Dataset Information

Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial.

ABSTRACT: Posttraumatic stress disorder (PTSD) and its comorbidities are endemic among injured trauma survivors. Previous collaborative care trials targeting PTSD after injury have been effective, but they have required intensive clinical resources. The present pragmatic clinical trial randomized acutely injured trauma survivors who screened positive on an automated electronic medical record PTSD assessment to collaborative care intervention (n = 60) and usual care control (n = 61) conditions. The stepped measurement-based intervention included care management, psychopharmacology, and psychotherapy elements. Embedded within the intervention were a series of information technology (IT) components. PTSD symptoms were assessed with the PTSD Checklist at baseline prerandomization and again, 1-, 3-, and 6-months postinjury. IT utilization was also assessed. The technology-assisted intervention required a median of 2.25 hours (interquartile range = 1.57 hours) per patient. The intervention was associated with modest symptom reductions, but beyond the margin of statistical significance in the unadjusted model: F(2, 204) = 2.95, p = .055. The covariate adjusted regression was significant: F(2, 204) = 3.06, p = .049. The PTSD intervention effect was greatest at the 3-month (Cohen's effect size d = 0.35, F(1, 204) = 4.11, p = .044) and 6-month (d = 0.38, F(1, 204) = 4.10, p = .044) time points. IT-enhanced collaborative care was associated with modest PTSD symptom reductions and reduced delivery times; the intervention model could potentially facilitate efficient PTSD treatment after injury.

SUBMITTER: Zatzick D

PROVIDER: S-EPMC5549940 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial.

Zatzick Douglas D O'Connor Stephen S SS Russo Joan J Wang Jin J Bush Nigel N Love Jeff J Peterson Roselyn R Ingraham Leah L Darnell Doyanne D Whiteside Lauren L Van Eaton Erik E

Journal of traumatic stress 20151001 5

Posttraumatic stress disorder (PTSD) and its comorbidities are endemic among injured trauma survivors. Previous collaborative care trials targeting PTSD after injury have been effective, but they have required intensive clinical resources. The present pragmatic clinical trial randomized acutely injured trauma survivors who screened positive on an automated electronic medical record PTSD assessment to collaborative care intervention (n = 60) and usual care control (n = 61) conditions. The stepped ...[more]

PMID: 26467327

Similar Datasets

Project description:ImportanceTo date, few multisite investigations have evaluated early interventions for injured patients with posttraumatic stress disorder (PTSD) symptoms.ObjectiveTo simultaneously assess the effectiveness and implementation of a brief stepped collaborative care intervention targeting PTSD and comorbidity.Design, setting, and participantsA stepped-wedge cluster randomized clinical trial was conducted at 25 US level I trauma centers. Participants included hospitalized survivors of physical injury who underwent a 2-step evaluation for PTSD symptoms. Patients reporting high levels of distress on the PTSD Checklist (PCL-C) were randomized (N = 635) per the stepped-wedge protocol to enhanced usual care control (n = 370) or intervention (n = 265) conditions. The study was conducted from January 4, 2016, through November 2018. Data analysis was performed from November 4, 2019, to December 8, 2020.InterventionsThe Trauma Survivors Outcomes and Support collaborative care intervention included proactive injury case management that assisted patients transitioning from hospital inpatient to outpatient and community settings. The intervention also integrated evidence-based pharmacotherapy and psychotherapeutic elements targeting PTSD symptoms and comorbidity.Main outcomes and measuresThe primary study outcome was PTSD symptoms assessed with the PCL-C at baseline in the surgical ward and at 3, 6, and 12 months postinjury. Secondary outcomes included depressive symptoms, alcohol use, and physical function. Subgroup analyses examined the effect of baseline risk factors for enduring PTSD and quality of protocol implementation on study outcomes. Primary statistical analyses were conducted using the intent-to-treat sample.ResultsA total of 327 men (51.5%) were included in analysis; mean (SD) age was 39.0 (14.2) years. The investigation attained follow-up of 75% to 80% of the participants at 3 to 12 months. The intervention lasted a mean (SD) of 122 (132) minutes. Mixed model regression analyses revealed statistically significant changes in PCL-C scores for intervention patients compared with control patients at 6 months (difference, -2.57; 95% CI, -5.12 to -0.03; effect size, 0.18; P < .05) but not 12 months (difference, -1.27; 95% CI, -4.26 to 1.73; effect size, 0.08; P = .35). Subgroup analyses revealed larger PTSD treatment effects for patients with 3 or more baseline risk factors for enduring PTSD and for patients, including firearm injury survivors, treated at trauma centers with good or excellent protocol implementation. Intervention effects for secondary outcomes did not attain statistical significance.Conclusions and relevanceA brief stepped collaborative care intervention was associated with significant 6-month but not 12-month PTSD symptom reductions. Greater baseline PTSD risk and good or excellent trauma center protocol implementation were associated with larger PTSD treatment effects. Orchestrated efforts targeting policy and funding should systematically incorporate the study findings into national trauma center requirements and verification criteria.Trial registrationClinicalTrials.gov Identifier: NCT02655354.

Project description:BACKGROUND:Despite the growing consensus that collaborative care is effective, limited research has focused on the importance of collaborative care fidelity as it relates to mental health clinical outcomes. OBJECTIVE:To assess the relationship of collaborative care fidelity on symptom trajectories and clinical outcomes among military service members enrolled in a multi-site randomized controlled trial for the treatment of depression and posttraumatic stress disorder (PTSD). DESIGN:Study data for our analyses came from a two-parallel arm randomized trial that evaluated the effectiveness of a centralized collaborative care model compared to the existing collaborative care model for the treatment of PTSD and depression. All patients were included in the analyses to evaluate how longitudinal trajectories of PTSD and depression scores differed across various collaborative care fidelity groupings. PARTICIPANTS:A total of 666 US Military Service members screening positive for probable PTSD or depression through primary care. MAIN MEASURES:Disease registry data from a web-based clinical management support tool was used to measure collaborative care fidelity for patients enrolled in the trial. Participant depression and PTSD symptoms were collected independently from research survey assessments at four time points across the 1-year trial period. Treatment utilization records were acquired from the Military Health System administrative records to determine mental health service use. KEY RESULTS:Consistent and late fidelity to the collaborative care model predicted an improving symptom trajectory over the course of treatment. This effect was more pronounced for patients with depression than for patients with PTSD. CONCLUSIONS:Long-term fidelity to key collaborative care elements throughout care episodes may improve depression outcomes, particularly for patients with elevated symptoms. More controlled research is needed to further understand the influence of collaborative care fidelity on clinical outcomes. TRIAL REGISTRATION:Clinicaltrials.gov Identifier NCT01492348.

Project description: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.

Project description:BackgroundPosttraumatic stress disorder (PTSD) is characterized as a disorder of exaggerated defensive physiological arousal. The novel aim of the present research was to investigate within PTSD a potential dose-response relationship between past trauma recurrence and current comorbidity and intensity of physiological reactions to imagery of trauma and other aversive scenarios.MethodsA community sample of principal PTSD (n = 49; 22 single-trauma exposed, 27 multiple-trauma exposed) and control (n = 76; 46 never-trauma exposed, 30 trauma exposed) participants imagined threatening and neutral events while acoustic startle probes were presented and the eye-blink response (orbicularis occuli) was recorded. Changes in heart rate, skin conductance level, and facial expressivity were also indexed.ResultsOverall, PTSD patients exceeded control participants in startle reflex, autonomic responding, and facial expressivity during idiographic trauma imagery and, though less pronounced, showed heightened reactivity to standard anger, panic, and physical danger imagery. Concerning subgroups, control participants with and without trauma exposure showed isomorphic patterns. Within PTSD, only the single-trauma patients evinced robust startle and autonomic responses, exceeding both control participants and multiple-trauma PTSD. Despite greater reported arousal, the multiple-trauma relative to single-trauma PTSD group showed blunted defensive reactivity associated with more chronic and severe PTSD, greater mood and anxiety disorder comorbidity, and more pervasive dimensional dysphoria (e.g., depression, trait anxiety).ConclusionsWhereas PTSD patients generally show marked physiological arousal during aversive imagery, concordant with self-reported distress, the most symptomatic patients with histories of severe, cumulative traumatization show discordant physiological hyporeactivity, perhaps attributable to sustained high stress and an egregious, persistent negative affectivity that ultimately compromises defensive responding.

Project description:ImportancePsychiatric interventions offered after natural disasters commonly address subsyndromal symptom presentations, but often remain insufficient to reduce the burden of chronic posttraumatic stress disorder (PTSD).ObjectiveTo simulate a comparison of a stepped care case-finding intervention (stepped care [SC]) vs a moderate-strength single-level intervention (usual care [UC]) on treatment effectiveness and incremental cost-effectiveness in the 2 years after a natural disaster.Design, setting, and participantsThis study, which simulated treatment scenarios that start 4 weeks after landfall of Hurricane Sandy on October 29, 2012, and ending 2 years later, created a model of 2 642 713 simulated agents living in the areas of New York City affected by Hurricane Sandy.InterventionsUnder SC, cases were referred to cognitive behavioral therapy, an evidence-based therapy that aims to improve symptoms through problem solving and by changing thoughts and behaviors; noncases were referred to Skills for Psychological Recovery, an evidence-informed therapy that aims to reduce distress and improve coping and functioning. Under UC, all patients were referred only to Skills for Psychological Recovery.Main outcomes and measuresThe reach of SC compared with UC for 2 years, the 2-year reduction in prevalence of PTSD among the full population, the 2-year reduction in the proportion of PTSD cases among initial cases, and 10-year incremental cost-effectiveness.ResultsThis population of 2 642 713 simulated agents was initialized with a PTSD prevalence of 4.38% (115 751 cases) and distributions of sex (52.6% female and 47.4% male) and age (33.9% aged 18-34 years, 49.0% aged 35-64 years, and 17.1% aged ≥65 years) that were comparable with population estimates in the areas of New York City affected by Hurricane Sandy. Stepped care was associated with greater reach and was superior to UC in reducing the prevalence of PTSD in the full population: absolute benefit was clear at 6 months (risk difference [RD], -0.004; 95% CI, -0.004 to -0.004), improving through 1.25 years (RD, -0.015; 95% CI, -0.015 to -0.014). Relative benefits of SC were clear at 6 months (risk ratio, 0.905; 95% CI, 0.898-0.913), with continued gains through 1.75 years (risk ratio, 0.615; 95% CI, 0.609-0.662). The absolute benefit of SC among cases was much stronger, emerging at 3 months (RD, -0.006; 95% CI, -0.007 to -0.005) and increasing through 1.5 years (RD, -0.338; 95% CI, -0.342 to -0.335). Relative benefits of SC among cases were equivalent to those observed in the full population. The incremental cost-effectiveness of SC compared with UC was $3428.71 to $6857.68 per disability-adjusted life year avoided, and $0.80 to $1.61 per PTSD-free day.Conclusions and relevanceThe results of this simulation study suggest that SC for individuals with PTSD in the aftermath of a natural disaster is associated with greater reach than UC, more effectiveness than UC, and is well within the range of acceptability for cost-effectiveness. Results should be considered in light of limitations inherent to agent-based models.

Project description:BackgroundCollaborative care for depression is more effective in improving treatment outcomes than primary care physicians' (PCPs) usual care (UC). However, few trials of collaborative care have targeted anxiety.ObjectiveTo examine the impact and 12-month durability of a centralized, telephone-delivered, stepped collaborative care intervention (CC) for treating anxiety disorders across a network of primary care practices.DesignRandomized controlled trial with blinded outcome assessments.ParticipantsA total of 329 patients aged 18-64 referred by their PCPs in response to an electronic medical record (EMR) prompt. They include 250 highly anxious patients randomized to either CC or to UC, and 79 moderately anxious patients who were triaged to a watchful waiting (WW) cohort and later randomized if their conditions clinically deteriorated.InterventionTwelve months of telephone-delivered CC involving non-mental health professionals who provided patients with basic psycho-education, assessed preferences for guideline-based pharmacotherapy, monitored treatment responses, and informed PCPs of their patients' care preferences and progress via the EMR.Main measuresMental health-related quality of life ([HRQoL]; SF-36 MCS); secondary outcomes: anxiety (Hamilton Anxiety Rating Scale [SIGH-A], Panic Disorder Severity Scale) and mood (PHQ-9).Key resultsAt 12-month follow-up, highly anxious patients randomized to CC reported improved mental HRQoL (effect size [ES]: 0.38 [95 % CI: 0.13-0.63]; P = 0.003), anxiety (SIGH-A ES: 0.30 [0.05-0.55]; P = 0.02), and mood (ES: 0.45 [0.19-0.71] P = 0.001) versus UC. These improvements were sustained for 12 months among African-Americans (ES: 0.70-1.14) and men (ES: 0.43-0.93). Of the 79 WW patients, 29 % met severity criteria for randomization, and regardless of treatment assignment, WW patients reported fewer anxiety and mood symptoms and better mental HRQoL over the full 24-month follow-up period than highly anxious patients who were randomized at baseline.ConclusionsTelephone-delivered, centralized, stepped CC improves mental HRQoL, anxiety and mood symptoms. These improvements were durable and particularly evident among those most anxious at baseline, and among African-Americans and men.

Dataset Information

Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial.

Publications

Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets