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Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial: protocol for a batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness-implementation trial

Por: Prendergast · N. T. · Kahn · J. M. · Angus · D. C. · Argote · L. · Barnes · B. · Chang · C.-C. H. · Graff · S. · Hess · D. R. · Onyemekwu · C. A. · Rak · K. J. · Russell · J. L. · Seaman · J. B. · Toth · K. M. · Girard · T. D.
Introduction

Many patients who are extubated after receiving mechanical ventilation for acute respiratory failure experience extubation failure (ie, require reintubation hours to days after extubation). High-quality evidence shows that extubating patients directly to non-invasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC), rather than conventional low-flow oxygen, can prevent extubation failure. These guideline-recommended interventions, however, require care coordination involving multiple intensive care unit (ICU) team members and are infrequently used. Interprofessional education (IPE), which teaches members of multiple professions together, could effectively address this implementation gap in complex, team-based, critical care settings, particularly when paired with a customisable protocol.

Methods and analysis

This batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness–implementation trial will test three hypotheses: (1) when compared with traditional online education (OE), IPE increases implementation of preventive postextubation respiratory support, (2) the benefits of IPE are increased when paired with a clinical protocol and (3) preventive postextubation NIV for high-risk patients and preventive postextubation HFNC for low-risk patients reduce in-hospital mortality when compared with conventional postextubation oxygen therapy. The trial will recruit 24 clusters made up of one or more ICUs that care for at least 100 mechanically ventilated patients per year in a large multihospital health system in the USA. All clusters will receive OE, IPE and a clinical protocol, with timing determined by randomisation. We will also randomise half of the clusters to education promoting postextubation NIV for patients at high risk of extubation failure and preventive, postextubation HFNC for patients at lower risk, whereas the other half will be randomised to education promoting postextubation HFNC for all eligible patients. We will include all patients who are invasively mechanically ventilated for at least 24 hours. The primary implementation endpoint is the rate of use of postextubation NIV or HFNC among eligible participants. The primary clinical endpoint is in-hospital mortality truncated at 60 days from intubation.

Ethics and dissemination

This study was approved by the institutional review board of the University of Pittsburgh and an independent data safety monitoring board. We describe the methods herein using the Standard Protocol Items for Randomised Trials framework and discuss key design decisions. We will disseminate results to participating healthcare providers, through publication in a peer-reviewed medical journal and via presentations at international conferences.

Trial registration number

NCT05523479.

Type I hybrid effectiveness-implementation randomised controlled trial to address intergenerational impact of war trauma and resilience among second-generation refugee children in the USA: Resettled Refugee Families for Healing (RRF4H) study protocol

Por: Tutlam · N. T. · Liyew · T. W. · Betancourt · T. S. · Powell · B. J. · Guo · S. · McKay · M. · Ssewamala · F. M.
Introduction

Children from refugee families resettled in the USA face higher risks of serious mental health challenges compared with their native-born peers. Research shows that refugee youth in high-income countries frequently suffer from trauma-associated disorders such as post-traumatic stress disorder (PTSD), depression and anxiety. The high prevalence of trauma-associated mental health problems among these youth may be attributed to their own trauma exposure, especially if born in conflict zones, and post-resettlement challenges like poverty, acculturation difficulties, racism and discrimination. However, they may also suffer from the effects of intergenerational trauma, where parental war trauma impacts them. This study aims to adapt and test an intervention addressing intergenerational trauma-related emotional and behavioural health outcomes among US-born children of refugee parents in Omaha and Lincoln, Nebraska.

Methods and analysis

This is a two-arm cluster randomised type I hybrid effectiveness-implementation trial. Guided by the Social Action and Family Systems theories and applying them to the intergenerational transmission of trauma framework, the combination intervention consists of family strengthening model delivered through multiple family groups+peer mentoring programme called TeenAge Health Consultants (TAHC) adapted for delivery in virtual environment (Virtual TAHC). A total of 154 US-born adolescents of parent resettled as refugees (77 per study arm), ages 14–17 and at least one biological parent per youth (dyads) will be recruited from four comparable communities utilising community-based participatory research approach and randomised to usual care or intervention group. The intervention will be implemented for up to 16 weeks, with assessments at baseline, after intervention completion and 6 months follow-up. To determine study feasibility, we will use binary metrics of participant enrolment of 70% or more and retention of 80% or more at 12 months. To assess study acceptability, we will determine participant satisfaction with the study based on the Client Satisfaction Questionnaire (CSQ-8). To maximise rigour, our analyses will follow an intention-to-treat (ITT) approach. For primary inferential analyses, we will fit two-level generalised linear mixed models to continuous primary outcomes. The models will include fixed effects for study arm, time and their interaction terms. We will perform time-averaged comparisons of post-baseline repeatedly measured observations across study arms to examine intervention effects over the duration of the postintervention study period. To delineate barriers and facilitators to implementation and implementation strategies, we will apply a more integrative approach, using both inductive and deductive approaches guided by the grounded theory and integrative theory that combines both deductive and inductive approaches. Finally, we will integrate findings from the quantitative and qualitative analysis to provide additional explanation and context for our quantitative findings.

Ethics and dissemination

Voluntary written informed assent and consent will be obtained from all participants, adolescents and their parents, respectively. All study procedures received approval from Washington University in St. Louis Institutional Review Board (IRB #202307081).

Study findings will be disseminated through publications in scientific journals and presentations at national and international conferences. We also plan to provide community education about the study through a dissemination conference at the end of the study.

Trial registration number

NCT06176638.

Cost analysis of post-stroke dysphagia during acute hospitalisation: a cross-sectional study in Vietnam

Por: Thong · T. H. · Hien · N. T. T. · Tung · L. T. · Thang · P. · Trung · T. H. · Tien · V. D. · Hanh · H. T. · Lam · T. H.
Objectives

To estimate the healthcare costs associated with post-stroke dysphagia during acute hospitalisation and to identify factors influencing these costs in a tertiary hospital setting in Vietnam.

Design

A cross-sectional study using clinical and billing data from hospital records.

Setting

The study was conducted at the Neurology Center of Bach Mai Hospital, a tertiary care facility in Hanoi, Vietnam, between June 2020 and January 2022.

Participants

A total of 951 patients aged ≥18 years with acute ischaemic stroke confirmed by CT or MRI were included. Dysphagia was assessed using the Gugging Swallowing Screen.

Outcome measures

Direct healthcare costs during hospitalisation were collected from the hospital billing system and categorised as medications, diagnostic imaging, medical supplies, accommodation, food, procedures and laboratory tests. All costs were converted to USD. Associations between patient characteristics and total healthcare costs were analysed using generalised linear models (Gamma distribution with log link), applying robust standard errors.

Results

The median treatment cost was 10.08 million VND (436.24 USD) in the dysphagia group vs 6.37 million VND (275.78 USD) in the non-dysphagia group. Costs increased with dysphagia severity, reaching 22.64 million VND (979.49 USD) among patients with severe dysphagia. In multivariate analysis, dysphagia was associated with a 21% increase in costs (exp(β) = 1.21; 95% CI 1.10 to 1.33; p14, pneumonia, prolonged hospitalisation and higher educational level.

Conclusions

Post-stroke dysphagia substantially increases acute hospitalisation costs in Vietnam. Early screening, standardised management and preventive care for complications may improve outcomes and reduce costs.

Trial registration number

The study was registered on the Research Registry website (https://www.researchregistry.com/) under the unique identification number: researchregistry8203.

Knowledge and attitude of parents towards the human papillomavirus vaccine for their daughters and associated factors in Debre Tabor town, northwest Ethiopia: a community-based cross-sectional study

Por: Aragaw · G. M. · Aynalem · G. L. · Abiy · S. A. · Taye · E. B. · Chernet · S. A. · Haile · T. T. · Tsega · N. T. · Mesele · T. T. · Seyoum · A. T. · Tsega · A. G. · Mengistie · B. A.
Objective

This study aims to assess parents’ knowledge and attitude towards the human papillomavirus (HPV) vaccination of their daughters and the associated factors in Debre Tabor town, northwest Ethiopia.

