Falls - Tailoring Interventions for Patient Safety

NCT00675935 | Completed

• 1 other identifier: 62572
• Study Type: interventional
• Target: 10,264
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Patient Falls

Keywords

Patient falls; fall risk; fall prevention

Outcome Measures

Primary Outcomes (1)

• The outcome measure will be rate of patients falls per 1000 patient days

  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)?

  1/2009-6/2009

Secondary Outcomes (2)

• Falls with injury as a secondary outcome measure.

  1/2009-6/2009

• To evaluate the effectiveness of the FPTK prototype on documentation of planned and completed tailored interventions

  1/2009-6/2009

Study Arms (2)

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

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.

Interventions

Fall Prevention Tool Kit prototype using a randomized design OTHER

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.

Also known as: FPTK

1

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Anyone who does not meet criteria above.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Robert Wood Johnson Foundation: collaborator
• Massachusetts General Hospital: collaborator
• North Shore Medical Center: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Dykes PC, Carroll DL, Hurley A, Lipsitz S, Benoit A, Chang F, Meltzer S, Tsurikova R, Zuyov L, Middleton B. Fall prevention in acute care hospitals: a randomized trial. JAMA. 2010 Nov 3;304(17):1912-8. doi: 10.1001/jama.2010.1567.

  PMID: 21045097 DERIVED

Study Officials

• Lana Tsurikova, MSc, MA

  Partners Healthcare Sys

  STUDY DIRECTOR

• Patricia C. Dykes, RN, DNSc

  Partners Healthcare Sys

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Program Director, Center for Patient Safety, Research and Practice

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 12, 2008
• Study Start: September 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

US (2)