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Fall PatientsNCT06339125

Predictive Analytics and Computer Visualization Enhances Patient Safety to Prevent Falls

A study testing Fall prevention algorithm and Inspiren camera visualization in people with Fall Patients and Fall Injury, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Annually, in the United States there are 700,000 - 1,000,000 inpatient falls reported, and one-third of patients sustain an injury. The average estimated cost per fall is $6,694, resulting in over $1.4 -1.9 billion dollars in losses each year (AHRQ, 2017). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Fall Patients, Fall Injury
What is being tested?
Fall prevention algorithm and Inspiren camera visualization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,350 participants
Where
1 siteUnited States
Study dates
24 Sep 2024to 24 Sep 2025
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

  • Adult medical patients admitted to the study units
  • All nurses working on the study units

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Predictive Analytics Combined With Computer Visualization Enhances Patient Safety and Eases Nurse Burden for Preventing Falls

Annually, in the United States there are 700,000 - 1,000,000 inpatient falls reported, and one-third of patients sustain an injury. The average estimated cost per fall is $6,694, resulting in over $1.4 -1.9 billion dollars in losses each year (AHRQ, 2017). This study aims to compare the impact of different fall prevention strategies on the rate of occurrence of falls and falls with injury in an academic medical center on three adult medical units. While maintaining the usual standard of care for fall prevention, each unit will add one of the following: (1) use of a fall risk alert to nurses using an algorithm based on electronic health record data or (2) computerized camera visualization or (3) a combination of both.

Read the detailed description

To decrease falls in the hospital setting, and building on previous nursing fall research, as well as the MFS and the Fall TIPS program, a decision support algorithm was developed to identify changes in clinical factors as they occur to alert nurses to the need to adjust fall prevention interventions. Nurses, through a collaboration with RGI Informatics, then deployed the an algorithm on one clinical general care unit. The RGI software uses the algorithm live streaming EHR data from Epic to identify patients whose risk of falling may have increased and provide clinical decision support to nurses through an alert on their hospital issued cell phones. Preliminary results demonstrated feasibility and a statistically significant reduction (p <0.01) in falls with injury over an 11-month period.

Mutually exclusive preliminary work, on a second inpatient general care unit, involving a computerized patient visualization system also yielded reduction in falls. Combined usage of the two technologies may yield a synergistic effect thereby further reducing the incidence of falls in the acute care setting. To date, there is no evidence derived from evaluation of patient outcomes from simultaneous testing of the two technologies. Thus, the purpose of this study is to determine the impact of three different fall prevention interventions (RGI/MGH Algorithm only, Inspiren only and combined RGI Algorithm and Inspiren) on patients at risk for falls and falls with injury on three adult general care units in a large academic medical center.

The proposed solution is the only known strategy that extracts and synthesizes physiologic and physical data from multiple sources, to create a dimensional view of a patient's safety profile related to fall risk. Timely alerts will inform nurses of patient's fall risk, reason for risk and their clinical decisions regarding fall prevention strategies. This initial proposal focuses on patients at risk for falls and the investigators are confident that this innovative approach is adaptable to address other critical safety issues for example, pressure injuries and catheter associated urinary tract infections. Detailed information about RGI Analytics and Inspiren is provided below.

Methodology: An observational cohort, mixed-methods study design will be conducted to determine the impact and effectiveness of usual care and three different fall prevention strategies that exceed the standard of care on three inpatient units over one year. Unit 1 will employee streaming analytics and the algorithm only, Unit 2 will employee Inspiren's AUGI computer visualization only and Unit 3 will employee the combined streaming analytic/algorithm and Inspiren's AUGI device. Unit 4, the control unit, will serve as an internal comparison group from the same institution. In addition to the study interventions all four units will continue to maintain usual evidence-based practice, standards of care for fall prevention. Patient, unit, and nurse demographic data collected for the study currently can be accessed from or calculated from existing sources. Sources include the ADT, financial, acuity, and quality data stored in a Datawarehouse. Unit patient demographic data in the aggregate will include age, gender, and race. Nurse demographic data will include the number of fulltime equivalents, years of experience as a nurse, years of experience at the academic medical center, and highest level of education. Unit data will include counts of patient admissions, patient days, length of stay, nursing acuity, patient type by gender, age, race, ethnicity, number of unit falls and unit falls with injuries, and nurse staffing indicators. Nurse perceptions of the three interventions units will be measured in association with the intervention using real time feedback from cell phone alerts (helpful/not helpful), nurse feedback, and quarterly surveys. The Fall Prevention Efficiency Scale (Dykes, et al., 2021) is a peer reviewed 13-item tool that focuses on four key areas: saves time, does not waste time, is worth the time and is helpful in preventing falls. The survey questions will be adapted to meet the needs of this study and will be administered via REDCap, a Harvard Catalyst secure, web application for managing on-line survey tools.

Research questions

  1. In the acute care, inpatient hospital setting, is there a difference in rate of occurrence of falls and injurious falls, comparing three distinct methods of alerting nurses at the point of care to a change in a patients risk of falling while maintaining all other current standards of care for fall prevention and adding these new standards during the study: (1) use of streaming analytics and a fall risk algorithm that alerts nurses to a change in fall risk, (2) computer visualization and artificial intelligence interpretation of patient movement and (3) a combination of both technologies?
  2. What are the perceptions of nurses related to:
  3. The impact of three study technologies implemented to assist with the identification of increased fall risk.
  4. The reduction of nurse burden on the assessment of fall risk and the recommendation for additional interventions to prevent falls.

Research aims:

  1. Compare the impact of the three fall prevention innovations, within and between units and to one control unit (all four units using same usual standard of care) on falls and falls with injury.
  2. Determine the perceived effectiveness of fall prevention innovations and alerts on clinical decision support and nurse burden using nurse surveys, responses to alerts and focus groups.
Being tested
Fall prevention algorithm, Inspiren camera visualization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fall prevention algorithmOther

    Also called RGI fall prevention algorithm

    Algorithm generates fall prevention alerts to nurses in real time, using evidenced based electronic health record information regarding changes in care that may suggest the need for additional fall prevention strategies

  • Inspiren camera visualizationOther

    Also called Computerized camera visualization

    The Inspiren computer camera visualization is an additional strategy for nurses to employ when there is a change in a patient's fall risk.

Study groups in NCT06339125
Study groupRoleWhat they receive
Unit 1ExperimentalUsual care and live streaming electronic health record driven Algorithm alerts nurses to possible increase in fall risk for review of interventions in place.
Receives: Other: Fall prevention algorithm
Unit 2ExperimentalUsual care and computer camera visualization detects and anticipates patient movement for patients at risk for falls and alerts nurses with fall risk potential.
Receives: Other: Inspiren camera visualization
Unit 3ExperimentalUsual care and live streaming electronic health record driven Algorithm alerts nurses to possible increase in fall risk for review of interventions in place. AND Computer camera visualization detects and anticipates patient movement for patients at risk for falls and alerts nurses with fall risk potential.
Receives: Other: Fall prevention algorithm; Other: Inspiren camera visualization
Unit 4No interventionControl group, no intervention and usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fall patient

    Rate of patient falls per 1000 patient days, National Database Nurse Sensitive Indicators

    Measured: Measured monthly/quarterly over one year

  2. Fall injury

    Rate of falls with injury per 1000 patient days, National Database Nurse Sensitive Indicators

    Measured: Measured monthly/quarterly over one year

Secondary outcomes (2)
  1. Nurse perceptions

    Questionnaire of Nurse perceptions of fall prevention strategies

    Measured: three, six, and 12 months

  2. Nurse perceptions

    Focus groups of nurse perceptions

    Measured: three, six, and twelve months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2024
  2. Study start24 Sep 2024
  3. Primary completion23 Sep 2025
  4. Study completion24 Sep 2025

Resources

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
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
An observational cohort, mixed-methods study design will be conducted to determine the impact and effectiveness of usual care and three different fall prevention strategies that exceed the standard of care on three inpatient units at MGH over one year. Unit 1 will employ streaming analytics and the MGH algorithm only, Unit 2 will employee Inspiren's AUGI computer visualization only and Unit 3 will employ the combined streaming analytic/MGH algorithm and Inspiren's AUGI device. Unit 4, the control unit, will serve as an internal comparison group from the same institution. In addition to the study interventions all four units will continue to maintain usual MGH evidence-based practice, standards of care for fall prevention.
Masking
None (open label)
Enrolment
5,350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06339125
Sponsor's protocol ID
2023p003637
Status last verified
Apr 2026
First submitted
25 Mar 2024
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will collected in the aggregate at the unit level as rates per 1000 patient days, not patient specific

Publications

  • Dykes PC, Carroll DL, Hurley A, Lipsitz S, Benoit A, Chang F, Meltzer S, Tsurikova R, Zuyov L, Middleton B. Fall prevention in acute care hospitals: a randomized trial. JAMA. 2010 Nov 3;304(17):1912-8. doi: 10.1001/jama.2010.1567.

