By the time the World Health Organization (WHO) declared COVID-19 a global pandemic in March, professionals at LMC Manna Research already had direct experience with the virus. A week before the WHO announcement, one of the company’s sites in Ontario, Canada, had experienced a COVID-19-positive patient; the news led to immediate site shutdown, and a lot of important questions.
In the months since, LMC Manna Research has taken a good look at its practices and procedures, especially around patient safety. To help inform their actions, the company conducted a survey of patients on a number of issues related to the virus.
Outsourcing-Pharma (OSP) recently spoke with Nazneen Qureshi (NQ), director of patient engagement and innovation for LMC Manna Research, about what the survey uncovered, and how it might inform patient engagement going forward.
OSP: Could you offer an overview/perspective on how COVID-19 has impacted the clinical research field?
NQ: The pandemic has afforded the entire research ecosystem an opportunity to challenge the status quo – we were quick to pivot and adjust our operations overnight. All trials halted enrollment and patients were concerned to leave their homes, so we knew that patient engagement would be key to minimize study disruption as best as possible.
OSP: One of LMC Manna Research’s sites had a COVID-positive patient back in March—how did that impact you?
NQ: A week prior to WHO’s announcement, one of our sites experienced an encounter with a COVID-positive patient, resulting in staff exposure and immediate site shutdown. Priorities immediately shifted, and the need for increased patient safety required an emergent change across all site SOPs.
These unforeseen circumstances allowed clinical research to propel in the direction we have been anticipating at our sites over the past five years: focusing on patient care through traditional, direct-to-patient (going into patients homes/workplaces), virtual (remote), and hybrid study execution and delivery.
OSP: What has happened at your company in the months since that?
NQ: We had to change our operations to be sustainable. We activated technologies to make study participation easier such going completely electronic for select trials (consents, regulatory, source).
To further expedite the treatment and vaccinations for COVID-19, we are looking at options we may not have considered before, such us conducting research at retirement residences or places of work and performing virtual general awareness consents on how research trials work to break down barriers that may exist. We are even introducing a software called TablesReady used by restaurants to manage our waiting rooms through a digital waitlist and paging system to ensure patient and staff safety.
OSP: How have site operations and protocol changed?
COVID-19 impacted our site-level processes and procedures, with updates made to mitigate any potential risk(s) our patients and employees could face. Studies are now being conducted in three forms: traditionally (with modifications), virtually, or as a hybrid of the two. For traditional study activities, our in-clinic protocol changed, requiring PPE to be used by both patients and staff.
Clinics are maintaining physical distancing, with Plexiglas barriers installed within each office, and the number of patients allowed inside each clinic at one time restricted until further notice. In the virtual form of study participation, the trial visit is completely remote for the patient, with any required lab work completed by a designated staff member in the patient’s home.
The hybrid study model pulls from the other two types: most of the patient’s visit is conducted over the phone or through videoconferencing (i.e., adverse event reporting, document completion), with patients required to visit the clinic only for essential labs and vitals. Direct-to-patient care (home visits) have been supplemented to ensure investigational product continuity and to perform essential vitals/labs when the patient is unable to visit the clinic.
OSP: You mentioned some of the shifts that have occurred at the organization since COVID-19 were actually in the works before the pandemic struck. Could you talk about these specific changes and explain the foresight?
NQ: As an organization, we decided to go completely electronic in 2020; we knew it was important to embrace technology early on before it became a requirement. Though we anticipated the transition to occur over the course of the year, we had to expedite this entire process from start to finish within 4 months.
E-Consent was an option we considered, and trialed in the past. At that time, the technology did not support the needs of our site or the patients. It was not the convenient option.
But, with COVID-19, we had to make the decision that this was a requirement for our company. All of our sites must have the ability to enroll patients remotely, in order for us to continue to maintain enrollment amid the pandemic.
OSP: What are some of the chief concerns you’ve had during all of this, and how are you working to combat/prevent/alleviate them?
NQ: We were concerned as an organization about how we would maintain retention and stay sustainable with studies no longer enrolling. The insights our patients provided were invaluable.
