Implementation of P3C-LBP in Swedish Primary Care

Linköping University (LiU)

Status: Not yet enrolling

Conditions: Low Back Pain

Study type: Observational

Funder types: Other

Identifiers

NCT06240533

20240201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

300,000 participants in 4 patient groups

Historical baseline

Description:

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

Description:

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

Description:

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

Description:

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.