Efficiency And Quality In Post-Surgical Pain Therapy After Discharge

Not Applicable

Completed

Conditions: Opioid Use
Post-Surgical Complication
Opioid Dependence
Opioid Misuse

Registration Number: NCT05221866

Lead Sponsor: University of Nebraska

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 711

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 & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Cumulative Weekly Opioid Intake After Discharge	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 Outcome Measures

Name	Time	Method
Pain Assessment-Pain Intensity	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 \[mean=50, standard deviation (SD) =10\].
Pain Assessment-Pain Interference	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 \[mean=50, standard deviation (SD) =10\].
Opioid Prescription Amount in Morphine Milligram Equivalents on Day of Discharge	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).
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	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.
Number of Participants Who Disposed of Opioids	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.

Trial Locations

Locations (1): University of Nebraska Medical Center
🇺🇸
Omaha, Nebraska, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States