Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT06055205
Status:
RECRUITING
Last Update Posted:
2023-10-03
First Post:
2023-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pain and Coordination Plan for Reduced Opioid Use After Accidental Injuries
Sponsor:
University of Oslo
Organization:
Study Overview
Official Title:
A Pain and Coordination Plan (PAC-plan) in Transition Between Hospital and Primary Care to Reduce Opioid Use in Patients After Accidental Injuries: A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAC-plan
Brief Summary:
This clinical trial aims to lower the number of people who use opioids and improve the quality of health in patients who have experienced accidental injury by implementing a Pain and Coordination Plan (PAC-plan). The PAC-plan will be given upon discharge from the hospital.
The main questions this study aims to answer are:
* Can the PAC-plan reduce opioid use in patients after accidental injuries?
* Can the PAC-plan increase quality of life in patients after accidental injuries?
Participants will be randomly assigned to the PAC-plan or usual care. The PAC-plan includes:
* an opioid management plan upon discharge from the hospital
* an appointment with his/her general practitioner within 2-4 weeks after discharge
* the general practitioner will be given the opportunity for increased collaboration with the hospital specialists
Participants in both groups will be asked to answer questionnaires about their health at discharge, and at 6 and 52 weeks after discharge from the hospital. In addition, the researchers will use data from the Norwegian Prescription Database to measure opioid use.
The main questions this study aims to answer are:
* Can the PAC-plan reduce opioid use in patients after accidental injuries?
* Can the PAC-plan increase quality of life in patients after accidental injuries?
Participants will be randomly assigned to the PAC-plan or usual care. The PAC-plan includes:
* an opioid management plan upon discharge from the hospital
* an appointment with his/her general practitioner within 2-4 weeks after discharge
* the general practitioner will be given the opportunity for increased collaboration with the hospital specialists
Participants in both groups will be asked to answer questionnaires about their health at discharge, and at 6 and 52 weeks after discharge from the hospital. In addition, the researchers will use data from the Norwegian Prescription Database to measure opioid use.
Detailed Description:
Introduction: Patients experiencing serious injuries are at risk of developing long-term opioid use, yet many don't receive plans for opioid reduction when discharged from the hospital. General Practitioners (GPs) also experience insufficient communication from the hospital on pain management plans. Opioids are often essential for managing acute pain in patients following serious injuries. However, it is crucial to prioritize safe and appropriate pain management in subsequent phases. The opioid epidemic in the USA, characterized by opioid use disorders and addiction, has resulted in high mortality rates and a public health crisis. In 2017, opioid dependence outside the USA was estimated to account for over 1% of age-standardized years lived with disability in 135 countries. Considering the devastating impact of the opioid epidemic in the USA, it is imperative to draw lessons from these experiences and implement preventive measures to avoid a similar crisis in other countries.
Aim: This study aims to explore if a Pain and Coordination Plan (PAC-plan) for patients after accidental injury can reduce opioid use and improve quality of life.
Methods: The study is designed as a prospective randomized controlled trial (RCT) to evaluate the effect of a PAC-plan. The PAC-plan consists of three main elements: an opioid management plan upon discharge from the hospital, an appointment with the participant's regular GP within 2-4 weeks after discharge and an opportunity for increased collaboration between GP and hospital specialists.
Patients will be recruited from the Division of orthopaedic surgery, Oslo University Hospital (OUH), Norway. OUH is a highly specialized hospital in charge of extensive regional and local hospital assignments in the South-Eastern Health region in Norway and is described as a level 1 trauma centre. The primary outcome is oral morphine equivalent (OMEQ) consumption 6 weeks after discharge. Secondary outcome measures are OMEQ 52 weeks after discharge. In addition, registry-based OMEQ, pain, health-related quality of life (HRQoL) and other Patient-reported outcome measures (PROMs) at 6 and 52 weeks. The registry-based OMEQ will be collected from the Norwegian Prescription Database (NorPD). Data will also be collected from the the Norwegian Patient Registry (NPR).
Aim: This study aims to explore if a Pain and Coordination Plan (PAC-plan) for patients after accidental injury can reduce opioid use and improve quality of life.
Methods: The study is designed as a prospective randomized controlled trial (RCT) to evaluate the effect of a PAC-plan. The PAC-plan consists of three main elements: an opioid management plan upon discharge from the hospital, an appointment with the participant's regular GP within 2-4 weeks after discharge and an opportunity for increased collaboration between GP and hospital specialists.
Patients will be recruited from the Division of orthopaedic surgery, Oslo University Hospital (OUH), Norway. OUH is a highly specialized hospital in charge of extensive regional and local hospital assignments in the South-Eastern Health region in Norway and is described as a level 1 trauma centre. The primary outcome is oral morphine equivalent (OMEQ) consumption 6 weeks after discharge. Secondary outcome measures are OMEQ 52 weeks after discharge. In addition, registry-based OMEQ, pain, health-related quality of life (HRQoL) and other Patient-reported outcome measures (PROMs) at 6 and 52 weeks. The registry-based OMEQ will be collected from the Norwegian Prescription Database (NorPD). Data will also be collected from the the Norwegian Patient Registry (NPR).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: