Clinical trial NCT06240533: Implementation of P3C-LBP in Swedish Primary Care
Official title: Implementation of a Patient Centered Coordinated Care Pathway for Low Back Pain (P3C-LBP) in Swedish Primary Care
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Low Back Pain
Keywords: Implementation
Care pathway
Patient centered care
Low back pain
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2024-02-05
Enrollment: 300000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Practitioner Confidence Scale
timeFrame: February 2024 and February 2025
measure: Patient sickness benefit days per month for LBP
timeFrame: Monthly January 2013 to December 2027
measure: Cost of health care per month for LBP
timeFrame: Monthly January 2013 to December 2027
Secondary outcomes:
measure: Determinants of Implementation Behaviour Questionnaire
timeFrame: February 2024 and February 2025
measure: Qualitative focus group interview
timeFrame: September 2024 to May 2025
measure: Use of medical imaging for LBP
timeFrame: Monthly January 2013 to December 2027
measure: Prescription of NSAIDS for LBP
timeFrame: Monthly January 2013 to December 2027
measure: Prescriptions of paracetamol for LBP
timeFrame: Monthly January 2013 to December 2027
measure: Prescriptions of opioids for LBP
timeFrame: Monthly January 2013 to December 2027
measure: Prescriptions of gabapentinoids for LBP
timeFrame: Monthly January 2013 to December 2027
measure: Prescriptions of antidepressants for LBP
timeFrame: Monthly January 2013 to December 2027
measure: Prescriptions of muscle relaxants for LBP
timeFrame: Monthly January 2013 to December 2027
measure: Referrals to specialist orthopedic clinics
timeFrame: Monthly January 2013 to December 2027
measure: Referrals to specialist pain rehabilitation clinics
timeFrame: Monthly January 2013 to December 2027
measure: New visits in primary care to physicians and physiotherapists for LBP
timeFrame: Monthly January 2013 to December 2027
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Östergötland health care region
Study officials:
affiliation: Department of Health, Medicine and Caring Sciences, Linköping University, Sweden
name: Allan Abbott, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Health, Medicine and Caring Sciences, Linköping University, Sweden
name: Allan Abbott, Professor
role: STUDY_CHAIR
affiliation: Department of Health, Medicine and Caring Sciences, Linköping University, Sweden
name: Allan Abbott, Professor
role: STUDY_DIRECTOR
References: