Shared Decision-Making for Drug-Drug Interactions: Formative Evaluation of an Anticoagulant Drug Interaction.
NSAID
UTAUT
anti-inflammatory
decision making
decision making, shared
decision support
decision support systems, clinical
drug interaction
non-steroidal
patient-centered care
pharmaceutical
pharmacotherapy
pharmacy
risk management
unified theory of acceptance and use of technology
user-centered design
warfarin
Journal
JMIR formative research
ISSN: 2561-326X
Titre abrégé: JMIR Form Res
Pays: Canada
ID NLM: 101726394
Informations de publication
Date de publication:
19 Oct 2022
19 Oct 2022
Historique:
received:
01
06
2022
accepted:
22
09
2022
revised:
21
08
2022
entrez:
19
10
2022
pubmed:
20
10
2022
medline:
20
10
2022
Statut:
epublish
Résumé
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. 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. 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. 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. 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.
Sections du résumé
BACKGROUND
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
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
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
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
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.
Identifiants
pubmed: 36260377
pii: v6i10e40018
doi: 10.2196/40018
pmc: PMC9631167
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e40018Subventions
Organisme : AHRQ HHS
ID : U18 HS027099
Pays : United States
Informations de copyright
©Ainhoa Gomez Lumbreras, Thomas J Reese, Guilherme Del Fiol, Malinda S Tan, Jorie M Butler, Jason T Hurwitz, Mary Brown, Kensaku Kawamoto, Henrik Thiess, Maria Wright, Daniel C Malone. Originally published in JMIR Formative Research (https://formative.jmir.org), 19.10.2022.
Références
JAMA Intern Med. 2020 Sep 1;180(9):1215-1224
pubmed: 32897386
Arch Intern Med. 2005 May 23;165(10):1095-106
pubmed: 15911722
Aust N Z J Public Health. 2017 Apr;41(2):210-214
pubmed: 27774735
Cureus. 2021 Mar 8;13(3):e13766
pubmed: 33842142
JMIR Mhealth Uhealth. 2021 Jun 15;9(6):e26262
pubmed: 33962910
Am Heart J. 2017 Sep;191:1-11
pubmed: 28888264
J Am Pharm Assoc (2003). 2013 Jan-Feb;53(1):39-45
pubmed: 23636154
Neuroepidemiology. 2016;47(3-4):201-209
pubmed: 28135707
J Am Med Inform Assoc. 2016 Sep;23(5):899-908
pubmed: 26911829
CMAJ. 2007 Aug 14;177(4):347-51
pubmed: 17698822
Med Decis Making. 2015 Jan;35(1):114-31
pubmed: 25351843
Patient Educ Couns. 2012 Aug;88(2):284-90
pubmed: 22480628
Int J Med Inform. 2022 Mar 21;162:104749
pubmed: 35358893
Am J Health Syst Pharm. 2005 Oct 1;62(19):1983-91
pubmed: 16174833
Patient Prefer Adherence. 2018 Nov 06;12:2339-2355
pubmed: 30464421
Pharmacy (Basel). 2021 Jan 19;9(1):
pubmed: 33478093
BMJ Qual Saf. 2018 May;27(5):380-388
pubmed: 29269567
BMC Med Inform Decis Mak. 2021 Jan 6;21(1):4
pubmed: 33407411
Inform Health Soc Care. 2017 Mar;42(2):135-152
pubmed: 26890621
Acad Pediatr. 2019 Sep - Oct;19(7):828-834
pubmed: 30853573
JAMIA Open. 2021 Mar 19;4(1):ooab023
pubmed: 33763631
Med Decis Making. 1995 Jan-Mar;15(1):25-30
pubmed: 7898294
Thromb Haemost. 2020 Jul;120(7):1066-1074
pubmed: 32455439
Ann Pharmacother. 2019 Jul;53(7):665-674
pubmed: 30724102
JAMA Netw Open. 2021 Jul 1;4(7):e2118433
pubmed: 34323986
Nepal J Epidemiol. 2020 Sep 30;10(3):878-887
pubmed: 33042591
Hematology. 2021 Dec;26(1):277-283
pubmed: 33631081
Mayo Clin Proc. 2019 Apr;94(4):686-696
pubmed: 30642640
PLoS One. 2017 Mar 30;12(3):e0173904
pubmed: 28358864
J Gen Intern Med. 2012 Oct;27(10):1361-7
pubmed: 22618581
JMIR Hum Factors. 2021 Oct 26;8(4):e28618
pubmed: 34698649
J Popul Ther Clin Pharmacol. 2013;20(3):e229-37
pubmed: 24163147
J Gen Intern Med. 2006 Feb;21 Suppl 2:S1-8
pubmed: 16637954
Ann Pharmacother. 2003 Jan;37(1):12-6
pubmed: 12503926
J Am Med Inform Assoc. 2021 Oct 12;28(11):2514-2522
pubmed: 34387686
Open Heart. 2020 Apr 1;7(1):e001232
pubmed: 32341789
Risk Manag Healthc Policy. 2021 Nov 24;14:4739-4748
pubmed: 34866946
Ann Gen Psychiatry. 2020 Aug 5;19:43
pubmed: 32774442
Am Heart J. 2020 Feb;220:12-19
pubmed: 31759279
Am J Med Sci. 2016 Nov;352(5):472-480
pubmed: 27865294
J Interv Card Electrophysiol. 2019 Nov;56(2):159-163
pubmed: 30327992
BMC Med Inform Decis Mak. 2020 Sep 17;20(1):234
pubmed: 32943027