Lynn R. Webster, MD
Chief Medical Officer
PainScript
Salt Lake City, Utah
Scott Cashon, Scientists
CTO
PainScript
North Potomac, Maryland
Jeff Gudin, MD
Professor, Consultant
U of Miami Dept Anesthesiology, Periop Med and Pain Mangement
Miami, Florida
Charles E. Argoff, MD
Pain Medicine Specialist
Albany Medical Center
Albany Medical Center
Albany, New York
Mobile Health Technology & Pain Management
Purpose:
Chronic pain imposes a significant burden on individuals and society. Patient adherence is important for safety and treatment effectiveness. Like many chronic illnesses, more frequent Health Care Professional (HCP) interaction with chronic pain patients would benefit the provider’s ability to monitor treatment response to enhance patient safety as well as the efficacy of the treatment. Unfortunately, practical and payor limitations limit this approach, with much care reliant on delayed visits or suboptimal communication through telephone messages. This operational issue/work-flow problem leads to delayed care and unreported changes in clinical status especially including adverse events. In addition, documentation is lacking to justify the need for intervention or prescription changes with opioids as well as other medications. Current health record practices reduce the ability to track clinical data outside of direct face-to-face care, resulting in insufficient documented evidence to support practice treatment decisions and potentially provide litigation protection.
A mobile health (mHealth) technology platform has been developed (PainScript) that enhances communication between clinic staff and patients to improve outcomes. The PainScript platform is innovative in its focus on physician practice management, providing a patient-monitoring capability to support adherence with treatments (pharmacologic and nonpharmacologic) and provide early detection of adverse/serious adverse events.
An mHealth intervention is particularly timely now that the Covid-19 pandemic has increased telehealth utilization, changing the delivery of healthcare. Telehealth is a new and proven communication approach, focused on clinical information for improving care; different modalities, recognized by the AMA CPT, include remote Patient Monitoring (RPM), Digital Evaluation & Management (D E&M), Chronic Care Management (CCM), and Remote Therapeutic Monitoring (RTM). Specific examples identified for medication management include clinical questioning, dynamic text messages, smart pill containers/dispensers,1 interactive mobile apps,2 and support over the phone.
The majority of pain apps introduced in recent years have focused on the physical characteristics of pain, and few have supported clinician or staff access to real-time pain data and patient adherence.3 Furthermore, few available mHealth products for patients with chronic pain have the clinical evidence of improved patient outcomes needed for mHealth adoption and engagement. Here we review the PainScript platform as evaluated by clinicians and patients with chronic pain.
Methods:
The PainScript patient app provides a HIPAA-compliant and accessible connection between patients and providers. It is integrated into the practice electronic health record (EHR). Patients are enrolled using a smartphone and a digital telehealth app. Once enrolled, patients will provide clinical information, guided by their physician through text messaging, with 3 daily clinically validated questions. The platform is also able to send patients medication reminders and assesses side effects and changes in clinically important measures of outcome. The responses to the questions are then reviewed by the practice via a secure HIPAA-compliant private clinical dashboard. A designated qualified healthcare provider evaluates the triaged responses which lie outside the normative range set by the provider. If required, the results will be elevated to the appropriate level of provider for decision making.
Medication adherence is self-assessed by patients reporting metrics such as when they (1) take all meds as prescribed and (2) are not taking meds that are not prescribed. Assessment questions, direct and indirect, occur on a 14-day cycle to limit repetition of questions yet recur frequently enough to allow for sufficient sampling of clinical measurements. By the end of each 14-day cycle, the proposed National Chronic Pain Surveillance questions may also be covered.
Data collection began in November 2021 and has continued to the present. In this Abstract, all patients were reviewed for clinical responses over their first 12 weeks on the system. Note that regardless of when an individual response was collected, the data normalizes to when the patient answered the question relative to when they enrolled (for example, all Pain Scale answers from the first 2 weeks, week 3, week 4, etc.). We report here on experiences and data analysis from the platform.
Results:
Through June 30, 2022, patients provided more than 55,000 individual daily clinical responses to their physicians in diverse locations across the United States.
Based on initial observational data across all those patients from baseline through 12 weeks on the PainScript platform, there was a 5.5% improvement in average reported levels of pain, 13% improvement in reported levels of fatigue, 17% improvement in reported levels of depression, 28% improvement in reported levels of anxiety, and 28% improvement reported levels of cravings. No patient data was excluded from the observation. Through 12 weeks, patients achieved a 99.8% adherence to their prescribed medication regime – including taking/not taking prescription and non-prescription medications as directed.
In nine previous peer-reviewed and published trials, almost all co-funded by the NIH or NIMH, of the PainScript Medi-eXpert system (2003 -2016), Care Plan Adherence results are as follows: 98% satisfaction among caregivers, 95% care plan adherence rate in patients with heart disease (p=0.002), 90% care plan adherence rate in senior citizens with diabetes, heart failure and fifth- and sixth-grade education levels, and 92% care plan adherence rates in patients with diabetes HbA1c, which was reduced by 8.5% in three months (p< 0.002). In addition, medication adherence results are as follows: 94% medication adherence rate in patients with heart disease, 89% medication adherence rate in patients with HIV, substance-use disorder (SUD), mental illnesses, and homelessness, and 95% medication adherence rate in patients with schizophrenia.
Conclusion:
The modernization of healthcare will be equally important to all clinicians, especially those who treat patients with chronic pain. Preliminary data suggests that PainScript telehealth technology can improve patient care, treatment plan adherence, and medication adherence. The platform bridges a treatment gap that occurs between visits and has been shown to improve clinically important outcomes. Improving physician-patient communication and patient monitoring may reduce the risk of opioid misuse and addiction and provide clinicians with information that can help differentiate addiction from tolerance and physical dependence.4 It may also provide the practice a means to be compensated by the Centers for Medicare & Medicaid Services and many other payors for the time and expertise of providing daily contact with patients, as well as safeguard against legal liability due to enhanced communication and affirmative documentation.
References: 1. Schuman-Olivier Z, Borodovsky JT, Steinkamp J, et al. MySafeRx: a mobile technology platform integrating motivational coaching, adherence monitoring, and electronic pill dispensing for enhancing buprenorphine/naloxone adherence during opioid use disorder treatment: a pilot study. Addict Sci Clin Pract. 2018;13(1):21. doi:10.1186/s13722-018-0122-4
2. Guarino H, Acosta M, Marsch LA, Xie H, Aponte-Melendez Y. A mixed-methods evaluation of the feasibility, acceptability, and preliminary efficacy of a mobile intervention for methadone maintenance clients. Psychol Addict Behav. 2016;30(1):1-11. doi:10.1037/adb0000128
3. Zhao P, Yoo I, Lancey R, Varghese E. Mobile applications for pain management: an app analysis for clinical usage. BMC Medical Informatics and Decision Making. 2019;19(1):106. doi:10.1186/s12911-019-0827-7
4. Volkow ND, McLellan AT. Opioid Abuse in Chronic Pain — Misconceptions and Mitigation Strategies. New England Journal of Medicine. 2016;374(13):1253-1263. doi:10.1056/NEJMra1507771