PROMPT Wales project: national scaling of an evidence-based intervention to improve safety and training in maternity.

BACKGROUND: In healthcare, there is increasing recognition of the importance of developing and testing strategies to scale effective interventions. The NHS long-term plan (2019) acknowledges that often a gold standard approach to a problem already exists somewhere within the NHS, however, it has not been replicated widely across the system. METHODS: We describe the approach and process measures for national scaling of PROMPT (Practical Obstetric Multi-Professional Training) across 12 obstetric-led maternity units in Wales. PROMPT is an evidence-based training package for local maternity staff, previously associated with improvements in maternal and neonatal outcomes, reduction in litigation related to preventable harm and improved safety culture. PROMPT has previously been disseminated internationally using a train-the-trainer model. However, this has been associated with variations in uptake, fidelity and impact. In Wales, the project was supported by Welsh Government, and a structured scaling plan was developed, encompassing ongoing implementation support from a multi-professional team. RESULTS: PROMPT was successfully implemented in all obstetric led units in Wales, with 326 local PROMPT facilitators trained, and 82.5%-100% of maternity staff attended a local PROMPT course in the first 15 months of the project (January 2019-March 2020). All training courses included evidence-based authentic elements, and 93% of courses in the first year (100/107) were supported by a national implementation team, providing coaching, implementation support and quality assurance. CONCLUSIONS: Authentically scaling up complex interventions is a significant challenge. To replicate the improved outcomes demonstrated by PROMPT, intervention reach and fidelity must first be demonstrated.In this national scaling project, our scaling methodology led to the successful implementation of PROMPT across all health boards in Wales. Additionally, we demonstrated reduced variation in adoption, reach, timescale and intervention fidelity between maternity units with varying readiness for change, which had been difficult in two previous large-scale PROMPT implementation projects.

Exploring the reporting standards of RCTs involving invasive procedures for assisted vaginal birth: A systematic review.

OBJECTIVE: Assisted vaginal birth (AVB) is a complex intervention involving medical devices, comprising multiple components. This complexity creates difficulties when designing and conducting randomised controlled trials (RCTs), in terms of describing, standardising and monitoring the intervention, and accounting for differing clinician expertise. This review examines the reporting standards of complex interventions involving a medical device, in the context of AVB RCTs. STUDY DESIGN: Searches were undertaken from the start of indexing to March 2021, and limited to RCTs, feasibility and pilot studies including at least one device for AVB. RCTs were selected if they included participants having an AVB with any device, with or without a comparator group. Reporting details were assessed according to the Consolidating Standards of Reporting Trials extension for non-pharmacological treatments (CONSORT-NPT), focusing on intervention descriptions, standardization, adherence and clinician expertise. Screening of abstracts, full-text articles and data extraction was performed by two independent reviewers. RESULTS: Of 4098 abstracts and 83 full-text articles, 39 papers were included, investigating 80 interventions. Twenty-seven different named devices were identified. Intervention descriptions were provided in 20 (55%) papers with varying levels of detail and with only one covering the entire procedure. Standardization of interventions was mentioned in 25 papers (64%). Only eight (21%) papers reported any form of adherence to the intended procedure. Some data regarding expertise were reported in 25 (64%) papers. CONCLUSIONS: Despite some compliance with reporting standards, there is a lack of detail regarding intervention description, standardization, adherence and expertise in RCTs of AVB. This creates difficulties in understanding how intervention delivery was intended and what actually occurred. Clearer guidelines for the reporting of invasive procedures and devices are required.

Exploring standardisation, monitoring and training of medical devices in assisted vaginal birth studies: protocol for a systematic review.

INTRODUCTION: Assisted vaginal birth (AVB) can markedly improve maternal and neonatal outcomes arising from complications in the second stage of labour. Historically, both forceps and ventouse devices have been used to assist birth; however, they are not without risk and are associated with complications, such as cephalohaematoma, retinal haemorrhage and perineal trauma. As new devices are developed to overcome the limitations of existing techniques, it is necessary to establish their efficacy and effectiveness within randomised controlled trials (RCTs). A major challenge of evaluating complex interventions (ie, invasive procedures/devices used to assist vaginal birth) is ensuring they are delivered as intended. It can be difficult to standardise intervention delivery and monitor fidelity, and account for the varying expertise of clinicians (accoucher expertise). This paper describes the protocol for a systematic review aiming to investigate the reporting of device standardisation, monitoring and training in trials evaluating complex interventions, using AVB as a case study. METHODS AND ANALYSIS: Relevant keywords and subject headings will be used to conduct a comprehensive search of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature and ClinicalTrials.gov, for RCTs and pilot/feasibility studies evaluating AVB. Abstracts will be screened and full-text articles of eligible studies reviewed for inclusion. Information relating to the following categories will be extracted: standardisation of device use (ie, descriptions of operative steps, including mandatory/flexible parameters), monitoring of intervention delivery (ie, intervention fidelity, confirming that an intervention is delivered as intended) and accoucher expertise (ie, entry criteria for participation, training programmes and previous experience with the device). Risk of bias of included studies will be assessed. ETHICS AND DISSEMINATION: Ethical approval is not required because primary data will not be collected. Findings will be disseminated by publishing in a peer-reviewed journal and presentations at relevant conferences.

Touch in primary care consultations: qualitative investigation of doctors' and patients' perceptions.

BACKGROUND: Good communication skills are integral to successful doctor-patient relationships. Communication may be verbal or non-verbal, and touch is a significant component, which has received little attention in the primary care literature. Touch may be procedural (part of a clinical task) or expressive (contact unrelated to a procedure/examination). AIM: To explore GPs' and patients' experiences of using touch in consultations. DESIGN AND SETTING: Qualitative study in urban and semi-rural areas of north-west England. METHOD: Participating GPs recruited registered patients with whom they felt they had an ongoing relationship. Data were collected by semi-structured interviews and subjected to constant comparative qualitative analysis. RESULTS: All participants described the importance of verbal and non-verbal communication in developing relationships. Expressive touch was suggested to improve communication quality by most GPs and all patients. GPs reported a lower threshold for using touch with older patients or those who were bereaved, and with patients of the same sex as themselves. All patient responders felt touch on the hand or forearm was appropriate. GPs described limits to using touch, with some responders rarely using anything other than procedural touch. In contrast, most patient responders believed expressive touch was acceptable, especially in situations of distress. All GP responders feared misinterpretation in their use of touch, but patients were keen that these concerns should not prevent doctors using expressive touch in consultations. CONCLUSION: Expressive touch improves interactions between GPs and patients. Increased educational emphasis on the conscious use of expressive touch would enhance clinical communication and, hence, perhaps patient wellbeing and care.