Generalizability and Spread of an Evidenced-based Fall Pr... | NCT03499717

Studies
Generalizability and Spread of an Evidenced-based Fall Prevention Toolkit: Fall TIPS

NCT03499717

Sponsor

Brigham and Women's Hospital

Status

Completed

Last Update Posted

Jul 27, 2023Actual

Enrollment

37,231Actual

Phase

Not provided

Conditions

Patient Fall

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Apr 9, 2018

First Submission Date that Met QC Criteria

Apr 9, 2018

First Posted Date

Apr 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2023

Last Update Posted Date

Jul 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patricia C. Dykes, Program Director, Center for Patient Safety Research and Practice, Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Name	Class
Agency for Healthcare Research and Quality (AHRQ)	FED
Montefiore Medical Center	OTHER
Partners HealthCare	OTHER
Columbia University

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Does Fall TIPS reduce the incidence of falls and injurious falls?
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?
Do the benefits associated with Fall TIPS outweigh the costs from hospital and societal perspectives?
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?
What aspects of the implementation model were most/least helpful for promoting Fall TIPS adoption and use?

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

37,231Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Falls	Prevalence of patient falls in the study population	1/1/2014-12/31/2020

Secondary Outcomes

Measure	Description	Time Frame
Falls with Injury	Prevalence of patient falls with injury in the study population	1/1/2014-12/31/2020

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

110 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patricia C Dykes, MA,Ph.D,RN	Brigham and Women's Hospital	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33201236	Result	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.