UControlPain App (This is the Official IRB Title)
Condition: Opioid Use
Study type: Interventional

Summary: 
      It is estimated that 77% of all Americans own a smartphone and the use of health apps has
      doubled in the last two years. Consistent with this development, over half of US smartphone
      owners have downloaded a health-related mobile app. While patient engagement is an integral
      and well-established component of in-hospital Early Recovery After Surgery (ERAS) programs
      that drive improved perioperative outcomes, efforts to support such engagement are often
      limited to a patient's hospital stay. The objective of this aim is to empower patients to
      control their use of pain medications after surgery in a safe and effective fashion using a
      novel and innovative consumer health informatics app: UControlPain. This app will be
      leveraged to integrate three critical components of the study into one application: First,
      study recruitment and consent documentation. Second, application of the intervention engaging
      patients to take control of their pain management after discharge. Lastly, UControlPain will
      collect relevant patient outcomes including pain assessments, functional status, and
      quantification of opioid and non-opioid analgesic medication intake. Use of the app will
      reduce the amount of opioid medication required, while enhancing patient post-operative pain
      control by maximizing non-opioid therapy. Subjects will be able to employ flexible non-opioid
      therapy with acetaminophen and NSAIDs whenever possible and safe. The rationale is that
      testing of such a provider-prescribed consumer health informatics app (UControlPain) will lay
      the groundwork to scale this project towards more secure and efficient pain management
      practices after surgery on a systems level and beyond. Upon completion, the expectation is to
      have developed an effective consumer health informatics app to help patients better manage
      their post-surgical pain at home, reduce reliance on opioids, and improve opioid safety
      through enhanced storage and disposal behaviors.
    

Detailed description: 
      Prescription opioid overdose has emerged as a leading cause of death in the general
      population. Opioid-based therapy represents a corner-stone of post-operative pain management.
      With increasing emphasis on robust pain therapy, sales of opioid medications have increased.
      Parallel to this rise, opioid-associated deaths have also increased. Over-prescribed opioids
      after surgery can create a reservoir of opioids that become available for non-medical use.
      Effective strategies to maximize non-opioid pain therapy and to limit such a reservoir are
      lacking. Thus, there is an urgent need to individualize post-operative pain therapy and
      reduce reliance on opioids.

      Preliminary data indicate that postsurgical patients are prescribed combination preparations
      (opioid+acetaminophen) in 96% of cases. Opioid+acetaminophen combination products have
      received scrutiny from the FDA for causing liver injury from unintentional overdose when
      combined with additional over-the-counter (OTC) acetaminophen. If postoperative patients are
      prescribed opioid-only products, they can safely use OTC acetaminophen in addition to NSAIDs,
      e.g. ibuprofen, in a highly effective fashion. Such an Alternatives to Opioids (ALTO)-based
      approach can reduce the need for opioids while ensuring pain control and limiting
      opioid-associated side effects. A barrier to utilizing an ALTO-based approach is lack of
      patient knowledge on appropriate use and timing of drugs such as acetaminophen, especially
      when used in combination with other analgesics. Internet-based applications have been
      successfully used for substance use disorder treatment adherence. Importantly, patient-based
      interventions to improve adherence are especially effective in the first six weeks, yielding
      up to five-fold improvement in compliance. While consumer health informatics applications
      have been successfully tested to improve adherence for anti-depressants and diabetic
      medications such an approach has not yet been evaluated for perioperative pain therapy. Data
      from an ongoing observational study assessing pain outcomes and patient-reported pain
      medication intake after hospital discharge support the assumption that effective combinations
      of non-opioid pain medications (ALTO) are underutilized.

      The study is using an investigator engineered a functioning prototype of a consumer health
      informatics app: UControlPain. This study is a randomized controlled pilot trial of this
      consumer health informatics app, to test its effect on pain outcomes, analgesic medication
      requirements, and patient functional outcomes. For this study, the UControlPain will be
      introduced to hospitalized patients after surgery.

      Patients will be approached regarding interest in the study prior to hospital discharge. A
      trained member of the research team will explain the study to prospective participants. If
      the patient is interested in participation the consent will be reviewed with the patient and
      the study team will answer any questions the patient may have. Then the study staff will
      assist the patient in downloading the UControlPain app. The study patient will be provided
      with a hard copy of the consent/HIPAA form.

      Demographics and the best contact information will be collected from those enrolled patients
      who indicate they are interested in completing the surveys after their hospital discharge.
      Patients will be randomized to one of two conditions: 1) usual care versus 2) provision of
      the provider-prescribed education/tool part of the consumer health informatics app
      (UControlPain) using a random electronic 1:1 allocation scheme. If indicated and approved by
      the provider, opioid-only prescriptions will be written for opioid-based analgesia in both
      groups. Final dosing decisions and drug choices will remain at the discretion of the treating
      provider and nursing staff administering medications. While hospitalized patients will also
      be prompted to do a 6-minute walk test and measure the number of steps taken within 24 hours
      (if cleared by Physical Therapy to walk without assistance). These functional assessments
      will be performed daily while hospitalized and weekly for 4 weeks after discharge.

      One week after hospital discharge interested patients with be contacted and asked to complete
      the first of four surveys. All communication will be available in English. Patients will be
      paid with a $5 gift card or money order equivalent to complete the study assessments within
      the app or with an online link.

      UControlPain will provide general education on how to properly use ALTO, e.g.,
      over-the-counter medications before using opioids in patients where providers have not
      identified contraindications to such medications (e.g. acetaminophen and non-steroidal
      anti-inflammatory drugs). Other educational information presented in this part of the app
      will include information on safe-storage, signs of overdose, and resources for patients who
      are concerned about becoming addicted. The survey part of the study consists of a brief
      questionnaire asking about pain management following hospital discharge that will be sent out
      weekly x 4 starting one week after hospital discharge.
    

Intervention name(s): UControl Pain App with Education
Intervention type(s): Other
Intervention description(s): The intervention will include educational information on pain management, e.g., using acetaminophen and NSAIDs to manage pain, as well as information on addiction and safe storage of medications.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to one of two conditions: 1) usual care versus 2) provision of the provider-prescribed education/tool part of the consumer health informatics app (UControlPain) using a random electronic 1:1 allocation scheme.
Masking: Single (Participant)
Primary purpose: Other