Effectiveness of a Novel Cross Sectorial Collaborative Treatment Pathway for Chronic Pain Patients. A Multicenter Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 386
- 试验地点
- 5
- 主要终点
- Pain interference
研究概览
简要总结
In this multicenter randomized controlled trial, the aim is to evaluate the effectiveness of a standardized treatment pathway (STP) for patients referred to four participating pain clinics, by comparing it to treatment as usual (TAU) which is standard care at the clinics.
The STP differs from TAU in two key aspects:
- Structured cross-sector collaboration: Involvement of primary healthcare providers, particularly the patient's GP, in two digital collaborative meetings with the pain clinic.
- Time-bound treatment pathway: A clearly defined treatment trajectory with follow-up over a six-month period.
The study aims to answer whether the STP give larger improvements than TAU in the following outcomes:
- patients´ reported overall impression of change in health (primary outcome)
- pain interference (primary outcome)
- physical function and mental health
- satisfaction with and experience of continuity and integration of the health care services
All study participants will follow an initial care pathway at the pain clinic, which includes:
- a screening consultation with a study coordinator
- a multidisciplinary clinical assessment based on a biopsychosocial approach by at least to health care professions. The specific professional groups included in each assessment are determined individually based on patient needs.
The control group:
This group will receive standard care at the pain clinic. This will vary somewhat between the four pain clinics , but almost all patients will be offered a summary consultation with the pain clinic team where further plans for follow-up will be discussed. Some patients will be offered further treatment at the pain clinic.
All clinics will send a clinical summary to the referring physician with suggestions for further follow-up. If further collaboration with primary care is needed, it may preferably be written or arranged via telephone. Digital collaborative meeting will not be offered to this group.
The intervention group:
All patients in this group will be offered the STP with two digital collaborative meetings as described above.
详细描述
A new standardized treatment pathway (STP) has been developed by the Pain Research Group at St. Olav's Hospital. The STP is designed to establish structured collaboration between specialist and municipal health services, as well as the Norwegian Labor and Welfare Administration (Nav). In this study, the STP will be compared to the current standard of care, which typically involves multidisciplinary clinical assessments followed by a summary consultation between the pain clinic and the patient.
The key innovation of the STP lies in its cross-sectorial collaboration, most notably the inclusion of the patient's general practitioner (GP) in two structured video consultations with the patient and the multidisciplinary pain clinic. When relevant, a Nav representative or representatives from municipal and specialized health service may also participate. A collaborative treatment plan is developed during the first video consultation and reinforced through a six-month follow-up period, culminating in a second collaborative consultation.
Given that the STP is more resource-demanding than current practices at Norwegian pain clinics, involving coordinated efforts across multiple sectors, it is crucial to evaluate its overall effectiveness. Equally important is identifying which patient subgroups may benefit most from this approach, to ensure that resources are allocated efficiently and care is tailored to those with the greatest need.
The primary aim of this study is to evaluate the effectiveness of the STP for patients referred to one of four participating pain clinics, by comparing it to TAU in a randomized controlled trial.
Hypotheses, aims and objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients aged 18 years or older who have been granted the right to specialist health care in accordance with the Norwegian National prioritization guideline for pain clinics, and who are scheduled for multidisciplinary treatment involving at least two professionals from the pain clinic.
排除标准
- •Patients scheduled for monodisciplinary treatment. Patients referred solely for invasive procedures. Patients without sufficient language skills to understand the study information and provide informed consent. Patients are excluded if interpreter services are required.
- •Patients deemed unable to complete study-related tasks (e.g., questionnaires). Patients referred exclusively for stabilization or tapering of opioids or other medications considered addictive.
- •Patients who will be unable to participate in collaborative meetings or follow the treatment plan due to extensive ongoing or planned care trajectories within other specialist health services.
研究组 & 干预措施
Treatment as usual: Standard care at a multidisciplinary pain clinic
Standard care following present procedures at the multidisciplinary pain clinics involved in this study
干预措施: Treatment as usual (Other)
A collaborative treatment pathway for patients referred to multidisciplinary pain clinics.
The study intervention is a new standardized treatment pathway with exteded collaboration for patients referred to pain clinics.
干预措施: A collaborative treatment pathway for patients referred to multidisciplinary pain clinics in Norway (Other)
结局指标
主要结局
Pain interference
时间窗: At baseline and through to 18 months after baseline
Pain interference questions (q8-q14)from the Brief Pain Inventory questionnaire (BPI)
Pain interference
时间窗: At baseline and through to 18 months after baseline
Pain interference questions (q8-q14)from the Brief Pain Inventory questionnaire (BPI)
Overall impression of change in health
时间窗: Measured 18 months after baseline
Patient global impression of change questionnaire (PGIC)
次要结局
- Satisfaction with the patient's GPs(From baseline to 18 months after baseline)
- Patient's satisfaction with the pain clinic(From 2 weeks after 1.st collaborative meeting/ summary meeting to 18 months after baseline)
- Use of prescibed opioids or other potentially addictive medications(From baseline to 18 months after baseline)
- Health care utilisation, specialist health care(From baseline to 18 months after baseline)
- Health care utilisation, primary health care(From baseline to 18 months after baseline)
- Return to work and other decisions from the Norwegian social security systems (Nav)(from baseline to 18 months after baseline.)
- Sleep problems(From baseline to 18 months after baseline)
- Pain intensity(From baseline to 18 months after baseline)
- Physical function(From baseline and to 18 months after baseline)
- Mental health(From baseline to 18 months after baseline)
- Patient experience of continuity and integration of health care services(From baseline to 18 months after baseline)
- Trust in health care services and social security services(From baseline to 18 months after baseline)
- Collaboration between health care services(From baseline to 18 months after baseline)
- Physical function(From baseline and to 18 months after baseline)
- Mental health(From baseline to 18 months after baseline)
- Patient experience of continuity and integration of health care services(From baseline to 18 months after baseline)
- Trust in health care services and social security services(From baseline to 18 months after baseline)
- Collaboration between health care services(From baseline to 18 months after baseline)
- Satisfaction with the patient's GPs(From baseline to 18 months after baseline)
- Patient's satisfaction with the pain clinic(From 2 weeks after 1.st collaborative meeting/ summary meeting to 18 months after baseline)
- Use of prescibed opioids or other potentially addictive medications(From baseline to 18 months after baseline)
- Health care utilisation, specialist health care(From baseline to 18 months after baseline)
- Health care utilisation, primary health care(From baseline to 18 months after baseline)
- Return to work and other decisions from the Norwegian social security systems (Nav)(from baseline to 18 months after baseline.)
- Sleep problems(From baseline to 18 months after baseline)
- Pain intensity(From baseline to 18 months after baseline)
研究者
Astrid Woodhouse
Associate Professor
St. Olavs Hospital