Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05768516 |
| Other study ID # |
2023-00199 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 5, 2023 |
| Est. completion date |
April 30, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
University Hospital, Geneva |
| Contact |
Stephane Genevay, Prof. |
| Phone |
+41223723311 |
| Email |
stephane.genevay[@]hcuge.ch |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
