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Falls - Tailoring Interventions for Patient Safety (Falls TIPS)

This study has been completed.
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
Massachusetts General Hospital
North Shore Medical Center
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00675935
First received: May 8, 2008
Last updated: July 22, 2010
Last verified: July 2010
History of Changes
  Purpose

The goal of our project is to prevent patient falls by translating an individual patient's fall risk assessment into a decision support intervention that communicates fall risk status, and creates a tailored evidence-based plan of care that will be accessible to members of the care team to prevent falls.


Condition Intervention Phase
Patient Falls
 Other: Fall Prevention Tool Kit prototype using a randomized design
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Translating Fall Risk Status Into Interventions to Prevent Patient Falls: Falls TIPS (Tailoring Interventions for Patient Safety)

Resource links provided by NLM:

MedlinePlus related topics: Patient Safety
U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • The outcome measure will be rate of patients falls per 1000 patient days [ Time Frame: 1/2009-6/2009 ] [ Designated as safety issue: Yes ]

    Specific Aim: To evaluate the effectiveness of the FPTK prototype on reducing patient falls.

    1. Is the FPTK used to communicate fall risk status and facilitate adherence with the tailored patient safety plan of care recommendations?
    2. Is there a relationship between use of the FPTK and the incidence of falls (primary outcome measure)?


Secondary Outcome Measures:
  • Falls with injury as a secondary outcome measure. [ Time Frame: 1/2009-6/2009 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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?


Estimated Enrollment: 2000
Study Start Date: September 2007
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

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  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 2 units per hospital for participation. One unit will be randomized to receive the intervention; the other will serve as a control. Inclusion Criteria: Non-specialty (medical) units and units with similar types of patients and fall rates (fall rates higher than hospital mean).
  • Identify focus group/interview participants. Interdisciplinary staff members. Selection criteria: nurses, nursing assistants and other providers (12 total more heavily weighted w/nursing staff) to participate in the study focus groups.
  • Patients who have fallen (4 patients at each hospital) for participation in phone interview.
  • Patients for analysis must be adults admitted to intervention units.

Exclusion Criteria:

  • Anyone who does not meet criteria above.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00675935

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Brigham and Women's Hospital
Robert Wood Johnson Foundation
Massachusetts General Hospital
North Shore Medical Center
Investigators
Study Director: Lana Tsurikova, MSc, MA Partners Healthcare Sys
Principal Investigator: Patricia C. Dykes, RN, DNSc Partners Healthcare Sys
  More Information

No publications provided by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Patricia C. Dykes RN, DNSc, Partners HealthCare
ClinicalTrials.gov Identifier: NCT00675935     History of Changes
Other Study ID Numbers: 62572
Study First Received: May 8, 2008
Last Updated: July 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Patient falls
fall risk
fall prevention

ClinicalTrials.gov processed this record on May 23, 2013