Efficiency And Quality In Post-Surgical Pain Therapy After Discharge (EQUIPPED)

June 11, 2025 updated by: University of Nebraska
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prior to discharge from the hospital, patients will be approached regarding interest in the study with an introductory letter that describes the content and purpose of the study. Following informed consent, participants will be randomized to receive the consumer health informatics app (UControlPain) versus provision of an app with only data collection function (no educational components). Randomization will be implemented via REDCap by the study coordinators. Further, information on which type of app was installed will not be shared with providers or participants.

During the second half of the trial, a provider-facing electronic decision support tool will be activated. This will create a 2:2 design to test the provider-facing tool. 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 Type

Interventional

Enrollment (Actual)

711

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 19-89 years old
  • Access to a smartphone (iOS or Android)
  • Inpatient surgery requiring at least over-night hospitalization and anticipated discharge to home

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: UControlPain App With Only Data Collection Function (Control)
UControlPain App with only data collection function. No provider-facing prescription intervention.
Active Comparator: UControlPain Educational App Only
UControlPain app with education components. No provider-facing prescription intervention.
Behavioral: Empowering Patient to Steer Their Pain Management After Surgery
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.
Active Comparator: UControlPain App and Provider Facing Tool
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
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.
Behavioral: Provider-facing Prescription Aid
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.
Active Comparator: Provider Facing Tool Only
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Weekly Opioid Intake After Discharge
Time Frame: Baseline (discharge), weekly for four weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Assessment-Pain Intensity
Time Frame: Weekly for four weeks after discharge
The Patient-Reported Outcomes Measurement Information System (PROMIS) was used to measure pain intensity, with higher scores indicating more intense pain. The PROMIS was assessed four times after discharge, once per week for 28 days, and averaged. On the PROMIS 4-item scale pain intensity scores, higher scores indicate higher pain intensity. All PROMIS scores are analyzed as standardized T-scores [mean=50, standard deviation (SD) =10].
Weekly for four weeks after discharge
Pain Assessment-Pain Interference
Time Frame: Weekly for four weeks after discharge
The Patient-Reported Outcomes Measurement Information System (PROMIS) was used to measure pain interference, with higher scores indicating more intense pain. The PROMIS was assessed four times after discharge, once per week for 28 days, and averaged. On the PROMIS 4-item scale pain interference scores, higher scores indicate higher pain interference. All PROMIS scores are analyzed as standardized T-scores [mean=50, standard deviation (SD) =10].
Weekly for four weeks after discharge
Opioid Prescription Amount in Morphine Milligram Equivalents on Day of Discharge
Time Frame: Baseline (discharge)
Opioids prescribed on the day of discharge will be recorded by type of opioid, unit dispensed, and total amount dispensed. To account for different opioid potencies, the cumulative dose of opioids will be expressed in milligram morphine equivalents (MME).
Baseline (discharge)
Number of Participants With Opioids Prescribed From "Day of Discharge + 1" Until 28 Days After Discharge
Time Frame: Baseline (discharge) +1 day until day 28, up to 27 days total
Discovered by medical record review. This measure will account for opioids prescribed to patients because they run out prematurely. We will calculate opioid prescriptions 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
Time Frame: Baseline (discharge), weekly for four weeks
Number of participants who reported their disposal of any leftover opioids is recorded. This is reported on the weekly surveys done in 28 days post-discharge.
Baseline (discharge), weekly for four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Karsten Bartels, MD, PhD, MBA, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2022

Primary Completion (Actual)

December 10, 2023

Study Completion (Actual)

December 10, 2023

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

January 21, 2022

First Posted (Actual)

February 3, 2022

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 11, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0724-21-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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