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Patient FallsFalls TIPSNCT00675935

Falls - Tailoring Interventions for Patient Safety

A study testing Fall Prevention Tool Kit prototype using a randomized design in people with Patient Falls, run by Brigham and Women's Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 110 yearsHealthy volunteers can take part
Conditions the study is for
Patient Falls
What is being tested?
Fall Prevention Tool Kit prototype using a randomized design
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,264 participants
Where
2 sitesUnited States
Study dates
Sep 2007to Aug 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Anyone who does not meet criteria above.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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

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.

Read the 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?
  1. 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.
Conditions
Patient Falls
Being tested
Fall Prevention Tool Kit prototype using a randomized design
Keywords
Patient falls, fall risk, fall prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fall Prevention Tool Kit prototype using a randomized designOther

    Also called FPTK

    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.

Study groups in NCT00675935
Study groupRoleWhat they receive
1ExperimentalOne high-risk medical unit at each hospital will be randomly assigned to receive the fall prevention toolkit
Receives: Other: Fall Prevention Tool Kit prototype using a randomized design
2No interventionOne 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)?

    Measured: 1/2009-6/2009

Secondary outcomes (2)
  1. Falls with injury as a secondary outcome measure.

    Is there a relationship between use of the FPTK and the incidence of Fall-related injury (secondary outcome measure)

    Measured: 1/2009-6/2009

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

    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?

    Measured: 1/2009-6/2009

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionJun 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10,264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00675935
Sponsor's protocol ID
62572
Acronym
Falls TIPS
Status last verified
Jul 2024
First submitted
8 May 2008
Last updated
17 Jul 2024
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21045097

Questions about this trial

What is this clinical trial studying?

A study testing Fall Prevention Tool Kit prototype using a randomized design in people with Patient Falls, run by Brigham and Women's Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The outcome measure will be rate of patients falls per 1000 patient days (time frame: 1/2009-6/2009). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00675935, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.

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