Clinical trial NCT05768516: Can we Improve Care Pathway in Low Back Pain?
Official title: Can we Improve Care Pathway in Low Back Pain? A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Back Pain, Low
Keywords: Stratified care
Guideline implementation
Primary care
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Haute Ecole de Santé Vaud
name: Delta SA
name: University of Applied Sciences of Western Switzerland
name: smarter medicine choosing wisely Switzerland
First posted: 2023-03-14
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arms parallel pilot study. Two healthcare centres (one for each arm) have been selected for their convenience.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: This study aims to investigate a multi-level intervention in primary care to improve the care of patients with LBP.

In this pilot trial, it is the GPs that will be recruited to be in either arm. Five to seven GPs will be recruited in each study arm. As this is a pilot study, randomization was not felt necessary. To facilitate this pilot study, two health care centers (one for each arm) have been selected for their convenience. GPs from each arm will thus be recruited within the same health care center.

For the development of the intervention, various existing interventions that have been tested successfully elsewhere and had the possibility of being adapted in the context of Switzerland's primary care practice were selected. The investigators used available evidence to develop the multi-level intervention. The different components and the procedures of the multi-level intervention were developed by a team of LBP experts in collaboration with GPs, PTs, and OTs. Various meetings with GPs were conducted to determine the feasibility and their preferences for each component of the intervention.

The overall goal of the intervention is to help GPs provide high-value care, adapt the treatment plan to the risk of chronicity (stratified care), decrease unnecessary healthcare (i.e., unnecessary imaging), and facilitate interprofessional collaboration. The intervention includes the following components:

1. Stratifying the management of LBP according to risk factors for chronicity with the StartBack tool (SBT) has been shown to improve patient outcomes and reduce unnecessary overtreatment. This stratification into 3 stages, low, medium, and high, is mainly based on the presence of elements such as kinesiophobia and catastrophism. These elements are linked to anxiety, which is often involved in the erroneous prescription of imaging or inappropriate care (e.g. opioids). Thus, by adapting management to psychological factors it is possible to facilitate the reduction of unnecessary care together with the improvement of patients' outcomes. Based on previous work, the investigators developed a simple algorithm to determine the risk level based on the SBT and other variables that have been shown to improve the classification, such as work capacity. Based on the risk level, a management plan is proposed which may include PT.

   PTs in the intervention group will all have participated to a one-day course to upgrade their knowledge on good clinical practice in LBP care and get the certification.
2. Healthcare professional education. The first component is health practitioners' education to improve their knowledge about LBP guidelines, diagnostic triage, and best practice. Furthermore, they will be trained to improve patients' education (i.e. on reducing the use of imaging), to follow a care strategy based on a questionnaire-based chronicity risk stratification rather than a step-up strategy, and improve interprofessional communication.
3. Patient education. Many patients expect to have an MRI of their spine in the belief that it will uncover the source of their problem and define the appropriate treatment. Only through better education can they change their perspective, be reassured of their clinical course without imaging, and understand the utility of staying active. Different strategies will be implemented to reassure patients. First, an education booklet "Understanding My Low Back Pain", which showed promising results in reducing the use of imaging has been translated into French and 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, which provides accurate and reassuring messages about LBP.
4. Interprofessional collaboration. By improving communication between the different healthcare providers, patients will have access to the right care at the right time and will receive a more consistent and reassuring message about LBP. To this end, a structured assessment form and facilitated contact will be implemented. PTs and OTs will be trained to provide a simple structured report of the patient's progress with a suggestion for further management to the GPs.

The multi-level intervention will be only at the level of the GPs. Prior to the start of the study, GPs will be informed on all aspects of good clinical practice during a specific time dedicated to continuing medical education. This will be done in interactive sessions, starting from their own experience, and implementing specific information when needed. A clinical pathway according to the risk of chronicity and specifically adapted to the Swiss healthcare system will be discussed during two one-hour meetings. The education will be provided by a rheumatologist with internationally recognized experience in the management of LBP. An information meeting will then be held to explain in detail the mechanisms of the study and the different tools that will be provided.

At the time of patient's first consultation for a new episode of back pain, The GP will have access to an interactive specifically designed and validated booklet in French "Understanding My Low Back Pain" to help educate patients that imaging is not recommended and point towards the general principle of good clinical practice care.

After the medical consultation, When the patient returns the signed informed consent form, the medical assistant will tag the patient within the computer system. Five days after the medical consultation the patient will receive an email with a questionnaire including the SBT. GPs will receive via email a summary of the SBT indicating the risk of chronicity (low, medium, or high) and a proposed treatment approach based on stratified care. The risk assessment will be based on the validated SBT with the addition of the ability to work.

In the case of low-risk GP'a are encouraged to focus on information and reassurance, with the help of information on a website. The use of additional treatments should be reduced to a minimum. In the case of medium risk, the proposition will be to prescribe 6 individual sessions of exercise-based physiotherapy. At the end of the 6 sessions, the physiotherapist will provide the GP with a structured report of the patient's progress with a suggestion for further management based on the clinical course: end of treatment, continuation for a few more sessions, or referral for further assessment to consider the need for structured multidisciplinary intervention. In cases of high risk, patients will be referred for 1-2 sessions to a specifically trained occupational therapist to determine if there is a need for immediate integration in a structured multidisciplinary group intervention or if the patient can be treated according to the proposition for medium risk patients. GPs are free to organize the following appointment and treatment plan according to the proposition or not.

Six weeks later, a second email will be sent to the patients with the same set of questionnaires and the updated results, including the updated risk of chronicity, will be sent to the GPs again. GPs may use this information to adapt patient care.

During the entire process, the decision on how to treat the patients is in the hand of the treating GPs. It is his responsibility to follow the recommendation of the proposed clinical pathway or not.

GPs in the control group will have no specific training or intervention. They will treat patients according to their usual practice. The same information will be provided to patients in the informed consent form (i.e. participation in a study on back pain). Patients will receive the same SMS to verify their phone number and then receive the same questionnaire as in the "stratified care" group. However, no feedback will be provided to the GPs.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of imaging and opioids prescriptions
timeFrame: At 6 months
measure: Recruitment procedures
timeFrame: At 6 months
Secondary outcomes:
measure: Level of disabling low back pain (LBP)
timeFrame: At 6 weeks, 3 months and 6 months
measure: Percentage of LBP patients reaching "acceptable symptom states "
timeFrame: At 6 weeks, 3 months and 6 months
measure: Level of low back pain intensity
timeFrame: At 6 weeks, 3 months and 6 months
measure: Percentage of patients reaching a low level of low back pain intensity
timeFrame: At 6 weeks, 3 months and 6 months
measure: Global perceived change
timeFrame: At 6 weeks, 3 months and 6 months
measure: Low back pain trajectory
timeFrame: At 6 months
measure: Direct treatment costs of low back pain
timeFrame: At 6 months
measure: Working incapacity costs
timeFrame: At 6 months
measure: Beliefs about low back pain in healthcare practitioners
timeFrame: At 6 months
Other outcomes:
measure: Age
timeFrame: enrollment
measure: Sex
timeFrame: enrollment
measure: Body mass index
timeFrame: enrollment
measure: Comorbidities
timeFrame: enrollment
measure: Tobacco use
timeFrame: enrollment
Locations:
city: Le Lignon
country: Switzerland
facility: Centre médical Lignon
state: Geneva
city: Onex
country: Switzerland
facility: Centre médical Onex
state: Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Stéphane Genevay, Prof
role: PRINCIPAL_INVESTIGATOR
References: