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

NCT06055205 | Active Not Recruiting

• 1 other identifier: 487948 (REK)
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

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?
• 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.

Conditions

Opioid Use; Injury Traumatic; Pain, Postoperative

Keywords

Opioids; Injuries; Pain; Pain management; Collaboration

Outcome Measures

Primary Outcomes (1)

• Opioid use

  Opioid use last 24 hours measured in oral morphine equivalents (OMEQ), self-reported

  6 weeks post-discharge

Secondary Outcomes (20)

• Opioid use

  52 weeks post-discharge

• Opioid use measured in oral morphine equivalents (OMEQ), registry-based

  6 weeks post-discharge

• Opioid use measured in oral morphine equivalents (OMEQ), registry-based

  52 weeks post-discharge

• Numeric Rating Scale for pain intensity scores

  6 weeks post-discharge

• Numeric Rating Scale for pain intensity scores

  52 weeks post-discharge

Study Arms (2)

PAC-plan

EXPERIMENTAL

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.

Other: PAC-plan

Control

NO INTERVENTION

Treatment and follow-up as usual.

Interventions

PAC-plan 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.

PAC-plan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oslo: lead
• Oslo University Hospital: collaborator
• The Norwegian Research Fund for General Practice: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0424, Norway

Location

Related Links

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

MeSH Terms

Conditions

Wounds and Injuries; Pain, Postoperative; Pain; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Lene B Solberg, PhD MD

  Oslo University Hospital

  STUDY DIRECTOR

• Trygve Skonnord, PhD MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician performing the data analyses will be masked for group status. The participants, study nurses and study coordinator will not be masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: The study will use a prospective randomized controlled trial design. Participants will be assigned randomly to study conditions (1:1) through permuted block randomization with various sizes of the blocks (4, 6, 8, 10) in random order. The randomization will be performed manually by the principle investigator (PI). Sealed, opaque, numbered envelopes will be used, and will be opened after consent from the patient. For the intervention group, the study coordinator will contact the patient's general practitioner (GP) by calling the doctor's office to obtain consent for participation. For the control group, the GP will not be asked for consent. To ensure that no GPs are included in both groups, the GPs retain their initial allocation if they have additional patients in the project. In practice, this corresponds to cluster-randomization at the GP level (and will be treated as such in the statistical analyzes).

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: September 25, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)