Implementation of P3C-LBP in Swedish Primary Care

NCT06240533 | Not Yet Recruiting

• 1 other identifier: 20240201
• Study Type: observational
• Target: 300,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Implementation; Care pathway; Patient centered care; Low back pain

Outcome Measures

Primary Outcomes (3)

• Practitioner Confidence Scale

  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.

  February 2024 and February 2025

• Patient sickness benefit days per month for LBP

  Registry data from The Swedish Social Insurance Agency for diagnosis codes (ICD10: M54.5, M54.4, M54.3, M54.9)

  Monthly January 2013 to December 2027

• Cost of health care per month for LBP

  Registry data from the Östergötland health care region database for diagnosis codes (ICD10: M54.5, M54.4, M54.3, M54.9)

  Monthly January 2013 to December 2027

Secondary Outcomes (12)

• Determinants of Implementation Behaviour Questionnaire

  February 2024 and February 2025

• Qualitative focus group interview

  September 2024 to May 2025

• Use of medical imaging for LBP

  Monthly January 2013 to December 2027

• Prescription of NSAIDS for LBP

  Monthly January 2013 to December 2027

• Prescriptions of paracetamol for LBP

  Monthly January 2013 to December 2027

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• General practitioners and primary health care nurses participating in P3C implementation workshops

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Östergötland health care region

Linköping, 58191, Sweden

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Allan Abbott, Professor

  Department of Health, Medicine and Caring Sciences, Linköping University, Sweden

  PRINCIPAL INVESTIGATOR

• Allan Abbott, Professor

  Department of Health, Medicine and Caring Sciences, Linköping University, Sweden

  STUDY CHAIR

• Allan Abbott, Professor

  Department of Health, Medicine and Caring Sciences, Linköping University, Sweden

  STUDY DIRECTOR

Central Study Contacts

Allan Abbott, Professor

CONTACT

+46 733816914; allan.abbott@liu.se

Karin M Schröder, Assoc Prof

CONTACT

+46 700850752; karin.schroder@liu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 15 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)