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NCT Number: NCT06240533

Implementation of 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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Östergötland health care region

Linköping, 58191, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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)

  3. 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)

Secondary outcomes

  1. Determinants of Implementation Behaviour Questionnaire

    Time frame: February 2024 and February 2025

    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'.

  2. Qualitative focus group interview

    Time frame: September 2024 to May 2025

    Healthcare practitioners´ will be interviewed to explore barriers and facilitators determing the implementation of the P3C pathway for LBP

  3. Use of medical imaging for LBP

    Time frame: Monthly January 2013 to December 2027

    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).

  4. Prescription of NSAIDS for LBP

    Time frame: Monthly January 2013 to December 2027

    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)

  5. Prescriptions of paracetamol for LBP

    Time frame: Monthly January 2013 to December 2027

    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).

  6. Prescriptions of opioids for LBP

    Time frame: Monthly January 2013 to December 2027

    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)

  7. Prescriptions of gabapentinoids for LBP

    Time frame: Monthly January 2013 to December 2027

    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)

  8. Prescriptions of antidepressants for LBP

    Time frame: Monthly January 2013 to December 2027

    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)

  9. Prescriptions of muscle relaxants for LBP

    Time frame: Monthly January 2013 to December 2027

    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)

  10. Referrals to specialist orthopedic clinics

    Time frame: Monthly January 2013 to December 2027

    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.

  11. Referrals to specialist pain rehabilitation clinics

    Time frame: Monthly January 2013 to December 2027

    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.

  12. New visits in primary care to physicians and physiotherapists for LBP

    Time frame: Monthly January 2013 to December 2027

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Allan Abbott, Professor

CONTACT

[email protected]

+46 733816914

Karin M Schröder, Assoc Prof

CONTACT

[email protected]

+46 700850752

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

Implementation of a Patient Centered Coordinated Care Pathway for Low Back Pain (P3C-LBP) in Swedish Primary Care

Acronym: P3C-LBP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2024
Registry last updated
Feb 6, 2024

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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