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Does a protocolised oxygenation target impact clinical outcomes in mechanically ventilated patients in the intensive care unit across the 10 academic and community hospitals in the UCHealth system? Protocol and statistical analysis plan for an EHR-embedde

Por: Sottile · P. D. · Mikkelsen · M. E. · Peterson · R. A. · Mcgrath · M. · Carlson · N. · Higgins · C. · Clinton · M. I. · Barbour · A. · Kautz · S. V. · Kwan · B. M. · West · S. · Ginde · A. A. · Aggarwal · N.
Introduction

We designed the Optimising Care in Critically Ill at the UCHealth by Liberalising the Target O2 in Mechanically ventilated intensive care unit (ICU) Patients to determine the effectiveness of a multimodal educational and electronic health record order panel intervention in limiting occult hypoxaemia and hyperoxaemia in patients receiving invasive mechanical ventilation by targeting a prespecified oxygen saturation (SpO2 90%–96%) range.

Methods and analysis

This trial is a pragmatic electronic health record-embedded, multisite, cluster-randomised, stepped-wedge implementation of a multimodal educational and electronic health record order panel intervention aimed at achieving a standardised intermediate target range of SpO2 (90%–96%) or partial pressure of oxygen (PaO2 60–100 mm Hg) in mechanically ventilated adult patients admitted to the ICU across a 10 hospital health system that includes a large academic centre and smaller community hospitals.

The primary endpoint is ventilator-free days to day 30, defined as the number of days alive and not receiving support through invasive mechanical ventilation following the first initiation of invasive mechanical ventilation in a participating ICU during the hospitalisation. Secondary outcomes include a variety of clinical endpoints: hospital-free days to day 30, all-cause mortality to day 90, need for supplemental oxygen at discharge and incidence of occult hypoxaemia and hypoxaemia. We will analyse primary and secondary endpoints using a mixed effects modelling framework, with specific distributions chosen depending on the type of outcome (eg, binary, count, ordinal, time-to-event).

Ethics and dissemination

Research is performed under a waiver of informed consent for minimal-risk research, as approved by Colorado Multiple Institutional Review Board (24-0065). Results will be disseminated in peer-reviewed publications and at national and international conferences.

Trial registration number

NCT06501118.

Comparing perspectives of volunteers and patients on the Health Champions intervention in secondary mental healthcare: a qualitative study

Por: Pinto da Costa · M. · Chang · W. C. A. · Wu · Y. · Spence · S. · Cho · H. J. · Mcgrath · R. · Sadler · E. · Tredget · G. · Mdudu · I. · Gaughran · F. · Sevdalis · N. · Bakolis · I. · Williams · J.
Background

People with serious mental illness (SMI) can experience significant physical health challenges. The Health Champions intervention was developed to support their physical health through using trained volunteers. However, volunteer and patient perspectives on the impact and implementation of this intervention have yet to be understood.

Aims

To compare the views of patients and volunteers on the Health Champions intervention.

Design and setting

A qualitative thematic analysis was conducted on interviews with 29 study participants. Interviews were carried out either face-to-face, via Microsoft Teams, or by telephone and included 12 patients (6 men and 6 women) and 17 volunteers (the Health Champions) (5 men and 12 women).

Results

Four overarching themes were identified, highlighting both similarities and differences between stakeholders’ perspectives: (1) supporting goal setting; (2) impact on positive lifestyle; (3) experiences and perception of the programme and (4) navigating challenges during the programme. Both groups found the programme to be largely successful, by motivating patients to work towards their physical health goals and facilitating successful matching of patients with volunteers. Volunteers and patients valued good communication with the research team. Though both groups shared some views on the challenges with scheduling and a lack of face-to-face contact during the COVID-19 pandemic, their perceptions on how patients incorporated their health changes during and after the programme, as well as other administrative concerns such as views on the efficacy of journaling and breakdown of roles, differed.

Conclusions

The Health Champions intervention was perceived as useful to improve the physical health of patients with SMI. Differences in the views between the two stakeholders may result from their distinct experiences and expectations. Future volunteering programmes should further support the diverse physical health needs of patients with SMI.

