Patient safety incidents and medication errors during a clinical trial: experience from a pre-hospital randomized controlled trial of emergency medication administration.

AIM: To assess and evaluate patient safety incidents and in particular, medication errors, during a large multi-center pre-hospital trial of emergency therapy (PARAMEDIC2), in order to inform and improve future pre-hospital medicines trials. METHODS: The PARAMEDIC2 trial was undertaken across five NHS Ambulance Services in England and Wales with randomisation between December 2014 and October 2017. Patients with an out -of-hospital cardiac arrest unresponsive to initial resuscitation were randomly assigned to 1 mg intravenous adrenaline or matching placebo. Records were reviewed to identify trial medication errors involving documentation and/or clinical protocol errors occurring in trial participants. Causes of medication errors, including root cause analysis where available, were reviewed to identify patterns and themes contributing to these errors. RESULTS: Eight thousand sixteen patients were enrolled, of whom 4902 received trial medication. A total of 331 patient safety incidents was reported, involving 295 patients, representing an overall rate of 3.6% of these, 166 (50.2%) were documentation errors while 165 (49.8%) were clinical protocol/medication errors. An overall rate of 0-4.5% was reported across all five ambulance services, with a mean of 2.0%. These errors had no impact on patient care or the trial and were all resolved CONCLUSION: The overall medication error rate of 1.8% primarily consisted of administration of open-label adrenaline and confusion with trial medication packs. A similar number of patients had documentation errors. This study is the first to provide data on patient safety incidents relating to medication errors encountered during a pre-hospital trial of emergency medication administration and will provide supporting data for planning future trials in this area.

Facilitators and barriers to the delivery of the PARAMEDIC2 trial.

Background: PARAMEDIC2 was a medicines trial comparing adrenaline with placebo in out-of-hospital cardiac arrest (OHCA). At the time, United Kingdom (UK) Emergency Medical Systems (EMS) were inexperienced in delivering such research. Aim: To identify barriers and facilitators to delivery of the PARAMEDIC2 (Adrenaline) trial by five UK NHS EMS. Methods: This qualitative study took a grounded theory approach to thematic analysis of workshop data. Members of the trial teams from each service attended a workshop in November 2018 and discussed their experiences in answer to two prompt questions. Data were coded and themes presented. Results: Three main themes were identified: professionalism, organisational investment and unique features of EMS. The study provided an opportunity for recruiting paramedics and research paramedics to demonstrate their professionalism. Research paramedics felt it was part of their professional duty to initiate discussions with the patient/family regarding the trial rather than leave this task to the hospital teams as would usually happen. Organisational investment was reflected by prioritising trial training and further development of research paramedics. By these means, research culture was developed. The unique features of EMS such as geographical challenges were often addressed with technological solutions and through building relationships with internal teams. Conclusion: Barriers to trial delivery included infrequent exposure to the condition of interest and lack of continuity in research paramedic roles. Facilitators identified included flexibility of the research protocol, and organisational investment in the development of research paramedics.Participating in PARAMEDIC2 was challenging for the EMS involved, but ultimately strengthened their research culture.

Improving recording and reporting of dementia and frailty via electronic patient record by ambulance staff in a single service (IDEAS).

BACKGROUND: Dementia is common in older adults assessed by ambulance services. However, inconsistent reporting via the patient record may result in this diagnosis being overlooked by healthcare staff further down the care pathway. This can have a deleterious effect on subsequent patient care, increasing morbidity and mortality. We sought to understand how and where ambulance staff would like to record this finding on the electronic patient record (ePR). METHODS: We designed and implemented a survey of ambulance staff in a single service to understand how they identify patients with dementia, how they record dementia on the ePR and how the ePR could be improved to better capture dementia. Scoping questions on frailty were included. The survey was tested using cognitive interviewing. Analysis was conducted using descriptive statistics for closed questions and thematic analysis for open questions as appropriate. RESULTS: 131 surveys were completed; 60% of participants were paramedics and 40% were other grades of front line staff. Participants reported consulting electronic/paper sources, and individuals such as carers involved in the patients' care, to establish whether dementia had been diagnosed. Frailty assessments were prompted by social context, reduced mobility, a fall or diagnosis of dementia. Staff reported documenting dementia in 20 different areas on the ePR and 46% of participants stated a preference for a designated area to record the information. However, 15% indicated it was not necessary to record dementia or that no ePR changes were required. CONCLUSIONS: We have highlighted the variation in ambulance staff practice in recording of dementia. Alterations to the ePR are required to ensure that dementia is recorded consistently and is easily retrievable. Clearer guidance on when to assess frailty may also enhance information provision to care staff in other sectors, resulting in more appropriate clinical and social care.

Reducing ambulance conveyance for older people with and without dementia: evidence of the role of social care from a regional, year-long service evaluation using retrospective routine data.

INTRODUCTION: Older people, especially those with dementia, have a high risk of deterioration following admission to hospital. More than 60% of older people attended by South Central Ambulance Service (SCAS) clinicians are conveyed to hospital, although many conveyances may not have been due to life-threatening conditions. We aimed to understand patterns of conveyance and alternative referral pathways used following ambulance attendance to an older person. METHODS: Service evaluation, using routinely collected, anonymised electronic records. PARTICIPANTS: Electronic records of people aged ≥75 years for whom an ambulance was dispatched between April 2016 and March 2017 within the geographical boundaries of SCAS NHS Foundation Trust, who were alive on arrival of the ambulance. Conveyance rates are described according to patient and emergency-call characteristics. Logistic regression was used to produce adjusted odds ratios for conveyance. Alternative referral pathways used are described. RESULTS: Of 110,781 patients attended, 64% were conveyed to hospital. Factors associated with reduced odds of conveyance included out-of-hours calls (adjusted odds ratio (aOR) 0.82 [0.79-0.85]), living alone with a care package or with family plus care package (aOR 0.66 [0.62-0.69]; aOR 0.58 [0.54-0.62] respectively) and a record of dementia (0.91 [0.87-0.96]). Living in a nursing home was associated with an increased risk of conveyance (aOR 1.25 [1.15-1.36]). Patients with dementia with more income were significantly less likely to be conveyed than those with less income. Alternative referral services were used in 22% of non-conveyed patients, most commonly GP, out-of-hours and falls services. DISCUSSION: People aged ≥75 years have high rates of conveyance, which are influenced by factors such as out-of-hours calls, dementia and receipt of social care. Low use of alternative referral services may reflect limited availability or difficulty in access. A better understanding of how these factors influence ambulance clinician decision-making is integral to improvement of outcomes for older people.

Optimising ambulance service contribution to clinical trials: a phenomenological exploration using focus groups.

INTRODUCTION: Out-of-hospital cardiac arrest trials can prove challenging and there is a need to share learning from those that have recruited successfully. We have just completed three years of recruitment to PARAMEDIC2, a placebo-controlled trial of adrenaline in out-of-hospital cardiac arrest. This study was designed to describe the experience of operational ambulance staff involved in recruiting patients into PARAMEDIC2. METHODS: Four focus groups involving trial paramedics and supporting members of the emergency care team were conducted across different geographical regions of a single UK ambulance service participating in the PARAMEDIC2 study. Data analysis was supported by NVivo 12 and themes were identified using a thematic analysis approach. RESULTS: Forty-four participants contributed to the focus groups. Four overarching themes were identified: context for the research, ethical concerns, concerns at the patient's side and ongoing trial support. Participants felt that research such as PARAMEDIC2 is important and necessary to drive medical progress. They valued the opportunity to be part of a large project. Due to the deferred consent model employed, public awareness of the trial was felt to be important. Most expressed equipoise regarding adrenaline, but some felt concerned about enrolling younger patients and there was discussion around what constitutes a successful outcome. Struggles with ethical concerns were overcome through training and one-to-one discussion with research paramedics. Participants valued feedback on their performance of trial tasks, but also wanted feedback on their resuscitation skills. Cardiac arrest places a high cognitive demand on paramedics; simplicity and reinforcement of trial processes were key to facilitating recruitment. Caring for relatives was a high priority for paramedics and some felt conflicted about not discussing the trial with them. CONCLUSIONS: This study has provided insights into paramedic experience of a large-scale pre-hospital trial. Investment in time and resource to provide face-to-face training and personalised feedback to paramedics can foster engagement and optimise performance.

