Shared Decision-Making for Drug-Drug Interactions: Formative Evaluation of an Anticoagulant Drug Interaction.

BACKGROUND: Warnings about drug-drug interactions (DDIs) between warfarin and nonsteroidal anti-inflammatory drugs (NSAIDs) within electronic health records indicate potential harm but fail to account for contextual factors and preferences. We developed a tool called DDInteract to enhance and support shared decision-making (SDM) between patients and physicians when both warfarin and NSAIDs are used concurrently. DDInteract was designed to be integrated into electronic health records using interoperability standards. OBJECTIVE: The purpose of this study was to conduct a formative evaluation of a DDInteract that incorporates patient and product contextual factors to estimate the risk of bleeding. METHODS: A randomized formative evaluation was conducted to compare DDInteract to usual care (UC) using physician-patient dyads. Using case vignettes, physicians and patients on warfarin participated in simulated virtual clinical encounters where they discussed the use of taking ibuprofen and warfarin concurrently and determined an appropriate therapeutic plan based on the patient's individualized risk. Dyads were randomized to either DDInteract or UC. Participants completed a postsession interview and survey of the SDM process. This included the 9-item Shared Decision-Making Questionnaire (SDM-Q-9), tool usability and workload National Aeronautics and Space Administration (NASA) Task Load Index, Unified Theory of Acceptance and Use of Technology (UTAUT), Perceived Behavioral Control (PBC) scale, System Usability Scale (SUS), and Decision Conflict Scale (DCS). They also were interviewed after the session to obtain perceptions on DDInteract and UC resources for DDIs. RESULTS: Twelve dyad encounters were performed using virtual software. Most (n=11, 91.7%) patients were over 50 years of age, and 9 (75%) had been taking warfarin for more than 2 years (75%). Regarding scores on the SDM-Q-9, participants rated DDInteract higher than UC for questions pertaining to helping patients clarify the decision (P=.03), involving patients in the decision (P=.01), displaying treatment options (P<.001), identifying advantages and disadvantages (P=.01), and facilitating patient understanding (P=.01) and discussion of preferences (P=.01). Five of the 8 UTAUT constructs showed differences between the 2 groups, favoring DDInteract (P<.05). Usability ratings from the SUS were significantly higher (P<.05) for physicians using DDInteract compared to those in the UC group but showed no differences from the patient's perspective. No differences in patient responses were observed between groups using the DCS. During the session debrief, physicians indicated little concern for the additional time or workload entailed by DDInteract use. Both clinicians and patients indicated that the tool was beneficial in simulated encounters to understand and mitigate the risk of harm from this DDI. CONCLUSIONS: Overall, DDInteract may improve encounters where there is a risk of bleeding due to a potential drug-drug interaction involving anticoagulants. Participants rated DDInteract as logical and useful for enhancing SDM. They reported that they would be willing to use the tool for an interaction involving warfarin and NSAIDs.

Coordinated use of Health Level 7 standards to support clinical decision support: Case study with shared decision making and drug-drug interactions.

BACKGROUND: Despite advances in interoperability standards, it remains challenging and often costly to share clinical decision support (CDS) across healthcare organizations. This is due in part to limited coordination among CDS components. To improve coordination of CDS components, Health Level 7 (HL7) has developed a suite of interoperability standards with Fast Health Interoperability Resources (FHIR) specification as a common information model. Evidence is needed to determine the feasibility of implementing these CDS components; therefore, the objective of this study was to investigate the coordination of emerging HL7 standards with modular CDS architecture components. METHODS: We used a modular, standards-based architecture consisting of four components: data, logic, services, and applications. The implementation use-case was an application to support shared decision making in the context of drug-drug interactions (DDInteract). RESULTS: DDInteract uses FHIR as the data representation model, Clinical Quality Language for logic representation, CDS Hooks for the services layer, and Substitutable Medical Apps Reusable Technologies for application integration. DDInteract was first implemented in a sandbox environment and then in an electronic health record (Epic®) test environment. DDInteract can be integrated in clinical workflows through on-demand access from a menu or through CDS Hooks upon opening a patient's record or placing a medication order. CONCLUSION: In the context of drug interactions, DDInteract is the first application to leverage a full stack of emerging interoperability standards for each component of modular CDS architecture. The demonstrated feasibility of interoperable components can be generalized to other modular CDS applications.

A Shared Decision-making Tool for Drug Interactions Between Warfarin and Nonsteroidal Anti-inflammatory Drugs: Design and Usability Study.

BACKGROUND: Exposure to life-threatening drug-drug interactions (DDIs) occurs despite the widespread use of clinical decision support. The DDI between warfarin and nonsteroidal anti-inflammatory drugs is common and potentially life-threatening. Patients can play a substantial role in preventing harm from DDIs; however, the current model for DDI decision-making is clinician centric. OBJECTIVE: This study aims to design and study the usability of DDInteract, a tool to support shared decision-making (SDM) between a patient and provider for the DDI between warfarin and nonsteroidal anti-inflammatory drugs. METHODS: We used an SDM framework and user-centered design methods to guide the design and usability of DDInteract-an SDM electronic health record app to prevent harm from clinically significant DDIs. The design involved iterative prototypes, qualitative feedback from stakeholders, and a heuristic evaluation. The usability evaluation included patients and clinicians. Patients participated in a simulated SDM discussion using clinical vignettes. Clinicians were asked to complete eight tasks using DDInteract and to assess the tool using a survey adapted from the System Usability Scale. RESULTS: The designed DDInteract prototype includes the following features: a patient-specific risk profile, dynamic risk icon array, patient education section, and treatment decision tree. A total of 4 patients and 11 clinicians participated in the usability study. After an SDM session where patients and clinicians review the tool concurrently, patients generally favored pain treatments with less risk of gastrointestinal bleeding. Clinicians successfully completed the tasks with a mean of 144 (SD 74) seconds and rated the usability of DDInteract as 4.32 (SD 0.52) of 5. CONCLUSIONS: This study expands the use of SDM to DDIs. The next steps are to determine if DDInteract can improve shared decision-making quality and to implement it across health systems using interoperable technology.