    PubMed 21045097
  • Morse, JM, Morse R.M., Tylko, S.J. (1989). Development of a scale to identify the fall-prone patient. Can J Aging, 8:366-7.

  • Seibert K, Domhoff D, Bruch D, Schulte-Althoff M, Furstenau D, Biessmann F, Wolf-Ostermann K. Application Scenarios for Artificial Intelligence in Nursing Care: Rapid Review. J Med Internet Res. 2021 Nov 29;23(11):e26522. doi: 10.2196/26522.

    PubMed 34847057
  • Fehlberg EA, Cook CL, Bjarnadottir RI, McDaniel AM, Shorr RI, Lucero RJ. Fall Prevention Decision Making of Acute Care Registered Nurses. J Nurs Adm. 2020 Sep;50(9):442-448. doi: 10.1097/NNA.0000000000000914.

    PubMed 32826513
  • Dykes PC, Burns Z, Adelman J, Benneyan J, Bogaisky M, Carter E, Ergai A, Lindros ME, Lipsitz SR, Scanlan M, Shaykevich S, Bates DW. Evaluation of a Patient-Centered Fall-Prevention Tool Kit to Reduce Falls and Injuries: A Nonrandomized Controlled Trial. JAMA Netw Open. 2020 Nov 2;3(11):e2025889. doi: 10.1001/jamanetworkopen.2020.25889.

    PubMed 33201236
  • Costantinou E, Spencer JA. Analysis of Inpatient Hospital Falls with Serious Injury. Clin Nurs Res. 2021 May;30(4):482-493. doi: 10.1177/1054773820973406. Epub 2020 Nov 16.

    PubMed 33190509
  • Pierce JR Jr, Shirley M, Johnson EF, Kang H. Narcotic administration and fall-related injury in the hospital: implications for patient safety programs and providers. Int J Risk Saf Med. 2013;25(4):229-34. doi: 10.3233/JRS-130603.

    PubMed 24305561
  • Quigley PA, Hahm B, Collazo S, Gibson W, Janzen S, Powell-Cope G, Rice F, Sarduy I, Tyndall K, White SV. Reducing serious injury from falls in two veterans' hospital medical-surgical units. J Nurs Care Qual. 2009 Jan-Mar;24(1):33-41. doi: 10.1097/NCQ.0b013e31818f528e.

    PubMed 19092477
  • Zhao YL, Bott M, He J, Kim H, Park SH, Dunton N. Evidence on Fall and Injurious Fall Prevention Interventions in Acute Care Hospitals. J Nurs Adm. 2019 Feb;49(2):86-92. doi: 10.1097/NNA.0000000000000715.

    PubMed 30633063
  • Dykes PC, Khasnabish S, Adkison LE, Bates DW, Bogaisky M, Burns Z, Carroll DL, Carter E, Hurley AC, Jackson E, Kurian SS, Lindros ME, Ryan V, Scanlan M, Spivack L, Walsh MA, Adelman J. Use of a perceived efficacy tool to evaluate the FallTIPS program. J Am Geriatr Soc. 2021 Dec;69(12):3595-3601. doi: 10.1111/jgs.17436. Epub 2021 Aug 30.

    PubMed 34460098

Questions about this trial

What is this clinical trial studying?

A study testing Fall prevention algorithm and Inspiren camera visualization in people with Fall Patients and Fall Injury, run by Massachusetts General Hospital 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 2 inclusion and 1 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 4 May 2026. 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?

Fall patient (time frame: Measured monthly/quarterly over one year). 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?

On the ClinicalTrials.gov record for NCT06339125, which also lists 10 linked publications.

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 4 May 2026.

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