A Pain and Coordination Plan for Reduced Opioid Use After Accidental Injuries (PAC-plan)

University of Oslo

Status: Active, not recruiting

Conditions: Injury Traumatic; Pain, Postoperative; Opioid Use

Treatments: Other: PAC-plan

Study type: Interventional

Funder types: Other

Identifiers

NCT06055205

487948 (REK)

Details and patient eligibility

About

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?
• Is implementation of the PAC-plan after accidental injuries cost-effective?

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 use of opioids and other relevant drugs, the Norwegian Patient Registry (NPR) and the Norwegian Registry for Primary Health Care (KPR) for the use of health care services and Statistics Norway for data on sick leave and other social security benefits.

Full 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, and if the intervention is cost-effective.

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 and other addictive drugs, pain, health-related quality of life (HRQoL) and other Patient-reported outcome measures (PROMs) at 6 and 52 weeks, and finally use of health care services and sick leave. 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), the Norwegian Patient Registry (NPR), the Norwegian Registry for Primary Health Care (KPR) and Statistics Norway.

Enrollment: 271 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults ≥18 years of age who have undergone acute orthopaedic surgery following accidental injury
• Discharged on opioid medication

Exclusion criteria

• Unable to read, speak, and write Norwegian
• Severe cognitive impairment/inability to consent
• Not discharged to home
• Currently in cancer treatment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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271 participants in 2 patient groups

PAC-plan

Experimental group

Description:

The patients receive a Pain- and Coordination plan (PAC-plan) at discharge from the hospital. The PAC-plan includes: * Upon discharge, patients have a patient-centered conversation and receive written information covering patient education on opioids, a tapering plan, and a plan for contact and follow-up with the general practitioner. The information is based on the Norwegian National Guide for Addictive Medications. * Before discharge, patients are scheduled an appointment with the GP, preferably within the first 2 weeks (2-4 weeks), for a follow-up regarding the injury and pain management. * The GP is invited to maintain contact with the study nurse at the hospital for one year. The general practitioner can call for consultation with the study nurse, and if necessary, be connected with relevant medical specialists for advice and eventually further follow-up.

Treatment:

Other: PAC-plan

Control

No Intervention group

Description:

Treatment and follow-up as usual.