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Study to Test Efficacy of Interactive Wearable Device to Improve Pain Outcomes

November 16, 2017
Patients under treatment for chronic pain at a Geisinger multidisciplinary pain program will be followed with the aim of reducing pain by 30% by using a wearable interactive device that collects data and offers reminders.

With John J. Han, MD, and Tiziano Marovino, DT, MPH

A 12-month prospective, proof of concept study, Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System, has been launched to assess clinical outcomes of patients with chronic pain who use wearable technology devices such as the Apple Watch, iPhone apps, Pain App, and provider dashboards.1-3 

“All chronic pain patients will be candidates for this study,” said John J. Han, MD, an interventional pain management physician at the Geisinger Medical Group in Danville, Pennsylvania, “not just patients seeking relief from back and neck pain. Patients will be selected from Geisinger’s multidisciplinary pain program, which incorporates a comprehensive approach to patient care, encompassing everything that pain effects from emotional, physical and social aspects.”

“We expect patients to achieve an average 30% decrease in pain based on a visual analog pain scale.3 However, if a patient’s total pain resolves within the study timeframe, then we will continue to monitor the patient for the other outcomes, including depression, sleep, and activity levels since the long-term effects of this treatment modality on function and quality of life are just as important,” Dr. Han told Practical Pain Management.

Chronic pain patients will participate in a study to evaluate the effectiveness of lessening pain with a wearable device

Designing a Study to Track Patients Pain and Improve Outcomes

For this study, patients will receive both an Apple Watch and an iPhone that will have an interactive app on the watch designed to:

  • Gather real-time data that will be uploaded to the iPhone and subsequently moved to the Epic electronic health record system.
  • Send reminders to complete daily logs and prompts to engage in self-care, such as reminders to be more active.

In addition to the pain app, physician and patient dashboards have been developed to collect and display outcomes data captured by the patients’ wearable device for review by the patients' health care team.

“To carry out this study, we developed and seamlessly integrated an Apple watch app, the Pain app for iPhone/iPad, and interactive provider dashboard for Epic electronic health medical record system into an clinical application network system that will vastly increase quality and quantity of patients data collection, enhanced patient-provider communications, promote patient engagement, and empower patients to take more control of their well being and lead healthier lifestyle by providing education, tools, and support to individuals and their communities,” said Dr. Han.  

This observational cohort study will follow 240 patients and controls who are enrolled in a pain clinic to evaluate the effect of this wearable health technology during the next year while being treated in the Geisinger Health System.

Primary and secondary outcomes to be monitored and collected by a wearable device. Self-reported data, passive collection, and healthcare professional records will be collected as follows:

Primary outcomes:

  • Pain levels (11-point numerical pain scale)
  • Depression (patient health questionnaire)
  • Pain medication utilization (mean daily average morphine equivalents derived from health records)

Secondary outcomes:

  • Physical function (Oswestry disability index of neck and back pain)
  • Healthcare resource utilization based on 6 months prior to device use as compared with 6 months of device use, including the number of hospitalizations, and visits to the emergency department, primary care, rehabilitation, and pharmacy/medication orders placed.
  • Direct medical costs for inpatient, outpatient, rehabilitation services and prescriptions

Additional outcomes to be monitored:

  •  Sleep (quantity in hours and type measured by 3 axis actigraph)
  • Physical activity (number of steps per wearable device)

Potential Uses for Pain Management

Dr. Han offered one example for the use of this interactive app approach for patients with pain where the focus would be to reduce opioid medication consumption for breakthrough pain.  

“We designed the treatment algorithm to redirect patients to try opioid-sparing treatments first—before considering opioid medication—when they experience breakthrough pain,” said Dr. Han. When patients experience breakthrough pain, the Apple watch/iPhone app would send messages directing the patient to complete non-opioid treatment options, such as stretching, meditation, and hot/cold therapy. 

Daily and monthly trends for the breakthrough treatment options will be made readily available to patients for review and to help them modify their lifestyle patterns. 

“This information, as well as automated clinical data and other pertinent clinical information in EPIC electronic health medical record system will be automatically summarized in the interactive provider dashboard and readily available to healthcare providers who may then proactively intervene in timely manner as needed to avoid delay in the delivery of appropriate care and to prevent escalation of inappropriate use of opioid medication, as well as to promote a long-term, healthier lifestyle,” said Dr. Han.

“I foresee tremendous opportunities in the near future where this type of innovative network system may be used on all wearable devices and with electronic health medical record systems,” said Dr. Han, “and we will be able to develop the technology to reach out to communities using add-ons such as patient-to-patient, patient-community, and provider-to-population dashboards to encourage and promote sustainable, healthier lifestyle and ultimately, cost-effective improvement in function and quality of life for all patients.”

Clinical Relevance of the Study and Potential for Pain Care

"We are witnessing the tip of the iceberg with wearable device monitoring becoming much more sophisticated in terms of what can be measured," said Tiziano Marovino, DPT, MPH, DAIPM, a clinical research physical therapist and practitioner at Chronic Pain Solutions, an integrated rehabilitation center in Ypsilanti, Michigan, "and the use of wearable technology, a remote monitoring approach, is designed to provide clinical data insights into patient activity."

"In vivo studies have routinely monitored rat or porcine activity levels in highly controlled environments for researchers but human studies have lacked the ability to control the subject outside the research setting," Dr. Marovino said, "The value of wearable technology is the actionable data that it will provide. Therefore, wearable devices will presumably provide real-time insights into activity levels and sleep behaviors, two of the most important, modifiable risk factors allowing for data feedback."

"As such, the data from this study should simply confirm that people who are active and get adequate sleep will enjoy a higher quality of life, need to take less pain and other medications, utilize health care services less and evade depression," said Dr. Marovino.

"The limitation in all this will continue to be that not all people will make themselves available to this type of soft intervention," he said, "as such, it will be a challenge to make wearable technology use ubiquitous, and a standard of practice across patient populations. Perhaps insurance companies will offer an incentive (ie, premium discount) to people who use the device and share the data with their provider similar to gaining reimbursement for gym memberships or completion of a health risk assessment "

A full year is anticipated for recruitment of the study, with an estimated completion date of October 2019. 

This study is being underwritten by Purdue Pharma LP.  None of the authors indicated any direct financial conflicts.

About Geisinger

Geisinger, an integrated physician-driven health services organization, including the Geisinger Commonwealth School of Medicine and Geisinger Jersey Shore Hospital, which has been widely recognized for its innovative use of the electronic health record and the development of innovative care delivery models. Geisinger serves more than 3 million residents throughout Pennsylvania southern New Jersey across 13 hospitals, two research centers, and a health plan.

Last updated on: December 21, 2017
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