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NCT Number: NCT06055205

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Opioid Use Agnosia Injury Traumatic Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Opioid use

    Time frame: 6 weeks post-discharge

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

Secondary outcomes

  1. Opioid use

    Time frame: 52 weeks post-discharge

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

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

    Time frame: 6 weeks post-discharge

    The Norwegian Prescription Database, NorPD

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

    Time frame: 52 weeks post-discharge

    The Norwegian Prescription Database, NorPD

  4. Numeric Rating Scale for pain intensity scores

    Time frame: 6 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."

  5. Numeric Rating Scale for pain intensity scores

    Time frame: 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."

  6. EQ-5D-5L (EuroQol, 5 dimensions, 5 levels) for health-related quality of life

    Time frame: 6 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.

  7. EQ-5D-5L (EuroQol, 5 dimensions, 5 levels) for health-related quality of life

    Time frame: 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.

  8. Norwegian Injustice Experience Questionnaire (IEQ-N)

    Time frame: 6 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

  9. Norwegian Injustice Experience Questionnaire (IEQ-N)

    Time frame: 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

  10. Life Orientation Test Revised (LOT-R)

    Time frame: 6 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.

  11. Life Orientation Test Revised (LOT-R)

    Time frame: 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.

  12. Patient Health Questionnaire-9

    Time frame: 6 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).

  13. Patient Health Questionnaire-9

    Time frame: 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).

  14. HUNT (the Nord-Trøndelag health study) physical activity questionnaire (HUNT 1 PA-Q)

    Time frame: 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

  15. HUNT (the Nord-Trøndelag health study) physical activity questionnaire (HUNT1 PA-Q)

    Time frame: 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.

  16. Insomnia Severity Index (ISI) last 2 weeks

    Time frame: 6 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).

  17. Insomnia Severity Index (ISI) last 2 weeks

    Time frame: 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).

  18. Cost-effectiveness

    Time frame: 52 weeks post-discharge

    The cost-effectiveness of the intervention will be assessed by the incremental cost-effectiveness ratio (ICER), defined by the incremental costs (the difference in costs between the intervention group and the control group) per quality-adjusted life year (QALY) gained. In the health economic analysis, we will also present differences in costs associated with healthcare service consumption (based on data from the Norwegian Prescription Database (NorPD), the Norwegian Patient Registry (NPR), and the Norwegian Registry for Primary Health Care (KPR), as well as differences in sick leave and disability benefits (using data from Statistics Norway).

  19. Use of addictive and psychoactive drugs, registry-based

    Time frame: 6 weeks post-discharge

    Prescribed addictive medication (other than opioids) and psychoactive drugs (antidepressants and antipsychotics). Obtained from the Norwegian Prescription Database, NorPD.

  20. Use of addictive and psychoactive drugs, registry-based

    Time frame: 52 weeks post-discharge

    Prescribed addictive medication (other than opioids) and psychoactive drugs (antidepressants and antipsychotics). Obtained from the Norwegian Prescription Database, NorPD.

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Oslo University Hospital
  • The Norwegian Research Fund for General Practice

Registry information

Official study 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

Acronym: PAC-plan

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Sep 26, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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