Measuring the Effect of an ePRO-based Clinical Decision Support System in Knee- and Hip Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 223
- 试验地点
- 2
- 主要终点
- Oxford Hip Score
研究概览
简要总结
The randomised clinical trial investigates the effect of using a clinical decision support system (CDSS) aiming to provide the patients and surgeons with greater transparency concerning the obtainable changes in function and health related quality of life (HRQoL) when patients are to decide if they should undergo hip- or knee replacement surgery.
详细描述
Osteoarthritis (OA) affects 20 % of the adult population in Denmark, and the economic burden to society is estimated to DKK 4.6 billion per year1,2. Symptoms related to evolving OA can usually be effectively managed, and treatment may slow the progression of the disease, however, approximately 10,000 and 8,000 hip and knee replacements, respectively, are performed each year in Denmark due to end-stage OA3-5.
The Danish clinical guidelines for the treatment of OA are compliant with international guidelines and recommend non-pharmacological and complementary pharmacological treatment as first-line treatment modalities3. When non-surgical treatment options become insufficient to relieve pain and improve function, referral to an orthopaedic surgeon for evaluation of whether the patient is eligible for surgery is advised. However, the guidelines do not provide clear guidance on which non-pharmacological treatment(s) or when surgery will be most beneficial for the individual patient, and consequently under- or over-utilisation of healthcare services may occur 3,6 Furthermore, matching patient's expectations with the achievable changes in function level after surgery can be challenging, which might be a contributor to the 20 % proportion of orthopaedic patients that are unsatisfied7,8. It highlights the importance of an enhanced basis for shared decision-making between surgeon and patient, as-well-as bringing focus on each patient's wishes and needs, as these are individual and thus might not be representative of the general population.
Patient-centred care acknowledges the importance of individual values and preferences and empowers patients to take an active part in decisions concerning their health and treatment pathway9. It moves beyond the paternalistic approach to treatment, substituting in its place a partnership-like relation between patient and clinician9,10.
Patient reported outcomes (PRO) have been suggested as a means to improve patient involvement and patient value through a shift in the perception of what constitute "good outcomes", and PRO has on several occasions been shown to be important predictors of clinical outcomes11-13. PRO measures are available for most clinical areas, but implementing a more patient-centred health-care system through PRO is still challenged by i.a. information asymmetry, and lack of aligning expectations12,14.
Denmark has a long tradition of collecting patient-specific data in the health care sector. The challenge today is that the knowledge embedded in these patient-specific health-care data is not utilized to its full potential, neither within nor between the primary and the secondary health care sectors, and, currently, there is a lack of knowledge on how to incorporate data and ePRO (electronic Patient Reported Outcome) to support patients in clinical decision-making.
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 (Participant)
盲法说明
Patients are blinded from the randomisation, and blinding of the consulting surgeon is not possible since the intervention is an interface add-on to the conventional treatment.
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 referred from a general practitioner in the North Denmark Region to the orthopaedic clinic at Aalborg University Hospital
- •Patients with painful OA in hip- or knee joint.
排除标准
- •Patients unable to answer the questions in danish
结局指标
主要结局
Oxford Hip Score
时间窗: 1 year
The OHS is a short 12-item PRO questionnaire, which is specifically designed and developed to assess the primary outcome in randomised controlled trials with patients undergoing hip or knee replacement surgery. The questionnaires are reproducible, validated and sensitive to clinically important changes24. The primary outcome measure is the delta value in OHS, or OKS measured at baseline, defined as the first consultation in the clinic, and at 1-year follow-up.
Oxford Knee Score
时间窗: 1 year
The OKS is a short 12-item PRO questionnaire, which is specifically designed and developed to assess the primary outcome in randomised controlled trials with patients undergoing hip or knee replacement surgery. The questionnaires are reproducible, validated and sensitive to clinically important changes24. The primary outcome measure is the delta value in OHS, or OKS measured at baseline, defined as the first consultation in the clinic, and at 1-year follow-up.
次要结局
- HRQoL(1 year)
- SDM(2 hours)
