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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

Tracking Information
First Submitted Date January 23, 2017
First Posted Date January 27, 2017
Last Update Posted Date April 4, 2019
Actual Study Start Date February 3, 2017
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2017)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03034278 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 25, 2017)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 25, 2017)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Self-reported Usage Patterns of Opioid Analgesic Medications After Surgery
Official Title Improving Opioid Prescription Safety After Surgery
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Opioid Use
Intervention Other: Not applicable - no intervention
Not applicable - no intervention, observational survey study.
Study Groups/Cohorts Post surgery patients
Patients prescribed with opioid analgesic medications following surgery.
Intervention: Other: Not applicable - no intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 2, 2019)
785
Original Estimated Enrollment
 (submitted: January 25, 2017)
853
Estimated Study Completion Date July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03034278
Other Study ID Numbers 14-1938
1K23DA040923-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Karsten Bartels, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date April 2019