Rationale and design of the TAILOR-PCI digital study: Transitioning a randomized controlled trial to a digital registry

Am Heart J. 2021 Feb;232:84-93. doi: 10.1016/j.ahj.2020.10.069. Epub 2020 Oct 31.

Abstract

Background: Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) is the largest cardiovascular genotype-based randomized pragmatic trial (NCT#01742117) to evaluate the role of genotype-guided selection of oral P2Y12 inhibitor therapy in improving ischemic outcomes after PCI. The trial has been extended from the original 12- to 24-month follow-up, using study coordinator-initiated telephone visits. TAILOR-PCI Digital Study tests the feasibility of extending the trial follow-up in a subset of patients for up to 24 months using state-of-the-art digital solutions. The rationale, design, and approach of extended digital study of patients recruited into a large, international, multi-center clinical trial has not been previously described.

Methods: A total of 930 patients from U.S. and Canadian sites previously enrolled in the 5,302 patient TAILOR-PCI trial within 23 months of randomization are invited by mail to the Digital Study website (http://tailorpci.eurekaplatform.org) and by up to 2 recruiting telephone calls. Eureka, a direct-to-participant digital research platform, is used to consent and collect prospective data on patients for the digital study. Patients are asked to answer health-related surveys at fixed intervals using the Eureka mobile app and or desktop platform. The likelihood of patients enrolled in a randomized clinical trial transitioning to a registry using digital technology, the reasons for nonparticipation and engagement rates are evaluated. To capture hospitalizations, patients may optionally enable geofencing, a process that allows background location tracking and triggering of surveys if a hospital visit greater than 4 hours is detected. In addition, patients answer digital hospitalization surveys every month. Hospitalization data received from the Digital Study will be compared to data collected from study coordinator telephone visits during the same time frame.

Conclusions: The TAILOR-PCI Digital Study evaluates the feasibility of transitioning a large multicenter randomized clinical trial to a digital registry. The study could provide evidence for the ability of digital technology to follow clinical trial patients and to ascertain trial-related events thus also building the foundation for conducting digital clinical trials. Such a digital approach may be especially pertinent in the era of COVID-19.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19 / epidemiology
  • Clopidogrel / therapeutic use
  • Continuity of Patient Care
  • Feasibility Studies
  • Follow-Up Studies
  • Genotype
  • Geographic Information Systems
  • Health Surveys / methods
  • Humans
  • Internet-Based Intervention*
  • Ischemia / drug therapy
  • Mobile Applications
  • Multicenter Studies as Topic*
  • Patient Compliance
  • Patient Generated Health Data*
  • Patient Participation
  • Percutaneous Coronary Intervention
  • Postoperative Complications / drug therapy
  • Pragmatic Clinical Trials as Topic
  • Purinergic P2Y Receptor Antagonists / therapeutic use
  • Randomized Controlled Trials as Topic*
  • Registries*
  • Research Design
  • SARS-CoV-2
  • Telephone

Substances

  • Purinergic P2Y Receptor Antagonists
  • Clopidogrel