Can using the functional resonance analysis method, as an intervention, improve patient safety in hospitals?: a stepped wedge design protocol

Background Healthcare professionals are sometimes forced to adjust their work to varying conditions leading to discrepancies between hospital protocols and daily practice. We will examine the discrepancies between protocols, ‘Work As Imagined’ (WAI), and daily practice ‘Work As Done’ (WAD) to determine whether these adjustments are deliberate or accidental. The discrepancies between WAI and WAD can be visualised using the Functional Resonance Analysis Method (FRAM). FRAM will be applied to three patient safety themes: risk screening of the frail older patients; the administration of high-risk medication; and performing medication reconciliation at discharge. Methods A stepped wedge design will be used to collect data over 16 months. The FRAM intervention consists of constructing WAI and WAD models by analysing hospital protocols and interviewing healthcare professionals, and a meeting with healthcare professionals in each ward to discuss the discrepancies between WAI and WAD. Safety indicators will be collected to monitor compliance rates. Additionally, the potential differences in resilience levels among nurses before and after the FRAM intervention will be measured using the Employee Resilience Scale (EmpRes) questionnaire. Lastly, we will monitor whether gaining insight into differences between WAI and WAD has led to behavioural and organisational change. Discussion This article will assess whether using FRAM to reveal possible discrepancies between hospital protocols (WAI) and daily practice (WAD) will improve compliance with safety indicators and employee resilience, and whether these insights will lead to behavioural and organisational change. Trial registration Netherlands Trial Register NL8778; https://www.trialregister.nl/trial/8778. Registered 16 July 2020. Retrospectively registered.

I-KID study protocol: evaluation of efficacy, outcomes and safety of a new infant haemodialysis and ultrafiltration machine in clinical use: a randomised clinical investigation using a cluster stepped-wedge design

IntroductionThe I-KID study aims to determine the clinical efficacy, outcomes and safety of a novel non-CE-marked infant haemodialysis machine, the Newcastle Infant Dialysis Ultrafiltration System (NIDUS), compared with currently available therapy in the UK. NIDUS is specifically designed for renal replacement therapy in small babies between 0.8 and 8 kg.Methods and analysisThe clinical investigation is taking place in six UK centres. This is a randomised clinical investigation using a cluster stepped-wedge design. The study aims to recruit 95 babies requiring renal replacement therapy in paediatric intensive care units over 20 months.Ethics and disseminationThe study has high parent and public involvement at all stages in its design and parents will be involved in dissemination of results to parents and professionals via publications, conference proceedings and newsletters. The study has has ethics permissions from Tyne and Wear South Research Ethics Committee.Trial registration numbersIRAS ID number: 170 481MHRA Reference: CI/2017/0066ISRCT Number: 13 787 486CPMS ID number: 36 558NHS REC reference: 16/NE/0008Eudamed number: CIV-GB-18-02-023105Link to full protocol v6.0: https://fundingawards.nihr.ac.uk/award/14/23/26

The I-KID Study Protocol: Evaluation of Efficacy, Outcomes and Safety of a New Infant Haemodialysis and Ultrafiltration Machine in Clinical Use: a Randomised Clinical Investigation using a Cluster Stepped-wedge Design.

Introduction: The I-KID study aims to determine the clinical efficacy, outcomes and safety of a novel non-CE-marked infant haemodialysis machine, the Newcastle Infant Dialysis Ultrafiltration System (NIDUS), compared to currently available therapy in the UK. NIDUS is specifically designed for renal replacement therapy in small babies between 0.8 and 8 kilograms. Methods and analysis: The clinical investigation is taking place in six UK centres. This is a randomised clinical investigation using a cluster stepped-wedge design. The study aims to recruit 95 babies requiring renal replacement therapy in paediatric intensive care units over 20 months.

