TDS support is key for PROGRESS pain relief study

More than 50 million Americans experience chronic pain. Many of them struggle to find relief, particularly affordable, low-risk treatment options that help them reduce their own suffering when they need it most.

With the support of Stanford Health Care’s Technology and Digital Solutions group, we are rolling out the PROGRESS study to test two evidence-based pain relief skills treatments that patients can receive online and from home at no cost. The online PROGRESS study eliminates travel burdens and makes treatment more accessible, especially to groups that are often underserved in health care.

We are targeting representative enrollment of Stanford Health Care patients most commonly overlooked in health research, including older adults with Medicare/Medicaid (often lower income), racial and ethnic minorities, and people living in rural areas. Because PROGRESS is online, it involves a lot of effort from TDS to tailor our learning healthcare system, the Collaborative Health Outcomes Information Registry (CHOIR), to each study site, enhancing the patient-participant experience and ensuring rigor in data collection and study operations.

Since PROGRESS is what’s known as a comparative effectiveness trial, there is no “control group” — rather, every enrolled patient receives one of the two evidence-based pain treatments. This format makes the study more appealing to patients and clinicians who want to access to pain care, aligning it closely to Stanford’s clinical mission.

The study will compare the effects of an online single-session pain relief skills class called Empowered Relief® against a program of eight online sessions of Cognitive Behavioral Therapy. Both methods have been shown to relieve pain and help people have better sleep, better mood, less fatigue, and improved daily function. But the two methods have never been compared in a national study with diverse patients and online.

Improved Patient Experience

In designing the PROGRESS study we integrated advice from 2,000 patients and consulted multiple patient advisory boards to better understand how to best meet diverse patients’ needs and wants. TDS then implements their guidance in tailoring the informatics platform, patient surveys, participant compensation, and patient communications systems. Patients even receive their treatments through our online platform. Our electronic study platform hosts all patient experiences in one easy location; people can access it anywhere as long as they have access to the internet.

TDS Collaboration

The PROGRESS study represents about six months of TDS collaboration, development, and testing to launch this national, multi-site trial. Research Technology built this solution leveraging our existing CHOIR platform software and Google Cloud infrastructure. This improved our time to solution, reduced infrastructure cost and complexity, and helped innovate in terms of CHOIR features that are now available for future projects. New CHOIR features we released include: 

• Self-directed electronic screening and consent process with inclusion/exclusion criteria, waiting room and workflow for verification checks and randomization
• Versioning of consents and electronic re-consent process
• Integration of Amazon gift card incentives for participation (participants receive payments as they complete various activities)
• Scheduling of treatment activities 

The Research Technology team was able to leverage existing CHOIR features for collecting baseline information, pre- and post-treatment status, and followup outcomes at various time points. The administrative features and ability to isolate data between multiple study sites were valuable, and we leveraged existing role-based security controls. 

Since Research Tech was able to leverage our existing development and production environments, we did not need to provision or manage any new infrastructure. This greatly reduced the burden for our software development team, and kept the cloud resource costs minimal.

Uniquely Stanford

The PROGRESS study is “uniquely Stanford” in three ways. First, the CHOIR learning health system and informatics platform were developed at Stanford (by Sean Mackey, MD, PhD) in 2010. CHOIR is used in multiple Stanford clinics and academic centers throughout the U.S. to capture high-quality data to guide patient care and generate real-world research discoveries. Second, Empowered Relief® was created at Stanford by Beth Darnall, MD, PhD. Third, our Stanford pain psychology team is leading the national implementation of both Empowered Relief® and 8-session CBT.

We’re aiming to perform the study on 1,650 individuals; since we started in January of 2023, we’ve enrolled around 300. We’re currently on year two of a five-year study, and will follow participants for six months after treatment is finished. We hope the results of our study inform national pain treatment policies, and help patients, families and clinicians make informed decisions about their pain care.

This far-reaching study is helping to advance Stanford’s mission to be a national leader in health care research, particularly in research that seeks to enhance diversity and include underrepresented populations. Or, as stated in our Integrated Strategic Plan: “Discovered here, used everywhere.” 

PROGRESS study participants will gain new skills, set goals, and receive support while continuing their other pain treatments.

Special Thanks and Recognition

Beth Darnall, MD, PhD, Principal Investigator of the Patient-Centered Outcomes Research Institute, which provided $13.3 million in funding; Sean Mackey, MD, PhD, who created CHOIR and is the site-PI for the Stanford study site; Emma Adair, PROGRESS Core Manager; Matt Cheung, PhD, RPh; Kelly Adams, Kristen Honesto, Ashley Gomez, and the perhaps 80 other individuals, site PIs, clinical leads, study coordinators, and patient advisers who are essential to the success of PROGRESS.