The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Ma L
PROVIDER: S-EPMC10401723 | biostudies-literature | 2023 Jul
REPOSITORIES: biostudies-literature
Publications
The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial.
Ma Lu L Hu Xin X Song Lili L Chen Xiaoying X Ouyang Menglu M Billot Laurent L Li Qiang Q Malavera Alejandra A Li Xi X Muñoz-Venturelli Paula P de Silva Asita A Thang Nguyen Huy NH Wahab Kolawole W KW Pandian Jeyaraj D JD Wasay Mohammad M Pontes-Neto Octavio M OM Abanto Carlos C Arauz Antonio A Shi Haiping H Tang Guanghai G Zhu Sheng S She Xiaochun X Liu Leibo L Sakamoto Yuki Y You Shoujiang S Han Qiao Q Crutzen Bernard B Cheung Emily E Li Yunke Y Wang Xia X Chen Chen C Liu Feifeng F Zhao Yang Y Li Hao H Liu Yi Y Jiang Yan Y Chen Lei L Wu Bo B Liu Ming M Xu Jianguo J You Chao C Anderson Craig S CS
Lancet (London, England) 20230525 10395
<h4>Background</h4>Early control of elevated blood pressure is the most promising treatment for acute intracerebral haemorrhage. We aimed to establish whether implementing a goal-directed care bundle incorporating protocols for early intensive blood pressure lowering and management algorithms for hyperglycaemia, pyrexia, and abnormal anticoagulation, implemented in a hospital setting, could improve outcomes for patients with acute spontaneous intracerebral haemorrhage.<h4>Methods</h4>We performe ...[more]
Similar Datasets
Project description:The third INTEnsive care bundle with blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT3) is an international, multicenter, stepped-wedge (4 phases/3 steps) cluster randomized trial involving 110 hospitals in mainly low- and middle-income countries during 2017-2022. The aim is to determine the effectiveness of a goal-directed care bundle of intensive blood pressure (BP) lowering, glycemic control, antipyrexia, and anticoagulation reversal treatment versus usual standard of care, in patients with acute intracerebral hemorrhage (ICH). After a "usual care" period, hospitals were randomly allocated to implementing care-bundle protocols for control targets (systolic BP <140 mm Hg; glucose 6.1-7.8/7.8-10.0 mmol/L according to diabetes mellitus status; temperature ≤37.5°C; normalization of anticoagulation). A sample size of 8,360 patients (mean 19 per phase per site) provides 90% power (α = 0.05) for a 5.6% absolute improvement in the primary outcome of scores on the modified Rankin scale at 6 months, analyzed by ordinal logistic regression. A detailed statistical analysis plan (SAP) was developed to prespecify the method of analysis for all outcomes and key variables collected in the trial. The primary analysis will use ordinal logistic regression adjusted for the stepped-wedge design. The SAP also includes planned sensitivity analyses, including covariate adjustments, missing data imputations, and subgroup analysis. This SAP allows transparent, verifiable, and prespecified analyses in consideration of the challenges in conducting the study during the COVID pandemic. It also avoids analysis bias arising from prior knowledge of the findings in determining the benefits and harms of a care bundle in acute ICH.
