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

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.

• WHT (Other): 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.

Primary outcomes

• Numerical Pain Score (NPS) [Baseline, 12-month follow-up]: self reported 11-point pain scale. The numeric pain score (NPS) is self-reported by the patient on a scale of 0 to 10, with the following scale labels: no pain (0), mild pain (2), moderate pain (4), severe pain (6), very severe pain (8), and worst pain possible (10).
• Patient Health Questionnaire (PHQ-9) [Baseline, 12-month follow-up]: self reported measurement of depression. The scale ranges from 0 to 27, indicating the following levels of depression severity: none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).
• Mean Daily Morphine Equivalents (MEQs) [Baseline, 12-month follow-up]: calculated from health records, average amount of daily pain medication \[as measured by the daily milligrams of morphine equivalents (MME)\].

Secondary outcomes

• Oswestry Disability Index (ODI) [Baseline, 12-month follow-up]: self reported measure of functionality, related to back and neck pain. The ODI is a self-administered questionnaire assessing symptoms and severity of back or neck pain on a scale from 0 to 100. This measurement evaluates the loss of function in activities of daily living. Two ODI questionnaires were used in this study, one for neck pain and one for back pain. Interpretation of ODI scoring is as follows: minimal disability (0-20), moderate disability (21-40), severe disability (41-60), and crippled (61-80). Scores over 80 suggest the patient may be bedbound or exaggerating their symptoms and careful evaluation is recommended.

Other outcomes

• Activity Levels (WHT Group Only) [12 months]: number of daily steps as measured by WHT application. Insufficient data collected for analysis of this outcome measure.
• Sleep (WHT Group Only) [12 months]: quantity (hours) and quality as measured by WHT application. Insufficient data collected for analysis of this outcome measure.

Sex: All, ages: 18 Years to 75 Years

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

Participant flow

Outcome results

• Numerical Pain Score (NPS) (Primary), Mean, score on a scale: Wearable Health Tracker (WHT) 5.48 +/- 1.50; Historic Control (MPP) 6.50 +/- 1.57; Concurrent Control (MPM) 6.48 +/- 1.70
• Patient Health Questionnaire (PHQ-9) (Primary), Mean, score on a scale: Wearable Health Tracker (WHT) 14.07 +/- 5.65; Historic Control (MPP) 15.19 +/- 6.34; Concurrent Control (MPM) 14.63 +/- 4.90
• Mean Daily Morphine Equivalents (MEQs) (Primary), Mean, MME: Wearable Health Tracker (WHT) 51.38 +/- 44.84; Historic Control (MPP) 56.83 +/- 76.30; Concurrent Control (MPM) 43.42 +/- 68.62
• Oswestry Disability Index (ODI) (Secondary), Least squares mean, score on a scale: Wearable Health Tracker (WHT) 47.67 +/- 13.54; Historic Control (MPP) 55.05 +/- 12.43; Concurrent Control (MPM) 51.20 +/- 11.78
• Activity Levels (WHT Group Only) (Other pre specified)
• Sleep (WHT Group Only) (Other pre specified)

Adverse events

Time frame: Adverse events were collected up to 12 months for participants in the WHT group. Up to a 12-month retrospective review of AE data was performed for the patients in the MPP and MPM control groups.

• Study Protocol and Statistical Analysis Plan (PDF, 2017-09-12)

• Thomas Alfieri, PhD, Study director, Purdue Pharma LP
• John J Han, MD, Principal investigator, Geisinger Clinic