Purdue Pharma L.P. and Geisinger Present Interim Analysis from Wearable Health Technology Clinical Trial at PAINWeek® 2018 Annual Conference

Results Show Successful Uptake of Technology and Increased Patient-Provider Communication

STAMFORD, Conn. & DANVILLE, Pa.--(BUSINESS WIRE)--Purdue Pharma L.P. and Geisinger will present an interim analysis from their Wearable Health Technology (WHT) observational trial at the 12^th Annual PAINWeek^® Conference, September 4-8, 2018, Las Vegas.

Connecting Patients to Providers: Application of Wearable Health Technology to a Multidisciplinary Pain Program (poster #49) will be available for viewing after 3:30 p.m. PDT on Wednesday, September 5, 2018. The authors will be available to discuss the poster during the PAINWeek^® Poster Session and Reception on Thursday, September 6, 2018 from 6:30 – 8:30 p.m. PDT.

The ongoing, prospective, non-randomized, non-blinded trial with historic and concurrent controls will assess the effect of WHT on patient and health system outcomes. This interim analysis, which examined WHT usage and patient characteristics, found patients are using WHT frequently and consistently to document pain scores, medications, alternative therapies, sleep, and activity.

“We are encouraged by these interim data and pleased to report that adding wearable health technology to our Multidisciplinary Pain Program has been well received by patients and, furthermore, has increased communication between providers and patients,” said John J. Han, MD, director, Department of Pain Medicine, Geisinger. “The integration of wearable health technology augments the assessments conducted in clinic with patient-reported data. The additional data seem to be supporting more robust interactions between doctors, clinic staff, and patients compared to what we’ve seen when patients rely on memory to describe their pain between clinic visits.”

Data show that the interactive processes underlying doctor-patient relationships in pain management are important, as effective doctor-patient communication is correlated with better health outcomes.¹

The study, which was announced in October 2017, is designed to assess the effect of the addition of WHT on patient and health system outcomes within a multidisciplinary pain program for patients with chronic pain in the Geisinger healthcare system. The WHT under evaluation includes an Apple Watch^® and iPhone^® equipped with a novel pain application (Pain Watch) to measure daily patient-reported pain scores and breakthrough pain, medication use, physical activity, and sleep quality; and a customizable provider dashboard to facilitate review of the collected data and discussions with patients. The Pain Watch app and dashboard were designed specifically for this study.

The PAINWeek^® poster presentation includes an interim analysis of usage patterns for the first 55 patients enrolled in this ongoing study (75 percent female, mean age 50.8 years) and found participants:

• Regularly accessed the Pain App, with a median use frequency of 67.2 percent of days (Interquartile Range [IQR]: 37.6 percent - 92.3 percent).
  • For sleep data, the median usage was 54 percent of days (IQR: 27.4 percent - 79.1 percent).
• Documented multiple body locations of pain in a single day.
  • At least 50 percent of days with pain score entries had up to four body parts with end-of-day pain scores and five breakthrough pain scores.
• Regularly recorded use of alternative, non-pharmacologic therapies.
  • Most patients (n=53, 96 percent) recorded stretching, mindfulness, and hot/cold therapy to augment their pain management, with many applying various modalities multiple times per day.

The interim analysis also included a detailed examination of a subgroup of patients (n=28) with at least four months of data. In addition to capturing usage patterns, average pain scores were calculated for the subgroup.

• When breakthrough pain was recorded, patients typically recorded multiple breakthrough pain scores for various painful areas on the body; 67 percent of days had multiple entries.
  • The average breakthrough pain score was 5.4 out of 10 (Standard deviation [SD] 1.3, range 3.1 to 8.0, median 5.3).
  • Use of breakthrough medication was logged on 28.7 percent of study days, with a per-patient median of 21.8 percent (IQR: 3.0 percent - 41.7 percent).
• Use of alternative therapies was recorded on 42.9 percent of study days (66.2 percent of days with WHT use), with a per-patient median of 28.2 percent (IQR: 23.3 percent - 66.2 percent).
• Sleep patterns were recorded on 38.5 percent of study days (59.4 percent of days with WHT use), with a per-patient median of 23.7 percent (IQR: 11.3 percent - 78.2 percent).

“We’re pleased to see patients benefiting from the technology, reporting increased engagement with providers with additional emphasis on alternative therapies, activity levels, and sleep quality,” said Thomas Alfieri, PhD, director, Medical Affairs Strategic Research, Purdue Pharma. “We believe there is a strong potential for wearable health technology to be used by patients with chronic pain and other chronic conditions, and this analysis provides important information that will inform the use of such technologies in the future.”

Enrollment for the WHT study is ongoing. An analysis of the effect of WHT on patient and healthcare system outcomes will be conducted upon study completion.

The WHT study protocol (NCT03299556) is on clinicaltrials.gov and available at this link.

About Geisinger

One of the nation’s most innovative health services organizations, Geisinger serves more than 1.5 million patients in Pennsylvania and New Jersey. The system includes 13 hospital campuses, a nearly 600,000-member health plan, two research centers and the Geisinger Commonwealth School of Medicine. Geisinger is known for its focus on caring and innovative programs including the ProvenCare^® best-practice approach to maximize quality, safety and value; ProvenHealth Navigator^® advanced medical home; Springboard Health^® population health program to improve the health of an entire community; ProvenExperience™ to provide refunds to patients unhappy with their care experience; and Geisinger’s MyCode^® Community Health Initiative, the largest healthcare system-based precision health project in the world. With more than 215,000 volunteer participants enrolled, MyCode is conducting extensive research and returning medically actionable results to participants. A physician-led organization, with approximately 32,000 employees and more than 1,800 employed physicians, Geisinger leverages an estimated $12.7 billion positive annual impact on the Pennsylvania and New Jersey economies. Repeatedly recognized nationally for integration, quality and service, Geisinger has a long-standing commitment to patient care, medical education, research and community service. For more information, visit geisinger.org or connect with us on Facebook, Instagram, LinkedIn and Twitter.

About Purdue Pharma

Purdue Pharma L.P. develops and provides prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications and technologies through internal research & development and strategic industry partnerships. For more information, please visit www.purduepharma.com.

Reference:

¹ Esquibel AY, Borkan J. Doctors and patients in pain: conflict and collaboration in opioid prescription in primary care. PAIN. 2014;155:2575-2582.