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VR READY: a protocol for a non-randomised, single-arm, mixed methods, feasibility trial of a coproduced ViRtual REality intervention to AiD recoverY in people recently admitted to intensive care

Por: Drew · C. J. G. · Smallman · K. · Gill · S. · Greenstock · C. · Cullen · K. · Irving · A. · Twose · P. · Battle · C. · White · D. · Smalley · M. · Lynch · C.
Introduction

Post-intensive care syndrome (PICS) describes a cluster of ongoing symptoms experienced by a large proportion of patients previously admitted to critical care. Despite a large rise in survival following critical care, interventions to support recovery and combat PICS are lacking. It has been suggested that the use of digital tools such as virtual reality (VR) may play a useful role in the development of recovery-supporting interventions. We engaged with people with lived experience of critical care admission to coproduce a VR intervention (ViRtual REality to AiD recoverY post ICU (VR READY)). Here, we present a protocol for the initial feasibility and acceptability testing of this intervention.

Methods and analysis

This is a single-arm, single-site, non-randomised feasibility trial of VR READY. Up to 25 participants recently admitted to critical care will be recruited to use the VR READY intervention for at least 5 min per day for a period of 14 days. Participants must have capacity to consent and be free from ongoing delirium in order to participate. Outcomes relating to sleep and well-being will be measured at baseline and at day 14 after intervention delivery. The primary outcome is feasibility, which will be assessed according to prespecified criteria. Participants will complete a qualitative interview to assess acceptability of the intervention, trial design and outcomes approximately 1 month after completing the intervention period. No formal statistical analysis of outcomes will be conducted, but these will be summarised descriptively. Interviews will be subjected to reflexive thematic analysis.

Ethics and dissemination

This study received a favourable ethical opinion by North-East York Research Ethics Committee (Ref 23/NE/0113) in June 2024. Study results will be disseminated through the peer review literature, ISRCTN registry and directly to participants, which will be facilitated by the study public and patient involvement steering group.

Trial registration number

ISRCTN88854487.

Protocol for a multisite, observational clinical study of the association between skin colour and pulse oximeter accuracy in children undergoing cardiac catheterisation (PACH study)

Por: Ruppel · H. · Huang · L. · Petit · C. J. · Qureshi · A. M. · Bonafide · C. P. · Foglia · E. E. · Feldman · J. · Lane-Fall · M. B. · Lynch · J. M. · Chien · A. · Dunn · M. · OByrne · M. L.
Introduction

Prospective, real-world clinical studies of the association between skin color and pulse oximeter (SpO2) accuracy in children are needed to address the limitations of previous research. Such studies are essential for generating evidence for clinicians, regulators and industry. This is the protocol for a multisite study funded by the National Heart, Lung, and Blood Institute (R01HL171313; 1 January 2024–31 December 2028).

Methods and analysis

In this pragmatic, observational study conducted in three large paediatric cardiac catheterisation centres in the USA, children undergoing cardiac catheterisation with directly measured arterial oxygen saturation will be prospectively enrolled. The outcome variable (SpO2 bias) is the difference between contemporaneous paired measurements of pulse oximetry (SpO2) and the standard reference comparator, arterial blood sample oxygen saturation (SaO2), obtained during the catheterisation procedure. The independent variable is an objective measure of skin colour obtained via spectrophotometry. Our primary analysis is a multivariable regression model testing the relationship between skin colour and SpO2 bias, after adjusting for covariates. We will also conduct a moderator analysis to identify factors that may affect the magnitude of the association. The target sample size is 584 participants.

Ethics and dissemination

This study was approved by the University of Pennsylvania Institutional Review Board (#854895) under expedited review. Study risks are minimal. Parental permission, and child assent when applicable, are obtained prior to enrolment. In accordance with the NIH Public Access Policy, publications associated with the study will be made publicly available through PubMed Central. The analytic dataset will be contributed to a repository for future use. In collaboration with a children’s hospital-based research family advisory council, interpretation and dissemination of the results for lay, clinical and scientific audiences will be considered.

Trial registration number

Although not a clinical trial, this observational study is registered on ClinicalTrials.gov (identifier: NCT06529575) for public awareness.

Interactions that support older inpatients with cognitive impairments to engage with falls prevention in hospitals: An ethnographic study

Abstract

Aims

To explore the nature of interactions that enable older inpatients with cognitive impairments to engage with hospital staff on falls prevention.

Design

Ethnographic study.

Methods

Ethnographic observations on orthopaedic and older person wards in English hospitals (251.25 h) and semi-structured qualitative interviews with 50 staff, 28 patients and three carers. Findings were analysed using a framework approach.

Results

Interactions were often informal and personalised. Staff qualities that supported engagement in falls prevention included the ability to empathise and negotiate, taking patient perspectives into account. Although registered nurses had limited time for this, families/carers and other staff, including engagement workers, did so and passed information to nurses.

Conclusions

Some older inpatients with cognitive impairments engaged with staff on falls prevention. Engagement enabled them to express their needs and collaborate, to an extent, on falls prevention activities. To support this, we recommend wider adoption in hospitals of engagement workers and developing the relational skills that underpin engagement in training programmes for patient-facing staff.

Implications for Profession and Patient Care

Interactions that support cognitively impaired inpatients to engage in falls prevention can involve not only nurses, but also families/carers and non-nursing staff, with potential to reduce pressures on busy nurses and improve patient safety.

Reporting Method

The paper adheres to EQUATOR guidelines, Standards for Reporting Qualitative Research.

Patient or Public Contribution

Patient/public contributors were involved in study design, evaluation and data analysis. They co-authored this manuscript.

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