Optimising ambulance service contribution to clinical trials: a phenomenological exploration using focus groups.

INTRODUCTION: Out-of-hospital cardiac arrest trials can prove challenging and there is a need to share learning from those that have recruited successfully. We have just completed three years of recruitment to PARAMEDIC2, a placebo-controlled trial of adrenaline in out-of-hospital cardiac arrest. This study was designed to describe the experience of operational ambulance staff involved in recruiting patients into PARAMEDIC2. METHODS: Four focus groups involving trial paramedics and supporting members of the emergency care team were conducted across different geographical regions of a single UK ambulance service participating in the PARAMEDIC2 study. Data analysis was supported by NVivo 12 and themes were identified using a thematic analysis approach. RESULTS: Forty-four participants contributed to the focus groups. Four overarching themes were identified: context for the research, ethical concerns, concerns at the patient's side and ongoing trial support. Participants felt that research such as PARAMEDIC2 is important and necessary to drive medical progress. They valued the opportunity to be part of a large project. Due to the deferred consent model employed, public awareness of the trial was felt to be important. Most expressed equipoise regarding adrenaline, but some felt concerned about enrolling younger patients and there was discussion around what constitutes a successful outcome. Struggles with ethical concerns were overcome through training and one-to-one discussion with research paramedics. Participants valued feedback on their performance of trial tasks, but also wanted feedback on their resuscitation skills. Cardiac arrest places a high cognitive demand on paramedics; simplicity and reinforcement of trial processes were key to facilitating recruitment. Caring for relatives was a high priority for paramedics and some felt conflicted about not discussing the trial with them. CONCLUSION: This study has provided insights into paramedic experience of a large-scale pre-hospital trial. Investment in time and resource to provide face-to-face training and personalised feedback to paramedics can foster engagement and optimise performance.

A clinical audit of the electronic data capture of dementia in ambulance service patient records.

BACKGROUND: Dementia is a common diagnosis in older people. It is important to identify and record dementia on emergency call-outs, as it impacts on subsequent care decisions. Ambulance services are changing from paper to electronic patient records, but there are limited data on how frequently and in which sections of the electronic patient record dementia is being recorded. AIMS: To audit the proportion of ambulance electronic patient records where dementia is recorded for patients aged (i) 65 and above and (ii) 75 and above, and to describe the sections in the electronic patient record in which dementia is recorded, as there is currently no standardised button or field available. RESULTS: A total of 314,786 electronic patient records were included in the audit, over a one-year period. The proportion of attended calls with 'dementia' recorded in the electronic patient record in patients aged 65+ was 13.5%, increasing to 16.5% in patients aged 75+, which is similar to that recorded in previous literature. For patients aged 75+ conveyed to hospital, 15.2% had 'dementia' recorded in the electronic patient record, which may indicate under-recording. Recording of dementia between Clinical Commissioning Groups varied between 11.0% and 15.3%. Dementia was recorded in 16 different free-text fields, and 38.4% of records had dementia recorded in more than one field. CONCLUSION: This audit demonstrates high variability in both the frequency of recording dementia and also the location in the electronic patient record. To ensure consistent recording and ease of retrieval to inform patient care and handover, we propose that the electronic patient record should be modified to reflect paramedics' needs, and those of the healthcare staff who receive and act on the report. Enhanced training for paramedics in the importance and method of recording dementia is required. Future data will enable accurate monitoring of trends in conveyance, and inform justifications for alternative services and novel referral pathways.