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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03046771
Other study ID # GCO 14-1842
Secondary ID 1R03AG050917-01
Status Completed
Phase N/A
First received
Last updated
Start date January 19, 2017
Est. completion date May 30, 2019

Study information

Verified date January 2020
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hypothesis: 'Transport PLUS,' a low cost, easily generalizable intervention performed by Emergency Medical Technicians while transporting a patient home from the hospital, 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date May 30, 2019
Est. primary completion date August 23, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
Transport PLUS group
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.

Locations

Country Name City State
United States Icahn School of Medicine at Mount Sinai New York New York

Sponsors (2)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of falls Rate of falls following transport home by ambulance up to 3 months
Primary Rate of return ED visits Rate of return ED visits following transport home by ambulance 30 days
Secondary Rate of falls up to 12 months
Secondary Rate of return ED visits Numbers of patients with ED visits within 3 days of participation in study intervention or control arm. 3 days
Secondary Readmission Numbers of patients with readmissions after study intervention up to 90 days
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