Enhanced Implementation of Low Back Pain Guidelines in General Practice: A Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,101
- 试验地点
- 1
- 主要终点
- Referral of patients to a secondary care back centre
研究概览
简要总结
The aim of this study is to evaluate whether an enhanced strategy of implementation of the new guideline will lower the number of patients getting referred to secondary care spine centres compared to a normal implementation strategy.
详细描述
Introduction:
There is a need for more knowledge on how to introduce new guidelines effectively in general practice. A new low back pain treatment guideline is implemented in Denmark. This guideline demands that patients with low back pain who have not improved after eight weeks of primary care treatment should be referred to a secondary care spine centre.
Methods:
This is a cluster randomized trial. One hundred general practices define clusters and are randomly allocated to enhanced or usual implementation of the new guideline. The practices are all situated in the North Denmark Region and count two hundred general practitioners (GPs).
General practices in the control group will receive normal implementation of the new guideline, which include newsletters and briefings. In contrast the intervention group will receive an enhanced implementation strategy, adding visits from a consultant, two different stratification tools and feedback on guideline compliance. The two stratification tools: The STarT back screening tool (STarT) and a "Social and Occupational Screening" tool (SOS). The two screening tools subgroups patients and aids the clinicians in their choice of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provider number in the North Denmark Region (Practice level)
- •ICPC coded: L02, L03, L84, and L86 (Patient level)
- •Age 18-65 years (Patient level)
排除标准
- •No signed written consent form (Practice level)
- •Earlier participation in project testing (Practice level)
- •Already included (Patient level)
- •Patients with "red flags"/signs of serious pathology (Patient level)
- •Pregnancy (Patient level)
- •Insufficient Danish language skills (Patient level)
研究组 & 干预措施
Enhanced strategy
Enhanced implementation strategy
干预措施: Enhanced guideline implementation strategy (Behavioral)
Strategy as usual
Normal implementation strategy
干预措施: Guideline implementation as usual (Behavioral)
结局指标
主要结局
Referral of patients to a secondary care back centre
时间窗: 12 weeks
次要结局
- EQ-5D (Life quality)(4, 8, and 52 weeks)
- Employment status(4, 8, and 52 weeks)
- Cost-effectiveness(4, 8, and 52 weeks)
- Roland Morris 23q disability score(4, 8, and 52 weeks)
- Sick-leave(4, 8, and 52 weeks)
- Numerical pain rating(4, 8, and 52 weeks)