Low Back PainP3C-LBPNCT06240533
Implementation of P3C-LBP in Swedish Primary Care
An observational study of Low Back Pain, run by Linkoeping University at 1 site in Sweden.
Trial summary
The goal of this observational study is to evaluate the implementation of a patient centered coordination care (P3C) pathway for the management of patients with low back pain (LBP) in primary care, in Östergötland health care region, Sweden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- How many people
- 300,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2024to 31 Dec 2027
- How long will I take part?
- 15 Years
- Phase
- Observational
- 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
Study population: Study population for outcomes 2,3\&6-15 is patients with low back pain seeking primary care for low back pain between 2013 to 2027 Study population for outcome 1,4,5 is General practitioners and nurses in primary care in the region of Östergötland who attend the implementation workshop education during February 2024. Study population for outcome 4 is General partitioners and nurses in primary care in the region of Östergötland who have not attended the implementation education workshop and are willing to participate in an interview during May to october 2024.
Who may be able to join
- All patients with the low back diagnosis (M.54.5, M54.4, M54.3, M54.9) with a visit in primary care and patients with diagnosis M43.0,M43.1, M43.9,M47(all but not M47.0),M48.0, M48.0K, M48.8,M48.8K, M48.9, M51.0, M51.0K, M51.1,M51.1K, M51.2, M51.3, M51.4, M51.8, M51.9, M53.2, M53.3, M53.8,M53.9 referred from primary to specialist care for LBP.
- General practitioners and primary health care nurses participating in P3C implementation workshops
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implementation of a Patient Centered Coordinated Care Pathway for Low Back Pain (P3C-LBP) in Swedish Primary Care
The goal of this observational study is to evaluate the implementation of a patient centered coordination care (P3C) pathway for the management of patients with low back pain (LBP) in primary care, in Östergötland health care region, Sweden.
The main questions the study aims to answer are:
- Do health care quality indicators improve over time after repeated implementation interventions of a P3C pathway for patients with LBP.
- What are the health care practitioner perspectives regarding barriers and facilitators determining implementation success of a P3C pathway for patients with LBP.
Read the detailed description
BACKGROUND Since 2019, the Swedish government together with regional health care organisations have actioned the national development of patient centered coordinated care (P3C) pathways. P3C pathways are defined as health care processes guided by and organized effectively around the needs and preferences of the patient. The aim of this observational study is to evaluate the implementation of a patient centered coordination care (P3C) pathway for the management of patients with low back pain (LBP) in primary care, Östergötland health care region, Sweden. The P3C pathway covers primary care processes until the patient can self-manage or transitions to established chronic pain or other specialist care pathways. A national work group was formed consisting of representatives from all regional health care organisations in Sweden and included all relevant health care professions, academia, and patient organisations.
METHODS:
A mixed methods iterative design and consensus approach was applied in the development of the P3C pathway. The study will be performed in 3 phases:
Phase 1 - Historical baseline: Retrospective register based study of health care quality indicators covering historical time series data before dissemination of the P3C pathway for LBP (January 2013-June 2023).
Phase 2 - Dissemination by publication: Prospective register based study of health care quality indicators for phase 1 (January 2013-June 2023) compared to phase 2 (June 2023- February 2024) after dissemination by publication of the P3C pathway for LBP.
Phase 3 - Single-faceted implementation: Prospective register based study of health care quality indicators for phases 1+2 (January 2013-February 2024) compared to phase 3 (March 2024-February 2026) after single-faceted implementation (health care practitioner workshop) of the P3C pathway for LBP. Health care practitioner confidence in managing LBP and perspectives regarding barriers and facilitators determining implementation P3C pathway success will also be investigated via questionnaires directly after and 1 year prospectively after the implementation intervention. The qualitative interviews will be performed 3- 6 months post implementation.
