Purdue Pharma L.P. and Geisinger Announce First Patient Enrollment in Clinical Trial Assessing Effect of Wearable Health Technology on Chronic Pain Patients
STAMFORD, Conn., and DANVILLE, Pa. – October 5, 2017 – Today Purdue Pharma L.P. and Geisinger announced that the first patient has been enrolled in its study, ‘Effect of Wearable Health Technology on the Treatment of Patients with Chronic Pain at Geisinger.’
The study is designed to demonstrate how the use of wearable health technology by chronic pain patients treated at a specialty clinic may improve both patient and healthcare system outcomes.
This prospective, non-randomized, non-blinded trial with historic and concurrent controls will assess the effect of the addition of wearable health technology on patient and health system outcomes in approximately 240 multidisciplinary pain-program patients being treated in the Geisinger healthcare system. The wearable health technology includes an Apple Watch that will measure physical activity, patient-reported pain, disability, sleep quality, depression, medication use and heart rate, and will guide the patient toward non-pharmaceutical treatment alternatives such as stretching, mindfulness and thermotherapy. The Apple Watch will include a pain app developed for this study, a healthcare provider dashboard, and will integrate with Geisinger’s electronic medical record.
“The goal of this technology is to improve patient function and quality of life while reducing the need for analgesic medications. It provides objective measures of numerous aspects of pain, function and treatment effectiveness so that information can be gathered for the patient and the healthcare provider in between visits,” said Dr. Tracy Mayne, Head of Medical Affairs Strategic Research, Purdue Pharma L.P. “We are pleased to partner with Geisinger on this important initiative and believe real-time data may have the potential to support an improved understanding of chronic pain patients’ experiences and needs.”
When integrated with an expert-directed intervention program like a multidisciplinary pain program, wearable health technology can help drive successful patient behavior change and provide more comprehensive management of chronic disease states.1 It can also provide real-time data, allowing a healthcare provider to offer proactive care. Wearable health technology is currently being used in a variety of applications in diabetes (smart-phone connected continuous glucose monitors, pumps and pens).2 Additionally, a recent study in osteoarthritis of the knee found wearable health technology has been effective in improving mobility among patients with knee osteoarthritis through use of a smartphone application and wearable activity monitor.3
“We are incorporating advanced technology into the traditional healthcare setting to redirect and empower the patient to take more control of their own well-being. The proposed multi-level integrated platform will facilitate and accelerate the speed of communication between the patient and healthcare providers, thereby allowing quicker patient access to appropriate care,” said John J. Han, M.D., director, Department of Pain Medicine, Geisinger. “Furthermore, it is hoped providing more education as well as alternative, non-opioid treatment options and coaching to promote a long-term sustainable healthy lifestyle will improve patient function and quality of life.”
About the Wearable Health Technology (WHT) Study
The study will assess whether the addition of WHT for multidisciplinary pain program (MPP) patients has an impact on three primary clinical endpoints: pain scores, medical depression scores and a reduction in use of pain medication. A secondary clinical endpoint, difference in the change in physical function/disability over time, was also established. The study will also examine exploratory endpoints related to a difference in change in healthcare resource utilization and costs.
A secondary study aim will be to assess whether patients with WHT in the MPP program experience statistically significant improvements over time related to: sleep (number of hours and number of restful hours), activity level (steps, minutes of exercise) and daily pain scores.
The 12-month study will enroll 240 adult (≥18 to <76 years) chronic pain patients admitted to the MPP from October 5, 2017 to October 5, 2018 who consent to participate in the study. Two control groups will also be established:
- MPM control group: Approximately 240 patients from MPM clinics within Geisinger during the same 12‑month period.
- Historic MPP control group: Approximately 150 subjects who completed the MPP before the start of this study.
The study protocol (NCT03299556) is on clinicaltrials.gov and available at this link.
Geisinger is an integrated health services organization widely recognized for its innovative use of the electronic health record and the development of innovative care delivery models such as ProvenHealth Navigator®, ProvenCare® and ProvenExperience®. As one of the nation’s largest health service organizations, Geisinger serves more than 3 million residents throughout 45 counties in central, south-central and northeast Pennsylvania, and also in southern New Jersey at AtlantiCare, a Malcolm Baldrige National Quality Award recipient. In 2017, the Geisinger Commonwealth School of Medicine and Geisinger Jersey Shore Hospital became the newest members of the Geisinger Family. The physician-led system is comprised of approximately 30,000 employees, including nearly 1,600 employed physicians, 13 hospital campuses, two research centers, and a 583,000-member health plan, all of which leverage an estimated $12.7 billion positive impact on the Pennsylvania and New Jersey economies. Geisinger has repeatedly garnered national accolades for integration, quality and service. In addition to fulfilling its patient care mission, Geisinger has a long-standing commitment to medical education, research and community service. For more information, visit www.geisinger.org, or connect with us on Facebook, Instagram, LinkedIn, and Twitter.
About Purdue Pharma L.P.
Purdue Pharma L.P. is a privately held pharmaceutical company headquartered in Stamford, Conn. Purdue Pharma is part of a network of independent associated companies dedicated to providing patients and providers with innovative medicines. The company’s leadership and employees are committed to serving healthcare professionals, patients and caregivers quality products and educational resources that make a positive impact on healthcare — and on lives. For more information, please visit www.purduepharma.com.
Purdue Pharma L.P.
- Ajami S, Teimouri F. Features and application of wearable biosensors in medical care. J Res Med Sci. 2015; 20(12): 1208–1215.
- Heintzman ND. A digital ecosystem of diabetes data and technology: services, systems, and tools enabled by wearables, sensors, and apps. J Diabetes Sci Technol. 2015;10:35-41.
- Skrepnik N, Spitzer A, Altman R, Hoekstra J, Stewart J, Toselli R. Assessing the impact of a novel smartphone application compared with standard follow-up on mobility of patients with knee osteoarthritis following treatment with hylan G-F 20: a randomized controlled trial. JMIR Mhealth Uhealth. 2017;5:e64.