C-PRO - The Effect of Cross-sectorial Use of Patient-Reported Outcomes for Patients With Chronic Degenerative Shoulder Conditions
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,000
- 试验地点
- 12
- 主要终点
- Treatment cost per change in life quality
研究概览
简要总结
This research project aims to test if systematic (extensive) use of patient-reported outcomes across treatment boundaries can
- improve patients' and health professionals' understanding of individual patients' conditions and health changes,
- improve indications for treatment,
- strengthen patient empowerment, and
- reduce patients' utilization of health services.
The study will be performed in the particular context of patients with chronic degenerative conditions of the shoulder. These patients are characterized by contact with numerous health professionals from different health sectors, such as general practitioner, physiotherapists and surgical referral centres, which challenges coherence and communication for the individual treatment decisions. The research project will be performed as a randomized controlled trial (RCT) with a 1-year inclusion period and two years of follow-up.
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
- Single (Outcomes Assessor)
盲法说明
It is not possible to perform any blinding during collection and use of PRO data as part of the evaluation and treatment of the shoulder condition. However, following the end of PRO collection (and use), the following data collection and evaluation of the use of healthcare services and satisfaction with the treatment given will be performed with information of randomization blinded to the evaluators (VIVE).
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •shoulder pain with no acute trauma
排除标准
- •Age <18 years
- •Non-Danish citizenship
- •Unable to understand written or spoken Danish
- •Inability to master electronic means of communication and/or not having an electronic communication (E-boks)
- •Employee at participating centre or other relation to participating health professionals that might affect independent consent
- •Psychiatric conditions, mental conditions and substance abuse that might affect the ability to provide informed consent or responding to PROMs
- •Disseminated malignant condition, other serious medical conditions or other life crisis where the focus on a shoulder research project is unreasonable
- •Already included in the study with the contralateral shoulder
结局指标
主要结局
Treatment cost per change in life quality
时间窗: From inclusion time and the 2 following years.
The treatment cost during the study period expressed as the cost per improvement in life quality, similar to the cost per QALY (quality adjusted life years). The total cost will be calculated from hospital contacts, physiotherapy sessions and primary healthcare contacts. The EQ5D-5L will be used as a generic life quality measure. The primary outcome for the intervention and control group will be compared.
次要结局
- Treatment cost per change in life quality stratisfied according to the specific shoulder diagnosis(From inclusion time and the 2 following years)
- Patient satisfaction with the treatment of their shoulder problem(From inclusion time and the 2 following years)
- Number of patients treated with surgery(From inclusion time and the 2 following years)
- Number and types of complications during the treatment of the shoulder problem(From inclusion time and the 2 following years)
- Number of contacts with either the hospital or the family doctor due to problems with the treated shoulder(From inclusion time and the 2 following years)
- For patients still working: Number and duration (measured in days) of any periods of sick-leave/unemployment due to the shoulder problem(From inclusion time and the 2 following years)
- Development in the PRO score, represented by Oxford Shoulder Score, over time for each specific shoulder disease(From inclusion time and the 2 following years)
- If use of systematic PRO scores, represented by Oxford Shoulder Score, changes the referral-pattern between the involved sectors(From inclusion time and the 2 following years)
- PRO score, represented by Oxford Shoulder Score, as predictors?(From inclusion time and the 2 following years)
- Health professionals' assessments of history and usefulness of the prognosis tools developed for this study (the Database setup in Procordo).(From inclusion time and the 2 following years)
- Patient satisfaction with the PRO score system build in the Database system (Procordo)(From inclusion time and the 2 following years)
研究者
Anne Marie Nyholm
Principal investigator
University Hospital, Gentofte, Copenhagen