Phase 4 - Multi-faceted implementation (repeated health care practitioner workshops and follow-up): Prospective register based study of health care quality indicators for phases 1+2+3 (January 2013-February 2026) compared to phase 4 (March 2026-December 2027) after multi-faceted implementation of the P3C pathway for LBP.
- Conditions
- Low Back Pain
- Keywords
- Implementation, Care pathway, Patient centered care, Low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Historical baseline | Patients with LBP in a retrospective register based study of health care quality indicators covering historical time series data from regional health care databases in Sweden before dissemination by publication of the P3C pathway (January 2013-June 2023). | |
| Dissemination | Patients with LBP in a prospective register based study of health care quality indicators for phase 1 (January 2013-June 2023) compared to phase 2 (June 2023- February 2024) after dissemination by publication of the P3C pathway for LBP. | |
| Single-faceted implementation | Patients with LBP in a prospective register based study of health care quality indicators for phases 1+2 (January 2013-February 2024) compared to phase 3 (March 2024-February 2026) after single-faceted implementation (health care practitioner workshop) of the P3C pathway for LBP. Health care practitioner confidence in managing LBP and perspectives regarding barriers and facilitators determining implementation P3C pathway success will also be investigated via questionnaires and qualitative interviews directly after and 1 year prospectively the implementation intervention. | |
| Multi-faceted implementation | Patients with LBP in a prospective register based study of health care quality indicators for phases 1+2+3 (January 2013-February 2026) compared to phase 4 (March 2026-December 2027) after multi-faceted implementation (repeated health care practitioner workshops and follow-up) of the P3C pathway for LBP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Practitioner Confidence Scale
Healthcare practitioner rated´confidence in managing low back pain before and after a single-faceted implementation. The Practitioner Confidence Scale contains four items reported on a 5-point Likert scale, where a total score of 4 represents greatest self-confidence and 20 represents lowest self-confidence for managing patients with LBP.
Measured: February 2024 and February 2025
Patient sickness benefit days per month for LBP
Registry data from The Swedish Social Insurance Agency for diagnosis codes (ICD10: M54.5, M54.4, M54.3, M54.9)
Measured: Monthly January 2013 to December 2027
Cost of health care per month for LBP
Registry data from the Östergötland health care region database for diagnosis codes (ICD10: M54.5, M54.4, M54.3, M54.9)
Measured: Monthly January 2013 to December 2027
Secondary outcomes (12)
Determinants of Implementation Behaviour Questionnaire
Healthcare practitioners self rated barriers and facilitators determining implementation of the P3C pathway for LBP. Contains 10 items with 9-point Likert response scales ranging from 1='totally agree' to 9='totally disagree'.
Measured: February 2024 and February 2025
Qualitative focus group interview
Healthcare practitioners´ will be interviewed to explore barriers and facilitators determing the implementation of the P3C pathway for LBP
Measured: September 2024 to May 2025
Use of medical imaging for LBP
Number of patients per month with new visits to primary care due to diagnosis codes (ICD10: M54.5, M54.4, M54.3, M54.9) who have been investigated by medical imaging (KVÅ codes AN022, AN023, AN024; AN025, AN026, AN044, AN045, AN065, AN067, AN068).
Measured: Monthly January 2013 to December 2027
Prescription of NSAIDS for LBP
Number of patients per month with new visits to primary care due to diagnosis codes (M54.5, M54.4, M54.3, M54.9) who have been prescribed the following drugs ATC prescription codes for NSAIDS (M01AB01, M01AB02, M01AB05, M01AB55, M01AC01, M01AC02, M01AC05, M01AC06, M01AE01, M01AE02, M01AE03, M01AE14, M01AE52, N02BA01, N02BA51, N02BB01, N02BB51, M02AA10, M02AA13, M02AA15, M01AH01, M01AH05, M01AH06, M01AX01)
Measured: Monthly January 2013 to December 2027
Prescriptions of paracetamol for LBP
Number of patients per month with new visits to primary care due to diagnosis codes (M54.5, M54.4, M54.3, M54.9) who have been prescribed the following drugs ATC prescription codes for paracetamol (N02BE01, N02BE51).
