Model of Care for Hospitalized Older AdultsNCT00927160
Evaluation of the Mobile Acute Care of the Elderly (MACE) Unit
An observational study of Model of Care for Hospitalized Older Adults, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this study is to determine if a new model of care, the Mobile Acute Care of the Elderly Unit is beneficial in improving patient outcomes for elderly patients admitted to the hospital. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Model of Care for Hospitalized Older Adults
- How many people
- 346 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older adults hospitalized with a general medical condition in a tertiary hospital in an urban setting
Who may be able to join
- All patients admitted to general medical service either to Mobile Acute Care of the Elderly (MACE) Unit or to general medicine 75 years or older.
- Patients or surrogates must be reachable by the phone.
- Patient must have a Sinai affiliated physician who is identified by patient or surrogate to be primary care provider
Who cannot join
- The patient is less than 75 years old.
- The patient was admitted to specialty services including cardiology-telemetry unit, intensive care, surgery, Respiratory Care Unit (RCU).
- The patient was previously admitted to an outside hospital and now transferred to Mount Sinai for further care.
- The patient cannot be contacted by telephone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
The purpose of this study is to determine if a new model of care, the Mobile Acute Care of the Elderly Unit is beneficial in improving patient outcomes for elderly patients admitted to the hospital.
Read the detailed description
Inpatient hospitalizations for the elderly are fraught with hazards. Hospital complications such as delirium, falls, pressure ulcers are common in the elderly. These complications may be avoidable. Patient care units specializing in geriatric care, acute care of the elderly (ACE) units, were developed and tested and had demonstrated fewer patients discharged to nursing home, and improved ability of acutely ill older patients to perform basic activities of daily living at the time of discharge (1). However, ACE unit model have not been widely disseminated because of issues of financial viability and other limitations.
Mobile Acute Care of the Elderly (MACE) unit, a new model of geriatric inpatient care, was newly developed at the Mount Sinai Hospital and has been in use since July 2007.
MACE consists of a team care providers dedicated to the care of inpatient hospitalized elderly patients. The team consists of an attending geriatrician, a geriatrics fellow, a nurse practitioner, a social worker. The potential benefits of the MACE team over a general medicine medical service include specific attention to the needs of the elderly in the inpatient setting, potential complications, the avoidance of potentially harmful medications and improved communication in transition of care. Other quality outcome measures such as length of stay, re-hospitalization rates may be affected as a result of MACE care.
The purpose of the study is to evaluate patient care using quality markers including length of stay, re-hospitalization rates, patient satisfaction of patients admitted to the Mobile Acute Care of the Elderly Unit compared to a prospectively matched and propensity score matched control group from patients admitted to general medicine service.
Description of cohort group selection methods
We aim to enroll all Mobile ACE patients who satisfy our inclusion and exclusion criteria. To match patients on the General Medical Unit with similar characteristics to the Mobile ACE patients, we will match patients according to age (within 5 years), admitting diagnosis, and their ability to ambulate independently (functional status). We aim to match each Mobile ACE patient (case group) to one general medical unit patient (control group) with these matching characteristics. In order to do so, we will establish a pool of Mobile ACE patients and a pool of general medicine patients and enroll patients into each pool if they satisfy the inclusion and exclusion criteria according to a prospective matching protocol established and validated by Charpentier et al. (2)
This matching algorithm was selected because it has been demonstrated to achieve balance across prognostic factors in trials for which randomized allocation to treatment group is not possible. The method involves prospective individual matching of patients that have already been assigned to treatment groups (in this case, Mobile ACE unit and general medical unit). The method provide a methodologically rigorous alternative for achieving balance across treatment groups, with respect to important prognostic factors, in non-randomized trials where randomization is not possible.
For patients in the Mobile ACE unit who satisfy the inclusion and exclusion criteria, we will determine if there is a matching patient in the control group pool. If so, we will enroll the patient and matched the patient to the matching patient in the control group. If there is no match in the control group pool, we will enroll the patient into the case group pool. Because we aim to match patients concurrently, we will only match patients who have admission dates within 180 days of each other.
For patients in the general medical unit who satisfy the inclusion and exclusion criteria, the matching characteristics will be assessed and if there is a match in the pool of case group patients, the patient will be enrolled. If there is no successful match in the case group patients, we will enroll the patient to the pool of control group patients if the pool of control group patients is fewer than a predetermined size of 10 patients; or if the pool of control group patients is more than 10 patients, we will enroll the patient randomly by a predetermined probability to be in the pool of control group patients.
- Keywords
- Mobile Acute Care of the Elderly Unit, Geriatric Models of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MACE group | Elderly patients admitted to the Mobile Acute Care of the Elderly Unit. | |
| Usual Care group | Elderly patients admitted to the general medicine service in the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
Measured: Depending on hospital stay
Secondary outcomes (1)
Rehospitalization Rate
30 days for readmission rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Model of Care for Hospitalized Older AdultsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Hung, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927160
- Sponsor's protocol ID
- 08-0272
- Status last verified
- Aug 2013
- First submitted
- 22 Jun 2009
- Last updated
- 23 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Landefeld CS, Palmer RM, Kresevic DM, Fortinsky RH, Kowal J. A randomized trial of care in a hospital medical unit especially designed to improve the functional outcomes of acutely ill older patients. N Engl J Med. 1995 May 18;332(20):1338-44. doi: 10.1056/NEJM199505183322006.
PubMed 7715644Charpentier PA, Bogardus ST, Inouye SK. An algorithm for prospective individual matching in a non-randomized clinical trial. J Clin Epidemiol. 2001 Nov;54(11):1166-73. doi: 10.1016/s0895-4356(01)00399-7.
PubMed 11675169Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med. 2013 Jun 10;173(11):990-6. doi: 10.1001/jamainternmed.2013.478.
PubMed 23608775
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Mobile Acute Care of the Elderly (MACE) Unit
- ClinicalTrials.gov ID
- NCT00927160
- Acronym / sponsor ID
- 08-0272
- Keywords
- Mobile Acute Care of the Elderly Unit, Geriatric Models of Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 Jun 2009 (estimated)
- Results
- Posted 14 Aug 2013
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 study is to determine if a new model of care, the Mobile Acute Care of the Elderly Unit is beneficial in improving patient outcomes for elderly patients admitted to the hospital.
Detailed description
Inpatient hospitalizations for the elderly are fraught with hazards. Hospital complications such as delirium, falls, pressure ulcers are common in the elderly. These complications may be avoidable. Patient care units specializing in geriatric care, acute care of the elderly (ACE) units, were developed and tested and had demonstrated fewer patients discharged to nursing home, and improved ability of acutely ill older patients to perform basic activities of daily living at the time of discharge (1). However, ACE unit model have not been widely disseminated because of issues of financial viability and other limitations.
Mobile Acute Care of the Elderly (MACE) unit, a new model of geriatric inpatient care, was newly developed at the Mount Sinai Hospital and has been in use since July 2007.
MACE consists of a team care providers dedicated to the care of inpatient hospitalized elderly patients. The team consists of an attending geriatrician, a geriatrics fellow, a nurse practitioner, a social worker. The potential benefits of the MACE team over a general medicine medical service include specific attention to the needs of the elderly in the inpatient setting, potential complications, the avoidance of potentially harmful medications and improved communication in transition of care. Other quality outcome measures such as length of stay, re-hospitalization rates may be affected as a result of MACE care.
The purpose of the study is to evaluate patient care using quality markers including length of stay, re-hospitalization rates, patient satisfaction of patients admitted to the Mobile Acute Care of the Elderly Unit compared to a prospectively matched and propensity score matched control group from patients admitted to general medicine service.
