Efficiency And Quality In Post-Surgical Pain Therapy After Discharge

NCT05221866 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 711

Last updated 2025-07-01

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED
  • University of Nebraska

    lead OTHER

Principal Investigators

  • Karsten Bartels, MD, PhD, MBA · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
19 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-02
Primary Completion
2023-12-10
Completion
2023-12-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05221866 on ClinicalTrials.gov