--- title: Implementation of P3C-LBP in Swedish Primary Care nct_id: NCT06240533 overall_status: NOT_YET_RECRUITING sponsor: Linkoeping University study_type: OBSERVATIONAL primary_condition: Low Back Pain countries: Sweden canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06240533.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06240533" ct_last_update_post_date: 2024-02-06 last_seen_at: "2026-05-12T06:42:04.884Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **NCT ID:** [NCT06240533](https://clinicaltrials.gov/study/NCT06240533) ## Key Facts - **Status:** NOT_YET_RECRUITING - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 300000 - **Lead Sponsor:** Linkoeping University - **Conditions:** Low Back Pain - **Start Date:** 2024-02-01 - **Completion Date:** 2027-12-31 - **CT.gov Last Update:** 2024-02-06 ## 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 - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **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). - **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. - **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. - **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. ## Primary Outcomes - **Practitioner Confidence Scale** _(time frame: February 2024 and February 2025)_ — Healthcare practitioner rated´confidence in managing low back pain before and after a single-faceted implementation. The Practitioner Confidence Scale contains four items reported on a 5-point Likert scale, where a total score of 4 represents greatest self-confidence and 20 represents lowest self-confidence for managing patients with LBP. - **Patient sickness benefit days per month for LBP** _(time frame: Monthly January 2013 to December 2027)_ — Registry data from The Swedish Social Insurance Agency for diagnosis codes (ICD10: M54.5, M54.4, M54.3, M54.9) - **Cost of health care per month for LBP** _(time frame: Monthly January 2013 to December 2027)_ — Registry data from the Östergötland health care region database for diagnosis codes (ICD10: M54.5, M54.4, M54.3, M54.9) ## Secondary Outcomes - **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)_ ## Locations (1) - Östergötland health care region, Linköping, Sweden ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.östergötland health care region|linköping||sweden` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06240533.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06240533* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*