The primary objective of this multicenter, observational study is to determine the incidence of chronic opioid use 30 days and 3 months after an initial opioid prescription at ED discharge. Secondary objectives include assessing the incidence of…
ID
Source
Brief title
Condition
- Overdoses and underdoses NEC
Synonym
Research involving
Sponsors and support
Intervention
- Other intervention
N.a.
Outcome measures
Primary outcome
<p>The primary outcome of this study is the proportion of patients who continue to use opioids 30 days and 3 months after ED discharge. Reported opioid use will be cross-referenced with pharmacy prescription data from the LSP to verify opioid refills.</p>
Secondary outcome
<p>Incidence of opioid misuse, based on responses to the Current Opioid Misuse Measure (COMM) in the follow-up questionnaires. Opioid misuse is defined as a COMM score >8 at 30 days or 3 months post-discharge.</p>
Background summary
The prescription of opioids has increased significantly in recent years, raising concerns regarding opioid-related misuse, dependence, and associated adverse outcomes. Although emergency departments (EDs) frequently prescribe opioids for acute pain management, the extent to which these prescriptions contribute to persistent opioid use and opioid misuse remains unclear. Previous studies suggest that opioid prescriptions at the ED discharge may lead to prolonged opioid use, potentially resulting in opioid misuse or opioid use disorder (OUD). However, most of these studies originate from healthcare systems that differ significantly from the Dutch context. This study aims to assess the risk of chronic opioid use and misuse following an initial opioid prescription at ED discharge in the Netherlands.
Study objective
The primary objective of this multicenter, observational study is to determine the incidence of chronic opioid use 30 days and 3 months after an initial opioid prescription at ED discharge. Secondary objectives include assessing the incidence of opioid misuse within this population and identifying patient-related, opioid prescription-related, and hospital-related predictors associated with prolonged opioid use and misuse.
Study design
This is a prospective, multicenter, observational study conducted in five hospitals in the Netherlands. Adult opioid-naïve patients discharged from the ED with a new opioid prescription will be invited to participate. Data collection will be conducted via digital questionnaires at three time points: within 1-7 days, at 30 days, and at 3 months post-discharge.
Intervention
This study does not involve the testing of a new drug or intervention. Instead, it focuses on the observational assessment of real-world opioid prescribing practices and subsequent opioid use patterns among ED patients. There are no experimental treatments or additional medical procedures involved.
Study burden and risks
The burden on participants is minimal, as the study only requires completion of three digital questionnaires at predefined time points, each taking approximately 15-20 minutes. There are no additional medical procedures or interventions. Participation is voluntary, and patients can withdraw at any time without consequences. Given the observational nature of the study, there are no direct medical risks associated with participation. The findings of this study may contribute to improved opioid prescribing practices and patient counseling regarding the risks of prolonged opioid use and misuse.
VN Bahadoer
Alinusdreef 2
Leiden 2333 ZA
Netherlands
071 526 91 11
v.n.bahadoer@lumc.nl
VN Bahadoer
Alinusdreef 2
Leiden 2333 ZA
Netherlands
071 526 91 11
v.n.bahadoer@lumc.nl
Listed location countries
Age
Inclusion criteria
- 18 years and older
- Discharged home from the ED with a new opioid prescription
- Opioids include all medications in ATC-class N02A
Exclusion criteria
- <18 years
- Currently using opioid
- Patients unable to give consent for follow-up
- No understanding of Dutch or English language
- Patients admitted to the hospital from the ED
- Patients not having an email address
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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Research portal | NL-009239 |