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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

Tracking Information
First Submitted Date April 9, 2018
First Posted Date April 17, 2018
Last Update Posted Date July 24, 2019
Actual Study Start Date January 1, 2014
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 9, 2018)
Falls [ Time Frame: 1/1/2014-12/31/2020 ]
Prevalence of patient falls in the study population
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 9, 2018)
Falls with Injury [ Time Frame: 1/1/2014-12/31/2020 ]
Prevalence of patient falls with injury in the study population
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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?
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Patient Fall
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 9, 2018)
25214
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03499717
Other Study ID Numbers 2017P000670
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Patricia C. Dykes, Brigham and Women's Hospital
Study Sponsor Brigham and Women's Hospital
Collaborators
  • Agency for Healthcare Research and Quality (AHRQ)
  • Montefiore Medical Center
  • Partners HealthCare
  • Columbia University
Investigators
Principal Investigator: Patricia C Dykes, MA,Ph.D,RN Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date July 2019