Efficiency And Quality In Post-Surgical Pain Therapy After Discharge

Not Applicable

Completed

• Conditions: Opioid Use; Post-Surgical Complication; Opioid Dependence; Opioid Misuse
• Interventions: Behavioral: Empowering patient to steer their pain management after surgery; Behavioral: Provider-facing prescription aid

• 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 research seeks to test a provider-facing decision support tool and a patient-facing smartphone app to reduce the amounts of opioids prescribed and taken following discharge, while ensuring effective treatment of pain after surgery.

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, patients 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 patients.

Study Timeline

• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-02-03
• Study Start: 2022-03-14
• Status Verified: 2023-12
• Primary Completion: 2023-12-10
• Study Completion: 2023-12-10
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 711

Inclusion Criteria

1. >19-89 years old
2. Access to a smartphone (iOS or Android)
3. inpatient surgery requiring at least over-night hospitalization with anticipated discharge to home

Exclusion Criteria

1. Patients re-hospitalized within 30 days of previous hospitalization
2. Pregnant patients
3. Patients not able to read the English language
4. Patients discharged to a post-acute care facility
5. Patients with contraindications to opioids, acetaminophen, or NSAIDs
6. Patients meeting the AHRQ definition of long-term opioid therapy (opioid use on most days >3 months) prior to surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
UControlPain app AND provider facing tool	Provider-facing prescription aid	UControlPain app with education components and provider-facing prescription intervention.
UControlPain educational app only	Empowering patient to steer their pain management after surgery	UControlPain app with education components. No provider-facing prescription intervention.
UControlPain app AND provider facing tool	Empowering patient to steer their pain management after surgery	UControlPain app with education components and provider-facing prescription intervention.
Provider facing tool only	Provider-facing prescription aid	UControlPain App with only data collection function. Provider-facing prescription intervention.

Primary Outcome Measures

Name	Time	Method
Cumulative weekly opioid intake after discharge	4 weeks	Opioids reported taken will be recorded by type of opioid, unit, and total amount taken within the first 4 weeks 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 Interference	4 Weeks	The Patient-Reported Outcomes Measurement Information System (PROMIS) will be used to measure pain interference. On the PROMIS 4-item scale pain interference scores, higher scores indicating higher pain interference. All PROMIS scores are analyzed as standardized T-scores (mean=50, SD=10).
Opioid prescription on day of discharge	4 Weeks	Opioids prescribed 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.
Opioid disposal	4 Weeks	Method of disposal of any left-over opioids (if applicable)
Pain Assessment-Pain Intensity	4 weeks	The Patient-Reported Outcomes Measurement Information System (PROMIS) will be used to measure pain intensity. On the PROMIS 4-item scale pain intensity scores, higher scores indicating higher pain intensity. All PROMIS scores are analyzed as standardized T-scores (mean=50, SD=10).
Opioids prescribed from "day of discharge + 1" until 28 days after discharge	4 Weeks	To 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 dis-charge.

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States