Falls - Tailoring Interventions for Patient Safety - Full Text View

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 I Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Official Title:	Translating Fall Risk Status Into Interventions to Prevent Patient Falls: Falls TIPS (Tailoring Interventions for Patient Safety)

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

Primary Outcome Measures:

The outcome measure will be the number of fall prevention measures applied to each individual patient of the 30% random sample of admitted patients within each unit on the site visit day [ Time Frame: 2007-2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

falls with injury as a secondary outcome measure. [ Time Frame: 2007-2009 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	2000
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: No Intervention 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

Faulkner 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

Responsible Party:	Partners HealthCare ( Patricia C. Dykes RN, DNSc )
Study ID Numbers:	62572
First Received:	May 8, 2008
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00675935
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 October 23, 2008

Sponsors and Collaborators:	Brigham and Women's Hospital Robert Wood Johnson Foundation Massachusetts General Hospital Faulkner Hospital North Shore Medical Center
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00675935