Measured: Monthly January 2013 to December 2027
Prescriptions of opioids for LBP
Number of patients per month with new visits to primary care due to diagnosis codes (M54.5, M54.4, M54.3, M54.9) who have been prescribed the following drugs ATC prescription codes for opioids (N02AA59, N02AC04, N02AE01, N02AJ06, N02AJ08, N02AJ09, N02AX02, N02AX06, N02AA01, N02AA03, N02AA05, N02AA55, N02AB01 N02AB03, N02AG01, N02AG02)
Measured: Monthly January 2013 to December 2027
Prescriptions of gabapentinoids for LBP
Number of patients per month with new visits to primary care due to diagnosis codes (M54.4, M54.3, M48.0K, M48.8K, M51.0, M51.0K, M51.1, M51.1K) who have been prescribed the following drugs ATC prescription codes for gabapentinoids (N03AX12, N03AX16, N02BF01, N02BF02)
Measured: Monthly January 2013 to December 2027
Prescriptions of antidepressants for LBP
Number of patients per month with new visits to primary care due to diagnosis codes (M54.4, M54.3, M48.0K, M48.8K, M51.0, M51.0K, M51.1, M51.1K) who have been prescribed the following drugs ATC prescription codes for antidepressants (N06AX21, N06AB05, N06AB03, N06AA02, N06AA09, N06AA12, N06AA10, N06AA01, N06AX12, N06AX17)
Measured: Monthly January 2013 to December 2027
Prescriptions of muscle relaxants for LBP
Number of patients per month with new visits to primary care due to diagnosis codes (M54.5, M54.4, M54.3, M54.9) who have been prescribed the following drugs ATC prescription codes for muscle relaxant drugs (M03BB03, M03BC51, M03BA02, M03BX08, M03BX05, N04AB02, M03BA03, M03BX01, N05BA01)
Measured: Monthly January 2013 to December 2027
Referrals to specialist orthopedic clinics
Number of patients per month with new visits to primary care due to diagnosis codes (M43.0, M43.1, M43.9, M47(all except M47.0), M48.0, M48.0K, M48.8, M48.8K, M48.9, M51.0, M51.0K, M51.1, M51.1K, M51.2, M51.3, M51.4, M51.8, M51.9, M53.2, M53.3, M53.8, M53.9) who have been referred to specialized care - orthopaedic clinic.
Measured: Monthly January 2013 to December 2027
Referrals to specialist pain rehabilitation clinics
Number of patients per month with new visits to primary care due to diagnosis codes (M43.0, M43.1, M43.9, M47(all except M47.0), M48.0, M48.0K, M48.8, M48.8K, M48.9, M51.0, M51.0K, M51.1, M51.1K, M51.2, M51.3, M51.4, M51.8, M51.9, M53.2, M53.3, M53.8, M53.9) who have been referred to specialist care - pain rehabilitation clinics.
Measured: Monthly January 2013 to December 2027
New visits in primary care to physicians and physiotherapists for LBP
Number of patients per month with new visits to physicians and number of patients per month with new visits to physiotherapists in primary care due to diagnosis codes (M54.5, M54.4, M54.3, M54.9).
Measured: Monthly January 2013 to December 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Allan Abbott, Linkoeping University
- Investigators
- Allan Abbott, Professor, Principal investigator, Department of Health, Medicine and Caring Sciences, Linköping University, SwedenAllan Abbott, Professor, Study chair, Department of Health, Medicine and Caring Sciences, Linköping University, SwedenAllan Abbott, Professor, Study director, Department of Health, Medicine and Caring Sciences, Linköping University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240533
- Sponsor's protocol ID
- 20240201
- Acronym
- P3C-LBP
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Registry data is owned by the Swedish government
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Patient Centered Coordinated Care Pathway for Low Back Pain (P3C-LBP) in Swedish Primary Care
- ClinicalTrials.gov ID
- NCT06240533
- Acronym / sponsor ID
- P3C-LBP / 20240201
- Conditions
- Low Back Pain
- Keywords
- Implementation, Care pathway, Patient centered care, Low back pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300,000 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Feb 2024 (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.
The goal of this observational study is to evaluate the implementation of a patient centered coordination care (P3C) pathway for the management of patients with low back pain (LBP) in primary care, in Östergötland health care region, Sweden.
The main questions the study aims to answer are:
- Do health care quality indicators improve over time after repeated implementation interventions of a P3C pathway for patients with LBP.
- What are the health care practitioner perspectives regarding barriers and facilitators determining implementation success of a P3C pathway for patients with LBP.
Detailed description
BACKGROUND Since 2019, the Swedish government together with regional health care organisations have actioned the national development of patient centered coordinated care (P3C) pathways. P3C pathways are defined as health care processes guided by and organized effectively around the needs and preferences of the patient. The aim of this observational study is to evaluate the implementation of a patient centered coordination care (P3C) pathway for the management of patients with low back pain (LBP) in primary care, Östergötland health care region, Sweden. The P3C pathway covers primary care processes until the patient can self-manage or transitions to established chronic pain or other specialist care pathways. A national work group was formed consisting of representatives from all regional health care organisations in Sweden and included all relevant health care professions, academia, and patient organisations.
METHODS:
A mixed methods iterative design and consensus approach was applied in the development of the P3C pathway. The study will be performed in 3 phases:
Phase 1 - Historical baseline: Retrospective register based study of health care quality indicators covering historical time series data before dissemination of the P3C pathway for LBP (January 2013-June 2023).
Phase 2 - Dissemination by publication: Prospective register based study of health care quality indicators for phase 1 (January 2013-June 2023) compared to phase 2 (June 2023- February 2024) after dissemination by publication of the P3C pathway for LBP.
Phase 3 - Single-faceted implementation: Prospective register based study of health care quality indicators for phases 1+2 (January 2013-February 2024) compared to phase 3 (March 2024-February 2026) after single-faceted implementation (health care practitioner workshop) of the P3C pathway for LBP. Health care practitioner confidence in managing LBP and perspectives regarding barriers and facilitators determining implementation P3C pathway success will also be investigated via questionnaires directly after and 1 year prospectively after the implementation intervention. The qualitative interviews will be performed 3- 6 months post implementation.
Phase 4 - Multi-faceted implementation (repeated health care practitioner workshops and follow-up): Prospective register based study of health care quality indicators for phases 1+2+3 (January 2013-February 2026) compared to phase 4 (March 2026-December 2027) after multi-faceted implementation of the P3C pathway for LBP.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 15 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Historical baseline | – | –Patients with LBP in a retrospective register based study of health care quality indicators covering historical time series data from regional health care databases in Sweden before dissemination by publication of the P3C pathway (January 2013-June 2023). |
| Dissemination | – | –Patients with LBP in a prospective register based study of health care quality indicators for phase 1 (January 2013-June 2023) compared to phase 2 (June 2023- February 2024) after dissemination by publication of the P3C pathway for LBP. |
| Single-faceted implementation | – | –Patients with LBP in a prospective register based study of health care quality indicators for phases 1+2 (January 2013-February 2024) compared to phase 3 (March 2024-February 2026) after single-faceted implementation (health care practitioner workshop) of the P3C pathway for LBP. Health care practitioner confidence in managing LBP and perspectives regarding barriers and facilitators determining implementation P3C pathway success will also be investigated via questionnaires and qualitative interviews directly after and 1 year prospectively the implementation intervention. |
| Multi-faceted implementation | – | –Patients with LBP in a prospective register based study of health care quality indicators for phases 1+2+3 (January 2013-February 2026) compared to phase 4 (March 2026-December 2027) after multi-faceted implementation (repeated health care practitioner workshops and follow-up) of the P3C pathway for LBP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population for outcomes 2,3\&6-15 is patients with low back pain seeking primary care for low back pain between 2013 to 2027 Study population for outcome 1,4,5 is General practitioners and nurses in primary care in the region of Östergötland who attend the implementation workshop education during February 2024. Study population for outcome 4 is General partitioners and nurses in primary care in the region of Östergötland who have not attended the implementation education workshop and are willing to participate in an interview during May to october 2024.
