Clinical Researcher—May 2021 (Volume 35, Issue 4)

OVER THE TRANSOM

Gary W. Cramer

One thing you’ll hear over and over when seasoned clinical research professionals start talking about how they broke into the field is the astonishment (and trepidation) they felt as they began to scale the mountain of acronyms being tossed about so casually by the veterans around them. Even as someone who was long used to having to become an “instant expert” on topics that I was covering in my former newspaper, magazine, and public relations jobs, I was a little stunned upon arriving at ACRP and having to sort out my CRAs, CRCs, and CPIs from my CROs, CRFs, and CTAs.

In keeping with the technology theme of this issue, and in the spirit of throwing more acronyms at you than any human should have to face in a single column, here are excerpts from some otherwise timely news items that have crossed my desk recently from stakeholders in the clinical research enterprise (no endorsements implied).

The Rise of DCTs is Disrupting Traditional Patient Recruitment

As the pandemic has accelerated the adoption of decentralized clinical trials (DCTs), SubjectWell CEO Ivor Clarke has been thinking about how this manner of conducting trials challenges our current definition of recruiting, why centralized recruiting is critical for success with DCTs, and how much patients actually like concierge services, fewer in-person visits, and the technology and mobile apps that reduce their burden of trial participation.

In an April blog post, Clarke notes how, in a SubjectWell patient survey from October 2020, the following accommodations found in DCTs were rated as extremely or very important: study medicine delivered to the home (75%), remote communication with doctor (74%), lab samples collected at home (68%), concierge services (67%), and mobile applications (67%). However, DCTs “put ownership of the patient relationship up for grabs,” Clarke writes.

Traditionally, Clarke explains, “the recruiting relationship with patients stops with the referral, passing the responsibility to sites to shepherd patients though the study funnel.” With fewer principal investigators and site coordinators involved, DCTs alter how patient relationships—tied to such matters as screening, informed consent, study compliance, and follow-up visits—are managed.

“It may be difficult to substitute the consistency and personal touch provided by sites to pull patients from screening to consent,” Clarke notes. “Perhaps technology (eConsent, web prescreens, digital scheduling) will engage the patient and bridge the gap until a study contact is later assigned. Adding a patient-engagement step with education early in the recruitment process may be enough to keep patient trust and participation interest high.”

For more information, you can read Clarke’s blog here.

Expanding Decentralized Solutions to Bring Trials Closer to Patients

Syneos Health and Medable in April announced a strategic partnership to bring clinical trials closer to the patient. Through the partnership, Syneos Health will gain access to Medable’s digital platform for reducing physician burden, simplifying the patient journey, and collecting previously difficult-to-obtain data to speed therapies to patients across the clinical development lifecycle. In combination with Syneos Health’s Illingworth Research Group mobile research nursing capabilities, the company believes the platform will enable it to engage more diverse populations and increase access for patients who previously couldn’t participate in clinical trials.

Medable’s platform delivers onsite and at-home access on any web-enabled device utilizing TeleVisit, TeleConsent, TeleCOA (that’s for clinical outcome assessment, BTW [by the way]), and remote patient monitoring tools.

EHR Usability Issues Linked to Nurse Burnout and Patient Outcomes

Nurses and other clinicians rely heavily upon electronic health records (EHRs) when providing patient care. This includes clinical decision-making, care planning, patient surveillance, medication ordering and administration, and communication with other healthcare team members. While data show that EHR technology usability can put added burden on clinicians, the relationships between EHR usability and the job outcomes of hospital staff nurses and surgical patient outcomes have not been explored.

A new study from the University of Pennsylvania School of Nursing’s Center for Health Outcomes and Policy Research has investigated associations between EHR usability and nurse job outcomes (burnout, job dissatisfaction, and intention to leave) and surgical patient outcomes (inpatient mortality and 30-day readmission). The study found that employing EHR systems with suboptimal usability was associated with higher odds of adverse nurse job outcomes and surgical patient mortality and readmission. In fact, EHR usability may be more important to nurse job and patient outcomes than comprehensive EHR adoption. The results have been published in the journal Medical Care.

Gary W. Cramer (gcramer@acrpnet.org) is Managing Editor for ACRP.