Self-reported Usage Patterns of Opioid Analgesic Medications After Surgery

Completed

• Conditions: Opioid Use
• Interventions: Other: Not applicable - no intervention

• Registration Number: NCT03034278
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The primary objective of this study is to better understand post-discharge utilization of prescribed opioid analgesic medications following surgery. A secondary objective of this study is to gain a better understanding of prevailing modes of storage for opioid medications.

Detailed Description

Hypothesis:

Prescription of medications for analgesia after surgery frequently occurs on an empiric rather than individualized basis. The investigator will hypothesize that prescribed opioid medications for analgesia after discharge from the hospital / surgery center are frequently not taken.

Aims:

i) The descriptive first aim of this study is to define self-reported usage patterns of opioid analgesic medications at home following surgery.

ii) The descriptive second aim of this study is to define prevailing modes of storage and/or disposal for opioid medications prescribed to patients after hospital discharge following surgery.

iii) The analytical second aim of this study is to characterize patients who do not take significant amounts of their prescribed opioid medications.

Background \& Exploratory Objective (s):

Accidents (unintentional injuries) were the 5th leading cause of death among the general population in the United States in 2010. Among persons 1-44 years of age accidents represented the leading cause of death. And, within this group, pharmaceuticals were the #1 course of death. Of the 22,134 medication associated deaths in 2010, 75.2% included opioid analgesics. The trajectory of this development is alarming: Deaths from prescription opioid overdoses have more than tripled in recent years. Of special concern is that children are especially vulnerable to unintentional medication overdosing, accounting for 71,224 annual emergency room visits for this reason from 2004-2005 alone. In addition to the individual burden from morbidity and mortality, the costs of prescription opioid abuse to society are immense: The average health care costs for patients abusing opioids are 8 times higher than for non-abusers. In the United States alone, $55.7 billion were spent on sequelae in the workplace and in healthcare costs. Accordingly, prescription drug overdosing has been coined "An American Epidemic" and increasing resources to tackle this rapidly growing public health problem have been made available on a national (National Institutes of Health, U.S. Food and Drug Administration) and the state level as part of the Colorado Consortium for Prescription Drug Abuse created through Governor Hickenlooper's efforts with the National Governors Association.

Additionally, the prescription of opioids following surgery usually occurs using a "one size fits all approach", leading potentially to many unused opioids that are then likely to be utilized in a fashion unintended by prescribing clinician.

The goal of the proposed study is to assess self-reported intake relative to prescribed amounts of analgesic medications after surgery. Better knowledge of this relationship will permit the design of tools to individualize analgesic pharmacotherapy after hospital discharge. The goal is to reduce the amount of opioid prescriptions that are not needed and to improve non-opioid analgesia.

These data will inform future studies to design more patient-centered opioid prescribing tools, which are based on anticipated need. This will likely decrease the amounts of prescribed opioids that are available for non-medical use. Future studies will be aimed to standardize their use to provide improved analgesia upon discharge following surgery.

Study Timeline

• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-27
• Study Start: 2017-02-03
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 785

Inclusion Criteria

Adult patients undergoing:

• Cesarean section,
• Gastrointestinal surgery, or
• Thoracic surgery.

Exclusion Criteria

• Patients under the age of 18 years of age,
• Patients known or suspected to be pregnant at the time of discharge,
• Patients that are prisoners,
• Patients that are decisionally challenged,
• Patients that are blind, and
• Patients that are illiterate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post surgery patients	Not applicable - no intervention	Patients prescribed with opioid analgesic medications following surgery.

Primary Outcome Measures

Name	Time	Method
Ratio of patient-reported intake of oral opioids to prescribed amount of oral opioid medications	4 weeks after hospital discharge date.	A self-report survey will assess opioid medication use in surgical patients during the 4 weeks following hospital discharge.

Secondary Outcome Measures

Name	Time	Method
Storage of opioid medication in surgical patients after hospital discharge	4 weeks after hospital discharge date.	A self-report survey will assess storage of opioid medication in surgical patients up to 4 weeks after discharge from the hospital.

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States