Postoperative DeliriumNCT04999891
The Southeast and East Asian Post-Operative Delirium (SEAPOD) Study
An observational study of Postoperative Delirium and Hip Fractures, run by National University Hospital, Singapore at 13 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Postoperative Delirium, Hip Fractures
- What is being tested?
- Neurocognitive tests
- How many people
- 1,000 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 22 Aug 2021to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients aged 65 and above scheduled to undergo hip fracture surgery
Who may be able to join
- Ability to provide informed consent
- Elderly patients aged 65 years and above
- Scheduled to undergo elective or emergency hip fracture surgery
Who cannot join
- 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
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
Singapore5 sites, 5 recruiting
- Not yet recruiting
Singapore General Hospital
Singapore, 169608
Sophia Tsong Huey Chew
- Not yet recruiting
Khoo Teck Puat Hospital
Singapore
Edwin Chuen Ping Seet
- Recruiting
National University Health System
Singapore
Lian Kah Ti, 6772 4200, anatilk@nus.edu.sg
- Not yet recruiting
Ng Teng Fong General Hospital
Singapore
Lyn Li Lean
- Not yet recruiting
Tan Tock Seng Hospital
Singapore
Vera Qinyi Lim
Japan2 sites, 2 recruiting
- Not yet recruiting
Tohoku University School of Medicine
Sendai
Kotoe Kamata
- Not yet recruiting
Tokyo Women's Medical University
Tokyo
Yasuko Nagasaka
Malaysia2 sites, 2 recruiting
- Not yet recruiting
University of Malaya
Kuala Lumpur
Pui San Loh
- Not yet recruiting
Universiti Sains Malaysia
Malacca
Laila Ab Mukmin
South Korea2 sites, 2 recruiting
- Not yet recruiting
Severance Hospital
Seoul
Jeong Min Kim
- Not yet recruiting
St Mary's Hospital
Seoul
Hyung Mook Lee
Thailand2 sites, 2 recruiting
- Not yet recruiting
Ramathibodi Hospital
Bangkok
Varinee Lekprasert
- Not yet recruiting
Siriraj Hospital
Bangkok
Onuma Chaiwat
About this study
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:
- 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
- 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
- To quantify the direct and indirect costs, as well as resource utilization, resulting from the development of POD in each country
Read the detailed 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.
- Conditions
- Postoperative Delirium, Hip Fractures
- Being tested
- Neurocognitive tests
- Keywords
- Geriatrics
- Medical subject headings
- Emergence Delirium, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive testsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Cohort | Elderly patients aged 65 and above who are planned for hip fracture surgery. Receives: Other: Neurocognitive tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before surgery through to 1 year post surgery
Secondary outcomes (2)
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
Measured: Before surgery through to study completion, an average of 1 year
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
Measured: Before surgery through to 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start22 Aug 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lian Kah Ti, Principal investigator, National University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999891
- Sponsor's protocol ID
- 2020/01350
- Status last verified
- Aug 2022
- First submitted
- 24 Jun 2021
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22349963Lenze 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. doi: 10.1016/j.genhosppsych.2007.01.001.
PubMed 17336663Uzoigwe 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.
PubMed 23010072Handoll 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.
PubMed 19821396Morrison 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.
PubMed 9494307
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Southeast and East Asian Post-Operative Delirium (SEAPOD) Study
- ClinicalTrials.gov ID
- NCT04999891
- Acronym / sponsor ID
- 2020/01350
- Conditions
- Postoperative Delirium, Hip Fractures
- Keywords
- Geriatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 22 Aug 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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
- To quantify the direct and indirect costs, as well as resource utilization, resulting from the development of POD in each country
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Cohort | – | Other: Neurocognitive testsElderly patients aged 65 and above who are planned for hip fracture surgery. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients aged 65 and above scheduled to undergo hip fracture surgery
Key inclusion criteria (3 listed)
- Ability to provide informed consent
- Elderly patients aged 65 years and above
- Scheduled to undergo elective or emergency hip fracture surgery
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurocognitive testsBattery 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. | Other | Surgical Cohort |
Primary outcome
Development of POD in elderly patients undergoing hip fracture surgery
Time frame: Before surgery through to 1 year post surgery
Collection of patient's demographics, medical records and surgical records to establish risk factors for POD development
2 secondary outcomes
Healthcare cost of POD in different countries and health systems
Time frame: Before surgery through to study completion, an average of 1 year
Similarities and/or differences in POD occurrences in different countries and health systems
Time frame: Before surgery through to 1 year post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Background: PubMed 22349963Adams 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.
- Background: PubMed 17336663Lenze 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. doi: 10.1016/j.genhosppsych.2007.01.001.
- Background: PubMed 23010072Uzoigwe 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.
- Background: PubMed 19821396Handoll 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.
- Background: PubMed 9494307Morrison 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lian Kah Ti principal investigator
National University Health System
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium and Hip Fractures, run by National University Hospital, Singapore at 13 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Singapore, Japan, Malaysia, South Korea, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lian Kah Ti (6772 4200, anatilk@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of POD in elderly patients undergoing hip fracture surgery (time frame: Before surgery through to 1 year post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04999891, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.