Award Title: A Multicentre Study to Investigate a Protocol-Driven Multidisciplinary Service Model to Tackle ‘Spurious Penicillin Allergy’ in Secondary Care (SPACE study)
Funder: Department of Health and Social Care

Abstract: Background: This research addresses an important problem in health care: the high rate of patients inaccurately diagnosed with penicillin allergy (PenA).  More than 1 in 10 patients have a label of PenA in hospitals, meaning they can’t be given penicillins. Currently, patients with a PenA label who have an infection or need antibiotics to prevent infection are treated with non-penicillin antibiotics.  These are associated with higher chances of negative consequences: longer hospital stays, higher readmission rates, increased risk of serious infections such as MRSA, wound infections after operations, and resistance to antibiotics, making healthcare very difficult. Also, this is likely to cost the NHS several million pounds each year._x000D_
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However, most (9 out of 10) people with a PenA label prove not to actually be allergic when properly tested. Inaccurate PenA labels often happen because side effects and symptoms of infection are mistaken for an allergy. PenA testing involves a careful medical history, review of previous records, allergy skin tests and a ‘penicillin oral challenge’ (giving penicillin by mouth under supervision). This takes several hours, needs a specialist and can only be done in a small number of allergy clinics. Getting rid of incorrect PenA label is called ‘de-labelling’. Because PenA tests are not routinely available to most hospital patients, we have developed a simple method to de-label based on a careful review of the clinical history without the need for skin tests._x000D_
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Based on medical history and previous records, patients are grouped as ‘low risk’ or ‘high risk’. Nearly half of ‘PenA’ patients are ’low risk’. Studies suggest that giving penicillin by mouth to ‘low risk’ patients under medical supervision without doing allergy skin tests is safe. This is called a ‘direct’ oral penicillin challenge (DPC). More research is needed to find out how patients, doctors and hospital managers feel about DPC and how best it can be carried out in hospitals. This will help design new allergy testing pathways. _x000D_
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Aims: (a)To find out what patients, healthcare workers and managers think about DPC to remove incorrect PenA labels. (b) To design a safe way to start using DPC in hospitals and estimate costs._x000D_
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Design and Methods: This study will be carried out in 3 hospitals over 24 months and will need 122 patients from different types of wards including surgical and cancer patients who are at a higher risk of serious infections. Patients with a PenA label will be seen by a pharmacist or a nurse and placed in ‘low risk’ and ‘high risk’ groups. ‘Low risk’ patients will be offered the DPC. ‘High risk’ patients and those declining the DPC will be seen in an allergy clinic for further testing. We will collect information by interviewing patients in ‘low risk’ group and talk to groups of patients, healthcare workers and managers. We will find out how many ‘low risk’ patients are willing to undergo DPC and describe how they get on. We will look at the ways we might offer DPC in hospital and work out what it would cost. _x000D_
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Benefits: This study will help to improve antibiotic use in hospitals, improve patient experience and outcomes, reduce rates of serious hospital acquired infections, and save the NHS money. Patients and patient organisations have helped design this study and will be involved in every stage. We will share our findings with all those involved in the care of patients with infections and PenA and beyond.

Lay Abstract: Research Questions: _x000D_
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?_x000D_
2.            Is DPC acceptable to patients and healthcare professionals (HCPs) and managers in secondary care?_x000D_
3.            What are the facilitators and barriers to DPC in secondary care?_x000D_
4.            Is DPC cost-effective?_x000D_
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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. _x000D_
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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._x000D_
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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):  _x000D_
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.  _x000D_
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.  _x000D_
c.             WS3: Care pathway mapping for PenA and decision-analytic modelling will be carried out to determine cost-effectiveness of DPC._x000D_
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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._x000D_
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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.

Research Activity Codes: 7.3 MANAGEMENT AND DECISION MAKING;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health Categories: INFECTION