The clinical trials program at the Lehigh Valley Cancer Institute (LVCI) grew exponentially in a short period of time. A great problem to have, certainly, but challenging to the organization.
To ensure the successful absorption and growth of new trials, two nurses drove an initiative to reorganize LVCI’s framework of their current disease management teams. They incorporated clinical trial oversight and responsibility into disease management teams to improve organizational processes, encourage innovation, and ensure high quality care.
In 2010, LVCI, which is part of the Lehigh Valley Health Network (LVHN) in Eastern Pennsylvania, participated in pharmaceutical-sponsored studies and experienced great success with immunotherapy trials, so its pharmaceutical portfolio expanded quickly. In 2015, LVHN joined the Memorial Sloan Kettering (MSK) Cancer Alliance, and in 2016, it joined the Michigan Cancer Research Consortium. As a result, LVCI’s access to clinical trials boomed. Suddenly it had access to more than 100 trials.
Forming Disease Management Teams
In 2015, to accommodate the rapid growth of their cancer program, LVCI formed disease management teams comprised of representatives from medical, surgical, and radiation oncology, as well as pathology and radiology. The teams included nurse navigators, clinical nurse specialists, genetic counselors, representatives from Cancer Institute administration, and clinical nurses, while other related physicians sit on teams as needed. The teams worked on setting up processes and guidelines.
After a year of successfully orchestrating disease management teams, LVCI conducted a disease management team needs assessment. What it found was that access to an abundance of trials does not necessarily mean focused care is given to the patients who need it. With numerous locations spread across Eastern Pennsylvania, LVCI needed to improve its ability to:
- Increase recognition of potentially eligible patients
- Select a more appropriate choice of trials based on resources
- Match the choice of trials to the population in the community
- Educate staff about new and current trials
Morgan Horton, BSN, RN, CCRC, supervisor, Oncology Clinical Trials, LVCI, helped identify these areas for improvement. “We found that we were opening trials that weren't suitable for our patient population,” she said during a presentation at the Association of Community Cancer Centers 35th National Oncology Conference. “The communities are obviously very different between hospitals, so we need to select trials that suited our own community and pick accordingly so that we could best treat our patients.”
As a result of the assessment, in 2016 LVCI began to include the clinical trials team in the monthly disease management team meetings.
Megan Derr, MSN, RN, AOCNS, CMSRN, oncology clinical nurse specialist at LVCI, facilitates each of the 6 disease management teams, which include teams based around breast, thoracic, head and neck, skin and soft tissue, genitourinary, and gynecologic cancers.
"The disease management team’s role is quite expansive and ever-changing," Derr said. "The teams meet monthly per disease site to review best-practice guidelines and compare them to our practice patterns. If discrepancies are noted, dissemination and action plans may be created. They also review changes to NCCN and ASCO guidelines to ensure that we are staying current in the care that we are providing our patients."
As part of the MSK Cancer Alliance, they also meet with the MSK disease management team to discuss treatment guidelines and share recommendations. Additionally, the disease management teams focus on quality assurance and clinical process improvement.
"We have found that those doing the work are boots-on-the-ground, first-contact-with-patient clinical team members,” said Megan Derr, MSN, RN, AOCNS, CMSRN, oncology clinical nurse specialist at LVCI. “(They) truly are the ones that find the areas needing improvement, and our (disease management team) agenda really does tend to bubble up from the bottom, from the people in our clinics, rather than from top-down, with management making the agenda."
During the presentation, Derr distinguished between the disease management teams and multidisciplinary care clinics. Patients visit the health network’s multidisciplinary care clinics and will see multiple providers in one venue to discuss and plan their treatment. Meanwhile, disease management teams are not a venue for discussing individual patients’ specific cases, as their scope is care coordination and improvement as a whole.
“At each (disease management team), new studies are reviewed for feasibility: Can we do this study? Do we have enough chair time? Do we have the right stains? Do we have the right kind of imaging? Do we take care of patients that really need this trial?” questioned Derr.
“The trials are also reviewed for team buy-in,” she added. “Do our providers feel like this will benefit their patients? Are they going to accrue to it? And are they comfortable accruing to all arms of the study? And, how to we plan to disseminate this study to our cancer institute, and to our entire network? Who needs further education, and how can we best reach them?”
Staff education is another important task in ensuring appropriate growth. Through shared spreadsheets and improvements to their electronic medical records, LVCI has enabled more transparent sharing of information about trial availability and patient eligibility. Derr and Horton have developed a CE-accredited research education and case studies course as well.
In one year, the integration of clinical trials under the auspices of the disease management teams accelerated clinical trial accrual significantly. Accrual to treatment clinical trials increased from 52 patients in 2016 to 93 in 2017. “In addition, overall clinical trials accrual totals increased from 287 to 347. These accruals included clinical trials in areas such as quality of life, registries, tissues and blood collection, in addition to treatment clinical trials,” Horton said.
Derr said one message from the disease management team project came through loud and clear: “An oncology clinical nursing model facilitates high quality and personalized care.”
Lastly, Derr urged clinicians working in teams to consider being open to constructive criticism. “Feedback from key stakeholders is critical to determining necessary change for positive process improvement and should be encouraged,” she said. “It's never easy to hear what you can be better at … but if you take feedback from your key supporters, it really helps to make innovative change and move your program in the right direction.”
Derr M, Horton M. Cultivating change: A disease-specific, team-based approach to improving oncology clinical trials. Presented at: Association of Community Cancer Centers 35th National Oncology Conference; October 17-19; Phoenix, AZ.