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.

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.

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.

Approximately, 20 million older adults undergo major elective surgery annually, yet less than 10% engage in advance care planning (ACP). This is a critical missed opportunity to optimally engage in patient-aligned medical decisions and communications in the perioperative setting. The PREPARE ACP programme (easy-to-read advance directives (ADs) and a patient-directed, online ACP programme) has been shown to increase ACP documentation and patient and clinician empowerment to discuss ACP. Yet, a gap remains in extending PREPARE’s use to surgical populations. We hypothesise that by delivering PREPARE in a patient-facing electronic health record (EHR) centric presurgery workflow for older adults, supported by automated patient reminders and outreach from a healthcare navigator (HCN), we can enable patients and/or surgical teams to engage in ACP discussions.

This is a three-site, single-blinded, pragmatic randomised trial comparing increasing intensity of ACP-focused, patient-facing EHR messaging and HCN support. The outreach occurs prior to a new presurgical clinic visit. We will enrol 6000 patients (2000 each site) aged 65 and older and randomise them equally to the following study arms: (Arm 1) ACP-related cover letter and PREPARE URL information sent via patient portal and postal mail (includes cover letter, AD and PREPARE pamphlet); (Arm 2) Arm 1 plus reminder message via text or MyChart message and (Arm 3) Arm 2 plus HCN outreach and support. The primary outcome is clinically meaningful ACP documentation in the EHR (ie, surrogate designation, documented discussions and ADs) within 6 months of the new surgical visit. The rate of ACP documentation will be compared between treatment groups using generalised estimating equations. Secondary outcomes include a validated four-item ACP engagement survey, administered 2 weeks after the presurgical visit and 6 months later. All analyses will follow the intention-to-treat principle and recent Consolidated Standards of Reporting Trials guidelines.

The study will be conducted according to the Declaration of Helsinki, Protection of Human Volunteers (21 Code of Federal Regulations (CFR) 50), Institutional Review Boards (21 CFR 56) and Obligations of Clinical Investigators (21 CFR 312). The protocol and consent form were reviewed and approved by Advarra, an National Insitutes of Health (NIH)-approved, commercial, centralised Institutional Review Board (IRB). The IRB/Independent Ethics Committee of each participating centre reviewed and approved the protocol and consent and obtained reliance agreements with Advarra prior to study initiation. The study is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of the study will be disseminated to both academic and community stakeholders, complying with all applicable privacy laws.

ClinicalTrials.gov ID: NCT06090552.

Advarra Pro 00070994.

23-38948.

Protocol Date: 24 October 2024. Protocol Version: 4.

To explore multiprofessional views about system-wide factors influencing (impeding or facilitating) the delivery of stroke mechanical thrombectomy (MT) services and/or improvements to this pathway in England.

A pragmatic exploratory qualitative study using online focus groups and semi-structured interviews with National Health Service (NHS) professionals and those working in a stroke strategic/policy lead role. We thematically analysed the data using the Framework Approach to understand participants’ views on the challenges to improving current and future MT implementation.

NHS trusts and other key stroke strategic/policy organisations covering 10 geographical regions in England and a national perspective.

A total of 29 professionals, working in an NHS clinical and managerial position and/or a stroke strategic national/regional clinical/policy lead role, participated in five focus groups and six individual semi-structured interviews between April and June 2024.

We identified five themes relating to MT implementation progress and challenges (1) workforce, (2) clinical care pathways, (3) service/system, (4) cross-cutting theme: communications and (5) cross-cutting theme: culture. Our analysis emphasised the increasing complexity and inter-related factors shaping the emergency stroke pathway for MT provision and a need to acknowledge key people-related, organisational and sociocultural factors during service planning.

Despite the challenges and complexity, professionals were optimistic that further progress would be made with MT delivery in England. However, ongoing improvement strategies are required, which also acknowledge wider cultural factors and system-wide relationships and are not just focused on care pathways and resources.

In the UK, each year, approximately 2250 babies are stillborn, and there are an additional 1150 neonatal deaths. The death of a baby before or shortly after birth is a profoundly distressing experience for women and their families and is invariably followed by a period of grief. Most women who have experienced the loss of a baby will embark on another pregnancy, usually within a year. Parents need specialist support from doctors and midwives in a future pregnancy to reduce the risk of pregnancy complications and meet care and support needs. The Rainbow Clinic aims to meet these needs and was first established in 2013 at Saint Mary’s Hospital, Manchester. Initial studies have shown that this model of care improves pregnancy outcomes, decreases anxiety levels and is associated with a strong social return on investment. The Tommy’s National Rainbow Clinic Study aims to evaluate the care provided within this new model, to examine women’s experiences of care and identify areas of improvement and measure the impact on pregnancy outcomes for mothers and babies.

This is a prospective cohort study, measuring a range of maternal and neonatal outcomes following care in Rainbow Clinic. The primary outcome measure is the frequency of stillbirth in the subsequent pregnancy. Measures of maternal well-being include maternal anxiety and psychological symptoms (assessed using Generalised Anxiety Disorder 2-item screening tool (GAD-2), the Cambridge Worry Scale and the Edinburgh Postnatal Depression Scale). Women’s experiences of attending Rainbow Clinic will be recorded on a standardised patient experience tool. Data will be collected on resource use, including the number of appointments with health professionals and the number of ultrasound scans performed. Up to 2000 participants are expected to be enrolled in this study.

This study was given a favourable ethical opinion by the South Central—Hampshire B Research Ethics Committee (Reference 20/SC/0180). The results will be presented at international conferences and published in peer-reviewed open-access journals. Information from this study will inform the development and evaluation of models of specialist antenatal care for pregnancies after stillbirth and neonatal death.

The study is registered with the clinicaltrials.gov under the registration number NCT04393259.

Alzheimer’s disease and related dementias (ADRD) are conditions with progressive cognitive decline. Still, people living with late-stage ADRD (PLWD) have been reported to exhibit transient recovery of communication or behavioural abilities that had seemingly been lost. These lucid episodes (LEs) are underinvestigated and poorly understood. This study aims to advance scientific understanding of the incidence, prevalence and predictors of LEs and assess from family caregivers if LEs are associated with changes they make in care planning or experiences with burden, distress or grief.

This study recruited 545 caregivers from five ADRD-related registries in the USA. Eligibility included caregivers over 18 years who currently provide care to someone with moderate to very severe ADRD and can complete online questionnaires. Using a longitudinal observational study design, consented caregivers will be assessed monthly for 1 year using online questionnaires that inquire about witnessing LEs. If witnessed, the context and content of the LE is reported. Changes in caregiver decision-making about care for the PLWD, and caregiver burden, distress and grief are assessed at baseline, 6 and 12 months.

Analysis of baseline data will assess descriptive aspects of LEs that are currently unknown (eg, prevalence, content, antecedents, duration). Longitudinal analysis will examine the incidence of LEs, characteristics of PLWD and caregivers that are predictors of episodes, and the associations between LEs and caregiver outcomes (eg, burden, distress, grief).

This study is being conducted in accordance with all Federal Policies for the Protection of Human Subjects. The protocol has been approved by the Mayo Clinic Institutional Review Board (ID 22-006861). Findings will be presented at scientific conferences and disseminated through journal publications and outreach efforts with collaborating partners invested in brain health and caregiver support.

Distal radius fractures account for one-fifth of all fractures in the active elderly population and may cause chronic pain, loss of hand function and reduced work productivity, imposing a significant socioeconomic burden. Most are initially treated with closed reduction and casting, but 30% subsequently require surgery due to insufficient realignment. The current approaches for analgesia for closed reduction are suboptimal. A brachial plexus nerve block provides complete pain relief and muscle relaxation distal to the elbow, potentially creating better conditions for realignment of the fractured bone ends. This may ultimately translate into reduced need for surgery and result in better functional outcomes and fewer complications compared to a haematoma block, which is the current standard care in Denmark.

The BLOCK Trial is an investigator-initiated, parallel-group, allocation-concealed, outcome assessor and analyst-blinded, superiority, randomised, controlled, clinical multicentre trial performed at 11 Danish emergency departments. Eligible adult patients with a distal radius fracture who need closed reduction will be included and allocated 1:1 to either an ultrasound-guided brachial plexus nerve block or a haematoma block. The primary outcome is the proportion of patients with distal radius fracture surgery 90 days after closed reduction. We will include 1716 participants to detect or discard a relative risk reduction of surgery of 20%. Secondary outcomes include treatment-related complications, patient-reported wrist function, pain during closed reduction and proportion of patients with unacceptable radiographic fracture position immediately after closed reduction.

The trial is approved by the Danish Medicines Agency and the Danish Research Ethics Committees (EU CT number: 2024-512191-35-00). All results will be summarised on www.theblocktrial.com, clinicaltrials.gov and euclinicaltrials.eu after publication. Primary and secondary outcome results from 0 to 90 days will be presented in the main article and submitted to a peer-reviewed journal. Results from outcomes on the 12-month follow-up will be presented separately.

NCT06678438.

A qualitative study was undertaken to explore the nature of staffing strategies from the perspectives of nursing, medicine and health disciplines employed in a hospital setting.

Interviews were conducted in six hospitals in Canada between November 2022 and September 2023.

118 healthcare professionals and leaders who experienced changes in staffing strategies participated in this study. Three themes emerged to describe new or adaptive staffing strategies: (1) valuing new roles and teams; (2) being redeployed; and (3) enhancing coverage.

Our study elucidates the staffing strategies that were employed during the COVID-19 pandemic that included creating new and adapting existing roles and teams; redeploying healthcare professionals; and enhancing coverage. Study findings can be used to guide leaders to use a proactive systematic approach to staffing models that includes adaptable and flexible staffing models within local contexts.

The aim of this study was to explore the features of high-quality rural health student placements from the perspective of university staff involved in designing, delivering and evaluating these programmes.

A sequential explanatory mixed methods design was employed, integrating quantitative survey data with qualitative interview findings to provide a comprehensive understanding of the research question.

The study was conducted online and sampled staff from universities across Australia, focusing on rural health student placements. The study involved 121 university staff members who participated in the survey, with 10 of these participants also taking part in follow-up qualitative interviews.

Quantitative data were collected using an online survey distributed to university staff involved in designing, delivering and evaluating rural health student placements. The survey included Likert scale, open-ended and demographic questions, and a preliminary analysis was used to write the interview questions. Qualitative data were gathered through semi-structured interviews, which were transcribed and analysed using the Framework approach. The quantitative and qualitative results were integrated to produce a narrative summary of findings.

Key features identified as essential for high-quality rural health placements included safe and affordable accommodation, financial support and personal safety. High-quality supervision, cultural awareness training and opportunities for interprofessional education were also highlighted. The qualitative findings provided depth to the quantitative data, emphasising the importance of structuring learning within a continuum of education and fostering connections through co-location and community engagement.

This study identifies fundamental features of high-quality rural health placements in Australia, including accommodation, student safety, supervision and cultural responsiveness training. These findings can inform the design, delivery and evaluation of rural health student placements, contributing to the quality of these programmes as an efficacious learning experience.

Chronic low back pain (LBP) imposes significant burden on patients, healthcare systems and society. Physical therapy is a cost-effective method for improving pain and disability; however, only a small number of patients (7–13%) with LBP ever receive physical therapy services. Patients report obstacles to accessing physical therapy, such as transportation, provider availability and missed work. Access is especially limited in rural communities, where approximately 40% fewer physical therapists are available per capita than in metropolitan regions. This lack of access likely contributes to the greater rates of LBP-related disability and opioid consumption in rural communities. Innovative methods for improving access to physical therapy for patients with chronic LBP are urgently needed; these can help address differences in health outcomes and mitigate opioid dependence for patients with chronic LBP living in rural communities. Telerehabilitation increases access to physical therapy, which can potentially improve health outcomes for these patients.

This prospective, individually randomised group treatment trial will involve primary care clinics serving rural communities on Maryland’s Eastern Shore. We will enroll 434 individuals with chronic LBP. Eligible patients will be randomised to either standardised education for back pain delivered via website or to a risk-informed telerehabilitation. Standardised education will be delivered via a study website containing information consistent with materials provided by primary care providers. Risk-informed telerehabilitation will be delivered by trained physical therapists using a web-based, video-enabled telehealth platform. The primary outcome is LBP-related disability. Secondary outcomes are opioid use, pain intensity, health-related quality of life and LBP-related healthcare use assessed using standard patient-reported outcome measures, participant self-report and medical chart abstraction. Implementation outcomes are acceptability, adoption, feasibility and fidelity of our treatment approach guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework and assessed using surveys, semi-structured interviews and key performance metrics.

Ethics approval was obtained from the Johns Hopkins Medicine Institutional Review Boards (IRB), which serves as the single IRB for this trial. Upon completion, study data will be shared in compliance with National Institutes of Health guidelines.

NCT06471920.

Sepsis is a common condition with significant morbidity, mortality and annual costs of care in the billions of dollars. Despite innumerable studies on the causes of, and therapies for, sepsis, the mortality rate has not changed substantially in the last 20 years. Treatments remain generic, with current guidelines recommending the same approach for all patients, regardless of the litany of differences that exist at baseline. Moreover, the blanket administration of 30 cc/kg of intravenous fluid (IVF) to all patients is recognised as being directly harmful to some. Patient-level heterogeneity in prior sepsis trials is recognised as a substantial contributor to all these problems, yet no prior investigation has attempted to identify volume-informed septic phenotypes, a necessary first step towards precision care.

Predicated on prior studies demonstrating detectability of organ-level congestion, we hypothesise that central venous hypertension (1) is deleterious to the function of the lungs, liver, kidneys and vascular endothelium; (2) is worsened by cardiac dysfunction and IVF administration; and (3) contributes to adverse organ-specific and overall outcomes. Beginning in the emergency department, cardiac function will be assessed with echocardiography while congestion in the lungs and kidneys will be assessed using previously validated sonographic markers of congestion. Biomarkers for each organ will be collected concurrently, thereby increasing the fidelity of our phenotypic profiles by pairing indicators of macroscopic and microscopic stress and dysfunction. Data will also be collected at 24 hours and 7 days (or discharge, whichever comes first) after presentation. Classical and machine learning approaches will be used to analyse our large data stream and develop a rule-based system to identify distinct subpopulations of patients with sepsis who have greater risk/likelihood of both organ-specific and overall adverse outcomes.

This project has been approved by the Wayne State University Institutional Review Board, with patient enrolment beginning in April 2024. Findings will be reported and disseminated via conference presentations and open-access publications.

Acute pain is commonly experienced by millions of patients who undergo outpatient surgical procedures. Moreover, an increasing number of procedures are performed on an outpatient basis, requiring greater postoperative planning to ensure effective pain management. Analgesic approaches commonly involve prescription opioids and non-steroidal anti-inflammatory drugs (NSAIDs), but an optimal regimen that balances pain and adverse effects has not been identified. In addition, critical gaps in evidence exist regarding how opioids and NSAIDs compare as analgesic regimens after surgery.

The Comparing Analgesic Regimen Effectiveness and Safety after Surgery (CARES) trial is a pragmatic, international, multicentre randomised trial that enrols adults undergoing three elective surgical procedures (laparoscopic cholecystectomy, breast lumpectomy, hernia repair). Participants are randomised to receive discharge analgesic prescriptions that consist of either NSAIDs or low-dose opioids (ie, 10 pills of oxycodone 5 mg or equivalent), with both groups prescribed acetaminophen around-the-clock. The primary effectiveness outcome is patient-reported worst daily pain intensity over the first 7 days after surgery. The primary safety outcome is the occurrence of opioid and/or NSAID side effects over the first 7 days after surgery. Secondary outcomes are assessed by patient report and medical record review at 1 week, 1 month, 3 months and 6 months after surgery and include sleep disturbance, patient perception of improvement/change after treatment, pain interference, anxiety, depression, health-related quality of life, clinically important adverse events, substance use, opioid misuse, chronic pain, healthcare utilisation related to pain and quality of recovery.

Investigational review boards at the University of Michigan and other sites have approved the CARES trial. The first patient enrolled in CARES in February 2023, with recruitment anticipated through 2026. Dissemination builds on the input of patient partners and other members of an engaged Stakeholder Advisory Board, with activities spanning co-production of summaries to share results with study participants, publications in biomedical journals and lay press, presentations to scientific and community organisations, and other multimedia communication materials.

NCT05722002.

The opioid crisis is a significant burden on adolescent public health in the USA. Medical use of prescription opioids is a pathway via which adolescents transition to opioid misuse, opioid use disorder and overdose. More than half of all opioids prescribed to adolescents are for pain management following surgery. Yet, little is known about the critical period following surgery during which adolescents initiate opioid misuse or the modifiable mechanisms (such as sleep deficiency) contributing to this process. This prospective observational study will broaden our knowledge by examining associations between sleep deficiency and opioid use and misuse following surgery. We will also examine behavioural, psychological, family and social factors linking sleep deficiency with opioid use and misuse.

Adolescents (10–19 years) undergoing outpatient orthopaedic surgery, along with one parent, will be recruited from two paediatric hospitals, for a sample of 400 dyads. Adolescents will be assessed at six timepoints. Before surgery, participants will undergo comprehensive multimodal sleep assessments (sleep surveys and actigraphy). Participants will also report on previous substance use, pain intensity and psychosocial, family and social factors. Adolescents will then be closely monitored over the first 14 days following surgery using ecological momentary assessment methods to capture real-time, naturalistic, daily data on sleep, opioid use, pain and psychological factors (including mood, affect and subjective response to opioid use). Opioid use (total number of doses and duration) will be measured with an innovative electronic medication monitoring device following surgery. Follow-up assessments at 3 months, 6 months, 12 months and 24 months will track the development of opioid misuse over time. Our primary outcomes include opioid use during the immediate 14 days following surgery and the presence of opioid misuse at 24 months after surgery. Multilevel mediation models will determine associations between predictor variables and acute postsurgical opioid use. We will apply modern machine learning algorithms to develop and validate models predicting adolescent prescription opioid misuse at 24 months from surgery.

This study was approved by Advarra’s Center for Institutional Review Board Intelligence (CIRBI) (Protocol 00072049), which serves as the single IRB of record for this multisite study.