U.K. NIHR Publishes Point-Of-Care Trial Recruitment Study
By Cyndi Root
The National Institute for Health Research (NIHR) in the U.K. has published a study evaluating the effects of recruiting clinical trial prospects in a point of care environment. The study implemented methods to conduct simplified clinical trials using electronic health records (EHRs) and identified the barriers to enrollment from the physician’s perspective and the patient’s. The studies were called Retropro and eLung. Tjeerd-Pieter van Staa, study author, said in the Pharmaceutical Journal, “The concept technically works. You can use the EHR to identify eligible patients and GPs and patients are willing to participate, but paperwork is the biggest stumbling block.”
Point of Care Study
Recruiting physician offices for the point of care study titled, “The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials,” took over three years. Initially, 60 percent of the doctor’s offices expressed interest, but numbers dropped substantially over time, ending with 61 point-of-care sites. The U.K. researchers used an IT system with sophisticated controls to govern eligibility, installing computer software on the doctor’s desktop computers. The system alerted the GP to a patient’s eligibility for a clinical trial and facilitated the sign-up for the trial.
Study authors found that physicians were positive about discussing trial opportunities with patients during the visit. Doctors favored trials with non-acute illnesses. The trial consultation took about five minutes, which they found favorable. Most physicians reported that process was “straightforward and feasible,” generally giving positive support for EHR use in recruiting. Authors concluded that
EHR point-of-care trials are feasible. The recruitment of physicians proved difficult, though, which authors attribute to the complexity of trial approvals.
Retropro and eLung
In the Retropro trial, during the three-year physician recruitment phase, 30 physician sites were approved for the study, but only 17 were successful in recruiting at least one patient. In total, the study of hypercholesterolemia and high cardiovascular risk recruited 300 patients. In the eLung study, researchers signed up 31 patients.
The study appendices offer further insight into physician, patient, and investigator perspectives. One common insight from participants is that success in point-of-care trial recruitment is more likely if the physician is enthusiastic and has IT systems that interface well with new technologies.