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OpenTrials
Completed

NCT Number: NCT06339125

Predictive Analytics and Computer Visualization Enhances Patient Safety to Prevent 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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

  • 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?
  • What are the perceptions of nurses related to:
  • The impact of three study technologies implemented to assist with the identification of increased fall risk.
  • The reduction of nurse burden on the assessment of fall risk and the recommendation for additional interventions to prevent falls.

Research aims:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Fall prevention algorithm

Other

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

Other names: RGI fall prevention algorithm

Inspiren camera visualization

Other

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

Other names: Computerized camera visualization

Primary outcomes

  1. Fall patient

    Time frame: Measured monthly/quarterly over one year

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

  2. Fall injury

    Time frame: Measured monthly/quarterly over one year

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

Secondary outcomes

  1. Nurse perceptions

    Time frame: three, six, and 12 months

    Questionnaire of Nurse perceptions of fall prevention strategies

  2. Nurse perceptions

    Time frame: three, six, and twelve months

    Focus groups of nurse perceptions

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Crico

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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