DeliriumHELPNCT03628014
The Hospital Elder Life Program at the Jewish General Hospital
A study testing Inpatient-care program in people with Delirium and Fall Injury, run by Jewish General Hospital at 1 site in Canada.
Trial summary
Older patients (i.e.; ≥ 65 years) with a hip fracture, and who are admitted to orthopedics for surgery are particularly at risk of adverse health events such as delirium, recurrent falls and prolonged hospital stay caused by their frailty status. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium, Fall Injury, Mortality
- What is being tested?
- Inpatient-care program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- 5 Feb 2018to 30 May 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 65 and over
- admitted to orthopedic ward for hip surgery after a fracture
Who cannot join
- younger than 65 years of age
- palliative care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Measure of the Effects of the Hospital Elder Life Program at the Jewish General Hospital: a Pre-post Intervention Study
Older patients (i.e.; ≥ 65 years) with a hip fracture, and who are admitted to orthopedics for surgery are particularly at risk of adverse health events such as delirium, recurrent falls and prolonged hospital stay caused by their frailty status. The Hospital Elder Life Program (HELP) is a comprehensive inpatient-care program that ensures optimal care for older adults in the hospital and, thus, might reduce the incidence of postoperative adverse health events. The overall objective of this study is to examine in a quantitative fashion the effects of the HELP program on adverse health events in geriatric inpatients admitted to the orthopedic ward at JGH for surgery after a hip fracture.
Read the detailed description
Delirium and mobility impairment with high risk of falls are important medical complications after a hip surgery. More than 95% of hip fractures are caused by falling and the risk of a new fall after a hip surgery may be up to 50%. Both postoperative delirium and fall are associated with increased length of stay and high perioperative mortality.
The Hospital Elder Life Program (HELP) is a comprehensive inpatient-care program that ensures optimal care for older adults in the hospital. The primary goals of the HELP program are:
Maintaining cognitive and physical functioning of high risk older adults throughout hospitalization, maximizing independence at discharge, assisting with the transition from hospital to home, and preventing unplanned hospital readmissions. These goals have been accomplished using a multicomponent intervention strategy. In addition to targeted interdisciplinary geriatric assessment, the program uses an innovative volunteer model to provide personal, supportive attention to vulnerable older inpatients.
- Conditions
- Delirium, Fall Injury, Mortality
- Being tested
- Inpatient-care program
- Keywords
- older, hospital, program
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpatient-care programOther
Patients enrolled in the Hospital Elder Life Program can receive four types of personalized volunteer-led interventions based on the needs identified by the care team. These interventions include:
- Daily orientation and visiting program
- Basic active movements
- Meal assistance
- Recreational activities
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Other | The HELP Program is a comprehensive inpatient-care program that ensures optimal care for older adults in the hospital by using trained volunteers that do specific activities to help prevent or maintain functional decline. Receives: Other: Inpatient-care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of delirium after a hip surgery
As measure will be used the CAM ( Confusion Assessment Method)
Measured: 24 hours after surgery
Secondary outcomes (2)
Number of falls before having a hip fracture
The number of falls are recorded in medical chart
Measured: Up to one month
In-hospital mortality
Mortality during hospitalization.
Measured: Up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start5 Feb 2018
- Primary completion30 May 2018
- Study completion30 May 2018
Why it stopped: Recruitment difficulties and bad data quality
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Beauchet, Jewish General Hospital
- Investigators
- Olivier Beauchet, MD, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628014
- Sponsor's protocol ID
- CODIM-MBM-17-182
- Acronym
- HELP
- Status last verified
- Feb 2019
- First submitted
- 1 Feb 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Measure of the Effects of the Hospital Elder Life Program at the Jewish General Hospital: a Pre-post Intervention Study
- ClinicalTrials.gov ID
- NCT03628014
- Acronym / sponsor ID
- HELP / CODIM-MBM-17-182
- Conditions
- Delirium, Fall Injury, Mortality
- Keywords
- older, hospital, program
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties and bad data quality
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 14 Aug 2018 (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.
Older patients (i.e.; ≥ 65 years) with a hip fracture, and who are admitted to orthopedics for surgery are particularly at risk of adverse health events such as delirium, recurrent falls and prolonged hospital stay caused by their frailty status. The Hospital Elder Life Program (HELP) is a comprehensive inpatient-care program that ensures optimal care for older adults in the hospital and, thus, might reduce the incidence of postoperative adverse health events. The overall objective of this study is to examine in a quantitative fashion the effects of the HELP program on adverse health events in geriatric inpatients admitted to the orthopedic ward at JGH for surgery after a hip fracture.
Detailed description
Delirium and mobility impairment with high risk of falls are important medical complications after a hip surgery. More than 95% of hip fractures are caused by falling and the risk of a new fall after a hip surgery may be up to 50%. Both postoperative delirium and fall are associated with increased length of stay and high perioperative mortality.
The Hospital Elder Life Program (HELP) is a comprehensive inpatient-care program that ensures optimal care for older adults in the hospital. The primary goals of the HELP program are:
Maintaining cognitive and physical functioning of high risk older adults throughout hospitalization, maximizing independence at discharge, assisting with the transition from hospital to home, and preventing unplanned hospital readmissions. These goals have been accomplished using a multicomponent intervention strategy. In addition to targeted interdisciplinary geriatric assessment, the program uses an innovative volunteer model to provide personal, supportive attention to vulnerable older inpatients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Other | Other: Inpatient-care programThe HELP Program is a comprehensive inpatient-care program that ensures optimal care for older adults in the hospital by using trained volunteers that do specific activities to help prevent or maintain functional decline. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- age 65 and over
- admitted to orthopedic ward for hip surgery after a fracture
Key exclusion criteria (2 listed)
- younger than 65 years of age
- palliative care
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 |
|---|---|---|
| Inpatient-care programPatients enrolled in the Hospital Elder Life Program can receive four types of personalized volunteer-led interventions based on the needs identified by the care team. These interventions include: * Daily orientation and visiting program * Basic active movements * Meal assistance * Recreational activities | Other | Interventional |
Primary outcome
Presence of delirium after a hip surgery
Time frame: 24 hours after surgery
As measure will be used the CAM ( Confusion Assessment Method)
2 secondary outcomes
Number of falls before having a hip fracture
Time frame: Up to one month
In-hospital mortality
Time frame: Up to one month
Results and safety
The study was stopped early (reason given: Recruitment difficulties and bad data quality). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
Related trials for Delirium
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The Danish Out-of-Hospital Cardiac Arrest Study
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Lactium Premedication to Prevent Emergence Agitation
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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.
Olivier Beauchet, MD principal investigator
Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inpatient-care program in people with Delirium and Fall Injury, run by Jewish General Hospital at 1 site in Canada.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study was stopped early (reason given: Recruitment difficulties and bad data quality). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of delirium after a hip surgery (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2019.