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【ChiCTR1900021274】Prevention of postoperative delirium among hip fracture patients

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基本信息

登记号

ChiCTR1900021274

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2019-02-10

临床申请受理号

靶点

适应症

術後譫妄

试验通俗题目

Prevention of postoperative delirium among hip fracture patients

试验专业题目

Effects of a poStoperative deliriuM cAre bundle to prevent postoperative deliRium in geriaTric hip fracture patients (SMART) programme on postoperative delirium among patients with hip fracture: A quasi-experimental study

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

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临床试验信息

试验目的

The primary objective of this study is to examine the effects of the postoperative delirium care bundle in preventing hip fracture patients from developing postoperative delirium. The secondary objectives of this study are to examine the effects of such care bundle to reduce the severity and duration of postoperative delirium, mortality, cognitive functional decline, falls, length of stay, immobilisation, use of physical restraint and health care costs and to improve daily living activities.

试验分类

试验类型

非随机对照试验

试验分期

其它

随机化

N/A

盲法

The orthopaedic nurses and OTs are not blinded to the intervention group as they need to perform assessments and follow the care plan to provide appropriate interventions to patients. DLNs are not masked to the group allocation as they need to make a recommendation list to corresponding patients. Patients will be blinded to group allocation. RAs will be masked to the trial design and group allocation.

试验项目经费来源

Professional Development Training Funding

试验范围

目标入组人数

180

实际入组人数

第一例入组时间

2019-03-01

试验终止时间

2020-12-31

是否属于一致性

入选标准

1. aged at least 60 years considered as geriatric cases in local setting; 2. admitted to a study ward from the emergency department; 3. with planned hip fracture surgery within 72 hours after the hip fracture (a femoral neck fracture, the proximal femur, a trochanteric or a sub-trochanteric facture); 4. will be enrolled in this study within 24 hours of admission; 5. to be able to communicate in Cantonese; and 6. be willing to participate in this study.；

排除标准

1. take antipsychotic medications (e.g. chlorpromazine, clozapine, olanzapine, risperidone, haloperidol, quetiapine, paliperidone, amisulpride and sertindole) (Avidan, Fritz, Maybrier, Muench & Escallier, 2018); 2. admit for a part of high-energy trauma such as traffic accident or are moribund on admission; 3. develop delirium upon surgery or plan to be admitted to the Intensive Care Unit after surgery.；

研究者信息

研究负责人姓名

试验机构

香港護士協會

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址