Showcasing Innovative Operational and Recruitment Approaches in the ADAPTABLE Trial
Holly Robertson, PhD, ADAPTABLE Project Leader, Duke Clinical Research Institute
Matthew T. Roe, MD, MHS, ADAPTABLE Co-Principal Investigator, Duke Clinical Research Institute
Pragmatic clinical trial; ADAPTABLE; NCT02697916; Comparative effectiveness research; Aspirin study; Patient recruitment, eligibility, and enrollment; PCORnet; EHRs; Computable phenotype; Patient-powered research networks; Clinical data research networks; Common data model; Patient web portal; Patient engagement
The ADAPTABLE aspirin study is being conducted through the National Patient-Centered Clinical Research Network (PCORnet). The trial aims to find the best aspirin dose to prevent heart attacks and strokes in individuals living with heart disease.
ADAPTABLE uses innovative approaches to achieve efficiencies in patient recruitment, including:
- System-wide screening of electronic health records (EHRs) to identify patients to approach
- Eliminating data entry redundancies by obtaining information directly from EHRs via the Common Data Model (CDM)
- Collecting longitudinal patient-reported outcomes directly from participants via the patient web portal
The average monthly enrollment rates have exceeded those of comparable traditional clinical trials. Awareness of the study is promoted through the use of social media, blogs, and local events. Patient outreach is conducted electronically and through multiple approaches such as mail, email, and phone.
Patient recruitment lessons from the ADAPTABLE study emphasize that eligible patients want to know that their clinician endorses the study; that remote recruitment rarely succeeds without multiple phone follow-up; and that sustained clinician engagement is critical to success—champions are essential.
Deep collaborations between informatics experts and clinicians are necessary to optimize the implementation of the computable phenotype to identify eligible patients.
What IRB issues were raised, and how did the study sites address those concerns?
Are there age-related issues in participants’ access and comfort with technology?
How does ADAPTABLE’s informed consent process work with regard to format, platform, security, and literacy?
For More Information
@ADAPTABLEstudy, @PCTGrandRounds, @Collaboratory1, @PCORnetwork