NCT06339125

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

September 24, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2025

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

March 25, 2024

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Fall patient

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

    Measured monthly/quarterly over one year

  • Fall injury

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

    Measured monthly/quarterly over one year

Secondary Outcomes (2)

  • Nurse perceptions

    three, six, and 12 months

  • Nurse perceptions

    three, six, and twelve months

Study Arms (4)

Unit 1

EXPERIMENTAL

Usual care and live streaming electronic health record driven Algorithm alerts nurses to possible increase in fall risk for review of interventions in place.

Other: Fall prevention algorithm

Unit 2

EXPERIMENTAL

Usual care and computer camera visualization detects and anticipates patient movement for patients at risk for falls and alerts nurses with fall risk potential.

Other: Inspiren camera visualization

Unit 3

EXPERIMENTAL

Usual 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.

Other: Fall prevention algorithmOther: Inspiren camera visualization

Unit 4

NO INTERVENTION

Control group, no intervention and usual care.

Interventions

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

Also known as: RGI fall prevention algorithm
Unit 1Unit 3

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

Also known as: Computerized camera visualization
Unit 2Unit 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (10)

  • 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.

    PMID: 21045097BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 34847057BACKGROUND
  • 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.

    PMID: 32826513BACKGROUND
  • 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.

    PMID: 33201236BACKGROUND
  • 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.

    PMID: 33190509BACKGROUND
  • 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.

    PMID: 24305561BACKGROUND
  • 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.

    PMID: 19092477BACKGROUND
  • 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.

    PMID: 30633063BACKGROUND
  • 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.

Related Links

Study Officials

  • Colleen K Snydeman, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director, Quality, Practice, Innovation & Research

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 1, 2024

Study Start

September 24, 2024

Primary Completion

September 23, 2025

Study Completion

September 24, 2025

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Data will collected in the aggregate at the unit level as rates per 1000 patient days, not patient specific

Locations