Clinical Trials Logo

Clinical Trial Summary

The purpose of this project is to implement and evaluate a shared-decision making (SDM) tool called DDInteract that was developed to support decision making for drug-drugs interactions while on oral anticoagulants. DDInteract will be implemented in clinics at the University of Utah, University of Colorado and University of Vanderbilt. DDInteract will be launched from within the electronic health record (EHR) retrieving patient-specific risk factors, will calculate the risk of harm, and will allow providers and patients to dynamically explore "what if" scenarios to optimize treatment and minimize risk. DDInteract will enable shared-decision making using individually-tailored information on the potential benefits and harms of drug interactions in anticoagulated patients.


Clinical Trial Description

The purpose of this project are: 1) Examine contextual factors and define relevant implementation strategies to facilitate integration of DDInteract within 3 university-based healthcare systems; 2) Evaluate DDInteract in production/real-world situations to identify barriers and facilitators to adoption and use of DDInteract and to develop solutions to overcome those barriers; 3) Conduct a cluster randomized, multi-system trial to evaluate the effectiveness of DDInteract to mitigate exposure to drug interactions involving oral anticoagulants This project will implement a SDM tool designed to inform clinicians and patients about the risk of harm from drug interactions in patients receiving oral anticoagulants. An initial version of the DDInteract will be EHR-integrated and will be accessed directly in the EHR and auto-populate relevant patient-specific data including other medications that might interact with oral anticoagulants. This study will use a multi-center randomized cluster design using clinics from the above-mentioned institutions. Each organization will implement DDInteract in their electronic health record system and the study will evaluate the degree to which the tool is utilized within each organization. The implementation period will last 18 months. This project is supported by a R18 award from Agency for Healthcare Research and Quality (AHRQ). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06401863
Study type Interventional
Source University of Utah
Contact
Status Active, not recruiting
Phase N/A
Start date October 1, 2023
Completion date July 31, 2026

See also
  Status Clinical Trial Phase
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT01925638 - Effect of Ketoconazole on the Pharmacokinetics of Refametinib Phase 1
Completed NCT00621699 - Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects Phase 1
Completed NCT00442585 - S(+)-Ibuprofen Effects on Asprin Treated Volunteers Phase 1
Completed NCT00200759 - Drug Interactions and Bioavailability of Cranberry Phase 1
Completed NCT00915746 - A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers Phase 1
Completed NCT03748745 - A Drug-drug Interaction Study of SH229 Tablets and Daclatasvir Dihydrochloride Tablets in Healthy Subjects Phase 1
Completed NCT03324685 - A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen Phase 1
Completed NCT05433896 - Evaluating the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) Tablets in Healthy Adult Subjects Under Fasting Conditions Phase 1
Recruiting NCT03307863 - Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy Phase 4
Completed NCT02706535 - A Cross-over Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics (PK) of GSK525762 in Healthy Female Subjects of Non Child Bearing Potential Phase 1
Completed NCT02147808 - A Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Midazolam in Healthy Subjects Phase 1
Completed NCT02097953 - Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin Phase 0
Completed NCT01364987 - Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Mycophenolate Mofetil in Healthy Volunteers Phase 1
Completed NCT00709982 - A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM) /Ethinyl Estradiol (EE) in Healthy Women. Phase 1
Completed NCT00810303 - Pharmacokinetic and Pharmacodynamic Interactions Between the Cholesterol-lowering Ezetimibe and the Non-nucleoside Reverse Transcriptase Inhibitor Efavirenz During Chronic Treatment in Healthy Volunteers With Reference to Intestinal Expression of CYP3A4, UGT1A1, ABCB1 and ABCC2 Phase 1
Completed NCT04252300 - Study to Learn the Effect of Drug BAY1817080 on the Way the Body Absorbs, Distributes and Excretes Another Drug Rosuvastatin in Healthy Adult Participants Phase 1
Completed NCT02576366 - Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus Phase 4
Completed NCT02159326 - Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women Phase 1
Completed NCT01886209 - Phase 1 PK Interaction Study Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects Phase 1