UNIversity students LIFEstyle behaviours and Mental health cohort (UNILIFE-M): study protocol of a multicentre, prospective cohort study

Por: Schuch · F. B. · Waclawoscky · A. · Tornquist · D. · Oyeyemi · A. L. · Sadarangani · K. P. · Takano · K. · Teychenne · M. · Balanza-Martinez · V. · ONeil · A. · Romain · A. J. · McGrath · A. · Alselmi · A. · Andrade-Lima · A. · Zanetti · A. C. G. · Trompetero-Gonzalez · A.-C. · Heiss
Introduction

Students enrolling in higher education often adopt lifestyles linked to worse mental health, potentially contributing to the peak age onset of mental health problems in early adulthood. However, extensive research is limited by focusing on single lifestyle behaviours, including single time points, within limited cultural contexts, and focusing on a limited set of mental health symptoms.

Methods and analysis

The UNIversity students’ LIFEstyle behaviours and Mental health cohort (UNILIFE-M) is a prospective worldwide cohort study aiming to investigate the associations between students’ lifestyle behaviours and mental health symptoms during their college years. The UNILIFE-M will gather self-reported data through an online survey on mental health symptoms (ie, depression, anxiety, mania, sleep problems, substance abuse, inattention/hyperactivity and obsessive/compulsive thoughts/behaviours) and lifestyle behaviours (ie, diet, physical activity, substance use, stress management, social support, restorative sleep, environment and sedentary behaviour) over 3.5 years. Participants of 69 universities from 28 countries (300 per site) will be assessed at university admission in the 2023 and/or the 2024 academic year and followed up for 1, 2 and 3.5 years.

Ethics and dissemination

The study was first approved at a national level in Brazil (CAE:63025822.8.1001.5346). Study sites outside Brazil obtained additional ethics approval from their institutions using the main approval. Results from the UNILIFE-M cohort will be disseminated through scientific publications, presentations at scientific meetings, press releases, the general media and social media.

Implementation strategies to improve adoption of screening and linkages for non-medical drivers of health in care management using enabling technologies: study protocol for a cluster randomised trial

Por: Cook · N. · Gunn · R. · McGrath · B. M. · Donovan · J. · Pisciotta · M. · Owens-Jasey · C. · Fein · H. L. · Templeton · A. · Larson · Z. · Gold · R.
Introduction

Practice guidelines recommend addressing patient non-medical drivers of health such as access to nutritious food and transportation as part of whole-person care. Emergent electronic health record (EHR)-based tools can enable non-medical needs care coordination, but adoption commonly faces workflow and infrastructure barriers. Targeted implementation support strategies (eg, training, practice facilitation) can enhance technology adoption in healthcare settings, but no prior research has assessed if implementation strategies can improve how care managers use enabling technologies for non-medical needs care coordination. This study will test whether providing implementation support to primary care health centre care management teams improves the adoption of EHR-based enabling technologies to address patients’ non-medical needs.

Methods and analysis

This hybrid implementation-effectiveness type 2 pragmatic trial has a mixed methods design. The primary outcomes include: (1) Whether patients enrolled in care management programmes have been screened for unmet non-medical health-related needs and (2) Whether patients with identified unmet non-medical health-related needs received a referral to a community organisation to address their need. The secondary outcomes include: (1) Whether referrals for financial-related non-medical needs had a documented outcome in the EHR, such as successful connection to services, service unavailability or other disposition statuses, (2) Whether the referral outcomes indicated ‘successful connection to services’ and (3) Clinical markers including hypertension and diabetes control. Formative evaluation of barriers and facilitators to using EHR tools to conduct non-medical needs screening, referrals and tracking of receipt of services will include semi-structured interviews and a ‘guided tour’ of enabling technology used by care managers. A modified Delphi process will then inform the development of a set of implementation strategies for inclusion in the intervention. The intervention will be piloted in three health centres, refined, then tested in a stepped-wedge cluster-randomised trial in 20 health centres.

Ethics and dissemination

We obtained ethics approval for all study activities from Advarra Institutional Review Board (registration number #00000971). Results will be disseminated to Health Centres and Health Centre network nationally at meetings and we will disseminate to researchers via manuscripts in peer-reviewed journals and scientific meetings.

Trial registration number

NCT06489002.

