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Is there a role for anticoagulation with dabigatran in S. aureus bacteremia? Protocol for the adjunctive treatment domain of the Staphylococcus aureus Network Adaptive Platform (SNAP) randomised controlled trial

Por: McDonald · E. G. · Cheng · M. P. · Davis · J. S. · Goodman · A. L. · Lawler · P. R. · Marsh · J. · Mertz · D. · Paul · M. · Rodriguez-Bano · J. · Siegal · D. M. · Tong · S. Y. · Walls · G. · Lee · T. C. · The SNAP Global Trial Steering Committee · Bonten · Daneman · van Hal · Heriot
Introduction

Many patients receive oral anticoagulation for reduced stroke risk in atrial fibrillation or as treatment or prevention of venous thromboembolism. Oral factor Xa inhibitors (oral FXaI, eg, apixaban, edoxaban or rivaroxaban) are commonly prescribed for this indication. Dabigatran, an oral direct thrombin inhibitor, is similarly approved. In vitro and animal model evidence suggests that dabigatran also has direct effects on Staphylococcus aureus virulence and infection. Observational data have shown that dabigatran users are less likely to develop S. aureus bacteremia (SAB), and a small randomised controlled trial showed that dabigatran has anti-S. aureus effects when compared with low molecular weight heparins during bloodstream infection. We seek to answer whether dabigatran is superior to the oral FXaIs in achieving better SAB outcomes among patients who independently require oral anticoagulation. We report the intervention-specific protocol, embedded in an adaptive platform trial.

Methods and analysis

The S. aureus Network Adaptive Platform (SNAP) trial [NCT05137119] is a pragmatic, randomised, multicentre adaptive platform trial that compares different SAB therapies for 90-day mortality rates. For this intervention (‘Dabi-SNAP’), patients receiving therapy with an oral FXaI will be randomised to continue as usual or to change to dabigatran as of the next scheduled dose. All subjects will receive standard of care antibiotics and/or antibiotics allocated through other active domains in the platform. As the choice of anticoagulant may not demonstrate large differences in mortality, a ranked composite of death and adverse outcomes (Desirability of Outcome Ranking, or DOOR) was chosen as the primary outcome.

Ethics and dissemination

The study is conditionally approved by the research ethics board of the McGill University Health Centre: identifier 2025-10900. Trial results will be published open access in a peer-reviewed journal and presented at a global infectious disease conference. The trial is registered at clinicaltrials.gov with the identifier NCT06650501.

Trial registration number

NCT0665050.

Assessing the feasibility of a platform trial for Gram negative bloodstream infections: results from the vanguard phase of BALANCE+

Por: Daneman · N. · Johnstone · J. · Lee · T. C. · MacFadden · D. R. · McDonald · E. G. · Morpeth · S. C. · Ong · S. W. X. · Paterson · D. L. · Pinto · R. L. · Rishu · A. · Rogers · B. A. · Yahav · D. · Coburn · B. · Daley · P. · Das · P. · Fiest · K. · Findlater · A. · Fralick · M. · George · M
Objectives

Gram negative bloodstream infections (GN BSI) are a leading cause of mortality worldwide, and antibiotic treatment approaches remain understudied. BALANCE+ is a perpetual Bayesian adaptive platform trial to test multiple treatment questions for hospitalised patients with GN BSI. The vanguard phase objective was to test the feasibility of the main trial.

Design

Adaptive platform trial with five initial domains of investigation, each with open label 1:1 randomisation.

Setting

Ten hospitals across four Canadian provinces.

Participants

Individuals admitted to hospital with blood cultures yielding Gram negative bacteria.

Interventions

The five initial domains of investigation included: antibiotic de-escalation versus no de-escalation; oral transition to beta-lactam versus non-beta-lactam treatment; routine versus no routine follow-up blood cultures (FUBCs); central vascular catheter replacement versus retention; and, ceftriaxone versus carbapenem treatment for low risk AmpC organisms.

Primary outcome measures

Domain-specific recruitment rates and protocol adherence.