Key inclusion criteria (2 listed)
- All patients with the low back diagnosis (M.54.5, M54.4, M54.3, M54.9) with a visit in primary care and patients with diagnosis M43.0,M43.1, M43.9,M47(all but not M47.0),M48.0, M48.0K, M48.8,M48.8K, M48.9, M51.0, M51.0K, M51.1,M51.1K, M51.2, M51.3, M51.4, M51.8, M51.9, M53.2, M53.3, M53.8,M53.9 referred from primary to specialist care for LBP.
- General practitioners and primary health care nurses participating in P3C implementation workshops
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Practitioner Confidence Scale
Time frame: February 2024 and February 2025
Healthcare practitioner rated´confidence in managing low back pain before and after a single-faceted implementation. The Practitioner Confidence Scale contains four items reported on a 5-point Likert scale, where a total score of 4 represents greatest self-confidence and 20 represents lowest self-confidence for managing patients with LBP.
Patient sickness benefit days per month for LBP
Time frame: Monthly January 2013 to December 2027
Registry data from The Swedish Social Insurance Agency for diagnosis codes (ICD10: M54.5, M54.4, M54.3, M54.9)
Cost of health care per month for LBP
Time frame: Monthly January 2013 to December 2027
Registry data from the Östergötland health care region database for diagnosis codes (ICD10: M54.5, M54.4, M54.3, M54.9)
12 secondary outcomes
Determinants of Implementation Behaviour Questionnaire
Time frame: February 2024 and February 2025
Qualitative focus group interview
Time frame: September 2024 to May 2025
Use of medical imaging for LBP
Time frame: Monthly January 2013 to December 2027
Prescription of NSAIDS for LBP
Time frame: Monthly January 2013 to December 2027
Prescriptions of paracetamol for LBP
Time frame: Monthly January 2013 to December 2027
Prescriptions of opioids for LBP
Time frame: Monthly January 2013 to December 2027
Prescriptions of gabapentinoids for LBP
Time frame: Monthly January 2013 to December 2027
Prescriptions of antidepressants for LBP
Time frame: Monthly January 2013 to December 2027
Prescriptions of muscle relaxants for LBP
Time frame: Monthly January 2013 to December 2027
Referrals to specialist orthopedic clinics
Time frame: Monthly January 2013 to December 2027
Referrals to specialist pain rehabilitation clinics
Time frame: Monthly January 2013 to December 2027
New visits in primary care to physicians and physiotherapists for LBP
Time frame: Monthly January 2013 to December 2027
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 6 Feb 2024.
- Individual participant dataSharing planned: No. Registry data is owned by the Swedish government
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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.
Allan Abbott, Professor principal investigator
Department of Health, Medicine and Caring Sciences, Linköping University, Sweden
Allan Abbott, Professor study chair
Department of Health, Medicine and Caring Sciences, Linköping University, Sweden
Allan Abbott, Professor study director
Department of Health, Medicine and Caring Sciences, Linköping University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Linkoeping University at 1 site in Sweden.
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 0 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: opening soon, as of the sponsor's last update on 6 Feb 2024. 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 Sweden. 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?
Contact Allan Abbott, Professor (+46 733816914, allan.abbott@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Practitioner Confidence Scale (time frame: February 2024 and February 2025). The study lists 3 primary outcomes in all. 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 6 Feb 2024.