| S-EPMC10906468 | biostudies-literature
Project description:BackgroundEarly intensive blood pressure (BP) lowering remains the most promising treatment for acute intracerebral hemorrhage (ICH), despite discordant results between clinical trials and potential variation in the treatment effects by approach to control BP. As the third in a series of clinical trials on this topic, the INTEnsive care bundle with blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT3) aims to determine the effectiveness of a goal-directed care bundle protocol of early physiological control (intensive BP lowering, glycemic control, and pyrexia treatment) and reversal of anticoagulation, in acute ICH.MethodsINTERACT3 is a pragmatic, international, multicenter, stepped-wedge (4 phases/3 steps), cluster-randomized controlled trial to determine the effectiveness of a multifaceted care package in adult (age ≥ 18 years) patients (target 8360) with acute ICH (< 6 h of onset) recruited from 110 hospitals (average of 19 consecutive patients per phase) in low- and middle-income countries. After a control phase, each hospital implements the intervention (intensive BP lowering, target systolic < 140 mmHg; glucose control, target 6.1-7.8 mmol/L and 7.8-10.0 mmol/L in those without and with diabetes mellitus, respectively; anti-pyrexia treatment to target body temperature ≤ 37.5 °C; and reversal of anticoagulation, target international normalized ratio < 1.5 within 1 h). Information will be obtained on demographic and baseline clinical characteristics, in-hospital management, and 7-day outcomes. Central trained blinded assessors will conduct telephone interviews to assess physical function and health-related quality of life at 6 months. The primary outcome is the modified Rankin scale (mRS) at 6 months analyzed using ordinal logistic regression. The sample size of 8360 subjects provides 90% power (α = 0.05) to detect a 5.6% absolute improvement (shift) in the primary outcome of the intervention versus control standard care, with various assumptions.DiscussionAs the largest clinical trial in acute ICH, INTERACT3 is on schedule to provide an assessment of the effectiveness of a widely applicable goal-directed care bundle for a serious condition in which a clearly proven treatment has yet to be established.Trial registrationClinicalTrials.gov NCT03209258. Registered on 1 July 2017. Chinese Trial Registry ChiCTR-IOC-17011787. Registered on 28 June 2017.
| S-EPMC8686093 | biostudies-literature
Project description:Numerous publications have now addressed the principles of designing, analyzing, and reporting the results of stepped-wedge cluster randomized trials. In contrast, there is little research available pertaining to the design and analysis of multiarm stepped-wedge cluster randomized trials, utilized to evaluate the effectiveness of multiple experimental interventions. In this paper, we address this by explaining how the required sample size in these multiarm trials can be ascertained when data are to be analyzed using a linear mixed model. We then go on to describe how the design of such trials can be optimized to balance between minimizing the cost of the trial and minimizing some function of the covariance matrix of the treatment effect estimates. Using a recently commenced trial that will evaluate the effectiveness of sensor monitoring in an occupational therapy rehabilitation program for older persons after hip fracture as an example, we demonstrate that our designs could reduce the number of observations required for a fixed power level by up to 58%. Consequently, when logistical constraints permit the utilization of any one of a range of possible multiarm stepped-wedge cluster randomized trial designs, researchers should consider employing our approach to optimize their trials efficiency.
| S-EPMC6491976 | biostudies-literature
Project description:PurposeSupporting the provision of intensive care medicine through telehealth potentially improves process quality. This may improve patient recovery and long-term outcomes. We investigated the effectiveness of a multifaceted telemedical programme on the adherence to German quality indicators (QIs) in a regional network of intensive care units (ICUs) in Germany.MethodsWe conducted an investigator-initiated, large-scale, open-label, stepped-wedge cluster randomised controlled trial enrolling adult ICU patients with an expected ICU stay of ≥ 24 h. Twelve ICU clusters in Berlin and Brandenburg were randomly assigned to three sequence groups to transition from control (standard care) to the intervention condition (telemedicine). The quality improvement intervention consisted of daily telemedical rounds guided by eight German acute ICU care QIs and expert consultations. Co-primary effectiveness outcomes were patient-specific daily adherence (fulfilled yes/no) to QIs, assessed by a central end point adjudication committee. Analyses used mixed-effects logistic modelling adjusted for time. This study is completed and registered with ClinicalTrials.gov (NCT03671447).ResultsBetween September 4, 2018, and March 31, 2020, 1463 patients (414 treated on control, 1049 on intervention condition) were enrolled at ten clusters, resulting in 14,783 evaluated days. Two randomised clusters recruited no patients (one withdrew informed consent; one dropped out). The intervention, as implemented, significantly increased QI performance for "sedation, analgesia and delirium" (adjusted odds ratio (99.375% confidence interval [CI]) 5.328, 3.395-8.358), "ventilation" (OR 2.248, 1.198-4.217), "weaning from ventilation" (OR 9.049, 2.707-30.247), "infection management" (OR 4.397, 1.482-13.037), "enteral nutrition" (OR 1.579, 1.032-2.416), "patient and family communication" (OR 6.787, 3.976-11.589), and "early mobilisation" (OR 3.161, 2.160-4.624). No evidence for a difference in adherence to "daily multi-professional and interdisciplinary clinical visits" between both conditions was found (OR 1.606, 0.780-3.309). Temporal trends related and unrelated to the intervention were detected. 149 patients died during their index ICU stay (45 treated on control, 104 on intervention condition).ConclusionA telemedical quality improvement program increased adherence to seven evidence-based German performance indicators in acute ICU care. These results need further confirmation in a broader setting of regional, non-academic community hospitals and other healthcare systems.
