Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System

Study Overview
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Brief Summary
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This is a proof of concept study to measure the effect of Wearable Health Technology (WHT), including the Apple Watch, iPhone, Pain App and Provider Dashboards on important clinical outcomes in patients treated for chronic pain. WHT will be tested in a group of chronic pain patients treated at a specialty pain clinic, the Geisinger Multidisciplinary Pain Program (MPP). Primary and secondary outcomes include pain, physical function, depression, pain medicine use, amount of sleep, activity levels, healthcare resource utilization and cost. The WHT will collect self-reported data on pain, pain management therapies, and medication utilization, and passively collected data on subject activity levels and sleep. Additional data will be collected on device utilization by patients and health care professionals.

Detailed Description
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This is a prospective, non-randomized, non-blinded trial with historic and concurrent controls to assess the effect of the addition of WHT on patient and health system outcomes. WHT used in this study are the Apple Watch and iPhone, a pain application (Pain App) designed specifically for this study to be used with the watch and phone, and physician and patient dashboards also designed for this study to provide subjects and health care providers data displays of information captured by the WHT. The WHT will consist of: AppleWatch and iPhone Patient and provider tracking of patient-reported pain, pain management, medication usage, functionality, depression, activity and sleep (measured by 3 axis actigraph) Prompts to subjects to engage in self-care, including non-pharmaceutical pain management therapies consistent with MPP training Subjects will use the WHT 20 hours per day, every day for a period of 12 months. Subjects will attend study visits at baseline and months 2, 4, 6, 8, 10 and 12. Outcome data for control groups will be collected retrospectively from the electronic health record (EHR). Assessments will have occurred as part of their standard of care.

Official Title
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Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: WHT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admission to the MPP Completion of the 3-day MPP training Ability to understand and complete the informed consent form prior to the initiation of any study procedures Adequate motor skills needed to utilize WHT Willingness to utilize personal electronic devices and WHT, as expressed and documented during the informed consenting process Ability to understand spoken and written English Exclusion Criteria: Cancer diagnosis, AIDS, end-stage liver disease or end-stage renal disease Hospitalization >30 days during the 12 months prior to Index Date Nursing home or hospice care during the 12 months prior to Index Date Presence of an EHR Diagnosis description OPT-OUT CENTER RESEARCH which indicates the subject has opted out of (i.e., does not wish to be included in) any Geisinger retrospective research Has a terminated Medicine Use Agreement on their Problem List, indicator for substance abuse/dependence

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| WHT<br>The WHT group includes only patients newly enrolled in the Geisinger MPP program who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up. | Other: WHT<br>* Incorporating WHT into treatment for chronic pain. WHT includes patient and provider tracking of patient-reported pain, pain management, medication usage, functionality, depression, activity and sleep (measured by 3 axis actigraph); as well as prompts to subjects to engage in self-care, including non-pharmaceutical pain management therapies consistent with MPP training.<br>|
| Historic Control<br>Patients who were enrolled in the MPP in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment. | |
| Concurrent Control<br>Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Pain Score (NPS) | self reported 11-point pain scale | 12 months | 
| Patient Health Questionnaire (PHQ-9) | self reported measurement of depression | 12 months | 
| Mean daily morphine equivalents (MEQs) | calculated from health records, average amount of daily pain medication | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) | self reported measure of functionality, related to back and neck pain | 12 months | 
| Healthcare resource utilization | number of hospitalizations, emergency department visits, outpatient visits, rehabilitation visits, and pharmacy/medication orders | 6 months before WHT-use compared to months 7-12 post WHT-use | 
| Direct medical costs | total costs, and costs related to inpatient, outpatient, rehabilitation, and pharmacy | 6 months before WHT-use compared to months 7-12 post WHT-use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wearable Health Technology, iPhone, Apple Watch, Pain Medication