Clinical trial NCT06055205: A Pain and Coordination Plan for Reduced Opioid Use After Accidental Injuries
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use
Injury Traumatic
Pain, Postoperative
Keywords: Opioids
Injuries
Pain
Pain management
Collaboration
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: The Norwegian Research Fund for General Practice
First posted: 2023-09-26
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Opioid use
timeFrame: 6 weeks post-discharge
Secondary outcomes:
measure: Opioid use
timeFrame: 52 weeks post-discharge
measure: Opioid use measured in oral morphine equivalents (OMEQ), registry-based
timeFrame: 6 weeks post-discharge
measure: Opioid use measured in oral morphine equivalents (OMEQ), registry-based
timeFrame: 52 weeks post-discharge
measure: Numeric Rating Scale for pain intensity scores
timeFrame: 6 weeks post-discharge
measure: Numeric Rating Scale for pain intensity scores
timeFrame: 52 weeks post-discharge
measure: EQ-5D-5L (EuroQol, 5 dimensions, 5 levels) for health-related quality of life
timeFrame: 6 weeks post-discharge
measure: EQ-5D-5L (EuroQol, 5 dimensions, 5 levels) for health-related quality of life
timeFrame: 52 weeks post-discharge
measure: Norwegian Injustice Experience Questionnaire (IEQ-N)
timeFrame: 6 weeks post-discharge
measure: Norwegian Injustice Experience Questionnaire (IEQ-N)
timeFrame: 52 weeks post-discharge
measure: Life Orientation Test Revised (LOT-R)
timeFrame: 6 weeks post-discharge
measure: Life Orientation Test Revised (LOT-R)
timeFrame: 52 weeks post-discharge
measure: Patient Health Questionnaire-9
timeFrame: 6 weeks post-discharge
measure: Patient Health Questionnaire-9
timeFrame: 52 weeks post-discharge
measure: HUNT (the Nord-Trøndelag health study) physical activity questionnaire (HUNT 1 PA-Q)
timeFrame: 6 weeks post-discharge
measure: HUNT (the Nord-Trøndelag health study) physical activity questionnaire (HUNT1 PA-Q)
timeFrame: 52 weeks post-discharge
measure: Insomnia Severity Index (ISI) last 2 weeks
timeFrame: 6 weeks post-discharge
measure: Insomnia Severity Index (ISI) last 2 weeks
timeFrame: 52 weeks post-discharge
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Lene B Solberg, PhD MD
role: STUDY_DIRECTOR
affiliation: Department of General Practice, Institute of Health and Society, University of Oslo, Norway
name: Trygve Skonnord, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: