Opioid UsePAC-planNCT06055205
A Pain and Coordination Plan for Reduced Opioid Use After Accidental Injuries
A study testing PAC-plan in people with Opioid Use and Injury Traumatic, run by University of Oslo at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Injury Traumatic, Pain, Postoperative
- What is being tested?
- PAC-plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteNorway
- Study dates
- 25 Sep 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age who have undergone acute orthopaedic surgery following accidental injury
- Discharged on opioid medication
Who cannot join
- Unable to read, speak, and write Norwegian
- Severe cognitive impairment/inability to consent
- Not discharged to home
- Currently in cancer treatment
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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.
Read the 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, 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.
- Conditions
- Opioid Use, Injury Traumatic, Pain, Postoperative
- Being tested
- PAC-plan
- Keywords
- Opioids, Injuries, Pain, Pain management, Collaboration
- Medical subject headings
- Wounds and Injuries, Pain, Postoperative, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAC-planOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PAC-plan |
| Control | No intervention | Treatment and follow-up as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid use
Opioid use last 24 hours measured in oral morphine equivalents (OMEQ), self-reported
Measured: 6 weeks post-discharge
Secondary outcomes (20)
Opioid use
Opioid use last 24 hours measured in oral morphine equivalents (OMEQ), self-reported
Measured: 52 weeks post-discharge
Opioid use measured in oral morphine equivalents (OMEQ), registry-based
The Norwegian Prescription Database, NorPD
Measured: 6 weeks post-discharge
Opioid use measured in oral morphine equivalents (OMEQ), registry-based
The Norwegian Prescription Database, NorPD
Measured: 52 weeks post-discharge
Numeric Rating Scale for pain intensity scores
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."
Measured: 6 weeks post-discharge
Numeric Rating Scale for pain intensity scores
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."
Measured: 52 weeks post-discharge
EQ-5D-5L (EuroQol, 5 dimensions, 5 levels) for health-related quality of life
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.
Measured: 6 weeks post-discharge
EQ-5D-5L (EuroQol, 5 dimensions, 5 levels) for health-related quality of life
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.
Measured: 52 weeks post-discharge
Norwegian Injustice Experience Questionnaire (IEQ-N)
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
Measured: 6 weeks post-discharge
Norwegian Injustice Experience Questionnaire (IEQ-N)
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
Measured: 52 weeks post-discharge
Life Orientation Test Revised (LOT-R)
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.
Measured: 6 weeks post-discharge
Life Orientation Test Revised (LOT-R)
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.
Measured: 52 weeks post-discharge
Patient Health Questionnaire-9
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).
Measured: 6 weeks post-discharge
Patient Health Questionnaire-9
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).
Measured: 52 weeks post-discharge
HUNT (the Nord-Trøndelag health study) physical activity questionnaire (HUNT 1 PA-Q)
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
Measured: 6 weeks post-discharge
HUNT (the Nord-Trøndelag health study) physical activity questionnaire (HUNT1 PA-Q)
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.
Measured: 52 weeks post-discharge
Insomnia Severity Index (ISI) last 2 weeks
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).
Measured: 6 weeks post-discharge
Insomnia Severity Index (ISI) last 2 weeks
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).
Measured: 52 weeks post-discharge
Cost-effectiveness
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).
Measured: 52 weeks post-discharge
Use of addictive and psychoactive drugs, registry-based
Prescribed addictive medication (other than opioids) and psychoactive drugs (antidepressants and antipsychotics). Obtained from the Norwegian Prescription Database, NorPD.
Measured: 6 weeks post-discharge
Use of addictive and psychoactive drugs, registry-based
Prescribed addictive medication (other than opioids) and psychoactive drugs (antidepressants and antipsychotics). Obtained from the Norwegian Prescription Database, NorPD.
Measured: 52 weeks post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start25 Sep 2023
- Primary completion30 Apr 2026
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, The Norwegian Research Fund for General Practice
- Responsible party
- Principal investigator, Trygve Skonnord, University of Oslo
- Investigators
- Lene B Solberg, PhD MD, Study director, Oslo University HospitalTrygve Skonnord, PhD MD, Principal investigator, Department of General Practice, Institute of Health and Society, University of Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055205
- Sponsor's protocol ID
- 487948 (REK)
- Acronym
- PAC-plan
- Status last verified
- May 2026
- First submitted
- 19 Sep 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet known if there will be a plan to make individual patient data (IPD) available.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06055205
- Acronym / sponsor ID
- PAC-plan / 487948 (REK)
- Conditions
- Opioid Use, Injury Traumatic, Pain, Postoperative
- Keywords
- Opioids, Injuries, Pain, Pain management, Collaboration
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 271 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Oslo University Hospital, The Norwegian Research Fund for General Practice
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| PAC-plan | Experimental | Other: PAC-planThe 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. |
| Control | No intervention | –Treatment and follow-up as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ≥18 years of age who have undergone acute orthopaedic surgery following accidental injury
- Discharged on opioid medication
Key exclusion criteria (4 listed)
- Unable to read, speak, and write Norwegian
- Severe cognitive impairment/inability to consent
- Not discharged to home
- Currently in cancer treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAC-planThe 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. | Other | PAC-plan |
Primary outcome
Opioid use
Time frame: 6 weeks post-discharge
Opioid use last 24 hours measured in oral morphine equivalents (OMEQ), self-reported
20 secondary outcomes
Opioid use
Time frame: 52 weeks post-discharge
Opioid use measured in oral morphine equivalents (OMEQ), registry-based
Time frame: 6 weeks post-discharge
Opioid use measured in oral morphine equivalents (OMEQ), registry-based
Time frame: 52 weeks post-discharge
Numeric Rating Scale for pain intensity scores
Time frame: 6 weeks post-discharge
Numeric Rating Scale for pain intensity scores
Time frame: 52 weeks post-discharge
EQ-5D-5L (EuroQol, 5 dimensions, 5 levels) for health-related quality of life
Time frame: 6 weeks post-discharge
EQ-5D-5L (EuroQol, 5 dimensions, 5 levels) for health-related quality of life
Time frame: 52 weeks post-discharge
Norwegian Injustice Experience Questionnaire (IEQ-N)
Time frame: 6 weeks post-discharge
Norwegian Injustice Experience Questionnaire (IEQ-N)
Time frame: 52 weeks post-discharge
Life Orientation Test Revised (LOT-R)
Time frame: 6 weeks post-discharge
Life Orientation Test Revised (LOT-R)
Time frame: 52 weeks post-discharge
Patient Health Questionnaire-9
Time frame: 6 weeks post-discharge
Patient Health Questionnaire-9
Time frame: 52 weeks post-discharge
HUNT (the Nord-Trøndelag health study) physical activity questionnaire (HUNT 1 PA-Q)
Time frame: 6 weeks post-discharge
HUNT (the Nord-Trøndelag health study) physical activity questionnaire (HUNT1 PA-Q)
Time frame: 52 weeks post-discharge
Insomnia Severity Index (ISI) last 2 weeks
Time frame: 6 weeks post-discharge
Insomnia Severity Index (ISI) last 2 weeks
Time frame: 52 weeks post-discharge
Cost-effectiveness
Time frame: 52 weeks post-discharge
Use of addictive and psychoactive drugs, registry-based
Time frame: 6 weeks post-discharge
Use of addictive and psychoactive drugs, registry-based
Time frame: 52 weeks post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Website for the PAC-plan project at the University of OsloLink provided by the sponsor.
- Individual participant dataSharing planned: No. It is not yet known if there will be a plan to make individual patient data (IPD) available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lene B Solberg, PhD MD study director
Oslo University Hospital
Trygve Skonnord, PhD MD principal investigator
Department of General Practice, Institute of Health and Society, University of Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAC-plan in people with Opioid Use and Injury Traumatic, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid use (time frame: 6 weeks post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.