Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-01-02 @ 5:16 AM
Study NCT ID:
NCT00675935
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2008-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Falls - Tailoring Interventions for Patient Safety
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
Translating Fall Risk Status Into Interventions to Prevent Patient Falls: Falls TIPS (Tailoring Interventions for Patient Safety)
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Falls TIPS
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.
Detailed Description:
Patient falls are defined as "patients who experience an unplanned descent to the floor". Patient falls in hospitals are a key safety issue and represent the most frequently reported adverse event in acute care settings. Previous work related to fall risk assessment suggests that a large majority of falls (78%) occur as a result of the presence of physiological risk factors such as confusion, incontinence, poor balance and mobility problems. These falls are considered preventable and as such are classified as iatrogenic.
Phase 1 Specific Aim: To describe the current barriers, facilitators, and methods of fall risk communication in acute care settings (2 academic medical center and 2 community hospital units).
1. What fall risk communication exists within the context of patient care workflow that alerts nurses and other providers (physicians, physical therapists, pharmacists) regarding patients' fall risk status?
* What should the elements of alerts be at the point of care to support fall risk communication to nurses and other interdisciplinary team members?
* How should the alert be communicated to professional and paraprofessional providers, patients, and families?
2. What communication of actions to prevent falls exists within the context of patient care workflow that promotes use of a fall prevention plan of care?
* Based on empirical data to reduce barriers and enhance facilitators, how can information systems be used to create and communicate a tailored evidence-based fall risk patient safety plan of care derived from the nursing fall risk assessment?
* Based on the C-IC conceptual model, how should the tailored evidence-based fall risk patient safety plan of care be communicated to professional and paraprofessional providers, patients, and families?
Phase 2 Specific Aim: To develop a Fall Prevention Tool Kit (FPTK) prototype that includes 1) The Fall Risk Alert and Communication Plan that translates an individual patient's fall risk assessment into an interdisciplinary fall risk status communication and 2) The Patient Safety Plan of Care (PSPOC), that translates the individual patient's fall risk assessment into a decision support intervention that creates a tailored evidence-based plan of care to be used by professional and paraprofessional providers, patients, and family members across acute care settings.
The FPTK will be developed from fall risk assessment literature, evidence-based fall prevention guidelines and knowledge gained from Phase 1. FPTK components will target common risk communication/fall intervention requirements identified in Phase 1 across the four hospitals to facilitate testing the prototype in Phase 3 and to improve generalizability of our findings.
Phase 3 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) and fall-related injury (secondary outcome measure)?
3. 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?
Phase 4 Specific Aim: To evaluate satisfaction with the FPTK prototype and to generate recommendations for improvement.
1. Are the interdisciplinary team members, paraprofessionals, patients and family members satisfied with the FPTK?
2. What components are most useful and what recommendations can be made to improve the perceived usefulness and ease of use of the FPTK? If the FPTK works, then one will see that: 1) the tool kit is used and those helpful and useful components will be identified, 2) those who use the tool kit are satisfied with its use, 3) there is a decrease in the incidence of falls and falls with injury.
Phase 1 Specific Aim: To describe the current barriers, facilitators, and methods of fall risk communication in acute care settings (2 academic medical center and 2 community hospital units).
1. What fall risk communication exists within the context of patient care workflow that alerts nurses and other providers (physicians, physical therapists, pharmacists) regarding patients' fall risk status?
* What should the elements of alerts be at the point of care to support fall risk communication to nurses and other interdisciplinary team members?
* How should the alert be communicated to professional and paraprofessional providers, patients, and families?
2. What communication of actions to prevent falls exists within the context of patient care workflow that promotes use of a fall prevention plan of care?
* Based on empirical data to reduce barriers and enhance facilitators, how can information systems be used to create and communicate a tailored evidence-based fall risk patient safety plan of care derived from the nursing fall risk assessment?
* Based on the C-IC conceptual model, how should the tailored evidence-based fall risk patient safety plan of care be communicated to professional and paraprofessional providers, patients, and families?
Phase 2 Specific Aim: To develop a Fall Prevention Tool Kit (FPTK) prototype that includes 1) The Fall Risk Alert and Communication Plan that translates an individual patient's fall risk assessment into an interdisciplinary fall risk status communication and 2) The Patient Safety Plan of Care (PSPOC), that translates the individual patient's fall risk assessment into a decision support intervention that creates a tailored evidence-based plan of care to be used by professional and paraprofessional providers, patients, and family members across acute care settings.
The FPTK will be developed from fall risk assessment literature, evidence-based fall prevention guidelines and knowledge gained from Phase 1. FPTK components will target common risk communication/fall intervention requirements identified in Phase 1 across the four hospitals to facilitate testing the prototype in Phase 3 and to improve generalizability of our findings.
Phase 3 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) and fall-related injury (secondary outcome measure)?
3. 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?
Phase 4 Specific Aim: To evaluate satisfaction with the FPTK prototype and to generate recommendations for improvement.
1. Are the interdisciplinary team members, paraprofessionals, patients and family members satisfied with the FPTK?
2. What components are most useful and what recommendations can be made to improve the perceived usefulness and ease of use of the FPTK? If the FPTK works, then one will see that: 1) the tool kit is used and those helpful and useful components will be identified, 2) those who use the tool kit are satisfied with its use, 3) there is a decrease in the incidence of falls and falls with injury.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: