Clinical trial NCT03499717: Generalizability and Spread of an Evidenced-based Fall Prevention Toolkit: Fall TIPS
Official title: Generalizability and Spread of an Evidenced-based Fall Prevention Toolkit: Fall TIPS (Tailoring Interventions for Patient Safety)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Fall
Keywords: Fall Risk
Patient Falls
Fall Prevention
Patient Safety
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Montefiore Medical Center
name: Partners HealthCare
name: Columbia University
First posted: 2018-04-17
Enrollment: 37231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes all adult patients admitted to medical, surgical, neurology and oncology units at participating hospitals during the time of the study. Participating hospitals include the Partners Healthcare System, Montefiore Medical Center, and NewYork-Presbyterian/Columbia University Medical Center.

Brief 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.

Detailed 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?

Eligibility criteria: 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

Primary outcomes:
measure: Falls
timeFrame: 1/1/2014-12/31/2020
Secondary outcomes:
measure: Falls with Injury
timeFrame: 1/1/2014-12/31/2020
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Patricia C Dykes, MA,Ph.D,RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.