DeliriumNCT02119078
Acute Care for Elders (ACE) Program at OHSU Hospital
A study testing Acute Care of Elders focused geriatric care in people with Delirium and Age-Related Cognitive Decline, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this investigation is to assess the effectiveness of a multi-disciplinary Acute Care for Elders (ACE) program dedicated to the care of patients age 70 and older admitted to Oregon Health \& Science University's hospital medicine service. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Delirium, Age-Related Cognitive Decline, Frail Elderly
- What is being tested?
- Acute Care of Elders focused geriatric care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 20 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- admitted to the internal medicine service during the time frame of the study
- age 70 or older at time of hospital admission
- Exclusion Criteria (ACE faculty, health care providers and students):
- non-English-speaking
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University Hospital
Portland, Oregon, 97239
About this study
The purpose of this investigation is to assess the effectiveness of a multi-disciplinary Acute Care for Elders (ACE) program dedicated to the care of patients age 70 and older admitted to Oregon Health \& Science University's hospital medicine service. The ACE program will aim to improve the quality of care of older patients in the investigators hospital by implementing focused interventions and recommendations specific to geriatric needs and syndromes, including: reduced fall rate, decreased incidence and duration of delirium, early recognition and treatment of impaired mobility and function, careful minimization of medication use, prevention of unnecessary catheter and restraint use, decreased hospital readmission rates, improved transitional care following hospital discharge, and high levels of patient and referring physician satisfaction. Additionally, the ACE program aims to improve resident and student competence in treating geriatric syndromes, and to improve staff and learner satisfaction with caring for older adults. ACE programs have been well studied at other institutions, so the investigators will be implementing a program that is already standard of care, and studying the elements that are unique to OHSU.
This will be a quality improvement project. Study participants will be a convenience sample of OHSU faculty, staff, residents and students who are employed by or on rotation with General Medicine Team 1 of the Medicine Teaching Service. Faculty, staff, and learners (ACE team members) will receive the ACE training. Study personnel will conduct prospective and retrospective chart review of patients admitted to the ACE service to determine outcomes as noted above.
- Conditions
- Delirium, Age-Related Cognitive Decline, Frail Elderly, Hospital Acquired Pressure Ulcer, Drug-Related Side Effects and Adverse Reactions
- Being tested
- Acute Care of Elders focused geriatric care
- Keywords
- Geriatrics, Acute Care for Elders, Geriatric syndromes, Delirium, Falls, Polypharmacy
- Medical subject headings
- Delirium, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Care of Elders focused geriatric careOther
Patients admitted to the ACE Service will receive standard care as well as additional use of geriatric-specific order sets and protocols and oversight of care by a geriatric-trained Advanced Practice Provider (APP).
| Study group | Role | What they receive |
|---|---|---|
| ACE Service | Active comparator | Admission to the Acute Care for Elders (General Medicine Team 1) service. (See Intervention, below) Receives: Other: Acute Care of Elders focused geriatric care |
| Standard care (other General Medicine teams) | No intervention | Admission to one of the 4 non-ACE general medicine teaching teams at OHSU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of geriatric patients with adverse events
Incidence and duration of delirium (source: hospital problem list); incidence of hospital-acquired pressure ulcers (source: nursing documentation, problem list); number of prescriptions for Beers List medications during hospitalization and upon discharge (source: MAR)
Measured: During hospitalization, an expected average of 6 days
Secondary outcomes (1)
Resident confidence in treating geriatric syndromes
As measured by the Post-ACE Survey resident questionnaire, which includes 17 metrics of confidence (e.g. management of pain, identification of fall risk factors, delivering bad news, discussion of hospice care, performing a complete skin exam, documenting advanced directives, managing insomnia, performing bedside cognitive assessments.)
Measured: After 3 week rotation on the Acute Care for Elders service
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJan 2014
- Primary completion30 Jun 2017
- Study completion20 Dec 2020 (estimated)
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Bernstein, Oregon Health and Science University
- Investigators
- Juliana M Bernstein, MPAS, PA-C, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119078
- Sponsor's protocol ID
- RB00010420
- Status last verified
- Oct 2019
- First submitted
- 8 Apr 2014
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Care for Elders (ACE) Program at OHSU Hospital
- ClinicalTrials.gov ID
- NCT02119078
- Acronym / sponsor ID
- RB00010420
- Conditions
- Delirium, Age-Related Cognitive Decline, Frail Elderly, Hospital Acquired Pressure Ulcer, Drug-Related Side Effects and Adverse Reactions
- Keywords
- Geriatrics, Acute Care for Elders, Geriatric syndromes, Delirium, Falls, Polypharmacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 21 Apr 2014 (estimated)
- 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 purpose of this investigation is to assess the effectiveness of a multi-disciplinary Acute Care for Elders (ACE) program dedicated to the care of patients age 70 and older admitted to Oregon Health \& Science University's hospital medicine service. The ACE program will aim to improve the quality of care of older patients in the investigators hospital by implementing focused interventions and recommendations specific to geriatric needs and syndromes, including: reduced fall rate, decreased incidence and duration of delirium, early recognition and treatment of impaired mobility and function, careful minimization of medication use, prevention of unnecessary catheter and restraint use, decreased hospital readmission rates, improved transitional care following hospital discharge, and high levels of patient and referring physician satisfaction. Additionally, the ACE program aims to improve resident and student competence in treating geriatric syndromes, and to improve staff and learner satisfaction with caring for older adults. ACE programs have been well studied at other institutions, so the investigators will be implementing a program that is already standard of care, and studying the elements that are unique to OHSU.
This will be a quality improvement project. Study participants will be a convenience sample of OHSU faculty, staff, residents and students who are employed by or on rotation with General Medicine Team 1 of the Medicine Teaching Service. Faculty, staff, and learners (ACE team members) will receive the ACE training. Study personnel will conduct prospective and retrospective chart review of patients admitted to the ACE service to determine outcomes as noted above.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACE Service | Active comparator | Other: Acute Care of Elders focused geriatric careAdmission to the Acute Care for Elders (General Medicine Team 1) service. (See Intervention, below) |
| Standard care (other General Medicine teams) | No intervention | –Admission to one of the 4 non-ACE general medicine teaching teams at OHSU. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- admitted to the internal medicine service during the time frame of the study
- age 70 or older at time of hospital admission
- non-English-speaking
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Acute Care of Elders focused geriatric carePatients admitted to the ACE Service will receive standard care as well as additional use of geriatric-specific order sets and protocols and oversight of care by a geriatric-trained Advanced Practice Provider (APP). | Other | ACE Service |
Primary outcome
Number of geriatric patients with adverse events
Time frame: During hospitalization, an expected average of 6 days
Incidence and duration of delirium (source: hospital problem list); incidence of hospital-acquired pressure ulcers (source: nursing documentation, problem list); number of prescriptions for Beers List medications during hospitalization and upon discharge (source: MAR)
1 secondary outcome
Resident confidence in treating geriatric syndromes
Time frame: After 3 week rotation on the Acute Care for Elders service
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
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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.
Juliana M Bernstein, MPAS, PA-C principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Care of Elders focused geriatric care in people with Delirium and Age-Related Cognitive Decline, run by Oregon Health and Science University at 1 site in United States.
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 4 inclusion and 1 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 4 Nov 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 United States. 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?
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?
Number of geriatric patients with adverse events (time frame: During hospitalization, an expected average of 6 days). 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 4 Nov 2019.