Dataset Information

Protocol for a randomised clinical trial of multimodal postconcussion symptom treatment and recovery: the Concussion Essentials study.

ABSTRACT:

Introduction

While most children recover from a concussion shortly after injury, approximately 30% experience persistent postconcussive symptoms (pPCS) beyond 1-month postinjury. Existing research into the treatment of pPCS have evaluated unimodal approaches, despite evidence suggesting that pPCS likely represent an interaction across various symptom clusters. The primary aim of this study is to evaluate the effectiveness of a multimodal, symptom-tailored intervention to accelerate symptom recovery and increase the proportion of children with resolved symptoms at 3?months postconcussion.

Methods and analysis

In this open-label, assessor-blinded, randomised clinical trial, children with concussion aged 8-18 years will be recruited from The Royal Children's Hospital (The RCH) emergency department, or referred by a clinician, within 17?days of initial injury. Based on parent ratings of their child's PCS at ~10 days postinjury, symptomatic children (?2 symptoms at least 1-point above those endorsed preinjury) will undergo a baseline assessment at 3?weeks postinjury and randomised into either Concussion Essentials (CE, n=108), a multimodal, interdisciplinary delivered, symptom-tailored treatment involving physiotherapy, psychology and education, or usual care (UC, n=108) study arms. CE participants will receive 1?hour of intervention each week, for up to 8?weeks or until pPCS resolve. A postprogramme assessment will be conducted at 3?months postinjury for all participants. Effectiveness of the CE intervention will be determined by the proportion of participants for whom pPCS have resolved at the postprogramme assessment (primary outcome) relative to the UC group. Secondary outcome analyses will examine whether children receiving CE are more likely to demonstrate resolution of pPCS, earlier return to normal activity, higher quality of life and a lower rate of utilisation of health services, compared with the UC group.

Ethics and dissemination

Ethics were approved by The RCH Human Research Ethics Committee (HREC: 37100). Parent, and for mature minors, participant consent, will be obtained prior to commencement of the trial. Study results will be disseminated at international conferences and international peer-reviewed journals.

Trial registration number

ACTRN12617000418370; pre-results.

SUBMITTER: Anderson V

PROVIDER: S-EPMC7880104 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Protocol for a randomised clinical trial of multimodal postconcussion symptom treatment and recovery: the Concussion Essentials study.

Anderson Vicki V Rausa Vanessa C VC Anderson Nicholas N Parkin Georgia G Clarke Cathriona C Davies Katie K McKinlay Audrey A Crichton Ali A Davis Gavin A GA Dalziel Kim K Dunne Kevin K Barnett Peter P Hearps Stephen Jc SJ Takagi Michael M Babl Franz E FE

BMJ open 20210211 2

<h4>Introduction</h4>While most children recover from a concussion shortly after injury, approximately 30% experience persistent postconcussive symptoms (pPCS) beyond 1-month postinjury. Existing research into the treatment of pPCS have evaluated unimodal approaches, despite evidence suggesting that pPCS likely represent an interaction across various symptom clusters. The primary aim of this study is to evaluate the effectiveness of a multimodal, symptom-tailored intervention to accelerate sympt ...[more]

PMID: 33574145

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Project description:INTRODUCTION:Current management of concussion consists of early education, rest until symptom free, with gradual return to school and physical activity protocols. Although this management strategy is effective for most youth who sustain a concussion, it is not an appropriate strategy for youth with persistent postconcussion symptoms. Prolonged rest and periods of restricted activity may place youth at risk for secondary issues and contribute to the chronicity of postconcussion symptoms. The purpose of this study is to evaluate the efficacy of an active rehabilitation protocol for youth who are slow to recover from concussion. It is hypothesised that an active rehabilitation intervention can reduce persistent postconcussion symptoms, improve function and facilitate return to activity. This article describes the research protocol. METHODS AND ANALYSIS:This is a randomised clinical trial with blinded outcome measurement. Participants will be recruited and randomly assigned to 1 of 2 treatment groups, an active rehabilitation intervention or a standard care education group. Both groups will receive standard care education. However, the active rehabilitation group will participate in an additional low-intensity exercise programme consisting of aerobic, coordination and visualisation exercises. Both the active rehabilitation and the standard care education interventions will be 6?weeks in duration. The primary outcome measure is postconcussion symptoms. Secondary outcome measures include functional recovery (cognitive, motor, psychosocial and emotional functioning) and return to activity. Outcome measures will be administered preintervention and postintervention. The primary outcome measure will also be repeated 2?weeks into the intervention period. ETHICS AND DISSEMINATION:This study has been approved by the Holland Bloorview Kids Rehabilitation Hospital research ethics board (REB # 13-459). The findings from this study will be shared with the general public, sport associations, relevant brain injury organisations and healthcare professionals. TRIAL REGISTRATION NUMBER:NCT02257749.

Project description:ImportanceConcussions are a common occurrence in young athletes. Hypobaric hypoxemia, such as that experienced during airplane travel, can potentially cause alterations to cerebral blood flow and increased neuroinflammatory response. It remains unknown whether flying early after a concussion may influence the clinical course of injury.ObjectiveTo determine whether there is an association between concussion recovery and airplane travel in collegiate athletes and military cadets.Design, setting, and participantsThis cohort study was conducted by the National Collegiate Athletic Association and US Department of Defense Concussion Assessment, Research, and Education Consortium from August 3, 2014, to September 13, 2018. Participant groups were categorized by those who flew within 72 hours of injury and those who did not fly. All participants included in the final analyses had complete data of interest and only 1 injury during the study. Data analysis was performed from September 2018 to March 2020.Main outcomes and measuresRecovery outcome measures were defined as time (in days) from injury to return to activity, school, and baseline symptoms. Symptom and headache severity scores were derived from the Sports Concussion Assessment Tool-Third Edition. Scores for both groups were taken at baseline and a median of 2 days after injury.ResultsA total of 92 participants who flew (mean [SD] age, 19.1 [1.2] years; 55 male [59.8%]) and 1383 participants who did not fly (mean [SD] age, 18.9 [1.3] years; 809 male [58.5%]) were included in the analysis of symptom recovery outcomes (analysis 1). Similarly, 100 participants who flew (mean [SD] age, 19.2 [1.2] years; 63 male [63.0%]) and 1577 participants who did not fly (mean [SD] age, 18.9 [1.3] years; 916 male [58.1%]) were included in the analysis of symptom severity outcomes (analysis 2). No significant group differences were found regarding recovery outcome measures. Likewise, there were no group differences in symptom (estimated mean difference, 0.029; 95% CI, -0.083 to 0.144; P = .67) or headache (estimated mean difference, -0.007; 95% CI, -0.094 to 0.081; P = .91) severity scores.Conclusions and relevanceAirplane travel early after concussion was not associated with recovery or severity of concussion symptoms. These findings may help guide future recommendations on flight travel after concussion in athletes.

