TY  - JOUR
AU  - Gomez Lumbreras, Ainhoa
AU  - Reese, Thomas J
AU  - Del Fiol, Guilherme
AU  - Tan, Malinda S
AU  - Butler, Jorie M
AU  - Hurwitz, Jason T
AU  - Brown, Mary
AU  - Kawamoto, Kensaku
AU  - Thiess, Henrik
AU  - Wright, Maria
AU  - Malone, Daniel C
PY  - 2022
DA  - 2022/10/19
TI  - Shared Decision-Making for Drug-Drug Interactions: Formative Evaluation of an Anticoagulant Drug Interaction
JO  - JMIR Form Res
SP  - e40018
VL  - 6
IS  - 10
KW  - decision making, shared
KW  - decision support systems, clinical
KW  - decision making
KW  - decision support
KW  - user-centered design
KW  - patient-centered care
KW  - risk management
KW  - drug interaction
KW  - pharmacotherapy
KW  - pharmacy
KW  - pharmaceutical
KW  - warfarin
KW  - unified theory of acceptance and use of technology
KW  - UTAUT
KW  - NSAID
KW  - anti-inflammatory
KW  - non-steroidal
AB  - 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. 
SN  - 2561-326X
UR  - https://formative.jmir.org/2022/10/e40018
UR  - https://doi.org/10.2196/40018
UR  - http://www.ncbi.nlm.nih.gov/pubmed/36260377
DO  - 10.2196/40018
ID  - info:doi/10.2196/40018
ER  -