UControlPain App (This is the Official IRB Title)

NCT03833648 | Completed

• 1 other identifier: 18-1118
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• Mean Post-Discharge Opioid Intake at 4 weeks post-discharge (total)

  Milligram morphine equivalent (MME)

  Four weeks after hospital discharge, as reported on the surveys completed by the patient.

Secondary Outcomes (18)

• 6-minute Walk Test - Week 1

  One week after hospital discharge

• 6-minute Walk Test - Week 2

  Two weeks after hospital discharge

• 6-minute Walk Test - Week 3

  Three weeks after hospital discharge

• 6-minute Walk Test - Week 4

  Four weeks after hospital discharge

• In-Hospital Opioid Milligram Morphine Equivalent (MME)

  24 hours prior to hospital discharge

Other Outcomes (1)

• Opioid storage and disposal

  Hospital discharge until 4 weeks after discharge

Study Arms (2)

Arm 1 - Usual Care

NO INTERVENTION

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.

Arm 2 - UControl Pain App with Education

EXPERIMENTAL

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.

Other: UControl Pain App with Education

Interventions

UControl Pain App with Education 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.

Arm 2 - UControl Pain App with Education

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (21)

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  BACKGROUND

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MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Karsten Bartels, MD, PhD

  CU Anschutz Medical Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study participants will not know which version of the app they are instructed to install.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 7, 2019
• Study Start: June 19, 2019
• Primary Completion: April 20, 2020
• Study Completion: April 20, 2020
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)