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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03499717
Other study ID # 2017P000670
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date December 31, 2022

Study information

Verified date July 2023
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of our project is to evaluate the effectiveness of the Fall TIPS program with regard to inpatient falls and fall-related injuries.


Description:

This study will explore the effectiveness of the Fall TIPS (Tailoring Interventions for Patient Safety) program in regard to inpatient falls and fall-related injuries in three large hospital systems with different Electronic Medical Records (EMRs). We will collect and evaluate data on the perceived effectiveness of the Fall TIPS implementation process along with stakeholders' views of the toolkit. We will use an interrupted time series approach for evaluation of pre and post-Fall TIPS data related to patient falls and injurious falls. We will systematically analyze the costs and benefits of the Fall TIPS program from two perspectives: (1) the hospital, and (2) society as a whole. The hospital perspective will assist other hospitals in evaluating the decision to invest in implementing and adopting the Fall TIPS program, while the societal perspective will be instructive from a public policy stance By the end of the study, we will produce a set of recommendations to facilitate adoption, implementation, and maintenance of the Fall TIPS program, along with a manuscript that will answer the following research questions: 1. Does Fall TIPS reduce the incidence of falls and injurious falls? 2. Were there differences in Fall TIPS effectiveness among different healthcare systems and hospitals as well as variations associated with differing patient characteristics (gender, age, ethnic/racial), EMRs, and degrees of adherence with the Fall TIPS protocol? 3. Do the benefits associated with Fall TIPS outweigh the costs from hospital and societal perspectives? 4. What Fall TIPS components were most/least useful and what recommendations will improve the overall utility and ease of use of the Fall TIPS Toolkit? 5. What aspects of the implementation model were most/least helpful for promoting Fall TIPS adoption and use?


Recruitment information / eligibility

Status Completed
Enrollment 37231
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 110 Years
Eligibility Inclusion Criteria: - All adult patients admitted to medical, surgical, neurology and oncology units at participating hospitals during the time of the study Exclusion Criteria: - Anyone who does not meet the inclusion criteria

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Brigham and Women's Hospital Agency for Healthcare Research and Quality (AHRQ), Columbia University, Montefiore Medical Center, Partners HealthCare

References & Publications (1)

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. J — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Falls Prevalence of patient falls in the study population 1/1/2014-12/31/2020
Secondary Falls with Injury Prevalence of patient falls with injury in the study population 1/1/2014-12/31/2020
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