Description of cohort group selection methods
We aim to enroll all Mobile ACE patients who satisfy our inclusion and exclusion criteria. To match patients on the General Medical Unit with similar characteristics to the Mobile ACE patients, we will match patients according to age (within 5 years), admitting diagnosis, and their ability to ambulate independently (functional status). We aim to match each Mobile ACE patient (case group) to one general medical unit patient (control group) with these matching characteristics. In order to do so, we will establish a pool of Mobile ACE patients and a pool of general medicine patients and enroll patients into each pool if they satisfy the inclusion and exclusion criteria according to a prospective matching protocol established and validated by Charpentier et al. (2)
This matching algorithm was selected because it has been demonstrated to achieve balance across prognostic factors in trials for which randomized allocation to treatment group is not possible. The method involves prospective individual matching of patients that have already been assigned to treatment groups (in this case, Mobile ACE unit and general medical unit). The method provide a methodologically rigorous alternative for achieving balance across treatment groups, with respect to important prognostic factors, in non-randomized trials where randomization is not possible.
For patients in the Mobile ACE unit who satisfy the inclusion and exclusion criteria, we will determine if there is a matching patient in the control group pool. If so, we will enroll the patient and matched the patient to the matching patient in the control group. If there is no match in the control group pool, we will enroll the patient into the case group pool. Because we aim to match patients concurrently, we will only match patients who have admission dates within 180 days of each other.
For patients in the general medical unit who satisfy the inclusion and exclusion criteria, the matching characteristics will be assessed and if there is a match in the pool of case group patients, the patient will be enrolled. If there is no successful match in the case group patients, we will enroll the patient to the pool of control group patients if the pool of control group patients is fewer than a predetermined size of 10 patients; or if the pool of control group patients is more than 10 patients, we will enroll the patient randomly by a predetermined probability to be in the pool of control group patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MACE group | – | –Elderly patients admitted to the Mobile Acute Care of the Elderly Unit. |
| Usual Care group | – | –Elderly patients admitted to the general medicine service in the hospital |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older adults hospitalized with a general medical condition in a tertiary hospital in an urban setting
Key inclusion criteria (3 listed)
- All patients admitted to general medical service either to Mobile Acute Care of the Elderly (MACE) Unit or to general medicine 75 years or older.
- Patients or surrogates must be reachable by the phone.
- Patient must have a Sinai affiliated physician who is identified by patient or surrogate to be primary care provider
Key exclusion criteria (4 listed)
- The patient is less than 75 years old.
- The patient was admitted to specialty services including cardiology-telemetry unit, intensive care, surgery, Respiratory Care Unit (RCU).
- The patient was previously admitted to an outside hospital and now transferred to Mount Sinai for further care.
- The patient cannot be contacted by telephone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of Hospital Stay
Time frame: Depending on hospital stay
1 secondary outcome
Rehospitalization Rate
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7715644Landefeld CS, Palmer RM, Kresevic DM, Fortinsky RH, Kowal J. A randomized trial of care in a hospital medical unit especially designed to improve the functional outcomes of acutely ill older patients. N Engl J Med. 1995 May 18;332(20):1338-44. doi: 10.1056/NEJM199505183322006.
- Background: PubMed 11675169Charpentier PA, Bogardus ST, Inouye SK. An algorithm for prospective individual matching in a non-randomized clinical trial. J Clin Epidemiol. 2001 Nov;54(11):1166-73. doi: 10.1016/s0895-4356(01)00399-7.
- Derived from this study: PubMed 23608775Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med. 2013 Jun 10;173(11):990-6. doi: 10.1001/jamainternmed.2013.478.
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.
William Hung, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Model of Care for Hospitalized Older Adults, run by Icahn School of Medicine at Mount Sinai 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 23 Aug 2013. 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?
Yes. Results are posted in the registry (first posted 14 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Length of Hospital Stay (time frame: Depending on hospital stay). 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 NCT00927160, which also lists 3 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 23 Aug 2013.