- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03046771
Transport PLUS Intervention
Randomized Controlled Trial Evaluating Efficacy of EMS Providers Performing Discharge Comprehension and Home Fall Hazard Assessments
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
The moment of transition between the hospital and the home is susceptible to lapses in quality and loss of key information regarding a patient's care. An increasing amount of attention is being given to improving the transition of care by targeting factors that contribute to return Emergency Department (ED) visits and readmissions. Following a hospitalization, as many as 40% of patients over age 60 will experience a fall in the subsequent six months and 76% of older adult patients are uncertain about their follow-up care plan. Patients transported home by ambulance following an ED visit were found to have a significantly higher rate of return ED visits at 30 days then overall rates for older adult ED patients (27.8% vs. 11.5%).
In response to these challenges, the researcher's study group developed and piloted an innovative care model known as "Transport PLUS" in which specially trained emergency medical technicians (EMTs) who are already transporting an older adult (65+ years in age) patient home from the ED add to their service two simple interventions - a home fall hazard assessment (FHA) and a discharge comprehension assessment (DCA). Both interventions are facilitated and measured using a checklist developed through a systematic review of the literature and existing tools, and later refined through EMT and patient focus groups.
This study will test the hypothesis that 'Transport PLUS,' a low cost, easily generalizable intervention, can improve transitions of care and improve patient safety following hospitalization as measured by decreased rates of falls and reduced rates of return to the hospital.
The researchers will conduct a pilot cluster randomized controlled trial comparing the Transport PLUS intervention to standard care in a population of older adult patients being discharged from the hospital. The researchers will randomize EMS providers to either perform Transport PLUS (the intervention) or to provide routine transport. It is estimated that approximately 400 patients over age 65 will be transported home from the study hospital by participating providers during the study enrollment period. Patient participants will receive Transport PLUS (n=200) or routine care (n=200) as determined by the transporting provider. Primary outcomes will be the rate of falls in the 3 months following hospitalization and 3-day and 30-day return ED visits (with or without a hospitalization). Process measures will include removal of fall hazards at 3 months and compliance with discharge instructions. Extending beyond the grant period, the researchers intend to follow the cohort for up to 1 year.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Emergency Medical Technicians (EMTs) are eligible to participate in study if
- employed by Hunter EMS
- over the age of 18 years, and
- certified as an EMT in New York State.
Patient participants are eligible if
- over the age of 65 years
- being discharged from the study hospital, and
- being transported directly to home.
Exclusion Criteria:
- EMTs who expect to leave the job in less than 1 year
- EMTs who have been previously trained in Transport PLUS.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Transport PLUS group
EMTs randomized to the Transport Plus group will view a 60-minute training video and then complete a 60-minute simulation training exercise on how to conduct the home fall hazard assessment (FHA) and the discharge comprehension assessment (DCA) and how to complete the FHA and DCA checklists.
The FHA involves performing a visual assessment of the home environment and noting certain fall hazards.
The DCA involves engaging the patient or caregiver in a conversation to assess their level of understanding of the elements of the discharge instructions.
The Transport Plus EMTs will offer to perform the FHA and DCA for all transports of patients aged 65 or older, who are being transported from The Mount Sinai Hospital to a private residence
|
The Transport Plus EMTs will offer to perform the FHA and DCA for all transports of patients aged 65 or older, who are being transported from The Mount Sinai Hospital to a private residence.
|
|
Ingen indgriben: Routine Care
Providers randomized to routine care will not be trained on the FHA or DCA or the completion of the checklists.
All EMTs in both groups (Transport Plus and standard education), will be asked to answer some demographic questions and will be trained to collect responses to 3questions commonly used to assess a patient's risk of falling and to collect best contact information for phone follow up from patients or their caregivers and to obtain permission for a follow-up phone call from research personnel.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of falls
Tidsramme: up to 3 months
|
Rate of falls following transport home by ambulance
|
up to 3 months
|
|
Rate of return ED visits
Tidsramme: 30 days
|
Rate of return ED visits following transport home by ambulance
|
30 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of falls
Tidsramme: up to 12 months
|
up to 12 months
|
|
|
Rate of return ED visits
Tidsramme: 3 days
|
Numbers of patients with ED visits within 3 days of participation in study intervention or control arm.
|
3 days
|
|
Readmission
Tidsramme: up to 90 days
|
Numbers of patients with readmissions after study intervention
|
up to 90 days
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kevin G Munjal, MD,MPH,MSCR, Icahn School of Medicine at Mount Sinai
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GCO 14-1842
- 1R03AG050917-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Transport PLUS group
-
University of Colorado, DenverCornell UniversityAfsluttetAdfærd, Adaptiv
-
The New SchoolColumbia University; Universidad del Norte; HIASRekrutteringMental sundhed velvære 1Colombia
-
Children's National Research InstituteTravere Therapeutics, Inc.AfsluttetAngst | Depressive symptomer | Post traumatisk stress syndrom | Problemer PsykosocialForenede Stater
-
Orthofix Inc.AfsluttetBrud, Knogle | Brud, lukket | Brud, åben | Fraktur af lårben | Skinnebensbrud | Lemfraktur | Brud ikke-forening | Deformitet af lemmer | Lemmerdefekt | Lemmer asymmetriForenede Stater
-
Ohio State UniversityAfsluttetSpædbarnsdød | Graviditet for tidligtForenede Stater
-
Centro Hospitalar do PortoUniversity of Trás-os-Montes and Alto Douro; Foundation for Science and... og andre samarbejdspartnereRekrutteringIntermitterende Claudication | Perifer arteriel sygdom (PAD)Portugal
-
University of MichiganAfsluttet
-
University of British ColumbiaChild and Family Research InstituteAfsluttet
-
Ohio State UniversityAfsluttet
-
Chinese University of Hong KongAktiv, ikke rekrutterendeIntellektuel handicap, mildHong Kong