Self-reported Usage Patterns of Opioid Analgesic Medications After Surgery
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|ClinicalTrials.gov Identifier: NCT03034278|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2017
Last Update Posted : April 4, 2019
|Condition or disease||Intervention/treatment|
|Opioid Use||Other: Not applicable - no intervention|
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.
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 Type :||Observational|
|Actual Enrollment :||785 participants|
|Official Title:||Improving Opioid Prescription Safety After Surgery|
|Actual Study Start Date :||February 3, 2017|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Post surgery patients
Patients prescribed with opioid analgesic medications following surgery.
Other: Not applicable - no intervention
Not applicable - no intervention, observational survey study.
- Ratio of patient-reported intake of oral opioids to prescribed amount of oral opioid medications [ Time Frame: 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.
- Storage of opioid medication in surgical patients after hospital discharge [ Time Frame: 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.
- Description of surgical patients from their electronic medical record [ Time Frame: Date of admission to hospital up to thirty days after hospital discharge date. ]For each surgical patient who completes the study survey we will access their electronic medical record and characterize them by age, gender, race, type of insurance, body mass index, comorbid medical conditions, type of surgical procedure and severity, pre-operative and in-hospital opioid use, and use of acetaminophen and NSAIDs. We will then relate these patient characteristics to the participants responses on the study surveys.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034278
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Karsten Bartels, MD||University of Colorado, Denver|