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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
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Opioid Use Other: Not applicable - no intervention

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.


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Study Type : Observational
Actual Enrollment : 785 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Post surgery patients
Patients prescribed with opioid analgesic medications following surgery.
Other: Not applicable - no intervention
Not applicable - no intervention, observational survey study.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Study Design/Methods:

Survey population: Patients ages 18-89 undergoing surgery at the University of Colorado Hospital are eligible. We will focus on patients after Cesarean section surgery, gastrointestinal, and thoracic surgery.

Following exclusion of all patients under the age of 18 years, patients who do not understand Spanish or English, and patients returning to institutional settings (e.g. prison, jail, mental health facility), pregnant women, and decisionally challenged patients, the investigators will include all remaining patients in the sample.

The investigators will focus on adult patients after 1) Cesarean section, 2) thoracic surgery procedures, and 3) gastrointestinal surgery procedures.

Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Karsten Bartels, MD University of Colorado, Denver

Publications:
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03034278     History of Changes
Other Study ID Numbers: 14-1938
1K23DA040923-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
opioid use

Additional relevant MeSH terms:
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Analgesics, Opioid
Analgesics
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents