Known as the Aspirin Study—A Patient-Centered Trial, it showcases use of Real-World Data (RWD) in clinical research. A demonstration project of PCORnet (The National Patient-Centered Clinical Research Network), with Duke University leading as the study sponsor. The investigators are using electronic health records and claims data to capture the results for the primary (death, hospitalization for myocardial infarction, others) as well as secondary (revascularization procedures, hospitalization for serious bleeding) endpoints. According to ClinicalTrials.gov 15,000 patients will be enrolled, but other reports peg the participant number at 20,000. The study commenced in 2016 and it is targeted for closure in 2020.
In this pragmatic, patient-centered clinical trial, the investigators will compare the effectiveness of two doses of aspirin (81 mg and 325 mg) currently in widespread use in the United States in the secondary-prevention population of patients with established ASCVD (atherosclerotic cardiovascular disease). The trial will use a novel format, using existing electronic health records (EHRs), as well as a web-based patient portal to collect patient-reported outcomes (PROs), and available patient encounter data to supplement/support the EHR. Patients who are identified as candidates for the trial will be directed to the electronic patient portal for the eConsent as well as an abbreviated eligibility confirmation and randomization.
One of the important aims of ADAPTABLE is to engage patients, their healthcare providers, and trial investigators in using the infrastructure PCORnet has developed and continues to refine. A total of 15,000 high-risk patients with ASCVD will be randomly assigned (in an open-label fashion) in a 1:1 ratio to instructions to use a daily aspirin dose of either 81 mg or 325 mg daily. The investigators expect the entire sample of patients will be enrolled over 36 months, with a maximum follow-up of 40 months.
Collaborators in this important RWD-based clinical trial include:
- Duke University
- Patient-Centered Outcomes Research Institute
- Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN)
- Greater Plains Collaborative Clinical Data Research Network
- Mid-South Clinical Data Research Network
- Research Action for Health Network (REACHnet)
- Patient-Centered Scalable National Network for Effectiveness Research
- PaTH Clinical Data Research Network
- New York City Clinical Data Research Network
- Health eHeart Patient Powered Network
- OneFlorida Clinical Data Research Network
- HealthCore-Anthem Research Network
- The Patient-Centered Network of Learning Health Systems
ADAPTABLE is embracing a new paradigm of patient engagement in clinical research. The ADAPTABLE patient partners, Adaptors, work alongside researchers in all aspects of the trial, including designing the protocol, consent form, study portal, and study materials.
Former FDA Commissioner, Robert Califf, MD, describes research of interest to the Food and Drug Administration (FDA) and how ADAPTABLE serves as a model of evidence generation to answer critical, pragmatic questions quickly.
Who Are the Adaptors?
In ADAPTABLE, the role of the patient has shifted from participant to partner. Adaptors are patient representatives who have been involved in ADAPTABLE from the beginning. Working with the study team, Adaptors helped design the protocol, consent form, study portal, and study materials. Adaptors will be integral in disseminating study updates and results to other patients and in the community. Adaptors participate in investigator meetings, on the Steering Committee, and two Adaptors serve as patient representatives on the Executive Committee. In this video, Dr. Matthew Roe talks about collaborating with Adaptors at the ADAPTABLE Kick-off Meeting.
Health eHeart Alliance, a PCORnet Patient-Powered Research Network, leverages unique patient-centered processes to support the Adaptors Team. Mark Pletcher is the Principal Investigator and Madelaine Faulkner is the Project Director and facilitates the Adapter team. Health eHeart supports the role of the patient leaders by helping to ensure patient-friendly processes, creating space for the patient voice via Adapter-centered meetings, and supporting shared understanding among the researchers and patients in the study.
Principal Investigator Matthew Roe identified some lessons in a Clinical Leader editorial, a year into the study. Back then they were:
- Making the study design as simple as possible and avoid introducing too much complexity
- Ensuring the trial conduct and execution can be implemented seamlessly into clinical practice (do not interrupt patient flow or clinical care)
- Considering the example of best practice advisories (BPAs) as a way to implement the study into clinical practice—the decision support methodology and infusion into EHR tool can be used to identify potential research participants
- BPAs working well when the alerts are programmed as a pop up note that appears on the clinician’s EHR screen vs. being posted on a supplemental screen requiring more navigation and less seamless integration into core workflow
- The ADAPTABLE introduced a new model to answer relevant and associated health questions with great importance to patients and their clinicians
Matthew Roe, Principal Investigator
Adrian Hernandez, Co-Investigator
Schuyler Jones, Co-Investigator
Holly Robertson, Operations
Lisa Berdan, Operations
Tyrus Rorick, Operations