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Multidisciplinary Mobile Unit for Preventing Hospitalization of Nursing Home Residents (MMU-1)

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ClinicalTrials.gov Identifier: NCT04085679
Recruitment Status : Terminated (The local Healthcare authorities extended the planned intervention to all nursing homes of the district after the emergence of multiple outbreaks of severe COVID-19 in several nursing homes.)
First Posted : September 11, 2019
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Tiziana Meschi, Azienda Ospedaliero-Universitaria di Parma

Brief Summary:

Elderly patients residing in nursing homes are particularly at risk of experiencing urgent medical problems needing admission to the Emergency Department (ED). This circumstance contributes to ED overcrowding, increases the risk of ward admission of elderly patients, and puts them at an even higher risk of hospitalization-related adverse events. The study hypothesis is that a complex intervention, delivered directly in nursing homes by hospital physicians in case of urgent medical problems, would contribute to reduce hospitalization of older nursing home residents.

The intervention consists in a hospital-based "multidisciplinary mobile unit" (MMU), composed of a hospital specialist and a resident in emergency-urgency medicine who are coordinated by a senior physician serving as "flow manager". The team is active on work days, 8 am to 6 pm, and is activated by general practitioners of nursing homes, in case of urgent medical needs of one of the residents. The activation is made by a phone call to the "flow manager", who triages the clinical needs of the case. The output of the phone consultation may include therapeutic advice provided by phone, immediate on-site visit by the MMU team (specialist and resident), scheduled visit by the MMU team, or direct admission to the hospital unit where MMU is based, avoiding ED visits. The MMU team is provided with a portable ultrasound system, an essential set of drugs and medical devices useful in a urgency setting (central venous lines, nasogastric tubes, rectal tubes, bladder catheters). During on-site visits, the MMU team performs diagnosis, stabilization and therapeutic advice, with the mission of avoiding ED visits and hospital admissions whenever possible.

The MMU intervention is already active in two nursing homes, since December 2018. The aim of this prospective, pragmatic, multicenter, quasi-experimental study (sequential design with two cohorts) is to test the effects of the implementation of the MMU care model in terms of reduction of unplanned hospitalization rates (primary outcomes), mortality, health service use and costs (secondary outcomes).

Two nursing homes (i.e., the ones who already benefit from the intervention) will serve as study group, and two nursing homes with similar geographical location will serve as control group. All residents of the participating nursing homes will be eligible for study inclusion. The study will last for 18 months, and a number of 338 residents is planned for inclusion.


Condition or disease Intervention/treatment
Frailty Disability Multimorbidity Respiratory Failure Abdominal Pain Infection Other: Multidisciplinary Mobile Unit (MMU)

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Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Implementation of a Strategy to Prevent Hospital Admission in Nursing Home Residents: Protocol of a Quasi-experimental Study
Actual Study Start Date : January 15, 2020
Actual Primary Completion Date : December 30, 2020
Actual Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MMU active group
Subjects residing in nursing homes where the MMU care model has already been implemented
Other: Multidisciplinary Mobile Unit (MMU)
MMU is called in case of urgent clinical situations involving patients residing in nursing home

MMU control group
Subjects residing in nursing homes where the MMU care model has not yet been implemented (ED visits performed in case of urgent clinical situations)



Primary Outcome Measures :
  1. Hospitalization rate [ Time Frame: 1 year ]
    Calculated as all unplanned admissions divided per the sum of the person-time of the at-risk population (days of stay at the nursing home)


Secondary Outcome Measures :
  1. Crude all-cause death [ Time Frame: 1 year ]
    Number of deaths on person-time of the at-risk population

  2. Hospital mortality rate [ Time Frame: 1 year ]
    The frequency of patients dead while in hospital (death rate/1000)

  3. Length of hospital stay [ Time Frame: 1 year ]
    Duration of a single episode of hospitalization, with inpatient days calculated by subtracting day of admission from day of discharge

  4. Adverse events or complications [ Time Frame: 1 year ]
    Frequency of events occurred within 48 hours from MMU team activation and subsequent patient stabilization, for which hospital access becomes necessary

  5. Cost analysis [ Time Frame: 1 year ]
    Hospitalization-related costs



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects residing in the nursing homes participating to the study will be eligible for inclusion, regardless of their clinical conditions. Participating nursing homes are public facilities which ensure the presence of nursing staff 24 hours a day and of a physician at least 4 hours a day (high-intensity care facilities). The possible role of distance to the hospital is considered by including in each group one nursing home located next to the hospital and one located >5 km of distance.
Criteria

Inclusion Criteria:

  • All residents of the participating nursing homes, regardless of age, gender or clinical conditions

Exclusion Criteria:

  • Unwillingness to sign informed consent form (patient him/herself or legal representatives)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085679


Locations
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Italy
UO Medicina Interna e Lungodegenza Critica, Azienda Ospedaliero-Universitaria di Parma
Parma, Emilia-Romagna, Italy, 43126
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Parma
Investigators
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Principal Investigator: Tiziana Meschi, M.D. Azienda Ospedaliero-Universitaria di Parma (Parma University Hospital)
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tiziana Meschi, Head of Geriatric-Rehabilitation Department, Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier: NCT04085679    
Other Study ID Numbers: MMU-1
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tiziana Meschi, Azienda Ospedaliero-Universitaria di Parma:
Multidisciplinary care
Hospital-community care integration
Mobile specialist team
Personalization of care
Nursing home
Additional relevant MeSH terms:
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Respiratory Insufficiency
Frailty
Abdominal Pain
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive