The THISTLE Study
PMF received a grant from the Chief Scientist’s Office in Scotland to undertake a stepped-wedge study of PROMPT implementation in all maternity units in Scotland. The 12 units which attended the Train-The-Trainers (T3) programme in 2015 are all running local PROMPT courses in their own units. This study will analyse key maternity outcomes from each maternity unit, both before and after the training to enable to ascertain where there has been any significant change in each unit’s outcomes. Collection of the data continues to be ongoing and PMF are awaiting the results.

THISTLE-Plus
The THISTLE-Plus Study is a qualitative study funded by the Health Foundation and was  run in parallel with the wider THISTLE Study, as well as being a collaboration between clinical researchers from PMF and qualitative researchers from the University of Bristol. THISTLE-Plus is an in-depth process evaluation of the implementation of PROMPT, investigating the facilitators and inhibitors to the introduction of training. The principal aim of the study has been to identify and explore the factors affecting the implementation of PROMPT, in order to inform efforts to improve its delivery at scale and across different contexts. The study involved 4 Scottish maternity units and employed a mixed-method approach to data collection which took place in 2016. A total of 10 focus group discussions and 8 semi-structured interviews were conducted with local PROMPT trainers and multi-professional staff across 4 Scottish maternity units with 4 local PROMPT training days observed. In addition, 350 maternity staff completed Safety Attitude Questionnaires to measure local workplace culture. Data analysis is currently nearing completion, this has involved statistical analysis, coding of the interview and focus group transcripts, to develop a thematic framework to describe and explain the factors affecting implementation of PROMPT training. 

THISTLE Study publication

The THISTLE Study findings have recently been published in the BMJ Quality & Safety (July 2019). The THISTLE Study paper is an ‘Open Access’ paper and can be viewed via this link: Effect of hands-on interprofessional simulation training for local emergencies in Scotland: the THISTLE stepped-wedge design randomised controlled trial

We encourage you to read the paper in full, as it provides a very useful insight into the challenges of scaling up PROMPT; in particular, how best to implement the ‘active ingredients’ of PROMPT most effectively. The study has demonstrated that background policies and initiatives can sometimes conflict to reduce the effect of previously effective training programmes. We are now investigating a Social Franchising model, which includes more support for units to effectively implement PROMPT and we look forward to sharing our results soon.

We recommend the evaluation of all training programmes using robust study designs, to progress the evidence base for improvement, and ultimately benefit the whole health community.

Study summary

The THISTLE study was a multi-centre Stepped-Wedge Randomised Controlled Trial (SW-RCT) funded by the CSO (Chief Scientist Office) and conducted by the University of Aberdeen to assess the implementation of an intrapartum emergencies training package (PROMPT) across 12 maternity units in Scotland between 2014 and 2016. The primary outcome being measured was the proportion of infants born with a low Apgar score (score < 7 at 5 minutes) for each vaginal or emergency caesarean term birth (≥37weeks).

In 2014, a multi-professional team of staff (4-6 team members) from each participating unit attended a PROMPT Train the Trainers (T3) programme at the Simulation Centre in Larbert and took away the PROMPT training package (2^nd edition). Following attendance at the T3 training, all units were requested to implement PROMPT courses locally within a specified time period as part of the SW-RCT. The units aimed to train 100% of their maternity staff over the following year and provided study information on numbers and types of staff trained, and also examples of their local PROMPT programmes, to provide information on the context of their local courses.

The units received no additional study funding to aid their set-up and roll-out of local PROMPT training, and no additional implementation support was provided by the PMF core faculty, other than the standard telephone and email support that is offered to all maternity units who undertake PROMPT T3 training.

Main findings

The main findings of the study were that local implementation of PROMPT training at scale across the Scottish maternity units was more difficult than anticipated, and that local PROMPT training, as evaluated in the THISTLE Study, had no effect on the rate of Apgar < 7 ^5mins during the study period.

Discussion

It is important that these findings are considered in context of both the appropriateness of the SW-RCT study design, and also the variation in content and authenticity of the implementation of PROMPT locally.

The stepped-wedge study design unfortunately proved difficult to employ for this training intervention, as it was reliant on units being able to implement local training within their allocated time step.  However, the study team had no control over the ability of the units to actually implement their local training within this allocated time slot, and therefore, this hampered the planned ‘intention to treat’ analysis.

Authenticity of local training implementation was inconsistent. Some core components of PROMPT, particularly the multi-professional intrapartum fetal monitoring training, was not included in the majority of local PROMPT courses, as there was a separate national fetal monitoring training programme introduced during the THISTLE Study period (only 3 of the 12 participating units included fetal monitoring training as part of their local PROMPT courses). Furthermore, all units struggled to train 100% of their maternity staff in the study period. Therefore, difficulties with implementation and the challenges of the policy landscape are likely to have had a major impact on the primary outcome.

We are very grateful to all of the Scottish maternity units for participating in this study, which has provided PMF, and the Improvement community more generally, with valuable information about the challenges of implementation at scale. We are now investigating a Social Franchising model, which includes more support for units to effectively implement PROMPT and we look forward to sharing our results soon.

We recommend the evaluation of all training programmes using robust study designs, to progress the evidence base for improvement, and ultimately benefit the whole health community.