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Not yet recruiting NCT06240533

Implementation of P3C-LBP in Swedish Primary Care

Observational Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Low Back Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Practitioner Confidence Scale [Time frame: February 2024 and February 2025]
  • Patient sickness benefit days per month for LBP [Time frame: Monthly January 2013 to December 2027]
  • Cost of health care per month for LBP [Time frame: Monthly January 2013 to December 2027]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Östergötland health care region — Linköping

Identifiers

NCT: NCT06240533 · 20240201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