UControlPain App (This is the Official IRB Title)

NCT ID: NCT03833648

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-19
• Study Completion Date: 2020-04-20

Brief 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.

Conditions

Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Arm 1 - Usual Care

No intervention, patients will receive treatment as usual. Patients will download the UControl Pain app on their personal cell phones and will complete the four study surveys via the app or via REDCap.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm 2 - UControl Pain App with Education

Patients will install the UControl Pain app on their personal cell phones. The app will include educational information about pain management, e.g., using acetaminophen and NSAIDs for pain, as well as information on addiction and safe storage of medications. Subjects will also complete the four study surveys via the app or via REDCap.

Group Type: EXPERIMENTAL

UControl Pain App with Education

Intervention Type: OTHER

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.

Interventions

UControl Pain App with Education

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

We will study up to 120 adult surgical patients, with the aim of having usable data from at least 90 patients.

Inclusion Criteria: 1) Patients ages 18-89 undergoing inpatient surgery at the University of Colorado Hospital are eligible. 2) Technical capacity and willingness to use and download the UControlPain app on their personal cell phone.

Exclusion Criteria: 1) Patients under the age of 18 years, 2) Patients returning to institutional settings (e.g. prison, jail, mental health facility), 3) Pregnant women, 4) Decisionally challenged patients, 5) Blind or illiterate patients, and 6) Medical contraindications to use of opioids, acetaminophen, or NSAIDs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karsten Bartels, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CU Anschutz Medical Campus

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Countries

United States

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Other Identifiers

18-1118

Identifier Type: -

Identifier Source: org_study_id