Shared Responsibility Between General Practitioners and Highly Specialized Hospitals in Complex Chronic Conditions: the Case of Spinal Cord Injury in a Nationwide Intervention Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 273
- 试验地点
- 2
- 主要终点
- Average difference in total score of Doctor's Opinions on Collaboration (DOC)
研究概览
简要总结
It is an interventional study that aims to assess a new primary care model of collaboration between specialized centers and primary care physicians in Switzerland, in order to reduce morbidity and improve patients' and providers' experience with delivery of follow-up care in individuals with chronic spinal cord injury as compared to current best practice.
详细描述
This model will lead to awareness, recognition and interactive communication between GPs and specialists and guidelines on the shared-role relationship.
The study interventions are educational modules on bladder, bowel, skin-care, and pain management which will be provided to participating GPs by Spinal Cord Injury specialists. In addition visits by specialized nurses to the participating GPs at their practices to support the establishment of specialized care on-site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •GPs practicing in medium to large group practice
- •The practice is wheelchair accessible and remote to SCI specialized centers
- •Proficiency certificate in ultrasonography
- •Diagnosed with traumatic or non-traumatic, sensory or motor complete or incomplete, chronic SCI
- •18 years or older
- •Permanently reside in Switzerland
- •Reside farther than 25 minutes driving distance from a specialized SCI center
- •Understand German, English, Italian
- •Informed consent
- •Additionally in treatment group: Patients with chronic SCI Living in the region of a participating GP irrespective if they visit the participating primary care practice.
- •Additionally in control group: individuals with SCI who live outside the catchment areas
排除标准
- •Acute SCI or during first rehabilitation phase - Congenital conditions leading to paraplegia or tetraplegia, including spina bifida - Neurodegenerative disorders such as multiple sclerosis and amyotrophic lateral sclerosis - Guillain-Barré syndrome
结局指标
主要结局
Average difference in total score of Doctor's Opinions on Collaboration (DOC)
时间窗: Change from baseline to 12 and 24 months post intervention
DOC is a validated questionnaire covering organization, communication, professional expertise, image and knowing each other. It will be completed by GPs and SCI specialists. The DOC will be converted to an interval score and scaled from 0 to 100 with minimum and maximum score (0=completely agree, 100=completely disagree)
Average difference in total score of Modified Spinal Cord Injury Secondary Conditions Scale (SCI-SCS) score
时间窗: Change from baseline to 12 and 24 months post intervention
Modified Spinal Cord Secondary Conditions Scale (SCI-SCS) targets secondary conditions associated with SCI composite endpoint, excluding diabetes mellitus and joint and muscle pain. Modified (SCI-SCS) includes 14 health conditions and chronic pain. Self reporting through questionnaires on pressure sores, urinary tract infections, spasticity, postural hypotension, bowel, and bladder problems, etc...). The rating scale uses a 4-point ordinal scale ranging from 0 (not experienced/insignificant problem never limiting activity) to 3 (significant/chronic problem).
次要结局
- Average difference in number of patients visits to a specialist or a SCI center(Change from baseline to 12 and 24 months post intervention)
- Average difference in subscore on UTIs(Change from baseline to 12 and 24 months post intervention)
- Average difference in the number of inpatient hospitalization(Change from baseline to 12 months and 24 months post intervention)
- Physicians' satisfaction(Change in overall satisfaction scores from baseline to 12 and 24 months post intervention)
- Average difference in subscore on pressure sores(Change from baseline to 12 and 24 months post intervention)