A Pain and Coordination Plan for Reduced Opioid Use After Accidental Injuries

NCT ID: NCT06055205

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-25
• Study Completion Date: 2028-12-31

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.

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).

Conditions

Opioid Use; Injury Traumatic; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

PAC-plan

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.

Group Type: EXPERIMENTAL

PAC-plan

Intervention Type: OTHER

The participants will be asked to complete electronic questionnaires at baseline, and at 6 weeks and 52 weeks after discharge from the hospital. The completion of these questionnaires will take place during the 6-week follow-up appointment at the hospital (a standard follow-up for all patients undergoing surgery at the Division of Orthopedic Surgery, Oslo University Hospital, Norway). Additionally, participants will be invited for a phone-based follow-up appointment with the study coordinator 52 weeks after discharge. The participants will receive the questionnaires electronically via SMS or email. If electronic options are not feasible, data can be collected through paper questionnaires sent by mail. Data will not be directly obtained from general practitioners.

Control

Treatment and follow-up as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PAC-plan

The participants will be asked to complete electronic questionnaires at baseline, and at 6 weeks and 52 weeks after discharge from the hospital. The completion of these questionnaires will take place during the 6-week follow-up appointment at the hospital (a standard follow-up for all patients undergoing surgery at the Division of Orthopedic Surgery, Oslo University Hospital, Norway). Additionally, participants will be invited for a phone-based follow-up appointment with the study coordinator 52 weeks after discharge. The participants will receive the questionnaires electronically via SMS or email. If electronic options are not feasible, data can be collected through paper questionnaires sent by mail. Data will not be directly obtained from general practitioners.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

The Norwegian Research Fund for General Practice

UNKNOWN

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Trygve Skonnord

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lene B Solberg, PhD MD

Role: STUDY_DIRECTOR

Oslo University Hospital

Trygve Skonnord, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Department of General Practice, Institute of Health and Society, University of Oslo, Norway

Locations

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Trygve Skonnord, PhD MD

Role: CONTACT

trygve.skonnord@medisin.uio.no

+47 41323232

Lene B Solberg, PhD MD

Role: CONTACT

l.b.solberg@gmail.com

+47 97669950

Facility Contacts

Lene B Solberg, PhD MD

Role: primary

l.b.solberg@gmail.com

+47 97669950

Related Links

https://www.med.uio.no/helsam/english/research/projects/pain-and-coordination-plan/index.html

Website for the PAC-plan project at the University of Oslo

Other Identifiers

487948 (REK)

Identifier Type: -

Identifier Source: org_study_id