- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03499717
Generalizability and Spread of an Evidenced-based Fall Prevention Toolkit: Fall TIPS
Generalizability and Spread of an Evidenced-based Fall Prevention Toolkit: Fall TIPS (Tailoring Interventions for Patient Safety)
Study Overview
Status
Conditions
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?
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Falls
Time Frame: 1/1/2014-12/31/2020
|
Prevalence of patient falls in the study population
|
1/1/2014-12/31/2020
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Falls with Injury
Time Frame: 1/1/2014-12/31/2020
|
Prevalence of patient falls with injury in the study population
|
1/1/2014-12/31/2020
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patricia C Dykes, MA,Ph.D,RN, Brigham and Women's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017P000670
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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