Can we Improve Care Pathway in Low Back Pain? A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 4
- 主要终点
- Number of imaging and opioids prescriptions
研究概览
简要总结
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.
详细描述
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:
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged over 18
- •Patient consulting a general practitioner for a new episode of LBP
- •Patients is part of "Delta Network"
排除标准
- •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
结局指标
主要结局
Number of imaging and opioids prescriptions
时间窗: At 6 months
The number of imaging procedure and opioids prescription in each group will be calculated
Recruitment procedures
时间窗: At 6 months
The number of patients included in the pilot trial in a 6-month period (number of participants/month/GP)
次要结局
- Percentage of LBP patients reaching "acceptable symptom states "(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)
- Low back pain trajectory(At 6 months)
- Working incapacity costs(At 6 months)
- Beliefs about low back pain in healthcare practitioners(At 6 months)
- Level of disabling low back pain (LBP)(At 6 weeks, 3 months and 6 months)
- Level of low back pain intensity(At 6 weeks, 3 months and 6 months)
- Direct treatment costs of low back pain(At 6 months)
研究者
Stephane Genevay
Professor
University Hospital, Geneva