NOHARM, an NIH Pragmatic Trials Collaboratory Trial, is a cluster-randomized, stepped-wedge trial of a bundled intervention that relies heavily on the electronic health record to encourage perioperative patients to consider using nonpharmacologic approaches to manage their postoperative pain. The goal is to diminish patients’ reliance on opioids after surgery and, as a result, reduce rates of inappropriate and prolonged use of opioids.

Dr. Andrea L. Cheville, Co-PI of the Non-pharmacological Options in postoperative Hospital-based And Rehabilitation pain Management (NOHARM) project, discussed the study in an interview during the NIH Pragmatic Trials Collaboratory’s Steering Committee meeting in April.

NOHARM includes 5 steps with 22 clusters randomized to each step. The clusters are defined by surgical type as well as site. The project includes 4 health systems that fall under the Mayo enterprise and share a common electronic health record.

“We have now gone live with 2 of our steps, a total of about 10 clusters, and the surgical types that are included are transplant, cardiac, pulmonary, gynecologic, C-section, orthopedic, and colorectal surgeries,” said Cheville. “The statisticians from the Collaboratory were truly vital allies in parameterizing our choice of procedures and the stepped-wedge so I really cannot call them out enough.”

In May, the project was set to go live with a third step, the automated assignment of a portal-delivered conversation guide to patients.

“The goal of the guide is to educate patients that they are likely to have pain, that it’s important to take seriously and plan for, the benefits and the potential harms of opioid use, and the availability of equally effective, safer nonpharmacologic options that have additional benefits with respect to function and anxiety and sleep quality,” Cheville said.

NOHARM has engaged more than 36,000 patients with a target of roughly 100,000 patients total. Cheville said the project has learned that patients’ receptivity to different pain management options is dynamic over the course of their perioperative journey.

NOHARM, like other trials, has faced challenges related to COVID-19, and the fact that sites may experience surges at different times. A COVID-19 surge at one site can mean that nurses trained in the intervention are deployed elsewhere or that their ability to ingest new information and change practice patterns is stressed and challenged.

“We are trying to find a happy medium between advancing the trial, ensuring high-fidelity delivery, and consistent implementation across all of our clusters while being very respectful to the taxing demands imposed by the COVID-19 epidemic on all of the stakeholder groups,” Cheville said.

Cheville said being part of the NIH Pragmatic Trials Collaboratory has been extremely beneficial for NOHARM, particularly having access to experts who are available to help with methodology, informatics, the electronic health record, parameterization, and statistics.

“If I had to pinpoint one attribute of the Collaboratory it would be the freedom to share our weaknesses, our fears, the things that keep us up at night, with colleagues who are grappling and troubleshooting exactly the same issues in parallel, who truly are walking the walk. Feeling part of a community, that’s been vital for our own psychosocial well-being,” Cheville said.

View the full video here.