Efficiency And Quality In Post-Surgical Pain Therapy After Discharge

NCT05221866 | Completed Results DMC

• 1 other identifier: 0724-21-FB
• Study Type: interventional
• Target: 711
• Locations: 1 country
• Sites: 1

Brief Summary

Following inpatient surgery, more than 80% of patients are prescribed opioids for use after discharge, yet up to 90% of patients report leftover opioids, and only 16% maximize non-opioid therapy. The proposed study seeks to test a provider-facing decision support tool and a participant-facing smartphone app to reduce the amount of opioids prescribed and taken following discharge, while ensuring effective treatment of pain after surgery. Adult participants with smart phones having had inpatient surgery requiring at least over-night hospitalization with anticipated discharge to home will be randomized to one of the two groups. Study measurements will include self-reported cumulative amounts of opioids taken after discharge, non-opioid analgesic taken, prescribed post-discharge opioid doses in morphine milligram equivalents (MME), pain intensity and pain interference scores (PROMIS), need for additional opioid prescriptions within one-month post-discharge, as well as any self-reported disposal of leftover medications.

Conditions

Opioid Use; Opioid Dependence; Opioid Misuse; Post-Surgical Complication

Outcome Measures

Primary Outcomes (1)

• Cumulative Weekly Opioid Intake After Discharge

  Opioids reported as taken will be recorded by type of opioid, units, and total amount taken within the first 28 days after hospital discharge. To account for different opioid potencies, the cumulative dose of opioids will be expressed in milligram morphine equivalents (MME).

  Baseline (discharge), weekly for four weeks

Secondary Outcomes (5)

• Pain Assessment-Pain Intensity

  Weekly for four weeks after discharge

• Pain Assessment-Pain Interference

  Weekly for four weeks after discharge

• Opioid Prescription Amount in Morphine Milligram Equivalents on Day of Discharge

  Baseline (discharge)

• Number of Participants With Opioids Prescribed From "Day of Discharge + 1" Until 28 Days After Discharge

  Baseline (discharge) +1 day until day 28, up to 27 days total

• Number of Participants Who Disposed of Opioids

  Baseline (discharge), weekly for four weeks

Study Arms (4)

UControlPain App With Only Data Collection Function (Control)

NO INTERVENTION

UControlPain App with only data collection function. No provider-facing prescription intervention.

UControlPain Educational App Only

ACTIVE COMPARATOR

UControlPain app with education components. No provider-facing prescription intervention.

Behavioral: Empowering Patient to Steer Their Pain Management After Surgery

UControlPain App and Provider Facing Tool

ACTIVE COMPARATOR

UControlPain app with education components and provider-facing prescription intervention. Once half of the subjects are enrolled, the provider-facing tool will be turned on. Participants will be masked to when the provider-facing tool is activated.

Behavioral: Empowering Patient to Steer Their Pain Management After Surgery; Behavioral: Provider-facing Prescription Aid

Provider Facing Tool Only

ACTIVE COMPARATOR

UControlPain App with only data collection function. Provider-facing prescription intervention. Once half of the subjects are enrolled, the provider-facing tool will be turned on. Participants will be masked to when the provider-facing tool is activated.

Behavioral: Provider-facing Prescription Aid

Interventions

Empowering Patient to Steer Their Pain Management After Surgery BEHAVIORAL

Participants will be randomized to receive the consumer health informatics app (UControlPain) versus an app with only data collection function (no educational components) in an intent-to-treat design. Randomization will be implemented via REDCap by the study coordinators so that all investigators will remain blind to group assignment. Further, information on which type of app was installed will not be shared with providers or participants.

UControlPain App and Provider Facing Tool; UControlPain Educational App Only

Provider-facing Prescription Aid BEHAVIORAL

Providers will be given information to inform a participant-centered post-discharge pain management plan. This tool will be activated once half the subjects are enrolled. Participants will be masked when the provider-facing tool is turned on.

Provider Facing Tool Only; UControlPain App and Provider Facing Tool

Eligibility Criteria

• Age: 19 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Access to a smartphone (iOS or Android)
• Inpatient surgery requiring at least over-night hospitalization and anticipated discharge to home

You may not qualify if:

• Re-hospitalization within 30 days
• Pregnant
• Unable to read the English language
• Discharge to a post-acute care facility
• Contraindications to opioids, acetaminophen, or NSAIDs
• Long-term opioid therapy (AHRQ definition - opioid use on most days \>3 months) prior to surgery

Sponsors & Collaborators

• University of Nebraska: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

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MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Karsten Bartels
• Organization: University of Nebraska Medical Center

anesthesiology.research@unmc.edu

402-559-4081

Study Officials

• Karsten Bartels, MD, PhD, MBA

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomization to the participant facing app will be implemented via REDCap. There will be no randomization in regard to the provider-facing intervention.The provider-facing intervention will be turned on once half the subjects are enrolled.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participant-facing app will be trialed prior to and after implementation of a provider-facing prescription intervention using a 2x2 design. Four arms will be described: the UControlPain App with Only data collection, the UControlPain Educational app only, the UControlPain App and provider-facing tool, and the UControlPain App with only data collection function and provider-facing tool. Once half of the subjects are enrolled, the provider-facing tool will be turned on.

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: February 3, 2022
• Study Start: May 2, 2022
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2023
• Last Updated: July 1, 2025
• Results First Posted: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)