Project description:ImportanceThe natural progression of symptom change and recovery remains poorly defined in children after concussion.ObjectivesTo describe the natural progression of symptom change by age group (5-7, 8-12, and 13-18 years) and sex, as well as to develop centile curves to inform families about children after injury recovery.Design, setting, and participantsPlanned secondary analysis of a prospective multicenter cohort study (Predicting Persistent Postconcussive Problems in Pediatrics). The setting was 9 pediatric emergency departments within the Pediatric Emergency Research Canada (PERC) network. Participants were aged 5 to 18 years with acute concussion, enrolled from August 1, 2013, to May 31, 2015, and data analyses were performed between January 2018 and March 2018.ExposuresParticipants had a concussion consistent with the Zurich Consensus Statement on Concussion in Sport diagnostic criteria and 85% completeness of the Postconcussion Symptom Inventory (PCSI) at each time point.Main outcomes and measuresThe primary outcome was symptom change, defined as current rating minus preinjury rating (delta score), at presentation and 1, 2, 4, 8, and 12 weeks after injury, measured using the PCSI. Symptoms were self-rated for ages 8 to 18 years and rated by the child and parent for ages 5 to 7 years. The secondary outcome was recovery, defined as no change in symptoms relative to current preinjury PCSI ratings (delta score = 0). Mixed-effects models incorporated the total score, adjusting for random effects (site and participant variability), fixed-effects indicators (age, sex, time, age by time interaction, and sex by time interaction), and variables associated with recovery. Recovery centile curves by age and sex were computed.ResultsA total of 3063 children (median age, 12.0 years [interquartile range, 9.2-14.6 years]; 60.7% male) completed the primary outcome; 2716 were included in the primary outcome analysis. For the group aged 5 to 7 years, symptom change primarily occurred the first week after injury; by 2 weeks, 75.6% of symptoms had improved (PCSI change between 0 and 2 weeks, -5.3; 95% CI, -5.5 to -5.0). For the groups aged 8 to 12 years and 13 to 18 years, symptom change was prominent the first 2 weeks but flattened between 2 and 4 weeks. By 4 weeks, 83.6% and 86.2% of symptoms, respectively, had improved for the groups aged 8 to 12 years (PCSI change between 0 and 4 weeks, -9.0; 95% CI, -9.6 to -8.4) and 13 to 18 years (PCSI change between 0 and 4 weeks, -28.6; 95% CI, -30.8 to -26.3). Sex by time interaction was significant only for the adolescent group (β = 0.32; 95% CI, 0.21-0.43; P < .001). Most adolescent girls had not recovered by week 12.Conclusions and relevanceSymptom improvement primarily occurs in the first 2 weeks after concussion in children and in the first 4 weeks after concussion in preadolescents and male adolescents. Female adolescents appear to have protracted recovery. The derived recovery curves may be useful for evidence-based anticipatory guidance.

Project description:BackgroundUp to 25% of concussed individuals experience persistent post-concussion symptoms (PPCSs) which may interfere with the return to pre-injury activities and cause significant stress. Given that multiple etiological factors are thought to contribute to PPCSs, an interdisciplinary approach is recommended. This pilot study aims to primarily investigate the feasibility of a novel interdisciplinary treatment for PPCSs. Given this intervention is novel, uncertainty exists in terms of potential recruitment and retention rates, adverse events, and treatment adherence and fidelity. These factors will be explored to inform the feasibility of a phase-2 randomised controlled trial. Preliminary efficacy of this intervention will also be explored.MethodsFifteen individuals with mild traumatic brain injury and PPCSs will receive up to 12 weeks of interdisciplinary treatments including psychology, physiotherapy, and medical interventions. Primary feasibility outcomes including data on recruitment and retention rates and treatment adherence will be explored descriptively. The cognitive therapy rating scale will be used to assess treatment fidelity. A single-case series with multiple baseline design will be used to explore preliminary efficacy. Participants will be randomly assigned to baseline phases of 2, 4, or 6 weeks. Regarding patient-centred secondary outcomes, the Rivermead Post-Concussion Symptoms Questionnaire will be assessed three times a week during baseline and treatment phases. Secondary outcomes also include measures of mood, sleep and fatigue, physical functioning, return to activity, and health-related quality of life. Patient-centred outcomes will be assessed at baseline, pretreatment, post-treatment, and one- and three-month follow-up. Thematic analysis of participant experiences will be explored through qualitative interviews.DiscussionResults from this trial will inform the feasibility and preliminary efficacy of this interdisciplinary concussion intervention and whether proceeding to a future definitive phase-2 randomised controlled trial is worthwhile. Understanding the end-user perspective of the treatment will also enable modifications to the treatment protocol for future trials to best suit the needs of individuals with PPCSs after mTBI. Outcomes from this trial can be directly translated into community rehabilitation programmes.Trial registrationANZCTR, ACTRN12620001111965. Registered 27 October 2020, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379118.

Project description:BACKGROUND:Despite evidence from clinical trials that intravenous (IV) thrombolysis is a cost-effective treatment for selected acute ischaemic stroke patients, there remain large variations in the rate of IV thrombolysis delivery between stroke services. This study is evaluating whether an enhanced care pathway delivered by paramedics (the Paramedic Acute Stroke Treatment Assessment (PASTA)) could increase the number of patients who receive IV thrombolysis treatment. METHODS:Study design: Cluster randomised trial with economic analysis and parallel process evaluation. SETTING:National Health Service ambulance services, emergency departments and hyper-acute stroke units within three geographical regions of England and Wales. Randomisation: Ambulance stations within each region are the units of randomisation. According to station allocation, paramedics based at a station deliver the PASTA pathway (intervention) or continue with standard stroke care (control). Study intervention: The PASTA pathway includes structured pre-hospital information collection, prompted pre-notification, structured handover of information in hospital and assistance with simple tasks during the initial hospital assessment. Study-trained intervention group paramedics deliver this pathway to adults within 4 h of suspected stroke onset. Study control: Standard stroke care according to national and local guidelines for the pre-hospital and hospital assessment of suspected stroke. PARTICIPANTS:Participants enrolled in the study are adults with confirmed stroke who were assessed by a study paramedic within 4 h of symptom onset. PRIMARY OUTCOME:Proportion of participants receiving IV thrombolysis. SAMPLE SIZE:1297 participants provide 90% power to detect a 10% difference in the proportion of patients receiving IV thrombolysis. DISCUSSION:The results from this trial will determine whether an enhanced care pathway delivered by paramedics can increase thrombolysis delivery rates. TRIAL REGISTRATION:ISRCTN registry, ISRCTN12418919 . Registered on 5 November 2015.

Project description:BackgroundKidney failure prevalence is increasing worldwide. Haemodialysis, peritoneal dialysis or kidney transplantation are undertaken to extend life with kidney failure. People receiving haemodialysis commonly experience fatigue, pain, nausea, cramping, itching, sleeping difficulties, anxiety and depression. This symptom burden contributes to poor health-related quality of life (QOL) and is a major reason for treatment withdrawal and death. The Symptom monitoring WIth Feedback Trial (SWIFT) will test the hypothesis that regular symptom monitoring with feedback to people receiving haemodialysis and their treating clinical team can improve QOL.MethodsWe are conducting an Australia and New Zealand Dialysis and Transplant (ANZDATA) registry-based cluster randomised controlled trial to determine the clinical- and cost-effectiveness at 12 months, of 3-monthly symptom monitoring using the Integrated Palliative Outcome Scale-Renal (IPOS-Renal) survey with clinician feedback, compared with usual care among adults treated with haemodialysis. Participants complete symptom scoring using a tablet, which are provided to participants and to clinicians. The trial aims to recruit 143 satellite haemodialysis centres, (up to 2400 participants). The primary outcome is change in health-related QOL, as measured by EuroQol 5-Dimension, 5-Level (EQ-5D-5L) instrument. Secondary outcomes include overall survival, symptom severity (including haemodialysis-associated fatigue), healthcare utilisation and cost-effectiveness.DiscussionSWIFT is the first registry-based trial in the Australian haemodialysis population to investigate whether regular symptom monitoring with feedback to participants and clinicians improves QOL. SWIFT is embedded in the ANZDATA Registry facilitating pragmatic recruitment from public and private dialysis clinics, throughout Australia. SWIFT will inform future collection, storage and reporting of patient-reported outcome measures (PROMs) within a clinical quality registry. As the first trial to rigorously estimate the efficacy and cost-effectiveness of routine PROMs collection and reporting in haemodialysis units, SWIFT will provide invaluable information to health services, clinicians and researchers working to improve the lives of those with kidney failure.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12620001061921 . Registered on 16 October 2020.

