Accidental FallsNCT03675503
Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids
A study testing Fall Prevention Decision Support in people with Accidental Falls and Harm Reduction, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This project proposes to evaluate the potential for nurses to assess if a patient who uses an ambulatory aid at home is fit to use one in the hospital, and the effect that providing ambulatory aids to hospitalized patients will have on reducing hospital falls, with a matched pair cluster-randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Accidental Falls, Harm Reduction
- What is being tested?
- Fall Prevention Decision Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 2015
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any one determined to be in need of walking aid and
- Can stand up from a seated position independently without assistance
- Can use ambulatory aid at home without assistance/supervision
- Can sit up in bed AND rise to a standing position independently
Who cannot join
- Not able to give consent
- Not able to use ambulatory aid independently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids: A Randomized Controlled Trial
This project proposes to evaluate the potential for nurses to assess if a patient who uses an ambulatory aid at home is fit to use one in the hospital, and the effect that providing ambulatory aids to hospitalized patients will have on reducing hospital falls, with a matched pair cluster-randomized controlled trial.
Hypothesis 1: Of the patients who use an ambulatory aid at home, patients who receive an ambulatory aid in the hospital will have a lower fall rate as compared to patients who do not receive an ambulatory aid in the hospital.
Hypothesis 2: After adequate training, nurses will be able to accurately assess whether or not patients need an ambulatory aid when compared to the gold-standard assessments of physical therapists.
Read the detailed description
This research project proposes to study the effectiveness of a specific falls prevention intervention in a high risk population by providing ambulatory aids upon admission to the hospital to patients who previously used one at home after a standardized evaluation by a Registered Nurse. This will be a randomized controlled trial within three hospitals in a large academic medical center.
Primary Objectives:
Specific Aim 1: Evaluate the effectiveness in preventing falls by providing an ambulatory aid to patients who use an ambulatory aid at home, and who are deemed fit to use the device in the hospital by their nurse.
Specific Aim 2: Evaluate the nurses' ability to assess the appropriateness of providing an ambulatory aid, such as a cane or walker, to a patient who uses an assistive device at home.
- Conditions
- Accidental Falls, Harm Reduction
- Being tested
- Fall Prevention Decision Support
- Keywords
- Fall Prevention, Hospital Acquired Conditions, Nurse Education, Assistive Devices
- Medical subject headings
- Harm Reduction, Iatrogenic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall Prevention Decision SupportOther
Decision support used by nurses to appropriately provide ambulatory aids to hospitalized patients in order to reduce hospital falls
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No change in the standard of care. |
| Fall Prevention Decision Support | Experimental | Nursing assesses patient using the "Assistive Device Checklist" and provides assistive devices to patients, if appropriate.
Decision support aimed at preventing hospital falls and empowering nurses. Receives: Other: Fall Prevention Decision Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number Falls
Participants's self reported number of falls will be assess at baseline and 6 months after trial.
Measured: Baseline and Six months after study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Interim data analysis indicated too many variables prevented the ability to drawn conclusive evidence the devices affected falls.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Single blind
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary S Ellen Lindros, Principal investigator, Albert Einstein College of Medicine Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675503
- Sponsor's protocol ID
- 2013-2984
- Status last verified
- May 2023
- First submitted
- 7 Sep 2018
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Hospital Falls by Empowering Nurses to Provide Ambulatory Aids: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03675503
- Acronym / sponsor ID
- 2013-2984
- Conditions
- Accidental Falls, Harm Reduction
- Keywords
- Fall Prevention, Hospital Acquired Conditions, Nurse Education, Assistive Devices
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim data analysis indicated too many variables prevented the ability to drawn conclusive evidence the devices affected falls.
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Sep 2018 (actual)
- 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.
This project proposes to evaluate the potential for nurses to assess if a patient who uses an ambulatory aid at home is fit to use one in the hospital, and the effect that providing ambulatory aids to hospitalized patients will have on reducing hospital falls, with a matched pair cluster-randomized controlled trial.
Hypothesis 1: Of the patients who use an ambulatory aid at home, patients who receive an ambulatory aid in the hospital will have a lower fall rate as compared to patients who do not receive an ambulatory aid in the hospital.
Hypothesis 2: After adequate training, nurses will be able to accurately assess whether or not patients need an ambulatory aid when compared to the gold-standard assessments of physical therapists.
Detailed description
This research project proposes to study the effectiveness of a specific falls prevention intervention in a high risk population by providing ambulatory aids upon admission to the hospital to patients who previously used one at home after a standardized evaluation by a Registered Nurse. This will be a randomized controlled trial within three hospitals in a large academic medical center.
Primary Objectives:
Specific Aim 1: Evaluate the effectiveness in preventing falls by providing an ambulatory aid to patients who use an ambulatory aid at home, and who are deemed fit to use the device in the hospital by their nurse.
Specific Aim 2: Evaluate the nurses' ability to assess the appropriateness of providing an ambulatory aid, such as a cane or walker, to a patient who uses an assistive device at home.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No change in the standard of care. |
| Fall Prevention Decision Support | Experimental | Other: Fall Prevention Decision SupportNursing assesses patient using the "Assistive Device Checklist" and provides assistive devices to patients, if appropriate. Decision support aimed at preventing hospital falls and empowering nurses. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- any one determined to be in need of walking aid and
- Can stand up from a seated position independently without assistance
- Can use ambulatory aid at home without assistance/supervision
- Can sit up in bed AND rise to a standing position independently
Key exclusion criteria (2 listed)
- Not able to give consent
- Not able to use ambulatory aid independently
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 |
|---|---|---|
| Fall Prevention Decision SupportDecision support used by nurses to appropriately provide ambulatory aids to hospitalized patients in order to reduce hospital falls | Other | Fall Prevention Decision Support |
Primary outcome
Change in Number Falls
Time frame: Baseline and Six months after study
Participants's self reported number of falls will be assess at baseline and 6 months after trial.
Results and safety
The study was stopped early (reason given: Interim data analysis indicated too many variables prevented the ability to drawn conclusive evidence the devices affected falls.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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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.
Mary S Ellen Lindros principal investigator
Albert Einstein College of Medicine Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fall Prevention Decision Support in people with Accidental Falls and Harm Reduction, run by Montefiore Medical Center 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 4 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: stopped early, as of the sponsor's last update on 10 May 2023. 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 was stopped early (reason given: Interim data analysis indicated too many variables prevented the ability to drawn conclusive evidence the devices affected falls.). Results are not available in the source record.
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?
Change in Number Falls (time frame: Baseline and Six months after study). 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 10 May 2023.