Transforming Rehabilitation: Personalised Care for a Better Quality of Life (PREPARE, Phase 2)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Length of inpatient rehabilitation stay (days)
研究概览
简要总结
The general aim of the project is training and testing a predictive model of inpatient rehabilitation stay after hip and knee replacement for osteoarthritis. This specific part focuses on data collection and analysis for the model validation.
详细描述
The following variables will be investigated to evaluate their predictive value towards length of rehabilitation stay (primary outcome), place of discharge, burden of care at discharge and/or functional recovery (secondary outcomes):
- Patient age at admission
- Patient sex
- Patient profession
- Living status (e.g. home or residential unit)
- Diagnosis
- Surgical procedure
- American Society of Anesthesiologists Score
- Body Mass Index before surgery
- Day of surgery
- Duration of surgery (minutes)
- Surgical access technique
- Surgical ward stay
- Pre-existing comorbidities
- Pharmacological treatment of pre-existing conditions
- Hemoglobin levels at inpatient rehabilitation admission
- Pain (Numeric Rating Scale) at inpatient rehabilitation admission
- Function - cognitive domains at inpatient rehab admission
- Barthel Index of Activities of Daily Living (ADL) at inpatient rehab admission
- Physiotherapic functional evaluations
- Rehabilitation program
- Function - cognitive domains at inpatient rehab discharge
- Inpatient rehabilitation stay
- Place of discharge
- Use of walking aids at discharge
- Need of assistance with the ADL at discharge
- Barthel Index of Activities of Daily Living at inpatient rehab admission
Due to retrospective study design, patients will not be recruited ex-novo and will be used data already stored in the internal databases.
Data retrieved from clinical records and other sets internal to the hospital will be collected on a dedicated Excel sheet and divided per section of interest (baseline, intervention, outcomes).
Data from 1710 patients who underwent total hip or knee replacement and subsequent inpatient rehabilitation in our hospital were collected, in the previous part of this project, to train the model.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 admitted for THR and TKR at IRCCS Galeazzi Orthopedic Institute in 2018 (any month) and subsequently discharged to inpatient rehabilitation in the same structure.
- •Aged ≥18 years.
- •International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9CM) Diagnoses: 715.15, 16, 25, 26 (primary and secondary osteoarthritis of the hip and knee).
- •ICD-9CM Surgical procedures: 81.51, 81.54 (total joint replacement of the hip and knee).
排除标准
- •Age < 18 years (if any).
结局指标
主要结局
Length of inpatient rehabilitation stay (days)
时间窗: Up to 30 days
The number of days needed by the patient to be discharged in safety
次要结局
- Need of care at discharge(Last day of inpatient rehabilitation stay: up to 30 days)
- Barthel Index of autonomy in Activities of Daily Living (ADL)(Last day of inpatient rehabilitation stay: up to 30 days.)
- Place of discharge(Last day of inpatient rehabilitation stay: up to 30 days.)