Mitigating Implicit Bias in Patient-Clinician Communication in Clinical Encounters: Protocol from the COmmuNity-engaged SimULation Training (CONSULT) Trial

Background : Healthcare professionals have negative implicit biases toward minority and poor patients. Few communication skills interventions target implicit bias as a factor contributing to disparities in health outcomes. We report the protocol from the COmmuNity-engaged SimULation Training for Blood Pressure Control (CONSULT-BP), a trial evaluating a novel intervention targeting graduate medical and nursing trainees designed to mitigate the effects of implicit bias in clinical encounters. The CONSULT-BP intervention combines knowledge acquisition, bias awareness, and practice of bias mitigating skills in simulation-based communication encounters with racially/ethnically diverse standardized patients. The trial evaluates the effect of this 3-part program on patient BP outcomes, self-reported patient medication adherence, patient-reported quality of provider communication, and trainee bias awareness.Methods : We are conducting a cluster randomized trial of the intervention among cohorts of internal medicine (IM), family medicine (FM), and doctorate nurse practitioner (DNP) trainees at a single academic medical center. We are enrolling entire specialty cohorts of IM, FM, and NP trainees over a 3-year period, with each academic year constituting an intervention cycle. There are 3 cycles of implementation corresponding to 3 sequential academic years. Within each academic year, we randomize training times to 1 of 5 start dates using a stepped wedge design. The stepped wedge design compares outcomes within training clusters before and after the intervention, as well as across exposed and unexposed clusters. Primary outcome of blood pressure control is measured at the patient-level for patients clustered within trainees. Eligible patients for outcomes analysis are: English-speaking; non-White racial/ethnic minority; Medicaid recipient (regardless of race/ethnicity); hypertension; not have pregnancy, dementia, schizophrenia, bipolar illness, or other serious comorbidities that would interfere with hypertension self-control; not enrolled in hospice. Secondary outcomes include trainee bias awareness. A unique feature of this trial is the engagement of academic and community stakeholders to design, pilot test and implement a training program addressing healthcare.Discussion: Equipping clinicians with skills to mitigate implicit bias in clinical encounters is crucial to addressing persistent disparities in healthcare outcomes. Our novel, integrated approach may improve patient outcomes.Trial registration : NCT03375918Protocol version : 2.0 (October 16, 2020)

Design, rationale and analysis plan for the Stand Up for Health trial in contact centres: a stepped wedge feasibility study

Background Contact centres are one of the most sedentary workplaces, with employees spending a very high proportion of their working day sitting down. About a quarter of contact centre staff regularly experience musculoskeletal health problems due to high levels of sedentary behaviour, including lower back pain. There have been no previous randomised studies specifically aiming to reduce sedentary behaviour in contact centre staff. To address this gap, the Stand Up for Health (SUH) study aims to test the feasibility and acceptability of a complex theory-based intervention to reduce sedentary behaviour in contact centres. Methods The Stand Up for Health study has a stepped wedge cluster randomised trial design, which is a pragmatic design whereby clusters (contact centres) are randomised to time points at which they will begin to receive the intervention. All contact centre staff have the opportunity to experience the intervention. To minimise the resource burden in this feasibility study, data collection is not continuous, but undertaken on a selective number of occasions, so the stepped wedge design is “incomplete”. Eleven contact centres in England and Scotland have been recruited, and the sample size is approximately 27 per centre (270 in total). The statistical analysis will predominantly focus on assessing feasibility, including the calculation of recruitment rates and rates of attrition. Exploratory analysis will be performed to compare objectively measured sedentary time in the workplace (measured using an activPAL™ device) between intervention and control conditions using a linear mixed effects regression model. Discussion To our knowledge, this is the first stepped wedge feasibility study conducted in call centres. The rationale and justification of our novel staircase stepped wedge design has been presented, and we hope that by presenting our study design and statistical analysis plan, it will contribute to the literature on stepped wedge trials, and in particular feasibility stepped wedge trials. The findings of the study will also help inform whether this is a suitable design for other settings where data collection is challenging. Trial registration The trial has been registered on the ISRCTN database: http://www.isrctn.com/ISRCTN11580369