A Pain and Coordination Plan for Reduced Opioid Use After Accidental Injuries
- Conditions
- Injury TraumaticPain, PostoperativeOpioid Use
- Interventions
- Other: PAC-plan
- Registration Number
- NCT06055205
- Lead Sponsor
- University of Oslo
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 232
- Adults ≥18 years of age who have undergone acute orthopaedic surgery following accidental injury
- Discharged on opioid medication
- Unable to read, speak, and write Norwegian
- Severe cognitive impairment/inability to consent
- Not discharged to home
- Currently in cancer treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PAC-plan 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.
- Primary Outcome Measures
Name Time Method Opioid use 6 weeks post-discharge Opioid use last 24 hours measured in oral morphine equivalents (OMEQ), self-reported
- Secondary Outcome Measures
Name Time Method Opioid use 52 weeks post-discharge Opioid use last 24 hours measured in oral morphine equivalents (OMEQ), self-reported
Norwegian Injustice Experience Questionnaire (IEQ-N) 52 weeks post-discharge Perceived injustice measured with the Injustice Experience Questionnaire (IEQ). The IEQ is a self-report 12-item questionnaire and each item is scored on a five-point scale from zero ("never") to four ("all the time"). The total score on the IEQ ranges from 0 to 48, with higher scores indicating higher levels of perceived injustice
Opioid use measured in oral morphine equivalents (OMEQ), registry-based 52 weeks post-discharge The Norwegian Prescription Database, NorPD
HUNT (the Nord-Trøndelag health study) physical activity questionnaire (HUNT1 PA-Q) 52 weeks post-discharge The HUNT 1 PA-Q consists of three sets of questions addressing the average number of times exercising each week, the average intensity and average hours each time. Each set of questions has five, three, or four response choices, respectively. The HUNT 1 PA-Q measures physical exercise as the product of average frequency (0.0-5.0 points), duration (0.10-1.00 points) and intensity (1-3 points) each week, giving an index ranging from 0.00 to 15.00, with 15.00 as the best score.
EQ-5D-5L (EuroQol, 5 dimensions, 5 levels) for health-related quality of life 52 weeks post-discharge Health-related quality of life measured with the EQ-5D-5L. The EQ-5D-5L consists of two parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ visual analogue scale (EQ VAS) records the patient's self-rated health on a VAS ranging from 0 to 100, with higher scores indicating better self-reported health.
HUNT (the Nord-Trøndelag health study) physical activity questionnaire (HUNT 1 PA-Q) 6 weeks post-discharge The HUNT 1 PA-Q consists of three sets of questions addressing the average number of times exercising each week, the average intensity and average hours each time. Each set of questions has five, three, or four response choices, respectively. The HUNT 1 PA-Q measures physical exercise as the product of average frequency (0.0-5.0 points), duration (0.10-1.00 points) and intensity (1-3 points) each week, giving an index ranging from 0.00 to 15.00, with 15.00 as the best score
Insomnia Severity Index (ISI) last 2 weeks 52 weeks post-discharge Perceived insomnia severity measured by the Insomnia Severity Index (ISI). The ISI consists of seven items and the participants rate each item on a scale from 0 to 4, from less to more severe. The total score is the sum of each individual item and can range from 0 to 28 (28 = most severe insomnia).
Numeric Rating Scale for pain intensity scores 52 weeks post-discharge Pain intensity, self-reported by Numeric Rating Scale (NRS-11). Scale from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Life Orientation Test Revised (LOT-R) 52 weeks post-discharge Optimism measured with the Life Orientation Test Revised (LOT-R). The measure consists of 10 items, and participants indicate their level of agreement with each item on a 5-point scale ranging from 0 (strongly disagree) to 4 (strongly agree). The scores on this scale can range from 0 to 24, with higher scores indicating greater levels of optimism and lower scores indicating lower levels of optimism.
Patient Health Questionnaire-9 52 weeks post-discharge Depression symptoms and severity measured by the Patient Health Questionnaire-9 (PHQ-9).The PHQ-9 consists of nine items and the participants rate the frequency of each symptom on a Likert scale ranging from 0 (not at all) to 3 (nearly every day). The scores can range from 0-27. In addition to a total score, categories are defined to indicate severity of depression symptoms. These categories are defined as follows: none (total score from 0 to 4), mild (total score from 5 to 9), moderate (total score from 10 to 14), moderately severe (total score from 15 to 19), and severe (total score from 20 to 27).
Trial Locations
- Locations (1)
Oslo University Hospital
🇳🇴Oslo, Norway