Implementation of P3C-LBP in Swedish Primary Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Implementation of a Best Practice Primary Health Care Model for Low Back Pain

NCT03147300

Low Back Pain

COMPLETED NA

Markers of Outcome - a Cohort Study of LBP in Primary Health Care

NCT03108339

Low-back Pain

COMPLETED

13-year Follow-up of Women With Chronic Low Back Pain in Primary Care - a Prospective Longitudinal Cohort Study

NCT03974191

Low Back Pain Chronic Widespread Pain Predictors +3 more

UNKNOWN

Chronic Low Back Pain Rehabilitation in Primary Care: an RCT

NCT02220543

Low Back Pain Chronic Pain Musculoskeletal Pain

COMPLETED NA

Identification of Risk Factors for Recurrence of Low Back Pain and Occupational Repercussions

NCT05286333

Low Back Pain

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No