Nurse-Led Audio-Recorded Reorientation to Reduce Delirium in Elderly Hip Fractures: A Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Protocol Adherence Rate
研究概览
简要总结
The goal of this pilot clinical trial is to learn if personalized audio-recorded reorientation messages can be successfully implemented in general hospital wards for elderly patients after hip fracture surgery. It will also explore whether this intervention might help prevent confusion (delirium) after surgery. The main questions it aims to answer are:
- Can the intervention be successfully delivered by nursing staff in a busy orthopedic ward?
- How many eligible patients can be recruited and retained in the study?
- Do patients tolerate listening to the personalized audio messages without problems?
- Does listening to personalized audio messages show any early signs of reducing confusion after surgery?
Researchers will compare patients who receive personalized audio messages to those who receive usual care to see if the intervention is feasible to implement and whether it shows promise for preventing delirium.
Participants will:
- Listen to 2-minute personalized audio-recorded reorientation messages played through an iPad and headphones three times daily for the first 3 days after surgery
- Have their orientation and mental status checked daily for three times by nursing staff
- Continue with all their regular medical care and treatments
- Be monitored until discharge from the study wards.
详细描述
Background and Rationale:
Hip fracture surgery is common among elderly patients, but recovery can be complicated by post-operative delirium (confusion), which affects up to 50% of patients and can lead to longer hospital stays, increased complications, and delayed rehabilitation. Non-pharmacological interventions, particularly reorientation strategies, have shown promise in preventing delirium, but implementation in busy hospital wards remains challenging.
Study Design and Innovation:
This pilot randomized controlled trial tests an innovative approach using personalized audio-recorded reorientation messages delivered via 'Shortcut' Application on the iPad technology. The messages are available in multiple languages (English, Mandarin, Malay, Tamil) to accommodate the diverse patient population, but the content is standardized across all participants. This technology-supported approach enables nurses to provide systematic reorientation interventions as part of their routine care.
Intervention Details:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older adults aged 60 years and above
- •Undergoing hip fracture repair surgery
- •No history of cognitive impairment as assessed by Abbreviated Mental Test (AMT)
- •Able to understand to any of the basic languages of Singapore (English, Malay, Mandarin, Tamil)
排除标准
- •Patients not admitted directly to orthopaedic (study) wards post-operation (such as those requiring post-operative high-dependency unit care)
- •Patients managed conservatively without surgical intervention.
- •Patients admitted for periprosthetic hip fracture repairs
- •Patients who are deaf and mute
研究组 & 干预措施
Audio-Recorded Reorientation Intervention
Participants in this arm receive personalized audio-recorded reorientation messages delivered three times daily during the first three post-operative days. Each message lasts approximately 2 minutes and contains personalized information including the current location, date and time, and encouraging messages. Messages are delivered via iPad and headphones by nursing staff during routine care. Audio messages are available in English, Mandarin, Malay, and Tamil to accommodate patient language preferences. Participants also receive all standard post-operative care and treatments.
干预措施: Audio-Recorded Reorientation Intervention (Behavioral)
Standard Care Control
Participants in this arm receive standard hip fracture care according to the hospital's established hip fracture pathway. Standard care includes early mobilization with sitting out of bed three times daily, allied health professional involvement (physiotherapist, occupational therapist, and dietitian), and routine orientation assessment.
Participants found to be disoriented are screened for delirium using the validated 4AT assessment tool administered by nursing staff. Those identified as at-risk or experiencing delirium receive a comprehensive delirium care bundle including environmental modifications, medication review, and enhanced monitoring. Standard reorientation interventions include whiteboard orientation displays and purple wrist tags for participants at risk of cognitive impairment to ensure enhanced monitoring and fall prevention.
No study-specific interventions are provided to this group beyond routine hospital care protocols.
结局指标
主要结局
Protocol Adherence Rate
时间窗: Postoperative day 1 to postoperative day 3
Percentage of planned audio-recorded reorientation sessions successfully delivered by the nurses across the first 3-day intervention period. Target adherence rate ≥95% to demonstrate intervention feasibility.
Recruitment Feasibility
时间窗: From enrollment to end of study participation (up to 2 weeks)
Recruitment feasibility measured by screening-to-enrollment rate, calculated as: (1) percentage of screened patients meeting eligibility criteria, and (2) percentage of eligible patients providing informed consent. These rates will be tracked throughout the study period to assess the feasibility of recruiting the target population for a future definitive trial. Target enrollment rate of ≥80% of eligible patients will indicate feasibility.
Study Retention Rate
时间窗: From enrollment to end of study participation (up to 2 weeks)
Percentage of enrolled participants who completed the study protocol without withdrawal, calculated as number completing study divided by total enrolled. Target retention rate ≥90% to demonstrate intervention feasibility.
Intervention Tolerance Rate
时间窗: Postoperative Day 1 to Postoperative Day 3
Completion of each audio-recorded reorientation session without early discontinuation or adverse reactions, assessed during each of the 9 planned sessions per participant. Target adherence rate ≥95% to demonstrate intervention feasibility.
次要结局
- Number of participants with delirium as assessed by 4AT (4 'A's Test) screening tool(From postoperative day 1 to end of study participation (up to 2 weeks))
- Length of stay in study ward measured in days(From admission to pilot ward until discharge/transfer from pilot ward (up to 2 weeks))
- Number of participants actively participating in prescribed physiotherapy and occupational therapy sessions(From postoperative day 1 to postoperative day 3)
- Cumulative analgesic consumption(From postoperative day 1 to postoperative day 3)