Implementation of P3C-LBP in Swedish Primary Care (P3C-LBP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain

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 Type: Observational
• Enrollment (Estimated): 300000

Contacts and Locations

• Study Contact: Name: Allan Abbott, Professor; Phone Number: +46 733816914; Email: allan.abbott@liu.se
• Study Contact Backup: Name: Karin M Schröder, Assoc Prof; Phone Number: +46 700850752; Email: karin.schroder@liu.se

Study Locations

• Sweden
  • Linköping, Sweden, 58191
    • Östergötland health care region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Allan Abbott, Professor, Department of Health, Medicine and Caring Sciences, Linköping University, Sweden; Study Chair: Allan Abbott, Professor, Department of Health, Medicine and Caring Sciences, Linköping University, Sweden; Study Director: Allan Abbott, Professor, Department of Health, Medicine and Caring Sciences, Linköping University, Sweden

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 26, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Implementation; Low back pain; Care pathway; Patient centered care
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 20240201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Registry data is owned by the Swedish government

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No