Falls - Tailoring Interventions for Patient Safety (Falls TIPS)
|ClinicalTrials.gov Identifier: NCT00675935|
Recruitment Status : Completed
First Posted : May 12, 2008
Last Update Posted : July 26, 2010
|Condition or disease||Intervention/treatment||Phase|
|Patient Falls||Other: Fall Prevention Tool Kit prototype using a randomized design||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Translating Fall Risk Status Into Interventions to Prevent Patient Falls: Falls TIPS (Tailoring Interventions for Patient Safety)|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||August 2009|
One high-risk medical unit at each hospital will be randomly assigned to receive the fall prevention toolkit
Other: Fall Prevention Tool Kit prototype using a randomized design
Based on the results from Phase 1, Phase 2 and consistent with the literature that suggests that multifaceted, tailored interventions are most effective against inpatient falls, the FPTK prototype will be comprised of two interrelated components 1) The Fall Risk Alert and Communication Plan (translates an individual patient's fall risk assessment into a decision support intervention that communicates fall risk status to team members.) and 2) The Patient Safety Plan of Care PSPOC (translates an individual patient's fall risk assessment into a decision support intervention that creates a tailored evidence-based plan of care). The goal of the FPTK Intervention is to communicate risk status and recommended tailored discipline specific-interventions to prevent falls.
Other Name: FPTK
No Intervention: 2
One high-risk medical unit at each hospital will be randomly assigned to receive usual care as it relates to fall prevention; i.e., receives no intervention.
- The outcome measure will be rate of patients falls per 1000 patient days [ Time Frame: 1/2009-6/2009 ]
Specific Aim: To evaluate the effectiveness of the FPTK prototype on reducing patient falls.
- Is the FPTK used to communicate fall risk status and facilitate adherence with the tailored patient safety plan of care recommendations?
- Is there a relationship between use of the FPTK and the incidence of falls (primary outcome measure)?
- Falls with injury as a secondary outcome measure. [ Time Frame: 1/2009-6/2009 ]Is there a relationship between use of the FPTK and the incidence of Fall-related injury (secondary outcome measure)
- To evaluate the effectiveness of the FPTK prototype on documentation of planned and completed tailored interventions [ Time Frame: 1/2009-6/2009 ]Is there a difference in the frequency with which tailored fall prevention interventions are documented when professional and paraprofessional providers, patients and family members have access to the FPTK when compared to usual care?
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675935
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Study Director:||Lana Tsurikova, MSc, MA||Partners Healthcare Sys|
|Principal Investigator:||Patricia C. Dykes, RN, DNSc||Partners Healthcare Sys|