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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499717
Recruitment Status : Active, not recruiting
First Posted : April 17, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
Agency for Healthcare Research and Quality (AHRQ)
Montefiore Medical Center
Partners HealthCare
Columbia University
Information provided by (Responsible Party):
Patricia C. Dykes, Brigham and Women's Hospital

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.

Condition or disease
Patient Fall

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?

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Study Type : Observational
Estimated Enrollment : 25214 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Generalizability and Spread of an Evidenced-based Fall Prevention Toolkit: Fall TIPS (Tailoring Interventions for Patient Safety)
Actual Study Start Date : January 1, 2014
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Falls [ Time Frame: 1/1/2014-12/31/2020 ]
    Prevalence of patient falls in the study population


Secondary Outcome Measures :
  1. Falls with Injury [ Time Frame: 1/1/2014-12/31/2020 ]
    Prevalence of patient falls with injury in the study population



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499717


Sponsors and Collaborators
Brigham and Women's Hospital
Agency for Healthcare Research and Quality (AHRQ)
Montefiore Medical Center
Partners HealthCare
Columbia University
Investigators
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Principal Investigator: Patricia C Dykes, MA,Ph.D,RN Brigham and Women's Hospital

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Responsible Party: Patricia C. Dykes, Program Director, Center for Patient Safety Research and Practice, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03499717    
Other Study ID Numbers: 2017P000670
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patricia C. Dykes, Brigham and Women's Hospital:
Fall Risk
Patient Falls
Fall Prevention
Patient Safety