| S-EPMC9841931 | biostudies-literature
Project description:BackgroundPrevious research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8-12 weeks. This study aims to assess the effectiveness, feasibility, and costs of a tailored strategy to implement the SAMBA model.Methods/designA cluster randomized controlled trial with stepped wedge design including an effect, process, and cost evaluation will be conducted in six municipalities (clusters) in Norway. The municipalities will be randomized for time of crossover from current usual care to the implementation of the SAMBA model by a tailored strategy. The tailored strategy includes interactive workshops for general practitioners (GPs) and PTs in primary care covering the SAMBA model for integrated OA care, educational material, educational outreach visits, feedback, and reminder material. Outcomes will be measured at the patient, GP, and PT levels using self-report, semi-structured interviews, and register based data. The primary outcome measure is patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire) at 6-month follow-up. Secondary outcomes include referrals to PT, imaging, and referrals to the orthopaedic surgeon as well as participants' treatment satisfaction, symptoms, physical activity level, body weight, and self-reported and measured lower limb function. The actual exposure to the tailor made implementation strategy and user experiences will be measured in a process evaluation. In the economic evaluation, the difference in costs of usual OA care and the SAMBA model for integrated OA care will be compared with the difference in health outcomes and reported by the incremental cost-effectiveness ratio (ICER).DiscussionThe results from the present study will add to the current knowledge on tailored strategies, which aims to improve the uptake of evidence-based OA care recommendations and improve the quality of OA care in primary health care. The new knowledge can be used in national and international initiatives designed to improve the quality of OA care.Trial registrationClinicalTrials.gov NCT02333656.
| S-EPMC4668617 | biostudies-literature
Project description:Importance:Clinician miscommunication contributes to an estimated 250 000 deaths in US hospitals per year. Efforts to standardize handoff communication may reduce errors and improve patient safety. Objective:To determine the effect of a standardized handoff curriculum, UW-IPASS, on interclinician communication and patient outcomes. Design, Setting, and Participants:This cluster randomized stepped-wedge randomized clinical trial was conducted from October 2015 to May 2016 at 8 medical and surgical intensive care units at 2 hospital systems within an academic tertiary referral center. Participants included residents, fellows, advance-practice clinicians, and attending physicians (n = 106 clinicians, with 1488 handoff events over 8 months) and data were collected from daily text message-based surveys and patient medical records. Exposures:The UW-IPASS standardized handoff curriculum. Main Outcomes and Measures:The primary aim was to assess the effect of the UW-IPASS handoff curriculum on perceived adequacy of interclinician communication. Patient days of mechanical ventilation, intensive care unit length of stay, reintubations within 24 hours, and order workflow patterns were also analyzed. Mixed-effects logistic regression was used to compute odds ratios and confidence intervals with adjustment for location, time period, and clinician. Results:A total of 63 residents and advance practice clinicians, 13 fellows, and 30 attending physicians participated in the study. During the control period, clinicians reported being unprepared for their shift because of a poor-quality handoff in 35 of 343 handoffs (10.2%), while UW-IPASS-period residents reported being unprepared in 53 of 740 handoffs (7.2%) (odds ratio, 0.19; 95% CI, 0.03-0.74; P = .03). Compared with the control phase, the perceived duration of handoffs among clinicians using UW-IPASS was unchanged (+5.5 minutes; 95% CI, 0.34-9.39; P = .30). Early morning order entry decreased from 106 per 100 patient-days in the control phase to 78 per 100 patient-days in the intervention period (-28 orders; 95% CI, -55 to -4; P = .04). Overall, UW-IPASS was not associated with any changes in intensive care unit length of stay, duration of mechanical ventilation, or the number of reintubations. Conclusions and Relevance:The UW-IPASS standardized handoff curriculum was perceived to improve intensive care provider preparedness and workflow. IPASS-based curricula represent an important step forward in communication standardization efforts and may help reduce communication errors and omissions. Trial Registration:isrctn.org Identifier: ISRCTN14209509.
