NCT03034278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
785

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

February 3, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

4.5 years

First QC Date

January 23, 2017

Last Update Submit

September 15, 2021

Conditions

Opioid Use

Keywords

opioid use

Outcome Measures

Primary Outcomes (1)

  • Ratio of patient-reported intake of oral opioids to prescribed amount of oral opioid medications

    A self-report survey will assess opioid medication use in surgical patients during the 4 weeks following hospital discharge.

    4 weeks after hospital discharge date.

Secondary Outcomes (1)

  • Storage of opioid medication in surgical patients after hospital discharge

    4 weeks after hospital discharge date.

Other Outcomes (1)

  • Description of surgical patients from their electronic medical record

    Date of admission to hospital up to thirty days after hospital discharge date.

Study Arms (1)

Post surgery patients

Patients prescribed with opioid analgesic medications following surgery.

Other: Not applicable - no intervention

Interventions

Not applicable - no interventionOTHER

Not applicable - no intervention, observational survey study.

Post surgery patients

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Adult patients undergoing:
  • Cesarean section,
  • Gastrointestinal surgery, or
  • Thoracic surgery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (5)

  • Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.

    PMID: 26824844BACKGROUND

  • Bartels K, Binswanger IA, Hopfer CJ. Sources of Prescription Opioids for Nonmedical Use. J Addict Med. 2016 Mar-Apr;10(2):134. doi: 10.1097/ADM.0000000000000192. No abstract available.

    PMID: 26985647BACKGROUND

  • Carrico JA, Mahoney K, Raymond KM, McWilliams SK, Mayes LM, Mikulich-Gilbertson SK, Bartels K. Predicting Opioid Use Following Discharge After Cesarean Delivery. Ann Fam Med. 2020 Mar;18(2):118-126. doi: 10.1370/afm.2493.

    PMID: 32152015RESULT

  • Abrams BA, Murray KA, Mahoney K, Raymond KM, McWilliams SK, Nichols S, Mahmoudi E, Mayes LM, Fernandez-Bustamante A, Mitchell JD, Meguid RA, Zanotti G, Bartels K. Postdischarge Pain Management After Thoracic Surgery: A Patient-Centered Approach. Ann Thorac Surg. 2020 Nov;110(5):1714-1721. doi: 10.1016/j.athoracsur.2020.04.048. Epub 2020 Jun 1.

    PMID: 32497643RESULT

  • Bartels K, Mahoney K, Raymond KM, McWilliams SK, Fernandez-Bustamante A, Schulick R, Hopfer CJ, Mikulich-Gilbertson SK. Opioid and non-opioid utilization at home following gastrointestinal procedures: a prospective cohort study. Surg Endosc. 2020 Jan;34(1):304-311. doi: 10.1007/s00464-019-06767-1. Epub 2019 Apr 3.

    PMID: 30945059RESULT

Study Officials

  • Karsten Bartels, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

January 27, 2017

Study Start

February 3, 2017

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)