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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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 groups in NCT00927160
Study groupRoleWhat they receive
MACE groupElderly patients admitted to the Mobile Acute Care of the Elderly Unit.
Usual Care groupElderly 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.

  1. Length of Hospital Stay

    Measured: Depending on hospital stay

Secondary outcomes (1)
  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.

  1. First posted24 Jun 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

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)
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
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 7715644
  • Charpentier 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 11675169
  • Hung 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

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.

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