跳至主要内容
临床试验/NCT04806191
NCT04806191已完成不适用

Making Shoulder Pain Simple in General Practice-implementing an Evidenced Based Guideline for Shoulder Pain, a Hybrid Design Cluster Randomised Study

University of Oslo2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年3月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
2
主要终点
Change in Shoulder Pain and Disability Index (SPADI)

研究概览

简要总结

Previous research suggests that general practitioners find handling patients with shoulder pain difficult and that the current care for shoulder pain is not in line with the best available evidence (1).This project aims to assess the effectiveness, costs and implementation of an evidence-based guideline for shoulder pain in general practice.

详细描述

A simplified and evidence-based algorithm for examination and treatment of patients with shoulder pain will be developed and implemented in general practice. The purpose is to improve quality of care and provide GPs with a simplified and efficient tool to handle patients with common shoulder- related pain. The study is a stepped-wedge, cluster-randomized trial with a hybrid design including a effectiveness, cost and implementation assessment of a guideline-based intervention in clinical practice (2). General practitioners in Norway will be recruited and the GP offices will be randomized to the time of crossover from current treatment as usual (TAU) to the implementation of the intervention. The intervention is a tailored strategy that includes workshops for general practitioners covering information and access to a decision support tool, an education program where the general practitioner learn an evidence-based approach to shoulder pain and access to patient information materials. Outcomes will be measured at patient and GP levels, using self-report questionnaires, focus group interviews and register based data.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessor will be blinded for treatment allocation. Randomization will be done after recruitment of GPs. GPs and study coordinators and outcome evaluators will be blinded to the allocation sequence with only the allocation of the next GP surgery being revealed by randomization list holder approximately 6 weeks before each intervention implementation point.

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

  • •Pain in the shoulder region
  • •Above 18 years

排除标准

  • •Unable to fill in self-report questionnaires or do not understand Norwegian
  • •Acute injury with clinical suspicion of fracture, luxation of shoulder joints or large tendon ruptures
  • •Clinical suspicion of referred pain to the shoulder area from other organs
  • •Signs of inflammatory joint disease
  • •Suspicion of malignant disease
  • •Symptoms and signs of cervical radiculopathy

研究组 & 干预措施

Intervention

Experimental

Patients will be assessed by GPs who have attended an outreach workshop and trained at using an evidence based strategy for shoulder examination and treatment. GPs will have access to a decision support tool and patients is offered a tailored information package for self management.

干预措施: Evidence based treatment strategy (Other)

Treatment as usual (TAU)

Active Comparator

The participants enrolled in the control period will receive treatment as offered in general practice.

干预措施: Treatment as usual (TAU) (Other)

Intervention

Experimental

Patients will be assessed by GPs who have attended an outreach workshop and trained at using an evidence based strategy for shoulder examination and treatment. GPs will have access to a decision support tool and patients is offered a tailored information package for self management.

干预措施: Targeted patient information package (Other)

结局指标

主要结局

Change in Shoulder Pain and Disability Index (SPADI)

时间窗: Change from 0 to 12 weeks

13 item patient reported questionnaire on shoulder pain and disability. (0 = no pain or shoulder disability, 100 = worst pain and disability).

次要结局

  • Patient reported quality of care index (treatment according to the guideline intervention)(0 week (after 1. visit to general practitioner))
  • Global patient perceived effect of treatment outcome (GPE)(Measured at 6,12 and 52 weeks. Primary analysis of interest is at 12 weeks.)
  • the EuroQol quality of life measure (EQ5D-5L)(Change from 0 weeks to 52 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Niels Gunnar JUEL

MD. PhD

University of Oslo

研究点 (2)

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