As we continue to adjust to our new norm with COVID-19, we need to continue focusing on patient engagement. Though a patient’s reason to leave a trial is most likely not due to COVID-19, inconsistencies in communication during these difficult times may be the reason instead.
In an environment so volatile, we need to keep our patients educated on the matter of COVID-19 and their health – they will want to hear it from us.
Sites are already overwhelmed with adopting new SOPs and handling patient safety. As an industry, we can engage patients in a unified, consistent manner to streamline communications and reduce site burden.
For example, TrialScout (a patient rating and review platform for clinical trials) has established a 12-week enhanced patient engagement program developed to address the new challenges during the COVID-19 pandemic. The program allows for a two-way communication between sites and patients for process updates, community-based forums, frequently asked questions, as well as lighthearted content and good news.
The most important thing that you can do right now is to stay engaged with participants in a two-way conversation that fosters trust, transparency, and respect. Help your site achieve trial continuity and the best possible retention rates through patient engagement!
OSP: Could you talk about the interviews with Phase 3 trial participants—overview of the patient population, what you were looking to determine, questions asked, and what you discovered?
NQ: With all these changes, the immediate concern recognized is how will COVID-19 impact our patients? How can we preserve patient retention?
At LMC Manna, we understood that there is no better way to answer these questions than to ask our patients. Interviews were conducted with patients who are currently enrolled in Phase 3 clinical trials, with questions focusing on the impact of COVID-19 during their trial participation; the average age of our respondents was 64 years old, participating in studies focusing on diabetes, lipid, or heart health research.
OSP: What did you learn from patients about things like interaction with staff, use of technology tools, patient attitudes toward participation, engagement/follow-up, etc?
NQ: When we asked our patients what form of study visit they preferred at this time, almost unanimously the answer was hybrid. Even with the impact of COVID-19, patients still want some form of human contact during their study participation.
It was highly noted by survey respondents that the changes implemented by the site staff during in person visits had not impacted their desire to interact or be at the clinic: “I like seeing people.” “If I got a good mask, hand sanitizer, gloves, I don’t think there’s significant risk to myself.”
Though our respondent audience was older, an interesting point arose: when it came to fully virtual visits, patients had no problem using platforms like Zoom, if direction had been provided in advance. Though we usually resorted to the website instructions to educate patients about the platform, we realized we had to simplify the language further to better suit our average patient.
In addition, there are individuals who do not have smartphones or computers, never mind access to any kind of video function. It’s important to consider and provide patients with the options that exist for them, rather than making the decision for them to proceed with fully remote visits; patients want to have that choice.
When asked how we could further support our patients, many appreciated medication deliveries and the option to have study visits in traditional, virtual, and hybrid forms, but what truly stuck out was the notion of “someone asking us if we are okay.” As many sites may have reduced workload, combined with the constant changes staff need to quickly adapt to, the element of simply checking in may have gotten lost during this critical time.
Patient engagement is more important right now than it ever was before. While we try our best to provide monthly newsletters with updates, there are far more changes occurring, and at a pace so rapid that it’s becoming difficult to keep all of our 2,000+ patients informed on a consistent basis.
The biggest, and most remarkable, takeaway was that amid the changes COVID-19 has brought to our sites, patients are still committed to continuing their trials. Trial participation only became a concern for respondents if they were diagnosed with COVID-19.
They are motivated to participate; they see the benefits to their health and that they are contributing to improving the health of others: “Medical advancement is based on studies, so you can’t expect medicines to advance without them, and if you can help, that’s great.”
OSP: If you could talk about TrialScout’s engagement program, feel free—I think I might cover them in a separate piece, but I would appreciate your insights and opinions.
TrialScout is the first-ever patient ratings and reviews platform for clinical trial sites. The platform has been recognized by industry and sites alike as the winner of the Patient Engagement Award at SCOPE 2020.
In response to COVID-19, TrialScout has established a 12-week patient engagement program. Sites are already overwhelmed with adopting new SOPs and handling patient safety. As an industry, we can engage patients in a unified, consistent manner to streamline communications and reduce site burden. The program allows for a two-way communication between sites and patients for updates, news, frequently asked questions, as well as lighthearted content and good news.