TSOS

August 11, 2025: New Living Textbook Chapter Explores Implementation in Pragmatic Clinical Trials

Posted on by Karen Staman

The NIH Pragmatic Trials Collaboratory Implementation Science Core, led by Devon Check and Hayden Bosworth, has developed a new chapter on implementation to assist study teams with the complex process of using and studying implementation strategies to help implement research findings into clinical care. The chapter includes sections on:

Case studies are used to illustrate how pragmatic clinical trials embedded in healthcare systems use implementation frameworks, including examples from RAMP, BEST-ICU, STOP CRC, TSOS, ABATE, STEP-2, and GRACE.

For more, see our collection of chapters on Dissemination and Implementation, which includes chapters on Dissemination to Different Stakeholders, Data Sharing and Embedded Research, and End-of-Trial Decision-Making.

December 12, 2024: A Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory

Posted on by Damon Seils

A graphic showing a collection of journal covers.In 2024, experts from the NIH Pragmatic Trials Collaboratory published the results of newly completed studies, shared insights from program leadership, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials. Their work included perspectives from the Coordinating Center, best practices from the Core Working Groups, and results from the NIH Collaboratory Trials.

The program contributed more than 30 articles to the peer-reviewed literature this year, including the primary results of the ICD-Pieces and Nudge trials. Several cross-Core and cross-Trial collaborations led to the sharing of important lessons from the conduct of multiple NIH Collaboratory Trials.

The total number of published articles from the program surpassed 340.

Coordinating Center

Cross-Core and Cross-Trial Collaborations

Core Working Groups

Biostatistics and Study Design Core

Electronic Health Records Core

Ethics and Regulatory Core

Community Health Improvement Core

Implementation Science Core

Patient-Centered Outcomes Core

NIH Collaboratory Trials

ABATE Infection

BackInAction

BeatPain Utah

EMBED

FM-TIPS

GGC4H

GRACE

I CAN DO Surgical ACP

ICD-Pieces

LIRE

NOHARM

Nudge

OPTIMUM

PRIM-ER

PROVEN

SPOT

STOP CRC

TSOS

September 16, 2024: Researchers Examine Feasibility of Enhanced TSOS Intervention for Trauma Survivors in Australia

Posted on by Damon Seils

Disability and RehabilitationResearchers in Australia examined the feasibility of implementing an enhanced version of the TSOS collaborative care intervention for patients at risk of persistent posttraumatic stress disorder (PTSD) and pain symptoms after major traumatic injury. They found the intervention was highly valued by most participants and could be implemented at low cost in the trauma system in Victoria, Australia.

The report was published this month in Disability and Rehabilitation.

The TSOS study, an NIH Collaboratory Trial led by principal investigator Doug Zatzick of the University of Washington, 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.

In the feasibility study in Australia, the researchers enrolled patients who had a range of complex clinical and social experiences and trauma-related concerns, many of whom would have been excluded from traditional trials of psychology-informed interventions. The study offers preliminary evidence for whether the intervention led to reduced PTSD symptoms and pain-related disability. Future effectiveness and efficacy studies will be needed.

Read the full report.

TSOS was supported within the NIH Pragmatic Trials Collaboratory by a cooperative agreement from the National Institute of Mental Health. Learn more about the NIH Collaboratory Trials.

May 22, 2024: In TSOS Study, Clinical and Demographic Characteristics Predict Response to PTSD Interventions

Posted on by Damon Seils

Photo of Dr. Doug Zatzick
Dr. Doug Zatzick

In a secondary analysis of data from the TSOS study pooled with data from 2 other comparative effectiveness trials, baseline patient clinical and demographic characteristics were associated with persistent symptoms of posttraumatic stress disorder (PTSD) and diminished treatment response. The report was published online ahead of print in Psychiatry.

The TSOS study, an NIH Collaboratory Trial led by principal investigator Doug Zatzick of the University of Washington, 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.

In the new analysis, a subgroup of injured trauma survivors developed persistent PTSD symptoms after hospital admission and were less likely than other patients to respond to stepped care interventions. Patients with 3 or more of the baseline risk characteristics identified in the analysis were significantly less likely to engage in treatment and required more clinician time. The baseline risk characteristics included greater early PTSD symptoms, greater numbers of pre-injury trauma, pre-injury PTSD symptoms, race other than White, and unemployment.

Read the full report.

TSOS 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 23, 2024: Younger, Uninsured Patients Among Those at Greatest Risk for Missing Follow-up Assessments in Trauma Research

Posted on by Damon Seils

Cover image of Injury journalIn an analysis of data from the TSOS study, younger patients and patients who were publicly insured or uninsured were among several subgroups of patients who were at significant risk of missing follow-up outcome assessments. The report was published this week in Injury.

Successful studies of interventions for patients with posttraumatic stress disorder (PTSD) require engaging with injured patients in long-term follow-up. Addressing the needs of patients who are at risk of not engaging in follow-up could improve outcomes and intervention procedures at trauma centers. Yet, many injury survivors are at significant risk for not following up with trauma outcome assessment procedures.

In the new secondary analysis from the TSOS study, the research team examined relationships between patients' clinical and demographic characteristics and rates of follow-up in the study. They found that younger age, public or no insurance, fewer comorbid conditions, and worse mental health function before injury were associated with lack of follow-up. Infrequent cell phone use and lack of internet access were also associated with missing outcome assessments.

Read the full report.

The TSOS study, an NIH Collaboratory Trial led by principal investigator Doug Zatzick of the University of Washington, 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.

TSOS 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.

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 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