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Completed

NCT Number: NCT05221866

Efficiency And Quality In Post-Surgical Pain Therapy After Discharge

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.

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Key information

Conditions

Opioid Use Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Dependence Opioid Misuse Opioid-Related Disorders Post-Surgical Complication Substance-Related Disorders

Age range

19 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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].

  2. 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].

  3. 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).

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Acronym: EQUIPPED

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2022
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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