UControlPain App (This is the Official IRB Title)

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.