What is the impact of an allied health service-learning programme for rural communities: a study protocol using the RE-AIM/PRISM framework

Por: McNeil · R. · McGrath · R. L. · Ackland · K. · Oates · R.-K. · Woodhart · L. · Wright · K.
Introduction

People in rural areas of Australia experience poorer health in almost every indicator compared with urban populations; however, rural communities have lower access to primary health, allied health and specialist healthcare. Timely access to care is compounded by persistent and widespread health workforce issues, including attracting and retaining staff.

Australian University Departments of Rural Health (UDRH) have been established to address the needs of rural populations with the goal of improving recruitment and retention of health professionals across rural and remote Australia. The work-integrated learning team within The University of Melbourne works with nursing and allied health university students on clinical placement to provide exposure to working in rural health, with a remit to build the capacity of the existing and future workforce. The service-learning model aims to provide reciprocal benefits to stakeholders through purposefully co-designed placements that respond to rural health needs by providing services to underserved communities and ensuring university students are exposed to real world, diverse practice settings.

The overarching aim of this project is to determine the impact of the SL programme for key stakeholders, predominately end users and those stakeholders involved in the delivery of the SL model. The key stakeholders are host site staff, allied health university students, allied health supervisors and the end users of the programme. End users are those individuals that have received allied health services through the programme, such as clients, residents and children.

Methods and analysis

This study will adopt a convergent mixed methods methodology underpinned by a RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance)/PRISM (Practical, Robust Implementation Sustainability Model) approach. Data collection will include document review, existing programme data review and primary data collection. This will involve conducting surveys and interviews with allied health university students, host organisations and allied health supervisors, and interviews with adult recipients of the service-learning programme. Art-based consultation will be conducted with school-aged children recipients of the service-learning programme. Analysis will be underpinned by the RE-AIM/PRISM framework to inform programme learnings and impact for key stakeholders.

Ethics and dissemination

This study has been approved by the University of Melbourne Human Research Ethics Committee (Project ID: 30409).

Findings will be published in a stakeholder project report and peer-review journals in the fields of rural health, implementation science and work integrated learning.

Ward AdmiSsion of Haematuria: an Observational mUlticentre sTudy (WASHOUT) - study protocol

Por: Bhatt · N. · Byrnes · K. · Ippoliti · S. · Varma · R. · Jie Chow · B. · Mak · Q. · Kerdegari · N. · Asif · A. · Nathan · A. · Ng · A. · McGrath · J. · Lamb · B. · Catto · J. · Challacombe · B. · Ribal · M. · MacLennan · G. · Gallagher · K. · Khadhouri · S. · Kasivisvanathan · V.
Introduction

Haematuria contributes significantly to emergency urology admissions with over 4 per 1000 annual UK emergency admissions and 10% readmitted within 30 days. However, there is limited focus on optimising inpatient pathways internationally. Existing studies highlight a substantial underlying malignancy rate (32%) in patients presenting with visible haematuria, yet many receive inconsistent care, leading to prolonged hospital stays and increased resource use. A systematic review performed by our research group found no large-scale prospective studies have been performed in this area, and little is known about current practice. This study aims to address these gaps by investigating current management practices and their impact on outcomes, with the goal of informing evidence-based guidelines and improving patient care.

Methods and analysis

The Ward AdmiSsion of Haematuria: an Observational mUlticentre sTudy is an international, multicentre prospective observational study designed to describe the management of patients with unplanned admission to hospital with haematuria under the care of the urology team. The study will use a collaborative methodology using the British Urology Researchers in Surgical Training model. This model delivers international multicentre studies by empowering trainees to lead all aspects of multi-centre clinical studies, building research skills cost-effectively while shaping the future urological consultant workforce. Data on demographics, comorbidities, management practices and outcomes will be collected using a standardised case report form and analysed using multilevel linear regression modelling. Primary outcomes include length of stay, while secondary outcomes cover hospitalisation free survival, mortality, readmission rates at 90 days and resource use. The study was launched in January 2024 and will continue follow-up data collection through December 2025. Patient and public involvement (PPI) has been integral to the study design, ensuring that outcomes reflect patient priorities and that the research addresses key areas of concern.

Ethics and dissemination

Ethical and regulatory approvals will be obtained as required in each participating region. In the UK, the study is classified as a service evaluation and does not require individual patient consent. Participating sites must obtain local audit department approval. Data will be collected and stored securely, ensuring patient confidentiality. Results will be disseminated through scientific conferences, peer-reviewed publications and patient advocacy groups.

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