| S-EPMC5875375 | biostudies-literature
Project description:ImportanceGiven that hypotonic maintenance intravenous fluids (IVF) may cause hospital-acquired harm, in November 2018, the American Academy of Pediatrics released a clinical practice guideline recommending the use of isotonic IVF for patients aged 28 days to 18 years without contraindications. No recommendations were made regarding laboratory monitoring; however, unnecessary laboratory tests may contribute to health care waste and harm patients.ObjectiveTo examine the effect of a quality improvement intervention bundle on (1) increasing the mean proportion of hours per hospital day with exclusive isotonic IVF use to at least 80% and (2) decreasing the mean proportion of hospital days with laboratory tests obtained.Design, setting, and participantsThis stepped-wedge, cluster randomized clinical trial (Standardization of Fluids in Inpatient Settings [SOFI]) was sponsored by a national quality improvement collaborative and was conducted across 106 US pediatric hospitals. The SOFI intervention period was from September 2019 to March 2020.InterventionsHospital sites were exposed to educational materials, a clinical algorithm and order set for IVF use, electronic medical record interventions to reduce laboratory testing, and "harms of overtesting" cards.Main outcomes and measuresPrimary outcomes were mean proportion of hours per hospital day receiving exclusive isotonic IVF and mean proportion of hospital days with laboratory test values obtained. Secondary measures included total IVF duration per hospital day, daily patient weight measurement while receiving IVF, serum sodium testing, and adverse events. Baseline data were collected for 2 months; intervention period data, 7 months. Outcomes were analyzed using linear mixed-effects regression models.ResultsA total of 106 hospitals were randomly assigned to 1 of 3 intervention start dates (wedges), and 100 hospitals (94%) completed the study. In total, 5215 hospitalizations were reviewed before the intervention, and 6724 hospitalizations were reviewed after the intervention. Prior to interventions, the mean (SD) proportion of hours per day with exclusive isotonic IVF use was 88.5% (31.7%). Interventions led to an absolute increase of 5.4% (95% CI, 3.9%-6.9%) above baseline in exclusive isotonic IVF use but did not change the proportion of hospital days during which a laboratory test value was obtained (estimated difference, 0.1%; 95% CI, -1.5% to 1.7%; P = .90), IVF use duration (estimated difference, -1.2%; 95% CI, -2.9% to 0.4%), serum sodium testing, or adverse events. There was an absolute increase of 4.4% (95% CI, 2.6%-6.2%) in the mean proportion of hospital days with a patient weight measurement while receiving IVF.Conclusions and relevanceIn this stepped-wedge, cluster randomized clinical trial, an intervention bundle significantly improved the use of isotonic maintenance IVF without a concomitant increase in adverse events or electrolyte testing. Further work is required to deimplement laboratory testing.Trial registrationClinicalTrials.gov Identifier: NCT03924674.