Project description:IntroductionPersistent symptoms after mild traumatic brain injury (mTBI) negatively affect daily functioning and quality of life. Fear avoidance behaviour, a coping style in which people avoid or escape from activities or situations that they expect will exacerbate their symptoms, maybe a particularly potent and modifiable risk factor for chronic disability after mTBI. This study will evaluate the efficacy of graded exposure therapy (GET) for reducing persistent symptoms following mTBI, with two primary aims: (1) To determine whether GET is more effective than usual care; (2) to identify for whom GET is the most effective treatment option, by evaluating whether baseline fear avoidance moderates differences between GET and an active comparator (prescribed aerobic exercise). Our findings will guide evidence-based care after mTBI and enable better matching of mTBI patients to treatments.Methods and analysisWe will conduct a multisite randomised controlled trial with three arms. Participants (n=220) will be recruited from concussion clinics and emergency departments in three Canadian provinces and randomly assigned (1:2:2 ratio) to receive enhanced usual care, GET or prescribed aerobic exercise. The outcome assessment will occur remotely 14-18 weeks following baseline assessment, after completing the 12-week treatment phase. The primary outcome will be symptom severity (Rivermead Post-concussion Symptoms Questionnaire).Ethics and disseminationInformed consent will be obtained from all participants. All study procedures were approved by the local research ethics boards (University of British Columbia Clinical Research Ethics Board, University of Calgary Conjoint Health Research Ethics Board, University Health Network Research Ethics Board-Panel D). Operational approvals were obtained for Vancouver Coastal Health Research Institute and Provincial Health Services Authority. If GET proves effective, we will disseminate the GET treatment manual and present instructional workshops for clinicians.Trial registration numberClinicalTrials.gov #NCT05365776.

Project description:IntroductionAn increasing proportion of cancer surgeries are ambulatory procedures requiring a stay of 1 day or less in the hospital. Providing patients and their caregivers with ongoing, real-time support after discharge aids delivery of high-quality postoperative care in this new healthcare environment. Despite abundant evidence that patient self-reporting of symptoms improves quality of care, the most effective way to monitor and manage this self-reported information is not known.Methods and analysisThis is a two-armed randomised, controlled trial evaluating two approaches to the management of patient-reported data: (1) team monitoring, symptom monitoring by the clinical team, with nursing outreach if symptoms exceed normal limits, and (2) enhanced feedback, real-time feedback to patients about expected symptom severity, with patient-activated care as needed.Patients with breast, gynaecologic, urologic, and head and neck cancer undergoing ambulatory cancer surgery (n=2750) complete an electronic survey for up to 30 days after surgery that includes items from a validated instrument developed by the National Cancer Institute, the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Information provided to patients in the Enhanced Feedback group is procedure-specific and based on updated PRO-CTCAE data from previous patients. Qualitative interviews are also performed. The primary study outcomes assess unplanned emergency department visits and symptom-triggered interventions (eg, nursing calls and pain management referrals) within 30 days, and secondary outcomes assess the patient and caregiver experience (ie, patient engagement, patient anxiety and caregiver burden).Ethics and disseminationThis study is approved by the Institutional Review Board at Memorial Sloan Kettering Cancer Center. The relationships between the study team and stakeholders will be leveraged to disseminate study findings. Findings will be relevant in designing future coordinated care models targeting improved healthcare quality and patient experience.Trial registration numberNCT03178045.

Dataset Information

Protocol for a randomised clinical trial of multimodal postconcussion symptom treatment and recovery: the Concussion Essentials study.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Protocol for a randomised clinical trial of multimodal postconcussion symptom treatment and recovery: the Concussion Essentials study.

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