Implementation of P3C-LBP in Swedish Primary Care

Low Back Pain Clinical Trial

— P3C-LBP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06240533
• Other study ID #: 20240201
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Linkoeping University
• Contact: Allan Abbott, Professor
• Phone: +46 733816914
• Email: allan.abbott[@]liu.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. General practitioners and primary health care nurses participating in P3C implementation workshops

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Locations

Country	Name	City	State
Sweden	Östergötland health care region	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	February 2024 and February 2025
Primary	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)	Monthly January 2013 to December 2027
Primary	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)	Monthly January 2013 to December 2027
Secondary	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'.	February 2024 and February 2025
Secondary	Qualitative focus group interview	Healthcare practitioners´ will be interviewed to explore barriers and facilitators determing the implementation of the P3C pathway for LBP	September 2024 to May 2025
Secondary	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).	Monthly January 2013 to December 2027
Secondary	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)	Monthly January 2013 to December 2027
Secondary	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).	Monthly January 2013 to December 2027
Secondary	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)	Monthly January 2013 to December 2027
Secondary	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)	Monthly January 2013 to December 2027
Secondary	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)	Monthly January 2013 to December 2027
Secondary	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)	Monthly January 2013 to December 2027
Secondary	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.	Monthly January 2013 to December 2027
Secondary	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.	Monthly January 2013 to December 2027
Secondary	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).	Monthly January 2013 to December 2027