To determine whether a novel urine collection device (the ‘Pee-in-Pot (PiP)’) produces the same rates of reportable urine culture results as standard of care (SOC) urine collection. To determine whether the PiP produces comparable microscopy results to SOC urine collection. To estimate the carbon footprint of the PiP compared to SOC urine collection.

A prospectively designed, single-centre, paired comparison study.

A district general hospital in Southwest England, including antenatal clinical, accident and emergency, medical and surgical ward environments.

Adults aged 18 or over.

Urine passed through the PiP device before being decanted into a 10 mL boric acid tube for microscopy and culture, compared with the same urine contained only in a sterile plastic vessel before being decanted into a boric acid tube for microscopy and culture.

The proportion of positive urine culture results.

The proportion of heavy mixed growth culture results. Comparison of particle counts: all small particles, bacteria, red blood cells and white blood cells.

Microscopy was performed for 1353 paired samples, of which 808 paired samples both underwent culture. Overall, urine cultures were positive in 9.3% (75/808) and 10.0% (81/808) of PiP and control cases, respectively. Overall matching between PiP and control arms for reportable positive culture results was 98.5% (796/808), with a Cohen’s Kappa test coefficient () of 0.9149 (almost perfect agreement). There was no significant difference in the rate of positive urine culture results between testing arms for any organisms (margin of non-inferiority prospectively defined as ±2.5% for Escherichia coli positive cultures). For microscopy, there was agreement in meeting culture thresholds for 1308 of 1353 paired samples with a difference in culturing rates of 0.00517 (95% CI –0.0045 to 0.015, ie, high level of agreement). The estimated base case carbon footprint of PiP testing was 95g CO2e compared to 270g CO2e for SOC testing.

This study found the PiP to be non-inferior for routine urine microscopy and culture testing and to have a lower carbon footprint compared with SOC urine testing.

People without access to recognised and understood speech and/or written communication methods can experience exceptional disadvantage in health settings. This can result in poor health outcomes, lengthier hospital admissions and adverse events, including preventable deaths. Despite numerous attempts to integrate augmentative and alternative communication into health settings, the first-person ‘voice’ of the patient is often not accessible or prioritised, deferring instead to others, such as parents or carers, or the ‘best guess’ by healthcare professionals. The Talking Scrubs project aims to form a bridge to augmentative and alternative communication by locating key communication icons on scrubs (and scrubs/vest) to be used with patients (in and of themselves) and/or to prompt the use of patient individualised communication methods. The paper describes the methodological process for Stage 4 of the project. Prior stages involved investigating the concept, developing and validating instrument measures and co-designing and feasibility pilot testing the scrubs/vests. Stage 4 (this protocol) aligns with the diagnostic process, to test the feasibility and effectiveness of the scrubs intervention at two large, metropolitan medical centres with 5–10 general practitioners, approximately 30 patients and up to 10 flow-on diagnostic screening clinicians such as nurses and phlebotomists. Stage 4 is the first time the instrument measures will be applied and re-tested post-validation.

Using mixed methods, Stage 4 will apply the communication self-efficacy instruments co-designed in Stage 2 and validated in Stage 3 to measure effectiveness of the scrubs intervention by comparing pre-intervention and post-intervention changes in both clinician and patient population groups. Qualitative interviews, agency recorded data and participant journal recordings (optional) will be used to identify feasibility. SPSS V.29 (IBM, Chicago, Illinois, USA) will be applied to analyse participant communication self-efficacy measures and NVIVO V.10 (Lumiverso, Denver, Colorado, USA) to the retrieved qualitative data.

Stages 3 and 4 have ethics approval from the University of South Australia Ethics Committee identification number 206 930 and are registered as a clinical trial with Australia and New Zealand Clinical Research Trials (ANZCRT) with registration number 12625000490471p. Stage 1 (national survey) and Stage 2 (stakeholder focus groups) received ethics approval from Flinders University. Findings will be disseminated through national and international health translation platforms, publications, media and on the Talking Scrubs website.

ANZCRT with the registration number ACTRN12625000490471p.