Design

A community-based cross-sectional study.

Setting

Debre Tabor town, Northwest Ethiopia.

Participants

A total of 702 participants were included in the study, with a response rate of 98.2%. Three out of the six kebeles in the town were randomly selected, and participants within the selected kebeles were recruited through a cluster sampling technique. An interviewer-administered structured questionnaire was used to collect data from 15 December 2021 to 15 February 2022.

Primary and secondary outcome measures

Parents’ level of knowledge and attitude towards the HPV vaccination of their daughters, and the associated factors.

Results

In the study, parents’ knowledge and attitude towards HPV vaccination were found to be 46.4% (95% CI 42.7% to 50.1%) and 61.5% (95% CI 58.0% to 65.2%), respectively. Parents with a higher level of education (adjusted OR (AOR)=2.27; 95% CI 1.39 to 3.69), media exposure (AOR=3.36; 95% CI 1.21 to 9.33) and a good attitude towards the HPV vaccine (AOR=8.81; 95% CI 5.78 to 13.44) were significantly associated factors that affect parents’ level of knowledge. Positive subjective norms (AOR=1.53; 95% CI 1.01 to 2.31) and perceived behavioural control towards the HPV vaccine (AOR=3.48; 95% CI 2.37 to 5.10) had statistically significant associations with parents’ attitude.

Conclusions

In this study, more than half of parents had poor knowledge of the HPV and its vaccination, while the majority of the participants showed a favourable attitude to the vaccine. Educational attainment, media exposure and a positive attitude were significantly associated with parental knowledge, and parents’ attitude was positively influenced by subjective norms and perceived behavioural control. This suggests a need to increase the parents’ level of awareness through educational interventions, particularly via media and community engagement. To improve the acceptance and uptake of the HPV vaccination, it is important to address negative attitudes and common misconceptions among parents on the safety, efficacy and necessity of the vaccine for their daughters.

Consensus on the definition, components, timeframe and grading of composite outcome of postoperative pulmonary complication--protocol for an international mixed-method consensus study (PrECiSIOn)

Por: Nasa · P. · Yurttas · T. · Battaglini · D. · Blot · S. · Fernandez-Bustamante · A. · Gama de Abreu · M. · van Meenen · D. M. · Myatra · S. N. · Serpa Neto · A. · Oppong · R. · Paulus · F. · Renukappa · S. · Schultz · M. J. · Slutsky · A. S. · Hemmes · S. N. T. · for the PrECiSIOn-gro
Introduction

Postoperative pulmonary complications (PPCs) represent a significant cause of postoperative morbidity and even mortality. However, there is a lack of consensus regarding this composite endpoint, the definition of the individual components, classification and optimal outcome measures. This study aims to refine the PPCs composite framework by evaluating its construct validity, assessing the necessity and risks of a composite measure and exploring the feasibility of differentiating severity categories.

Methods

A Delphi consensus process will be conducted, engaging an international multidisciplinary group of 30–40 panellists, including clinicians, researchers, patients, public representatives and health economists. Through iterative rounds, the study will seek agreement on the individual components of the PPCs composite. Additionally, consensus will establish a framework for a composite outcome measure based on a standardised severity classification, appropriate timeframes and weighted grading of PPCs.

Analysis

Consensus, defined by ≥75% concurrence in multiple choice questions or on Likert–scale statements, will be evaluated from round 2 onwards. Delphi rounds will be continued until all statements have reached stability of responses evaluated by 2 tests or the Kruskal-Wallis test.

Ethics and dissemination

The study will be conducted in strict compliance with the principles of the Declaration of Helsinki and will adhere to ACCORD guidance for reporting. Ethics approval has been obtained for this study from the University of Wolverhampton, UK (SOABE/202425/staff/3). Informed consent will be obtained from all panellists before the commencement of the Delphi process. The results of the study will be published in a peer–reviewed journal with the authorship assigned in accordance with ICMJE requirements.

Trial registration number

NCT06916598 (clinicaltrials.gov).

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