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Door-to-needle time for thrombolysis: a secondary analysis of the TIPS cluster randomised controlled trial.

ABSTRACT: OBJECTIVE:The current study aimed to evaluate the effects of a multi-component in-hospital intervention on the door-to-needle time for intravenous thrombolysis in acute ischaemic stroke. DESIGN:This study was a post hoc analysis of door-to-needle time data from a cluster-randomised controlled trial testing an intervention to boost intravenous thrombolysis implementation. SETTING:The study was conducted among 20 hospitals from three Australian states. PARTICIPANT:Eligible hospitals had a Stroke Care Unit or staffing equivalent to a stroke physician and a nurse, and were in the early stages of implementing thrombolysis. INTERVENTION:The intervention was multifaceted and developed using the behaviour change wheel and informed by breakthrough collaborative methodology using components of the health behaviour change wheel. PRIMARY AND SECONDARY OUTCOME MEASURES:The primary outcome for this analysis was door-to-needle time for thrombolysis and secondary outcome was the proportion of patients received thrombolysis within 60?min of hospital arrival. RESULTS:The intervention versus control difference in the door-to-needle times was non-significant overall nor significant by hospital classification. To provide additional context for the findings, we also evaluated the results within intervention and control hospitals. During the active-intervention period, the intervention hospitals showed a significant decrease in the door-to-needle time of 9.25?min (95%?CI: -16.93 to 1.57), but during the post-intervention period, the result was not significant. During the active intervention period, control hospitals also showed a significant decrease in the door-to-needle time of 5.26?min (95%?CI: -8.37 to -2.14) and during the post-intervention period, this trend continued with a decrease of 12.13?min (95%?CI: -17.44 to 6.81). CONCLUSION:Across these primary stroke care centres in Australia, a secular trend towards shorter door-to-needle times across both intervention and control hospitals was evident, however the TIPS (Thrombolysis ImPlementation in Stroke) intervention showed no overall effect on door-to-needle times in the randomised comparison. TRIAL REGISTRATION NUMBER:Trial Registration-URL: http://www.anzctr.org.au/ Unique Identifier: ACTRN 12613000939796.

SUBMITTER: Hasnain MG

PROVIDER: S-EPMC6924711 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Door-to-needle time for thrombolysis: a secondary analysis of the TIPS cluster randomised controlled trial.

Hasnain Md Golam MG Paul Christine L CL Attia John R JR Ryan Annika A Kerr Erin E D'Este Catherine C Hall Alix A Milton Abul Hasnat AH Hubbard Isobel J IJ Levi Christopher R CR

BMJ open 20191215 12

<h4>Objective</h4>The current study aimed to evaluate the effects of a multi-component in-hospital intervention on the door-to-needle time for intravenous thrombolysis in acute ischaemic stroke.<h4>Design</h4>This study was a post hoc analysis of door-to-needle time data from a cluster-randomised controlled trial testing an intervention to boost intravenous thrombolysis implementation.<h4>Setting</h4>The study was conducted among 20 hospitals from three Australian states.<h4>Participant</h4>Elig ...[more]

PMID: 31843839

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Project description:Better outcomes are obtained with stroke thrombolysis the more rapidly it is given, both in terms of the patient's level of functional ability and also mortality. Current UK performance targets (outside London) aim for a time of 45 minutes or less. Thrombolysis pathways involve multidisciplinary working across departmental boundaries as well as senior level decision making. Our system used telemedicine out of hours adding additional complexity to the pathway. The initial planning stages started by auditing current practice and mapping the existing pathway. The figures for door to needle times were held on a database on the stroke unit and collected in detail for the purposes of national reporting. The pathway was mapped by combining personal experience of working within the stroke service with the experiences of the general medical registrars who worked the system out of hours. The initial action was to present this information throughout the hospital at departmental meetings. Opinions were canvassed at these meetings on where the biggest barriers were within the pathway and how we could address them. An awareness campaign was held by advertising over the intranet. An intervention comprising the following elements was introduced over the period of a year: introduction of an ambulance pre-alert, revision of the existing pathway, and education to all those involved in thrombolysis. The cases where particularly long delays were noted were audited in more depth to identify barriers to flow through the system. This was reported in ward meetings for staff to contribute experience and to offer solutions. We went to commissioning group meetings to gain the support of the local ambulance service, and talked to A&E seniors about the project and the ways in which they could help. Median times were calculated from a stroke database. There was a fall in median door to needle time of 65.5 to 49 minutes over a period of 18 months. A complex intervention to improve door to needle time can and did produce good results with a reduction in times to within the London performance standards of care. The efficacy could be improved with an increased staffing level and provision of a formal setting within which to discuss changes and to keep up the momentum of change.

Project description:BackgroundRapid intravenous thrombolysis (IVT) for acute ischemic stroke (AIS) is crucial for improving outcomes. However, few randomized trials of interventions aimed at reducing in-hospital delay have been carried out in China. We aimed to evaluate the effect of a multicomponent intervention on thrombolytic door-to-needle time (DNT) of AIS patients via video teleconference based on the Behavior Change Wheel (BCW) method.Methods and findingsThis cluster-randomized trial, conducted between January 1, 2019 and December 31, 2019, randomly allocated 22 hospitals equally to PEITEM (Persuasion Environment reconstruction Incentivization Training Education Modeling) intervention or routine care plus stroke registry and subsequently enrolled 1,634 AIS patients receiving IVT within 4.5 hours upon stroke onset from participant hospitals. The PEITEM group received a 1-year PEITEM 6-component intervention based on the behavioral theory monthly via video teleconference. The primary outcome was the proportion of patients with a DNT of 60 minutes or less. A total of 987 patients participated in the PEITEM group (mean age, 69 years; female, 411 [41.6%]) and 647 patients in the control group (mean age, 70 years; female, 238 [36.8%]). Of all participants, the proportion of DNT ≤60 minutes in the PEITEM group was higher than in the control group (82.0% versus 73.3%; adjusted odds ratio, 1.77; 95% confidence interval (CI), 1.17 to 2.70; ICC, 0.04; P = 0.007). Among secondary outcomes, the average DNT was 43 minutes in the PEITEM group and 50 minutes in the control group (adjusted mean difference: -8.83; 95% CI, -14.03 to -3.64; ICC, 0.12; P = 0.001). Favorable functional outcome (score of 0 to 1 on the modified Rankin scale (mRS)) was achieved in 55.6% patients of the PEITEM group and 50.4% of the control group (adjusted odds ratio, 1.38; 95% CI, 1.00 to 1.90; ICC, 0.01; P = 0.049). Main study limitations include non-blinding of clinicians, and that specific interventions component responsible for the observed changes could not be determined.ConclusionsThe teleconference-delivered PEITEM intervention resulted in a moderate but clinically relevant shorter DNT and better functional outcome in AIS patients receiving IVT.Trial registrationClinicaltrials.gov NCT03317639.

Project description:Background The benefit of intravenous thrombolysis is time dependent. It remains unclear, however, whether dramatic shortening of door-to-needle time (DNT) among different types of hospitals nationwide does not compromise safety and still improves outcome. Methods and Results Multifaceted intervention to shorten DNT was introduced at a national level, and prospectively collected data from a registry between 2004 and 2019 were analyzed. Generalized estimating equation was used to identify the association between DNT and outcomes independently from prespecified baseline variables. The primary outcome was modified Rankin score 0 to 1 at 3 months, and secondary outcomes were parenchymal hemorrhage/intracerebral hemorrhage (ICH), any ICH, and death. Of 31 316 patients treated with intravenous thrombolysis alone, 18 861 (60%) had available data: age 70±13 years, National Institutes of Health Stroke Scale at baseline (median, 8; interquartile range, 5-14), and 45% men. DNT groups 0 to 20 minutes, 21 to 40 minutes, 41 to 60 minutes, and >60 minutes had 3536 (19%), 5333 (28%), 4856 (26%), and 5136 (27%) patients. National median DNT dropped from 74 minutes in 2004 to 22 minutes in 2019. Shorter DNT had proportional benefit: it increased the odds of achieving modified Rankin score 0 to 1 and decreased the odds of parenchymal hemorrhage/ICH, any ICH, and mortality. Patients with DNT ≤20 minutes, 21 to 40 minutes, and 41 to 60 minutes as compared with DNT >60 minutes had adjusted odds ratios for modified Rankin score 0 to 1 of the following: 1.30 (95% CI, 1.12-1.51), 1.33 (95% CI, 1.15-1.54), and 1.15 (95% CI, 1.02-1.29), and for parenchymal hemorrhage/ICH: 0.57 (95% CI, 0.45-0.71), 0.76 (95% CI, 0.61-0.94), 0.83 (95% CI, 0.70-0.99), respectively. Conclusions Ultrashort initiation of thrombolysis is feasible, improves outcome, and makes treatments safer because of fewer intracerebral hemorrhages. Stroke management should be optimized to initiate thrombolysis as soon as possible optimally within 20 minutes from arrival to a hospital.

