A Multicentre Study to Investigate a Protocol-Driven Multidisciplinary Service Model to Tackle ‘Spurious Penicillin Allergy’ in Secondary Care (SPACE study)

Research Questions:

1. Can a ‘direct’ oral penicillin challenge (DPC) be safely embedded into routine clinical practice within secondary care to de-label ‘low risk’ patients with a penicillin allergy (PenA) label? 2. Is DPC acceptable to patients and healthcare professionals (HCPs) and managers in secondary care?

3. What are the facilitators and barriers to DPC in secondary care? 4. Is DPC cost-effective?

Background: 6% of the population and 15-20% of inpatients carry a PenA label. However, 90-95% of PenA labels are incorrect. PenA labels lead to adverse clinical outcomes such as enhanced risk for serious hospital infections and longer hospital stay and are associated with higher estimated healthcare costs in the order of several million pounds annually.

PenA testing is onerous and requires a specialist. There is an unmet need for allergy services in the NHS. Hence, routine inpatient testing is not available.

Recent evidence suggests that a DPC (without performing allergy tests) is a safe option in ‘low risk’ patients (those least likely to be allergic based on history). Further research is needed to validate this intervention in routine secondary care practice and explore potential facilitators and barriers to implementation in different settings.

Aims: To explore behaviour, attitudes and acceptability of patients, HCPs and managers regarding use of DPC in ‘low risk’ patients and develop treatment pathways and a governance framework. This study will also explore practical issues pertaining to service implementation and delivery and determine potential cost-effectiveness.

Methods: This study will span over 24 months and involve 3 clinical settings (medical/infectious diseases wards, pre-surgical units and haematology-oncology units) in 3 hospitals. It will involve 3 workstreams (WS):

a. WS1: Patients will be stratified into ‘low risk’ and high risk’. ‘Low risk’ patients will undergo a DPC (total n=122). Uptake and safety of DPC will be determined.

b. WS2: One-to-one semi-structured interviews with patients will be conducted (10-15 per site subject to saturation checking). Focus group sessions will be held with prescribers, HCPs, clinical leaders and managers at each site.

c. WS3: Care pathway mapping for PenA and decision-analytic modelling will be carried out to determine cost-effectiveness of DPC.

Research team: Comprises a group of highly skilled and experienced multidisciplinary team with a strong track record in PenA, antimicrobial stewardship, behaviour science, implementation and social science, clinical pharmacy, health economics and biostatistics, thus covering all key areas relevant to this research. The applicants have co-designed this proposal with two major patient organisations including Allergy UK and The Sepsis UK Trust alongside patients previously de-labelled for PenA.

Impact and dissemination: This research has great potential to improve antimicrobial stewardship and quality of care. Greater use of penicillins as first line treatment for infections is likely to improve patient experience, reduce rates of serious hospital acquired infections, antimicrobial resistance and significantly reduce NHS costs. We have embedded strategies to disseminate results of this study to a global audience via regular updates and publications in social media and engagement with patient groups, patient organisations, national and international scientific societies.