Improving the Evaluation and Management of Penicillin Allergies in VA Community Living Centers

Background: Penicillin allergies are reported in 10% of the US population, with higher rates in hospitalized
and older patients. In the VA, reported penicillin allergy is similarly common.4 In 2000-2004, it was present in
13% of all national VA admissions and 16% of CLC admissions. However, <10% of patients are found to be
truly allergic based on skin testing. A penicillin allergy label leads to use of broader spectrum antibiotics which
increases the risk of antibiotic resistance, treatment failures, adverse effects and higher healthcare costs.
Significance: The nursing home population may be particularly vulnerable to mislabeling consequences, due
to high and frequently inappropriate antibiotic use. Penicillin allergy evaluation guidelines exist, but have been
infrequently applied. This is in part due lack of provider knowledge and lack of access to specialized allergy
testing. To address these gaps, an explicit evidence-based clinical pathway and toolkit were developed so that
non-allergists can perform allergy assessments and identify true low risk patients. These may be used to
improve the quality, safety and value of care in CLCs (HSRD priority areas).
Innovation & Impact: This and similar pathways, including those used by study co-investigators, have been
effectively and safely applied in an increasing number of settings. However, they still have not been applied to
nursing home populations, including VA nursing homes, also known as community living centers (CLCs). In our
prior study of VA Bedford CLC key stakeholders, findings suggested implementing this pathway was feasible,
but that staff and relative/family education is needed, and an intervention with prominent pharmacist
involvement is most likely to succeed. We now propose to implement this pathway. Improving penicillin allergy
assessment in this population will improve antibiotic use and decrease adverse events.
Specific Aims: This study will assess the feasibility of implementing a pharmacist-led intervention consisting
of an existing penicillin allergy assessment pathway and tools to de-label residents at low risk of having a true
allergy. Aim 1: Pilot implementation of the penicillin allergy assessment pathway and tools at 2 CLC sites and
examine their feasibility, effectiveness, and safety. Aim 2: Assess contextual factors affecting implementation.
Methodology: This is a 1.5-year study based at the VA Bedford and Boston CLCs. For Aim 1, we will start by
educating staff, residents and their relatives in the importance of verifying penicillin allergies and associated
evidence-based practices using existing materials. We will use an existing electronic health record (EHR)
history template, create an oral penicillin challenge (OPC) EHR order set and train staff in their use. Staff will
then implement the pathway and tools - clinical pharmacists will take detailed allergy histories using the EHR
template and risk stratify patients. For low risk patients, pharmacists will alert the unit attending to consider an
OPC. Attendings will order the OPC for eligible patients using the EHR order set to be administered on the
CLC unit. We will measure EHR template and OPC use, proportion of patients de-labeled by history or OPC,
and safety (% with reaction to OPC). We will examine the nature and severity of any OPC reaction. We will
also conduct audit and feedback provider-level results to unit staff. For Aim 2, we will conduct semi-structured
interviews partway through implementation with 5 staff to assess issues/concerns with the intervention, then
nearer the end with another 10 staff (total of 15). We will also interview 2-3 CLC leaders per site, plus up to 15
residents and relatives total. Guided by the Consolidated Framework for Implementation Research, interviews
will assess contextual factors, perceived complexity, plus satisfaction of staff, resident/relative satisfaction with
the intervention. Additionally, we will solicit feedback on the usefulness of educational strategies and materials.
Implementation/Next Steps: Pilot study findings will allow us to refine the intervention (the allergy
assessment pathway and tools) and implementation strategies which will then be tested more broadly in a
subsequent hybrid type 2 effectiveness-implementation trial, with the eventual goal of VA-wide use.

Grant Number: 1I21HX003900-01A1
NIH Institute/Center: VA
Principal Investigator: Ann Borzecki