NCT Number: NCT07396532
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Not applicable
Singapore, 544886
Location status: Recruiting
Di Zhang, RN, DNP
SUB_INVESTIGATOR
Elaine Goh, RN, BSN
CONTACT
Elaine Goh, RN, BSN
PRINCIPAL_INVESTIGATOR
Hui Yu Pang, RN, BSN
SUB_INVESTIGATOR
Sandy Ang, RN, BSN
SUB_INVESTIGATOR
Yoke Hui Wong, RN, DNP
SUB_INVESTIGATOR
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:
The audio messages are approximately 2 minutes long and include: reorientation information (patient's location, real-time update of date and time, reason for admission), explanation of their recovery process, encouragement for therapy participation, pain management guidance, and reassuring messages on who are taking care of them in the hospital. Messages are played through noise-canceling headphones to ensure clarity and minimize ward noise interference.
Implementation Approach:
Nursing staff receive brief training on the iPad system and the workflow process. The intervention is designed to be sustainable within existing workflow patterns without adding significant burden to clinical staff. Visual reminders of workflow process were also readily available in nursing stations to remind the nurses. Study team also do their rounds to ensure availability of equipment and to clarify doubts from nursing staff.
Target Population:
Elderly patients (≥60 years) admitted to orthopedic wards following hip fracture surgery who are at risk for developing post-operative delirium based on established risk factors.
Feasibility Focus:
As a pilot study, this research prioritizes understanding implementation challenges, staff acceptance, patient tolerance, and recruitment feasibility to inform the design of a future definitive trial examining delirium prevention effectiveness.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From postoperative day 1 to end of study participation (up to 2 weeks)
Delirium will be assessed using the 4AT (4 'A's Test), a validated 4-item screening instrument that evaluates alertness, attention (months backwards), acute change or fluctuating course, and AMT4 (age, date of birth, place, current year). The 4AT score ranges from 0-12, with scores ≥4 indicating possible delirium and scores ≥1 suggesting cognitive impairment. Delirium incidence will be reported as the number and percentage of participants who score ≥4 on the 4AT during their study participation period.
Time frame: From admission to pilot ward until discharge/transfer from pilot ward (up to 2 weeks)
Length of stay will be measured as the total number of days from admission to the pilot ward until discharge from the pilot ward (either to home, transfer to another ward, or transfer to community hospital). This measure captures only the time spent specifically in the study/pilot ward and does not include any subsequent stays in other wards or facilities. Length of stay will be calculated in whole days and reported as mean, median, and range.
Time frame: From postoperative day 1 to postoperative day 3
Allied health participation will be measured as the number and percentage of participants who actively engage in their prescribed physiotherapy (PT) and occupational therapy (OT) sessions during their stay in the pilot ward. Participation will be defined as attending and actively engaging in therapy sessions as documented by the treating therapists. Since all hip fracture patients receive standard PT/OT orders, this outcome measures engagement rather than referral rates. Data will be collected through therapy documentation review.
Time frame: From postoperative day 1 to postoperative day 3
Analgesic consumption will be measured as the total cumulative dose of commonly prescribed analgesics (morphine, paracetamol, and oxycodone) consumed by participants during post-operative days 1 to 3. All doses will be recorded in their respective units (morphine in mg, paracetamol in mg, oxycodone in mg) from medication administration records. This outcome assesses whether improved orientation and medication compliance messaging through the audio-recorded intervention affects analgesic usage patterns. Data will include both scheduled and PRN (as needed) doses administered.
Contact information is provided by the study sponsor or research team.
Sengkang General Hospital
Other
Nurse-Led Audio-Recorded Reorientation to Reduce Delirium in Elderly Hip Fractures: A Pilot Randomized Control Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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