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SCALE-UP II: protocol for a pragmatic randomised trial examining population health management interventions to increase the uptake of at-home COVID-19 testing in community health centres

Por: Del Fiol · G. · Orleans · B. · Kuzmenko · T. V. · Chipman · J. · Greene · T. · Martinez · A. · Wirth · J. · Meads · R. · Kaphingst · K. K. · Gibson · B. · Kawamoto · K. · King · A. J. · Siaperas · T. · Hughes · S. · Pruhs · A. · Pariera Dinkins · C. · Lam · C. Y. · Pierce · J. H. · Benson
Introduction

SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs).

Methods and analysis

The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2x2x2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2x2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors.

Ethics and dissemination

The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications.

Trial registration number

ClinicalTrials.gov: NCT05533918 and NCT05533359.

An mHealth application for chronic vascular access: A multi‐method evaluation

Abstract

Background

Healthcare consumers require diverse resources to assist their navigation of complex healthcare interactions, however, these resources need to be fit for purpose.

Aim

In this study, we evaluated the utility, usability and feasibility of children, families and adults requiring long-term intravenous therapy using a recently developed mobile health application (App), intravenous (IV) Passport.

Design

Multi-site, parallel, multi-method, prospective cohort study.

Methods

A multi-site, multi-method study was carried out in 2020–2021, with 46 participants (20 adults, 26 children/family) reporting on their experiences surrounding the use of the IV Passport for up to 6 months.

Results

Overall, utility rates were acceptable, with 78.3% (N = 36) using the IV Passport over the follow-up period, with high rates of planned future use for those still active in the project (N = 21; 73%), especially in the child/family cohort (N = 13; 100%). Acceptability rates were high (9/10; IQR 6.5–10), with the IV Passport primarily used for documenting new devices and complications. Thematic analysis revealed three main themes (and multiple subthemes) in the qualitative data: Advocacy for healthcare needs, Complexity of healthcare and App design and functionality.

Conclusion

Several recommendations were made to improve the end-user experience including ‘how to’ instructions; and scheduling functionality for routine care.

Implications for the Profession and/or Patient Care

The IV Passport can be safely and appropriately integrated into healthcare, to support consumers.

Impact

Patient-/parent-reported feedback suggests the Intravenous Passport is a useful tool for record-keeping, and positive communication between patients/parents, and clinicians.

Reporting Method

Not applicable.

Patient Contribution

Consumers reported their experiences surrounding the use of the IV Passport for up to 6 months.

Personal strategies to reduce the effects of landscape fire smoke on asthma-related outcomes: a protocol for systematic review and meta-analysis

Por: Beyene · T. · Gibson · P. G. · Murphy · V. · Jensen · M. E. · McDonald · V. M.
Introduction

Landscape fire smoke (LFS) contains several hazardous air pollutants that are known to be detrimental to human health. People with asthma are more vulnerable to the health impact of LFS than general populations. The aim of this review is to investigate the effectiveness of personal strategies to reduce the effect of LFS on asthma-related outcomes.

Methods and analysis

We will electronically search databases such as Medline, Embase, CINAHL and Cochrane Clinical Trials Register to identify eligible articles for the review. Screening of search results and data extraction from included studies will be completed by two independent reviewers. The risk of bias (RoB 2) will be assessed using the Risk of Bias Assessment Tool for Non-Randomised Studies for observational studies, the Cochrane Collaboration tool for assessing the RoB 2 for randomised controlled trials (RCTs) and the Risk Of Bias In Nonrandomized Studies of Interventions tool for non-RCTs. A random-effect meta-analysis will be performed to determine the pooled summary of findings of the included studies. If meta-analysis is not possible, we will conduct a narrative synthesis. Findings will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.

Ethics and dissemination

This study will synthesise the available evidence obtained from published studies and as such, no ethical approval is required. The review will be disseminated through peer-reviewed publications and conference presentations.

PROSPERO registration number

CRD42022341120.

Invasive device‐associated skin complications and mechanical dysfunctions in paediatric healthcare: A systematic review and meta‐analysis

Abstract

Aim

This study aimed to estimate the proportion and rate of skin complications and mechanical dysfunction associated with indwelling invasive devices in paediatric healthcare.

Design

This systematic review is reported in accordance with Cochrane standards for randomized controlled trials and the Meta-analysis of Observation Studies in Epidemiology for cohort studies.

Data Sources

MEDLINE, CINAHL, Embase, Web of Science, Scopus, Cochrane CENTRAL, clinical trial registries, and unpublished study databases were searched.

Review Methods

Cohort studies and trials published from January 2011 to June 2022, including (1) indwelling invasive devices, (2) paediatric participants admitted to a hospital, (3) reporting post-insertion device-associated skin complication and/or mechanical dysfunction, and (4) published in English, were included. Device-associated skin complication and mechanical dysfunction (infiltration, leakage, occlusion/blockage, dislodgement/malposition, breakage and others). Pooled proportion and incidence rate per 1000 device days are reported.

Results

This review synthesized 114 studies (30,782 devices; 1,635,649 device-days). Skin complications were reported in 40 studies, but none exclusively reported individual device-related pressure injuries. Mechanical dysfunctions were well-reported for central venous access devices, peripheral intravenous catheters, nasogastric/gastric tubes and peritoneal dialysis catheters but less for arterial catheters, extracorporeal membrane oxygenation and ventricular assist devices.

Conclusions

This systematic review highlights the need for standardized definitions and reporting methods to better surveil and benchmark device-related complications, particularly for understudied device types. Device-related pressure injuries were not reported in any of the included studies, and all devices except for vascular access devices require standardized reporting of complications.

Impact

Despite the widespread use of invasive devices, comprehensive data on their prevalence, utility, and associated paediatric complications is limited. This review identified prevalent skin complications, occlusions and dislodgments in children with devices, underscoring the need for standardized reporting to enhance surveillance and understanding of paediatric device-related complications.

Reporting Method

MOOSE (Meta-analyses Of Observational Studies in Epidemiology) Checklist.

Patient or Public Contribution

No Patient or Public Contribution.

Transition of young people from childrens into adults services: what works for whom and in what circumstances - protocol for a realist synthesis

Por: Sipanoun · P. · Aldiss · S. · Porter · L. · Morgan · S. · Powell · E. · Gibson · F.
Introduction

The process of transitioning young people from children’s or adolescents’ health services into adults’ services is a crucial time in the lives and health of young people and has been reported to be disjointed rather than a process of preparation in which they are involved. Such transitions not only fail to meet the needs of young people and families at this time of significant change, but they may also result in a deterioration in health, or disengagement with services, which can have deleterious long-term consequences. Despite the wealth of literature on this topic, there has yet to be a focus on what works for whom, in what circumstances, how and why, in relation to all young people transitioning from children’s into adults’ services, which this realist synthesis aims to address.

Methods and analysis

This realist synthesis will be undertaken in six stages: (1) the scope of the review will be defined; (2) initial programme theories (IPTs) developed; (3) evidence searched; (4) selection and appraisal; (5) data extraction and synthesis; and (6) finally, refine/confirm programme theory. A theory-driven, iterative approach using the ‘On Your Own Feet Ahead’ theoretical framework, will be combined with an evidence search including a review of national transition policy documents, supplemented by citation tracking, snowballing and stakeholder feedback to develop IPTs. Searches of EMBASE, EMCARE, Medline, CINAHL, Cochrane Library, Web of Science, Scopus, APA PsycINFO and AMED will be conducted from 2014 to present, supplemented with grey literature, free-text searching (title, abstract and keywords) and citation tracking. Data selection will be based on relevance and rigour and extracted and synthesised iteratively with the aim of identifying and exploring causal links between contexts, mechanisms and outcomes. Results will be reported according to the Realist And Meta-narrative Evidence Syntheses: Evolving Standards Quality and Publication Standards.

