The Southeast and East Asian Post-Operative Delirium (SEAPOD) Study

Hip Fractures Clinical Trial

Official title:

The Southeast and East Asian Post-Operative Delirium (SEAPOD) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04999891
• Other study ID #: 2020/01350
• Status: Recruiting
• Start date: August 22, 2021
• Est. completion date: December 2024

Study information

• Verified date: August 2022
• Source: National University Hospital, Singapore
• Contact: Lian Kah Ti
• Phone: 6772 4200
• Email: anatilk[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The specific aim of the study will be to investigate the incidences and risk factors for postoperative delirium (POD) after hip fracture surgery in elderly patients aged ≥ 65 years in five different Southeast and East Asian countries. The secondary objectives are outlined below: 1. To investigate factors in the hospital environments, such as noise levels, ambient lighting, nursing ratios, ward bedding and climate control, that contribute to similarities and/or differences in POD occurrences in different countries and health systems 2. To investigate patient factors, such as disease burden, mental health, education levels, and socioeconomic factors, that contribute to similarities and/or differences in POD occurrences in different countries and health systems 3. To quantify the direct and indirect costs, as well as resource utilization, resulting from the development of POD in each country

Description:

Hip fractures encompass all fractures of the upper (proximal) part of the thigh bone (femur). They are commonly divided into two types: intracapsular fractures, which represent those that occur within or proximal to the attachment of the hip joint capsule to the femur, and extracapsular, which represent fractures occurring below or distal to the attachment of the hip joint capsule. Hip fractures are common in elderly people with an annual incidence rate estimated as 1.29/1000 person-years in men and 2.24/1000 person-years in women. It is the most common condition requiring physical rehabilitation in older adults. The majority (>95%) of people undergo hip surgery following hip fracture. The location of the fracture, stability, and degree of comminution (number of pieces the bone breaks into) determine which operative procedure should be used to repair the hip fracture. The aim of surgery, irrespective of the type of operation, is to reduce pain, facilitate early weight-bearing mobility to improve outcome, and facilitate independence in activities of daily living, such as bathing, dressing, and continence. However, hip fracture is associated with significant pain and loss of independence and function. Although 33-37% of patients return to their prior level of function within six months including those needing assistance, only 24% of people are independently mobile six months after hip fracture. A major complication in elderly hip fracture patients is POD, with an incidence rate varying from 13% to 65%. POD after hip surgery was significantly associated with non-home discharge disposition, and higher odds of 30-day readmissions and 30-day mortality. POD is also associated with poor outcomes, such as lower rates of immediate postoperative weight bearing, increased pressure sores, and poorer recovery of activities of daily living. In addition, a recent meta-analysis showed that POD after hip surgery translates into long-term cognitive disease burden, by increasing the risk of incident dementia and cognitive decline by a marked odds ratio of 8.957. No strong evidence exists regarding the treatment of delirium. Several studies performed on delirium prevention in hip fracture patients have described the use of care bundles such as orthogeriatric care and comprehensive geriatric care as an effective potential treatment for this patient group, although the evidence remains weak. However, Inouye et al stated that in the general geriatric population, 30% to 40% of the delirium episodes could be prevented by addressing modifiable risk factors. Previous studies in the five Asian countries involved in this study show that the incidence of POD after hip fracture surgery varied greatly between countries and within countries: 12.8-27.9% in Japan, 5.07-51.3% in Korea, 13.4-45% in Thailand and 7.2% in Singapore. The incidence of POD in Malaysia can be estimated at 9-12% as reported in the recent HIP Attack trial. However, these studies were heterogenous in terms of patient selection, study methodology and hospital systems. These variations make it difficult to draw a direct comparison regarding the incidence of POD amongst Asian countries and to Western cohorts. Furthermore, the cost of POD to patients and institutions, both direct and indirect, is very poorly defined in Asian countries.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

Inclusion Criteria:

• Ability to provide informed consent
• Elderly patients aged 65 years and above
• Scheduled to undergo elective or emergency hip fracture surgery

Exclusion Criteria:

• History of psychiatric disease
• Baseline cognitive impairment or dementia (MOCA score < 24)
• Illiterate (unable to read or write with local language)
• Active history of substance abuse
• Has a second surgery planned within 5 days of index surgery
• Non-resident of Singapore
• Significant hearing and/or speech impairment
• Planned for admission into the intensive care unit after surgery

Related Conditions & MeSH terms

• Delirium
• Hip Fractures
• Postoperative Delirium

Intervention

Other:
• Neurocognitive tests
Battery of neurocognitive tests and questionnaires including MoCA, PHQ-9, Falls History, FIFE, STOPBANG, Nutritional Survey, Global Physical Activity Questionnaire, Brief Pain Index, NuDESC, 3D-CAM.

Locations

Country	Name	City	State
Japan	Tohoku University School of Medicine	Sendai
Japan	Tokyo Women's Medical University	Tokyo
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	St Mary's Hospital	Seoul
Malaysia	University of Malaya	Kuala Lumpur
Malaysia	Universiti Sains Malaysia	Malaka
Singapore	Khoo Teck Puat Hospital	Singapore
Singapore	National University Health System	Singapore
Singapore	Ng Teng Fong General Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
Thailand	Ramathibodi Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Malaysia,  Singapore,  Thailand, 

References & Publications (5)

Adams AL, Shi J, Takayanagi M, Dell RM, Funahashi TT, Jacobsen SJ. Ten-year hip fracture incidence rate trends in a large California population, 1997-2006. Osteoporos Int. 2013 Jan;24(1):373-6. doi: 10.1007/s00198-012-1938-5. Epub 2012 Feb 21. — View Citation

Handoll HH, Cameron ID, Mak JC, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD007125. doi: 10.1002/14651858.CD007125.pub2. Review. Update in: Cochrane Database Syst Rev. 2021 Nov 12;11:CD007125. — View Citation

Lenze EJ, Skidmore ER, Dew MA, Butters MA, Rogers JC, Begley A, Reynolds CF 3rd, Munin MC. Does depression, apathy or cognitive impairment reduce the benefit of inpatient rehabilitation facilities for elderly hip fracture patients? Gen Hosp Psychiatry. 2007 Mar-Apr;29(2):141-6. — View Citation

Morrison RS, Ahronheim JC, Morrison GR, Darling E, Baskin SA, Morris J, Choi C, Meier DE. Pain and discomfort associated with common hospital procedures and experiences. J Pain Symptom Manage. 1998 Feb;15(2):91-101. — View Citation

Uzoigwe CE, Burnand HG, Cheesman CL, Aghedo DO, Faizi M, Middleton RG. Early and ultra-early surgery in hip fracture patients improves survival. Injury. 2013 Jun;44(6):726-9. doi: 10.1016/j.injury.2012.08.025. Epub 2012 Sep 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of POD in elderly patients undergoing hip fracture surgery	Collection of patient's demographics, medical records and surgical records to establish risk factors for POD development	Before surgery through to 1 year post surgery
Secondary	Healthcare cost of POD in different countries and health systems	Quantify the direct and indirect costs, as well as resource utilization, resulting from the development of POD in each country by collecting hospitalization costs	Before surgery through to study completion, an average of 1 year
Secondary	Similarities and/or differences in POD occurrences in different countries and health systems	Collection of data such as noise levels, ambient lighting, nursing ratios, ward bedding and climate control, disease burden, mental health, education levels, and socioeconomic factors to establish similarities and/or differences in POD occurrences in different countries and health systems	Before surgery through to 1 year post surgery