Among the recommendations:

  • Use a single IRB of record to streamline regulatory processes and reduce variability among research sites.
  • Standardize research procedures but allow for real-world flexibility; this could include real-time, workflow-integrated study logging that captures and documents provider turnover and regulatory training compliance.
  • Implement thorough, specific, and practical training in procedures, especially around participant enrollment and tracking.
  • Ensure that research procedures, monitoring and oversight plans, and training are study specific to account for unique issues, contexts, and needs.

Thoughtful planning, communication, and development and dissemination of standardized procedures remain hallmarks of successful research operations both to advance biomedical research and to ensure appropriate safeguards for its participants. –Roberts et al.