Ethics and dissemination

This realist synthesis forms part of the National Transition Evaluation Study, which has received ethical and regulatory approval (IRAS ID: 313576). Results will be disseminated through peer-review publication, conference presentations and working with healthcare organisations, stakeholder groups and charities.

Trial registration number

NCT05867745.

PROSPERO registration number

CRD42023388985.

A surfactant‐based dressing can reduce the appearance of Pseudomonas aeruginosa pigments and uncover the dermal extracellular matrix in an ex vivo porcine skin wound model

Abstract

From previous studies, we have shown that viable colony forming units of bacteria and bacterial biofilms are reduced after sequential treatment with a surfactant-based dressing. Here, we sought to test the impact on visible bacterial pigments and the ultrastructural impact following the sequential treatment of the same surfactant-based dressing. Mature Pseudomonas aeruginosa biofilms were grown on ex vivo porcine skin explants, and an imaging-based analysis was used to compare the skin with and without a concentrated surfactant. In explants naturally tinted by bacterial chromophores, wiping alone had no effect, while the use of a surfactant-based dressing reduced coloration. Similarly, daily wiping led to increased immunohistochemical staining for P. aeruginosa antigens, but not in the surfactant group. Confocal immunofluorescent imaging revealed limited bacterial penetration and coating of the dermis and loose pieces of sloughing material. Ultrastructural analysis confirmed that the biofilms were masking the extracellular matrix (ECM), but the surfactant could remove them, re-exposing the ECM. The masking of the ECM may provide another non-inflammatory explanation for delayed healing, as the ECM is no longer accessible for wound cell locomotion. The use of a poloxamer-based surfactant appears to be an effective way to remove bacterial chromophores and the biofilm coating the ECM fibres.

Barriers and enablers to and strategies for promoting domestic plasma donation throughout the world: Overarching protocol for three systematic reviews

by Cole Etherington, Amelia Palumbo, Kelly Holloway, Samantha Meyer, Maximillian Labrecque, Kyle Rubini, Risa Shorr, Vivian Welch, Emily Gibson, Terrie Foster, Jennie Haw, Elisabeth Vesnaver, Manavi T. Maharshi, Sheila F. O’Brien, Paul MacPherson, Joyce Dogba, Tony Steed, Mindy Goldman, Justin Presseau

Introduction

The growing demand for plasma protein products has caused concern in many countries who largely rely on importing plasma products produced from plasma collected in the United States and Europe. Optimizing recruitment and retention of a diversity of plasma donors is therefore important for supporting national donation systems that can reliably meet the most critical needs of health services. This series of three systematic reviews aims to synthesize the known barriers and enablers to source plasma donation from the qualitative and survey-based literature and identify which strategies that have shown to be effective in promoting increased intention to, and actual donation of, source plasma.

Methods and analysis

Primary studies involving source or convalescent plasma donation via plasmapheresis will be included. The search strategy will capture all potentially relevant studies to each of the three reviews, creating a database of plasma donation literature. Study designs will be subsequently identified in the screening process to facilitate analysis according to the unique inclusion criteria of each review (i.e., qualitative, survey, and experimental designs). The search will be conducted in the electronic databases SCOPUS, MEDLINE, EMBASE, PsycINFO, and CINAHL without date or language restrictions. Studies will be screened, and data will be extracted, in duplicate by two independent reviewers with disagreements resolved through consensus. Reviews 1 and 2 will draw on the Theoretical Domains Framework and Intersectionality, while Review 3 will be informed by Behaviour Change Intervention Ontologies. Directed content analysis and framework analysis (Review 1), and descriptive and inferential syntheses (Reviews 2 and 3), will be used, including meta-analyses if appropriate.

Discussion

This series of related reviews will serve to provide a foundation of what is known from the published literature about barriers and enablers to, and strategies for promoting, plasma donation worldwide.

Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial

Por: Schlechter · C. R. · Del Fiol · G. · Jones · D. R. · Orleans · B. · Gibson · B. · Nahum-Shani · I. · Maxfield · E. · Locke · A. · Cornia · R. · Bradshaw · R. · Wirth · J. · Jaggers · S. J. · Lam · C. Y. · Wetter · D. W.
Introduction

Over 40% of US adults meet criteria for obesity, a major risk factor for chronic disease. Obesity disproportionately impacts populations that have been historically marginalised (eg, low socioeconomic status, rural, some racial/ethnic minority groups). Evidence-based interventions (EBIs) for weight management exist but reach less than 3% of eligible individuals. The aims of this pilot randomised controlled trial are to evaluate feasibility and acceptability of dissemination strategies designed to increase reach of EBIs for weight management.

Methods and analysis

This study is a two-phase, Sequential Multiple Assignment Randomized Trial, conducted with 200 Medicaid patients. In phase 1, patients will be individually randomised to single text message (TM1) or multiple text messages (TM+). Phase 2 is based on treatment response. Patients who enrol in the EBI within 12 weeks of exposure to phase 1 (ie, responders) receive no further interventions. Patients in TM1 who do not enrol in the EBI within 12 weeks of exposure (ie, TM1 non-responders) will be randomised to either TM1-Continued (ie, no further TM) or TM1 & MAPS (ie, no further TM, up to 2 Motivation And Problem Solving (MAPS) navigation calls) over the next 12 weeks. Patients in TM+ who do not enrol in the EBI (ie, TM+ non-responders) will be randomised to either TM+Continued (ie, monthly text messages) or TM+ & MAPS (ie, monthly text messages, plus up to 2 MAPS calls) over the next 12 weeks. Descriptive statistics will be used to characterise feasibility (eg, proportion of patients eligible, contacted and enrolled in the trial) and acceptability (eg, participant opt-out, participant engagement with dissemination strategies, EBI reach (ie, the proportion of participants who enrol in EBI), adherence, effectiveness).

Ethics and dissemination

Study protocol was approved by the University of Utah Institutional Review Board (#00139694). Results will be disseminated through study partners and peer-reviewed publications.

Trial registration number

clinicaltrials.gov; NCT05666323.

Decision‐making in nursing research and practice—Application of the Cognitive Continuum Theory: A meta‐aggregative systematic review

Abstract

Aim

To explore how the Cognitive Continuum Theory has been used in qualitative nursing research and to what extent it has been integrated in the research process using the Qualitative Network for Theory Use and Methodology (QUANTUM).

Background

Theory, research and nursing are intrinsically linked, as are decision-making and nursing practice. With increasing pressure on nurses to improve patient outcomes, systematic knowledge regarding decision-making is critical and urgent.

Design

A meta-aggregative systematic review.

Methods

Databases

CINAHL, Medline, PsycINFO, Embase and PubMed were searched from inception until May 2022 for peer-reviewed research published in English.

Seven studies were included and assessed for methodological quality using the Joanna Briggs Institute checklist for qualitative research. A meta-aggregative synthesis was conducted using Joanna Briggs methodology. The QUANTUM typology was used to evaluate the visibility of the Cognitive Continuum Theory in the research process.

Results

The review identified five synthesised findings, namely: 1. the decision-making capacity of the individual nurse, 2. nurses’ level of experience, 3. availability of decision support tools, 4. the availability of resources and 5. access to senior staff and peers. Only two of seven studies rigorously applied the theory. The included studies were mainly descriptive-exploratory in nature.

Conclusion

The transferability of the Cognitive Continuum Theory was demonstrated; however, evolution or critique was absent. A gap in the provision of a patient-centric approach to decision-making was identified. Education, support and research is needed to assist decision-making.

A new Person-Centred Nursing Model of the Cognitive Continuum Theory has been proposed to guide future research in clinical decision-making.

Relevance to Clinical Practice

Nurses make numerous decisions every day that directly impact patient care, therefore development and testing of new theories, modification and revision of older theories to reflect advances in knowledge and technology in contemporary health care are essential.

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