| S-EPMC8593833 | biostudies-literature
Project description:This article introduces the 'staircase' design, derived from the zigzag pattern of steps along the diagonal of a stepped wedge design schematic where clusters switch from control to intervention conditions. Unlike a complete stepped wedge design where all participating clusters must collect and provide data for the entire trial duration, clusters in a staircase design are only required to be involved and collect data for a limited number of pre- and post-switch periods. This could alleviate some of the burden on participating clusters, encouraging involvement in the trial and reducing the likelihood of attrition. Staircase designs are already being implemented, although in the absence of a dedicated methodology, approaches to sample size and power calculations have been inconsistent. We provide expressions for the variance of the treatment effect estimator when a linear mixed model for an outcome is assumed for the analysis of staircase designs in order to enable appropriate sample size and power calculations. These include explicit variance expressions for basic staircase designs with one pre- and one post-switch measurement period. We show how the variance of the treatment effect estimator is related to key design parameters and demonstrate power calculations for examples based on a real trial.
| S-EPMC10863363 | biostudies-literature
Project description:IntroductionWith the widespread use of electronic health records and handheld electronic devices in hospitals, informatics-based antimicrobial stewardship interventions hold great promise as tools to promote appropriate antimicrobial drug prescribing. However, more research is needed to evaluate their optimal design and impact on quantity and quality of antimicrobial prescribing.Methods and analysisUse of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland. Secondary outcomes will include antimicrobial use metrics, clinical and process outcomes. A multicentre stepped-wedge cluster randomised trial will randomise entities defined as wards or specialty regarding time of introduction of the intervention. We will include 36 hospital entities with seven measurement periods in which the primary outcome will be measured in 15 participating patients per time period per cluster. At participating wards, patients of at least 18 years of age using antimicrobials will be included. After a baseline period of 2-week measurements, six periods of 4 weeks will follow in which the intervention is introduced in 6 wards (in three hospitals) until all 36 wards have implemented the intervention. Thereafter, we allow use of the app by everyone, and evaluate the sustainability of the app use 6 months later.Ethics and disseminationThis protocol has been approved by the institutional review board of each participating centre. Results will be disseminated via media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.Trial registration numberClinicalTrials.gov registry (NCT03793946). Stage; pre-results.
| S-EPMC7279644 | biostudies-literature
Project description:PurposeOral chlorhexidine is used widely for mechanically ventilated patients to prevent pneumonia, but recent studies show an association with excess mortality. We examined whether de-adoption of chlorhexidine and parallel implementation of a standardized oral care bundle reduces intensive care unit (ICU) mortality in mechanically ventilated patients.MethodsA stepped wedge cluster-randomized controlled trial with concurrent process evaluation in 6 ICUs in Toronto, Canada. Clusters were randomized to de-adopt chlorhexidine and implement a standardized oral care bundle at 2-month intervals. The primary outcome was ICU mortality. Secondary outcomes were time to infection-related ventilator-associated complications (IVACs), oral procedural pain and oral health dysfunction. An exploratory post hoc analysis examined time to extubation in survivors.ResultsA total of 3260 patients were enrolled; 1560 control, 1700 intervention. ICU mortality for the intervention and control periods were 399 (23.5%) and 330 (21.2%), respectively (adjusted odds ratio [aOR], 1.13; 95% confidence interval [CI] 0.82 to 1.54; P = 0.46). Time to IVACs (adjusted hazard ratio [aHR], 1.06; 95% CI 0.44 to 2.57; P = 0.90), time to extubation (aHR 1.03; 95% CI 0.85 to 1.23; P = 0.79) (survivors) and oral procedural pain (aOR, 0.62; 95% CI 0.34 to 1.10; P = 0.10) were similar between control and intervention periods. However, oral health dysfunction scores (- 0.96; 95% CI - 1.75 to - 0.17; P = 0.02) improved in the intervention period.ConclusionAmong mechanically ventilated ICU patients, no benefit was observed for de-adoption of chlorhexidine and implementation of an oral care bundle on ICU mortality, IVACs, oral procedural pain, or time to extubation. The intervention may improve oral health.
| S-EPMC8490143 | biostudies-literature