Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT06240533
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implementation of P3C-LBP in Swedish Primary Care
Sponsor:
Linkoeping University
Organization:
Study Overview
Official Title:
Implementation of a Patient Centered Coordinated Care Pathway for Low Back Pain (P3C-LBP) in Swedish Primary Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P3C-LBP
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: