Fall, AccidentalNCT03046771
Transport PLUS Intervention
A study testing Transport PLUS group in people with Fall, Accidental and Fall, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall, Accidental, Fall, Hospital Readmission
- What is being tested?
- Transport PLUS group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2017to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- EMTs who expect to leave the job in less than 1 year
- EMTs who have been previously trained in Transport PLUS.
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
Official title: Randomized Controlled Trial Evaluating Efficacy of EMS Providers Performing Discharge Comprehension and Home Fall Hazard Assessments
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.
Read the detailed 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.
- Being tested
- Transport PLUS group
- Keywords
- falls, readmissions, emergency department visits, transitions of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transport PLUS groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Transport PLUS group | Experimental | 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 Receives: Behavioral: Transport PLUS group |
| Routine Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of falls
Rate of falls following transport home by ambulance
Measured: up to 3 months
Rate of return ED visits
Rate of return ED visits following transport home by ambulance
Measured: 30 days
Secondary outcomes (3)
Rate of falls
Measured: up to 12 months
Rate of return ED visits
Numbers of patients with ED visits within 3 days of participation in study intervention or control arm.
Measured: 3 days
Readmission
Numbers of patients with readmissions after study intervention
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start19 Jan 2017
- Primary completion23 Aug 2018
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall, AccidentalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kevin G Munjal, MD,MPH,MSCR, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046771
- Sponsor's protocol ID
- GCO 14-1842
- Other IDs
- 1R03AG050917-01
- Status last verified
- Jan 2020
- First submitted
- 6 Feb 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating Efficacy of EMS Providers Performing Discharge Comprehension and Home Fall Hazard Assessments
- ClinicalTrials.gov ID
- NCT03046771
- Acronym / sponsor ID
- GCO 14-1842
- Keywords
- falls, readmissions, emergency department visits, transitions of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transport PLUS group | Experimental | Behavioral: Transport PLUS groupEMTs 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 |
| Routine Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- EMTs who expect to leave the job in less than 1 year
- EMTs who have been previously trained in Transport PLUS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transport PLUS groupThe 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. | Behavioural | Transport PLUS group |
Primary outcome
Rate of falls
Time frame: up to 3 months
Rate of falls following transport home by ambulance
Rate of return ED visits
Time frame: 30 days
Rate of return ED visits following transport home by ambulance
3 secondary outcomes
Rate of falls
Time frame: up to 12 months
Rate of return ED visits
Time frame: 3 days
Readmission
Time frame: up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
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Preventing Loss of Independence Through Exercise in Community Living Centers
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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.
Kevin G Munjal, MD,MPH,MSCR 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?
A study testing Transport PLUS group in people with Fall, Accidental and Fall, 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 8 inclusion and 2 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 5 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of falls (time frame: up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.