Results

During the vanguard phase, 719 patients were screened, of whom 563 (78.3%) were eligible, with 179 (31.8%) enrolled into the platform. The platform recruitment rate was 1.37 patients/site-week. Recruitment varied by domain: routine versus no FUBC domain 1.23 patients/site-week; oral beta-lactam versus non-beta-lactam domain 0.48; de-escalation versus no de-escalation domain 0.28; low risk AmpC domain 0.02; catheter replacement versus retention domain 0.01. Domain specific protocol adherence rates were 145/158 (91.8%) for routine versus no routine FUBC, 53/60 (88.3%) for oral beta-lactam versus non-beta-lactam, 26/33 (78.8%) for de-escalation versus no de-escalation, 3/3 (100%) for low risk AmpC, and 0/1 (0%) for line replacement versus retention. There was complete ascertainment of all study outcomes in hospital 170/170 (100%) and near complete ascertainment at 90 days 162/170 (95.3%).

Conclusions

The vanguard phase demonstrated overall trial feasibility by recruitment rate and protocol adherence, with differences across interventions, leading to a transition to the main BALANCE+ platform trial with minimal protocol modifications.

Trial registration number

NCT05893147.

Perceptions and attitudes of healthcare workers towards the use of digital facial recognition application in a health setting in Uganda: An exploratory pilot study

by Patrick Kaggwa, Juliet Nabbuye Sekandi, Mcdonald Kerone Adenike, Peter Nabende, Sarah Nabukeera, Kenneth Kidonge Katende, Esther Buregyeya, Nazarius Mbona Tumwesigye

Background

Unique patient identification is often challenging in healthcare systems, especially in low- and middle-income countries. Digital facial recognition is a promising alternative to traditional identification methods. This pilot study explores the perceptions and attitudes of healthcare workers towards using facial recognition technology in a healthcare setting in Uganda.

Methods

We conducted an explorative qualitative study using key informant interviews with healthcare workers in Kampala, Uganda, to assess perceptions and attitudes towards digital facial recognition. We interviewed a total of 10 healthcare workers, including five doctors and five nurses, aged 20–39 years, with at least one year of professional experience. A trained interviewer provided a brief overview and demonstration of the facial recognition application and then used an open-ended interview guide to elicit responses about perceptions and attitudes. The interviews were audio recorded and transcribed verbatim. Data obtained from Key Informant Interviews were manually analyzed using thematic content analysis.

Results

Overall, the healthcare workers perceived digital facial recognition as a more effective and acceptable way to identify patients who receive service at outpatient clinics. Four themes emerged, including: i) Challenges affecting current patient identification standards, ii) Healthcare workers’ views on facial recognition, iii) Perceived digital facial recognition implementation challenges, and iv) Solutions to challenges of digital facial recognition. The healthcare workers recommended ensuring the protection patients’ images privacy, providing adequate technological infrastructure in clinics, and securing stable internet access for the successful implementation of digital facial recognition.

Conclusion

Our exploratory study indicates that overall, healthcare workers have a positive perception of the digital facial recognition application. However, it is crucial to acknowledge and address concerns regarding confidentiality and privacy to pave the way for the future implementation of the system.

Implementability of a co-designed programme to increase tailored exercise to reduce falls in older people from culturally and linguistically diverse communities: protocol for a pilot randomised controlled trial

Por: Said · C. M. · Ramage · E. R. · Sharma · H. · Batchelor · F. · Bicknell · E. · Bongiovanni · L. · Brijnath · B. · Cahill · P. · Callisaya · M. · Celestino · S. · Chudecka · A. · Engel · L. · Lim · W. K. · McDonald · C. E. · Pinheiro · M. · Sherrington · C. · Vogrin · S. · Zanker · J. · Zhe
Introduction

Falls are a critical problem for older people, including those from ethnically diverse communities, who are under-represented in research. The aim of this pilot trial is to evaluate (1) the implementability of a co-designed intervention developed to support the sustained uptake of tailored exercise to reduce falls (MOVE Together: Reduce Falls) and (2) the feasibility of conducting a randomised controlled trial (RCT) in older people from Italian, Arabic, Cantonese or Mandarin-speaking communities.

Methods and analysis

Investigator and assessor-blinded pilot two-arm parallel RCT. 60 older people at risk of falls from Italian, Arabic, Cantonese or Mandarin speaking communities will be recruited, with the option to enrol on their own or with another participant (dyad). Participants or dyads will be randomly assigned to the experimental or control arm. The experimental arm will receive MOVE Together: Reduce Falls, which provides up to 12 sessions with a physiotherapist over 12 months and supports participants to engage in individualised exercises. Both arms will receive educational resources in the participant’s preferred language. The primary outcome is implementability of the co-designed intervention, MOVE Together: Reduce Falls; operationalised as fidelity (>70% of intended sessions delivered), feasibility (> 95% of sessions delivered with no serious adverse events related or likely related to the intervention) and acceptability (>50% acceptability score). The secondary outcome is feasibility of the RCT protocol, which will be evaluated quantitatively (eg, recruitment and retention rates, completion of clinical outcome data including prospective collection of falls data for 12 months via falls calendars) and qualitatively (eg, barriers and enablers to data collection).

Ethics and dissemination

Ethical approval has been granted for this study (HREC/106010/MH-2024). Study findings will be published in peer-reviewed journals and presented at relevant conferences and community forums.

Trial registration number

ACTRN12624000658516.

Comparative effectiveness of opioid versus opioid-free analgesia after outpatient breast surgery: PAIN-Alt trial protocol

Por: Fiore · J. F. · Shirzadi · S. · Roversi · K. · Prakash · I. · Wong · S. · Meterissian · S. · Meguerditchian · A. N. · Desbiens · C. · Rivard · J. · Delisle · M. · Findlay-Shirras · L. · Abou Khalil · J. · Maciver · A. · Quan · M. L. · Verreault · K. · Johnston · S. · Feldman · L. · McDon
Introduction

Excessive opioid prescribing after surgery can lead to adverse events and exacerbate the opioid crisis. Patients undergoing outpatient breast surgery are often prescribed opioids to manage pain at home; however, the value of this approach is uncertain. The Postoperative Analgesia Intervention with Non-opioid Alternatives (PAIN Alt) trial will address the following research question: among patients undergoing outpatient breast surgery, does opioid-free analgesia (OFA) result in non-inferior 7-day pain intensity and pain interference in comparison to opioid analgesia (OA)?

Methods and analysis

This is a parallel, assessor-blind, open-label randomised trial conducted at seven university-affiliated hospitals in Canada. A sample of 540 adult patients (>18 years) undergoing outpatient mastectomy or lumpectomy will be included. Participants are allocated 1:1 to receive OA (around-the-clock non-opioids and opioids for breakthrough pain) or OFA (around-the-clock non-opioids, with adjustment of non-opioid drugs and/or non-pharmacological interventions for breakthrough pain). The co-primary outcomes are 7-day pain intensity and pain interference (measured using the Brief Pain Inventory). Secondary outcomes include adverse drug events, physical and mental health status, satisfaction with pain management, postoperative complications, chronic pain, opioid misuse, persistent opioid use, healthcare utilisation and costs. The primary statistical analyses will follow the intention-to-treat principle and be conducted using mixed-effects modelling.

Ethics and dissemination

This trial is coordinated by the McGill University Health Centre (ethics approval MP-37-2024-102530), with ethics approval being sought at all participating sites. Our results will be published in an open-access, peer-reviewed journal, presented at relevant conferences and disseminated to the public through press releases.

Trial registration number

NCT06507345.

Exploring Clinicians' Perspectives of Transition From Hospital to Home for Older Adults Living With Frailty: TRANSFER‐I a Focus Group Study

ABSTRACT

Aim

To investigate clinicians' perspectives on the transition from hospital to home and identify gaps in care for older adults living with frailty during the transfer of care.

Design

Qualitative reflexive thematic analysis of focus groups

Methods

Focus groups were conducted with clinicians using purposive sampling. Participants were eligible if they had provided or overseen the clinical care of a patient transferring from hospital to home. Verbatim transcripts were analysed, and themes were identified using NVivo through the development of codes and exploration of core commonalities.

Results

A total of 28 clinicians participated in five focus groups. Participants included nurses (n = 14), allied health (n = 8), medical officers (n = 2), managers and hospital executives (n = 4). Themes were categorised into four domains: (1) system fragmentation and finite resources challenge healthcare navigation for everyone; (2) the interplay of cultural and societal considerations in the context of ageing; (3) fragile cycle of care for older patients who frequent hospitalisation; and (4) effective communication and expertise being critical for quality care.

Conclusion

Despite decades of research, the transition from hospital to home for older adults living with frailty remains a persistent challenge. This study identified significant and continued unmet needs in navigating a complex health system, underscoring the evidence-practice gap in transitional care services. Results have informed the development and implementation of a feasibility study (TRANSFER-II), currently underway, that tests the feasibility of a nurse-coordinated model of transitional care support for older adults.

Implications for the Nursing Profession and Patient Care

Transfers from hospital to home, frequent readmissions and transitions in care are common for older adults living with frailty. Understanding the enablers and barriers in transitional care for this vulnerable population can enhance the quality of care, improve communication and inform the development of more effective transitional care models. The findings underline the critical role nurses play in addressing systemic gaps and improving continuity of care for older adults across diverse health systems.

Impact

Transitional care is complex, and older populations are more at risk of returning to hospital. Findings highlight the significant unmet needs in navigating a complex health system and revealed the fragile cycle of care for older adults who frequent hospital. Reiterating the importance of effective communication and clinical expertise in delivering safe patient-centred nursing care.

Reporting Method

This qualitative study was reported in accordance with the consolidated criteria for reporting qualitative research (COREQ) checklist.

Patient or Public Contribution

Patients and carers contributed to the design of this qualitative study through consultation with a consumer advisory group, where potential transitional care interventions were discussed. These discussions highlighted a need to further explore transitional care unmet needs, informing the development of this focus group study.

Cognitive dysfunction and its association with inflammation in acute exacerbations of COPD: protocol for a prospective hospital-based cohort

Por: De Luca · S. N. · Burrell · L. M. · Collins · A. · Jackson · M. · Vlahos · R. · McDonald · C. F.
Introduction

Chronic obstructive pulmonary disease (COPD) is characterised by progressive airflow limitation that is not fully reversible and is associated with an abnormal inflammatory response of lungs to noxious particles and gases. The inflammatory and reparative processes occurring in the lungs induce a ‘spill-over’ of inflammatory mediators into the circulation, resulting in an increase in systemic inflammation, which is further increased during acute exacerbations of COPD (AECOPD), leading to the development of extra-pulmonary comorbidities, such as cognitive impairment. Cognitive impairment affects up to 61% of people living with COPD. Heightened levels of inflammation have been linked to increased risk of cognitive impairments; however, the exact mechanisms remain unclear, thus hampering the development of therapeutics. This study aims to determine whether patients hospitalised with an acute COPD exacerbation show impaired cognitive function compared with recovery (~day 45), and whether such dysfunction is associated with systemic inflammation and oxidative stress.

Methods and analysis

A prospective, observational study will be conducted at Austin Health in Victoria, Australia. Eligible participants will be assessed during admission for AECOPD and following stabilisation (approximately day 45). The primary outcome is the difference in cognitive function between admission for AECOPD to recovery using non-verbal cognitive tests. Secondary outcomes are changes in systemic markers of inflammation, oxidative stress and ACE2 catalytic activity. Tertiary outcomes are anxiety and depression scores.

Ethics and dissemination

Ethical approval has been granted in Australia by Austin Health Human Research Ethics Committee (HREC 56099) with governance approval at Austin Hospital. The results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. Findings will be disseminated to consumers in publications for lay audiences.

The (Under) Valued Contribution of Doctorally Prepared Clinical Nurses to Healthcare—A Qualitative Study

ABSTRACT

Aim

Although the majority of doctorally prepared nurses work in academia, a percentage choose clinical work. Knowledge about the contribution of doctorally prepared clinical nurses (DPCNs) is growing, but further exploration is required. This research explored the value that DPCNs provide to nursing practice and healthcare.

Design and Methods

Using an interpretive descriptive approach, individual interviews were conducted with 18 DPCNs. Data was collected between 2021 and 2022. Reflexive thematic analysis informed the data analysis.

Results

Five key mechanisms drive DPCNs' value: being a knowledge expert; an enhanced approach to practice; increased credibility/prestige of the doctorate; valuable conversations; and new opportunities and collaborations. Challenges to value contribution were also highlighted, including identity issues; negative external perceptions; fragmented mentorship; no post-doctoral pathway; and little recognition from nursing leaders.

Conclusion

Doctorally prepared clinical nurses bring significant value to nursing and healthcare through distinct mechanisms that should be nurtured and strengthened.

Implications for Practice

Doctorally prepared clinical nurses add important value to healthcare. However, these nurses are under-utilised and require support to enhance their value contribution.

Impact

Identifying the mechanisms driving value provides a unique opportunity to acknowledge, support and enhance the value provided by DPCNs. The research will be impactful for nurses considering doctoral study, nursing leaders and healthcare managers.

Reporting Method

This research is reported following SRQR guidelines.

Patient or Public Involvement

This study did not include patient or public involvement in its design, conduct or reporting.

Intrinsic Influences on Medical Emergency Team Call Stand‐Down Decision‐Making: An Observational Study

ABSTRACT

Aim

The aim of this research was to describe factors that influence Intensive Care Unit liaison nurses' decision to stand down a medical emergency team call response. The decision to end a medical emergency team response for a deteriorating patient is referred to as the medical emergency team call stand-down decision. Intensive Care Unit liaison nurses, also known internationally as critical care outreach nurses, make medical emergency team call stand-down decisions in complex and challenging clinical environments. However, the factors influencing these decisions are not well described in the literature.

Design

Exploratory descriptive qualitative study.

Methods

Seven Intensive Care Unit liaison nurses who attended medical emergency team calls in a large acute metropolitan tertiary referral public hospital, with a mature three-tiered rapid response system, were observed and interviewed. Observations of 50 medical emergency team call responses and 50 post medical emergency team call interviews were conducted between March 2022 and August 2022. Findings were analysed using inductive content analysis.

Results

Intensive Care Unit liaison nurse decisions to stand down MET call responses were influenced by three intrinsic factors: (1) propositional knowledge, (2) experiential knowledge, (3) situational knowledge and information processing styles. Intensive Care Unit liaison nurses utilised these intrinsic factors to support their decision to terminate medical emergency team call response.

Conclusion

This study explored the intrinsic influences on individual Intensive Care Unit liaison nurses in deciding to end a medical emergency team call. By highlighting these individual influences on decision-making, the findings may be used to support medical emergency team responders educational needs and identification of potential heuristics and biases inherent in clinical decision-making which contribute to adverse events.

Patient or Public Contribution

No patient or public contribution.

Implications for Profession and/or Patient Care

By understanding the influences on an individual's clinical decision-making, strategies can be put in place for educational development and support for experiential learning. The study highlights areas of potential bias and heuristic use that may lead to sub-optimal clinical decisions and increased risk for deteriorating patients. Research findings can be applied internationally to a range of rapid response systems and critical care outreach teams that respond to deteriorating patients.

Reporting Method

The consolidated criteria for reporting qualitative research (COREQ) guidelines were used for reporting this study.

Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings (CanTreatCOVID): protocol for a randomised controlled adaptive platform trial of treatments for acute SARS-CoV-2 infection in community settings

Por: Hosseini · B. · Condon · A. · da Costa · B. R. · Daley · P. · Greiver · M. · Jüni · P. · Lee · T. C. · McBrien · K. · McDonald · E. G. · Murthy · S. · Selby · P. · Andrew · M. · Aubrey-Bassler · K. · Barber · D. · Barrett · B. · Butler · C. C. · Crampton · N. · Dahrouge · S. · Damji · A.
Introduction

SARS-CoV-2 is now endemic and expected to remain a health threat, with new variants continuing to emerge and the potential for vaccines to become less effective. While effective vaccines and natural immunity have significantly reduced hospitalisations and the need for critical care, outpatient treatment options remain limited, and real-world evidence on their clinical and cost-effectiveness is lacking. In this paper, we present the design of the Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings (CanTreatCOVID). By evaluating multiple treatment options in a pragmatic adaptive platform trial, this study will generate high-quality, generalisable evidence to inform clinical guidelines and healthcare decision-making.

Methods and analysis

CanTreatCOVID is an open-label, individually randomised, multicentre, national adaptive platform trial designed to evaluate the clinical and cost-effectiveness of therapeutics for non-hospitalised SARS-CoV-2 patients across Canada. Eligible participants must present with symptomatic SARS-CoV-2 infection, confirmed by PCR or rapid antigen testing (RAT), within 5 days of symptom onset. The trial targets two groups that are expected to be at higher risk of more severe disease: (1) individuals aged 50 years and older and (2) those aged 18–49 years with one or more comorbidities. CanTreatCOVID uses numerous approaches to recruit participants to the study, including a multifaceted public communication strategy and outreach through primary care, outpatient clinics and emergency departments. Participants are randomised to receive either usual care, including supportive and symptom-based management, or an investigational therapeutic selected by the Canadian COVID-19 Outpatient Therapeutics Committee. The first therapeutic arm evaluates nirmatrelvir/ritonavir (Paxlovid), administered two times per day for 5 days. The second therapeutic arm investigates a combination antioxidant therapy (selenium 300 µg, zinc 40 mg, lycopene 45 mg and vitamin C 1.5 g), administered for 10 days. The primary outcome is all-cause hospitalisation or death within 28 days of randomisation.

Ethics and dissemination

The CanTreatCOVID master protocol and subprotocols have been approved by Health Canada and local research ethics boards in the participating provinces across Canada. The results of the study will be disseminated to policy-makers, presented at conferences and published in peer-reviewed journals to ensure that findings are accessible to the broader scientific and medical communities. This study was approved by the Unity Health Toronto Research Ethics Board (#22-179) and Clinical Trials Ontario (Project ID 4133).

Trial registration number

NCT05614349

Cluster randomised controlled trial of a household-level, group preconception nutrition awareness and norm intervention (SUMADHUR) combined with multiple micronutrient supplements (MMS) for newly married households: a protocol

Por: Diamond-Smith · N. · Puri · M. C. · Borak · L. · Walker · D. · Charlebois · E. · Weiser · S. D. · McDonald · C. M.
Introduction

Micronutrient deficiencies remain prominent drivers of adverse maternal and child health outcomes in Nepal. Gender-based inequalities and norms around women’s status and access to nutrition exacerbate poor nutritional status. Many newly married, preconception women lack adequate nutrition due to delayed engagement with the health system and limited autonomy to prioritise their own health. To address this gap, the Sumadhur trial provides multiple micronutrient supplements (MMS) alongside a household-level behavioural intervention targeting newly married women, their husbands and mothers-in-law.

Methods and analysis

This will be a village-cluster randomised controlled trial across three districts in Nepal, enrolling 700 households, each comprising a triad of newly married woman, husband and mother-in-law. Villages will be randomised to receive either Sumadhur behavioural intervention+MMS (intervention) or standard of care (control). In intervention villages, participants will join weekly group sessions for 5 months, covering maternal and reproductive health, equitable household food allocation and nutrition information, and gender norms and household relationships. Women will receive three bottles of MMS (180 tablets each) over 18 months. Quantitative data collection at baseline, 6, 12 and 18 months will include surveys, venous blood draws (not at 12 months) and anthropometry. Primary outcomes will be anaemia prevalence and micronutrient status (iron, folate, vitamin B12). Secondary outcomes will include reproductive behaviours, birth outcomes and intrahousehold relationship dynamics. A nested qualitative component will employ longitudinal in-depth interviews with triads to understand the mechanisms of behavioural change. Impact will be measured through an intention-to-treat approach using mixed-effects logistic regression analyses.

Ethics and dissemination

The study is approved by institutional review boards in the Ethics Board of the Nepal Health Research Council and the University of California, San Francisco IRB. Results will be disseminated to participating communities, local stakeholders and international audiences through workshops, peer-reviewed publications and policy briefs.

All data will be made publicly available (deidentified) after the publication of the main impact paper.

Trial registration number

NCT06810440.

Enhancing Aboriginal and Torres Strait Islander research trial leadership and participation: insights from the initial stages of the Australian Fans in Training Project in the Northern Territory of Australia

Por: Brickley · B. · Bonson · J. · Danvers · J. · Ah Mat · J. · Stephensen · P. · McDonald · M. D. · Quested · E. · Maiorana · A. · Pavey · T. · Wharton · L. · Bennett · E. · Smith · J. A.
Introduction

Advancing equity, diversity and inclusion in health research trials is essential for improving health outcomes among priority populations. While evidence increasingly highlights the importance of cultural diversity in research trial leadership and participation, evidence-based strategies for enhancing this remain limited. This article outlines approaches to strengthen Aboriginal and Torres Strait Islander involvement in health research trials, drawing on insights from community engagement at the Darwin (Northern Territory) trial site of the Australian Fans in Training (Aussie-FIT) project.

Methodology

Community engagement at this site aimed to (1) build mutually beneficial relationships with community leaders, specifically Aboriginal and Torres Strait Islander men; (2) codesign engagement standards to enhance the quality of engagement with these leaders and more broadly with local community members and stakeholders. A culturally diverse community advisory group was established, which codesigned engagement standards tailored to community needs and preferences.

Strengths and limitations

While the codesigned standards supported Aboriginal and Torres Strait Islander trial leadership and participation during the trial, the extensive consultation needed to build cross-cultural relationships and develop the standards meant they were finalised only after trial recruitment had ceased. As a result, researchers were unable to fully implement them in the early stages of the trial.

Conclusions

This paper shared and critically discussed approaches used in the early stages of the Aussie-FIT trial to foster more equitable and inclusive practices in research trials. Implementation of these approaches and community-informed recommendations has the potential to enhance research quality, build trust with priority populations and address participation inequities, thus supporting effective trial design and improved health outcomes.

Trial registration number

This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623000437662).

Nurses' Experiences of Using Nursing Care Plans in the Electronic Medical Record in an Acute Medical Setting: A Mixed-Methods Study

imageNursing care plans within electronic medical record systems have the potential to support nurses in planning and prioritizing patient care; however, there is a gap in the literature related to nurses' experiences of how this may occur. The aims of this mixed-methods study included exploring nurses' documentation adherence, identifying barriers and enablers to care plans documentation, and making recommendations to enhance nurses' use of care plans within electronic medical records. An audit of 142 patients revealed the majority had at least one care plan initiated in the electronic medical record (n = 120, 84.5%), 63 patients had a care plan initiated within 24 hours of admission (n = 63, 44.4%), and only three had care plans documented against in the previous 48 hours (2.11%). Data from six focus groups were developed into two themes (each with two subthemes): “Mind the Gap” and “Making It Work for Us.” Barriers and enablers were identified and mapped to 10 of the 14 domains of the Theoretical Domains Framework. There was large variability in nurses' knowledge and understanding related to the need for care plans documentation. Assessment of usability and/or redesign of care plans within electronic medical records must align to nursing workflows to support clinical care delivery.

Clinical outcomes of nurse‐coordinated interventions for frail older adults discharged from hospital: A systematic review and meta‐analysis

Abstract

Aim

To determine the effects of nurse-coordinated interventions in improving readmissions, cumulative hospital stay, mortality, functional ability and quality of life for frail older adults discharged from hospital.

Design

Systematic review with meta-analysis.

Methods

A systematic search using key search terms of ‘frailty’, ‘geriatric’, ‘hospital’ and ‘nurse’. Covidence was used to screen individual studies. Studies were included that addressed frail older adults, incorporated a significant nursing role in the intervention and were implemented during hospital admission with a focus on transition from hospital to home.

Data Sources

This review searched MEDLINE (Ovid), CINAHL (EBSCO), PubMed (EBSCO), Scopus, Embase (Ovid) and Cochrane library for studies published between 2000 and September 2023.