Project description:Background Multiple studies have attempted to increase the rate of intravenous thrombolysis for ischemic stroke using interventions to promote adherence to guidelines. Still, many of them did not measure individual-level impact. This study aimed to make a posthoc comparison of the clinical outcomes of patients in the “Thrombolysis ImPlementation in Stroke (TIPS)” study, which aimed to improve rates of intravenous thrombolysis in Australia. Methods A posthoc analysis was conducted using individual-level patient data. Excellent (Three-month post treatment modified Rankin Score 0–2) and poor clinical outcome (Three-month post treatment modified Rankin Score 5–6) and post treatment parenchymal haematoma were the three main outcomes, and a mixed logistic regression model was used to assess the difference between the intervention and control groups. Results There was a non-significant higher odds of having an excellent clinical outcome of 57% (odds ratio: 1.57; 95% CI: 0.73–3.39) and 33% (odds ratio: 1.33; 95% CI: 0.73–2.44) during the active-and post-intervention period respectively, for the intervention compared to the control group. A non-significant lower odds of having a poor clinical outcome was also found in the intervention, relative to control group of 4% (odds ratio: 0.96; 95% CI: 0.56–2.07) and higher odds of having poor outcome of 44% (odds ratio: 1.44 95% CI: 0.61–3.41) during both active and post-intervention period respectively. Similarly, a non-significant lower odds of parenchymal haematoma was also found for the intervention group during the both active- (odds ratio: 0.53; 95% CI: 0.21–1.32) and post-intervention period (odds ratio: 0.96; 95% CI: 0.36–2.52). Conclusion The TIPS multi-component implementation approach was not effective in reducing the odds of post-treatment severe disability at 90?days, or post-thrombolysis hemorrhage. Trial registration Clinical Trial Registration-URL: http://www.anzctr.org.au/ Unique Identifier: ACTRN12613000939796.

Project description:BackgroundDepression and anxiety are increasingly prevalent in adolescents. The Brief Educational Workshops in Secondary Schools Trial investigated the effectiveness of a brief self-referral stress workshop programme for sixth-form students aged 16-18 years old.ObjectiveThis study conducted a secondary analysis on the outcomes of participants with elevated depressive symptoms at baseline.MethodsThis is an England-wide, multicentre, cluster randomised controlled trial to evaluate the clinical effectiveness and cost-effectiveness of a brief cognitive-behavioural therapy workshop (DISCOVER) compared with treatment-as-usual (TAU) (1:1). The primary outcome was depression symptoms (Mood and Feelings Questionnaire (MFQ)) at 6-month follow-up, using the intention-to-treat (ITT) population and analysed with a multilevel linear regression estimating a between-group adjusted mean difference (aMD). Cost-effectiveness, taking a National Health Service (NHS) and personal social services perspective, was explored using quality-adjusted life years (QALYs).FindingsBetween 4 October 2021 and 10 November 2022, 900 adolescents at 57 schools were enrolled. 314 students were identified as having elevated symptoms of depression at baseline (>27 on MFQ). In this prespecified subgroup, the DISCOVER arm included 142 participants and TAU included 172. ITT analysis included 298 participants. Primary analysis at 6 months found aMD to be -3.88 (95% CI -6.48, -1.29; Cohen's d=-0.52; p=0.003), with a similar reduction at 3 months (aMD=-4.00; 95% CI -6.58, -1.42; Cohen's d=0.53; p=0.002), indicating a moderate, clinically meaningful effect in the DISCOVER arm. We found an incremental cost-effectiveness ratio of £5255 per QALY, with a probability of DISCOVER being cost-effective at between 89% and 95% compared with TAU.Conclusions and clinical implicationsDISCOVER is clinically effective and cost-effective in those with elevated depressive symptoms. This intervention could be used as an early school-based intervention by the NHS.Trial registration numberISRCTN90912799.

Project description:ObjectivesAssess feasibility, acceptability and costs of delivering a physically active lessons (PAL) training programme to secondary school teachers and explore preliminary effectiveness for reducing pupils' sedentary time.Design and settingSecondary schools in East England; one school participated in a pre-post feasibility study, two in a pilot cluster-randomised controlled trial. In the pilot trial, blinding to group assignment was not possible.ParticipantsAcross studies, 321 randomly selected students (51% male; mean age: 12.9 years), 78 teachers (35% male) and 2 assistant head teachers enrolled; 296 (92%) students, 69 (88%) teachers and 2 assistant head teachers completed the studies.InterventionPAL training was delivered to teachers over two after-school sessions. Teachers were made aware of how to integrate movement into lessons; strategies included students collecting data from the environment for class activities and completing activities posted on classroom walls, instead of sitting at desks.Primary and secondary outcomesQuantitative and qualitative data were collected to assess feasibility and acceptability of PAL training and delivery. Outcomes were assessed at baseline and ~8 weeks post-training; measures included accelerometer-assessed activity, self-reported well-being and observations of time-on-task. Process evaluation was conducted at follow-up.ResultsIn the feasibility study, teachers reported good acceptability of PAL training and mixed experiences of delivering PAL. In the pilot study, teachers' acceptability of training was lower and teachers identified aspects of the training in need of review, including the outdoor PAL training and learning challenge of PAL strategies. In both studies, students and assistant head teachers reported good acceptability of the intervention. Preliminary effectiveness for reducing students' sedentary time was not demonstrated in either study.ConclusionsNo evidence of preliminary effectiveness on the primary outcome and mixed reports of teachers' acceptability of PAL training suggest the need to review the training. The results do not support continuation of research with the current intervention.Trial registration numberISRCTN38409550.

Dataset Information

Door-to-needle time for thrombolysis: a secondary analysis of the TIPS cluster randomised controlled trial.

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Door-to-needle time for thrombolysis: a secondary analysis of the TIPS cluster randomised controlled trial.

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