ASPA Research Study
Closing the Medication List Gap: Evaluating Polypharmacy Testing in Medication Reconciliation, Adherence and Drug-Drug Interaction Risk to Support Patient Safety
Navis Clinical Laboratories® and the Arizona State Physicians Association (ASPA) are collaborating on a prospective research study to evaluate the use of laboratory-based polypharmacy testing as a tool to support medication reconciliation, assess medication adherence and identify medication discrepancies that may warrant clinical review.
The study is intended to examine whether greater objective visibility into patients’ medication use is associated with improvements in medication reconciliation and adherence and decrease in medication-related risk over time. Navis and ASPA plan to co-author the study, with the goal of submitting the findings for publication in a peer-reviewed scientific or medical journal.
Background and Rationale
Medication reconciliation relies heavily on information contained in the medical record and provided by patients. However, medication lists may not always reflect what patients are actually taking. Patients may unintentionally omit prescribed medications, have difficulty recalling medication names or may not report over-the-counter (OTC) medications and other commonly used substances.
Navis Clinical Laboratories offers a proprietary polypharmacy laboratory test designed to provide objective information about medication exposure. The test identifies more than 140 drugs and metabolites associated with prescription and over-the-counter medications commonly used in cardiovascular, kidney, chronic pain, psychiatric, behavioral health and diabetes care. Testing also detects several commonly used over-the-counter medications and substances.
By comparing laboratory findings with the patient’s documented medication list, clinicians may gain additional information about potential medication adherence, unreported medication use and medication combinations that may require further clinical review.
Study Objectives
The study will evaluate medication discrepancies identified through polypharmacy testing and assess whether these discrepancies change over time following appropriate clinical intervention.
Study measures will include:
- Prescribed medications not detected through laboratory testing, indicating a potential medication adherence discrepancy.
- Medications detected through laboratory testing but not documented on the patient’s medication reconciliation list, indicating previously unrecognized or unreported medication exposure.
- Medication discrepancies requiring clinical review, including potential drug-drug interactions, contraindications or other medication-related findings identified through review of the patient’s medication profile.
- Changes in medication discrepancies over time following intervention by the treating provider.
The study will evaluate these measures as indicators of medication visibility, reconciliation and adherence, with the broader objective of assessing how polypharmacy testing may support medication management and patient safety.
Provider and Patient Participation
Participating providers will identify patients for whom polypharmacy testing is clinically appropriate and will follow participating patients over time to evaluate changes in medication discrepancies.
All testing and clinical decision-making remain at the discretion of the treating provider. Participation in the study does not require providers to order testing when it is not clinically appropriate, nor does the study direct or prescribe any specific treatment, medication change or clinical intervention.
Specimens may be collected using either urine or oral fluid, depending on the clinical circumstances and available testing protocols.
Navis Clinical Laboratories will provide participating clinicians with training, educational materials and ongoing support related to specimen collection, test ordering, results interpretation and study procedures.
Cost and Compensation
There is no fee to providers to participate in the research study.
Laboratory testing performed as part of routine clinical care will be billed to the patient, provider or applicable payer in accordance with standard CMS requirements, commercial insurance guidelines and other applicable billing and coverage policies, as with other laboratory testing.
Participating providers and patients will not receive payment or other compensation for participation in the study.
Publication
Navis Clinical Laboratories and ASPA will collaborate on the analysis and interpretation of study findings and will co-author the resulting research. The goal is to submit the completed study for publication in a peer-reviewed medical or scientific journal.
Through this collaboration, Navis and ASPA hope to contribute meaningful real-world evidence regarding medication-list discrepancies, medication adherence and the potential role of objective polypharmacy testing in supporting medication reconciliation and patient safety.
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