Results

Of 7945 abstracts screened, a total 16 randomised controlled trials were identified. The 16 randomised controlled trials had a total of 8795 participants, included in analysis. Due to the heterogeneity of the outcome measures used meta-analysis could only be completed on readmission (n = 13) and mortality (n = 9). All other remaining outcome measures were reported through narrative synthesis. A total of 59 different outcome measure assessments and tools were used between studies. Meta-analysis found statistically significant intervention effect at 1-month readmission only. No other statistically significant effects were found on any other time point or outcome.

Conclusion

Nurse-coordinated interventions have a significant effect on 1-month readmissions for frail older adults discharged from hospital. The positive effect of interventions on other health outcomes within studies were mixed and indistinct, this is attributed to the large heterogeneity between studies and outcome measures.

Relevance to Clinical Practice

This review should inform policy around transitional care recommendations at local, national and international levels. Nurses, who constitute half of the global health workforce, are ideally situated to provide transitional care interventions. Nurse-coordinated models of care, which identify patient needs and facilitate the continuation of care into the community improve patient outcomes.

Implications for the Profession and/or Patient Care

Review findings will be useful for key stakeholders, clinicians and researchers to learn more about the essential elements of nurse-coordinated transitional care interventions that are best targeted to meet the needs of frail older adults.

Impact

When frail older adults experience transitions in care, for example discharging from hospital to home, there is an increased risk of adverse events, such as institutionalisation, hospitalisation, disability and death. Nurse-coordinated transitional care models have shown to be a potential solution to support adults with specific chronic diseases, but there is more to be known about the effectiveness of interventions in frail older adults. This review demonstrated the positive impact of nurse-coordinated interventions in improving readmissions for up to 1 month post-discharge, helping to inform future transitional care interventions to better support the needs of frail older adults.

Reporting Method

This systematic review was reported in accordance with the Referred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Patient or Public Contribution

No Patient or Public Contribution.

INFORM‐AF II—Phase 1 pilot randomised controlled trial evaluating the effect of an atrial fibrillation digital education programme: study protocol

Abstract

Aim

To evaluate the effect of a novel, co-designed, digital AF educational program, ‘INFORM-AF’, to reduce re-hospitalisation of people with AF.

The secondary aims are to examine the effect of the intervention on: (a) reducing cardiovascular-related hospitalisation, (b) increasing medication adherence, AF-related knowledge, and Atrial fibrillation (AF)-related quality of life and (c) determining the cost-effectiveness of the intervention.

Background

AF is an increasingly prevalent cardiac arrythmia that involves complex clinical management. Comprehensive education is essential for successful self-management of AF and is associated with positive health-related outcomes. There has been an increase in technology-based education for AF. However, its effects on hospitalisation, medication adherence and patient-reported outcomes are unclear.

Design

A prospective, randomised (1:1), open-label, blinded-endpoint, multicentre clinical trial.

Methods

Eligible participants are aged 18 years or above, diagnosed with AF, and own a smartphone. The study will be conducted at two metropolitan hospitals. In the intervention group, participants will receive the AF educational program delivered via Qstream®. In the control group, participants will receive the Stroke Foundation ‘Living with AF’ booklet. The primary outcome is re-hospitalisation within 12 months from an indexed presentation or hospital admission.

Conclusion

This clinical trial is part of a developing program of work that will examine mHealth educational-behavioural interventions on cardiovascular outcomes. Findings from this pilot study will inform the development of a digital educational framework for patients living with AF.

Implications for the Profession and/or Patient Care

There remain many gaps in providing high-quality patient education for patients with AF. This trial will test a new theory-driven, smartphone-based education program on important clinical outcomes, including rehospitalisation.

Impact

This study evaluates a novel, co-designed, digital AF educational program, ‘INFORM-AF’, to reduce the re-hospitalisation of people with AF. Study results are expected to be reported in 2025. Findings are expected to inform practice recommendations for AF patient education that may be included in future clinical practice guideline recommendations.

Reporting Method

SPIRIT Checklist.

Patient or Publication Contribution

JL is a consumer co-researcher on the project and provided critical input into intervention design, and feedback and input across the study duration.

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