Can we Improve Care Pathway in Low Back Pain?

NCT05768516 | Unknown DMC

• 1 other identifier: 2023-00199
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 2

Brief Summary

The general objective of this pilot study is to investigate a new multi-level intervention in primary care to improve the care of patients with low back pain. Specifically, it will first investigate the feasibility of delivering this intervention in primary care in Switzerland. Second, it will evaluate the effectiveness of the intervention on the use of unnecessary imaging and unhelpful medication in primary care, the risk of developing chronic disabling care, and direct and indirect healthcare costs. In this two-arm parallel pilot study, it is the general practitioners that will be recruited to be in either arm. In the intervention group, they will deliver the multi-level intervention that consists of:

• Stratifying care based on the risk of chronicity
• Improving healthcare professional education
• Improving patient education
• Facilitating interprofessional communication General practitioners in the control group will have no specific training or intervention. They will treat patients according to their usual practice.

Conditions

Back Pain, Low

Keywords

Stratified care; Guideline implementation; Primary care

Outcome Measures

Primary Outcomes (2)

• Number of imaging and opioids prescriptions

  The number of imaging procedure and opioids prescription in each group will be calculated

  At 6 months

• Recruitment procedures

  The number of patients included in the pilot trial in a 6-month period (number of participants/month/GP)

  At 6 months

Secondary Outcomes (9)

• Level of disabling low back pain (LBP)

  At 6 weeks, 3 months and 6 months

• Percentage of LBP patients reaching "acceptable symptom states "

  At 6 weeks, 3 months and 6 months

• Level of low back pain intensity

  At 6 weeks, 3 months and 6 months

• Percentage of patients reaching a low level of low back pain intensity

  At 6 weeks, 3 months and 6 months

• Global perceived change

  At 6 weeks, 3 months and 6 months

Other Outcomes (5)

• Age

  enrollment

• Sex

  enrollment

• Body mass index

  enrollment

Study Arms (2)

Multi-level intervention

EXPERIMENTAL

General practioners in this arm will receive the multi-level intervention composed of Stratified care, Healthcare professional education, Patient education and Interprofessional collaboration.

Other: Implementation of best practice for low back pain in primary care

Usual care

NO INTERVENTION

GPs in the control group will have no specific training or intervention. They will treat patients according to their usual practice.

Interventions

Implementation of best practice for low back pain in primary care OTHER

1. Stratified care: GPs will use a simple algorithm based on the risk of chronicity to determine the management plan. The risk level bas will be based on the Start Back Tool (SBT) and other variables that have been shown to improve the classification, such as work capacity. 2. Healthcare professional education: GPs will receive education to improve their knowledge about low back pain guidelines, diagnostic triage, patient education, stratified care and best practice. 3. Patient education: An education booklet "Understanding My Low Back Pain" will be used by GPs during their consultations. Second, GPs, PTs and OTs will provide similar reassuring messages and direct patients to the website www.infomaldedos.ch. 4. Interprofessional collaboration: A structured assessment form and a facilitated contact will be implemented between healthcare providers.

Multi-level intervention

Eligibility Criteria

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

You may qualify if:

• Aged over 18
• Patient consulting a general practitioner for a new episode of LBP
• Patients is part of "Delta Network"

You may not qualify if:

• Patients that had already consulted their GP for LBP in the last three months (not a new episode)
• Patients unable to give consent and/or unable to answer the questionnaires, i.e. due to Dementia or language difficulties
• Known pregnancy
• Unable or unwilling to provide either a smartphone number or an email address.
• Unable or unwilling to give informed consent

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Haute Ecole de Santé Vaud: collaborator
• Delta SA: collaborator
• University of Applied Sciences of Western Switzerland: collaborator
• smarter medicine choosing wisely Switzerland: collaborator

Study Sites (2)

Centre médical Lignon

Le Lignon, Canton of Geneva, 1219, Switzerland

RECRUITING

Centre médical Onex

Onex, Canton of Geneva, 1213, Switzerland

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Stéphane Genevay, Prof

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephane Genevay, Prof.

CONTACT

+41223723311; stephane.genevay@hcuge.ch

Guillaume Christe, PhD

CONTACT

+41213168123; guillaume.christe@hesav.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and general practitioners will not be blinded to their group. No outcome will be measured be an external assessor (patients will fill out questionnaires at home). The statistical analysis will be blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two-arms parallel pilot study. Two healthcare centres (one for each arm) have been selected for their convenience.

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 14, 2023
• Study Start: June 5, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)