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.
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
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).
- 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?
- 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.
- Is the FPTK used to communicate fall risk status and facilitate adherence with the tailored patient safety plan of care recommendations?
- Is there a relationship between use of the FPTK and the incidence of falls (primary outcome measure) and fall-related injury (secondary outcome measure)?
- 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.
- Are the interdisciplinary team members, paraprofessionals, patients and family members satisfied with the FPTK?
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | One 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 |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- Is the FPTK used to communicate fall risk status and facilitate adherence with the tailored patient safety plan of care recommendations?
- 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)
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
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.
- First posted12 May 2008 (estimated)
- Study startSep 2007
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient FallsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Massachusetts General Hospital, North Shore Medical Center
- Responsible party
- Principal investigator, Patricia C. Dykes, Brigham and Women's Hospital
- Investigators
- Lana Tsurikova, MSc, MA, Study director, Partners Healthcare SysPatricia C. Dykes, RN, DNSc, Principal investigator, Partners Healthcare Sys
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Fall Risk Status Into Interventions to Prevent Patient Falls: Falls TIPS (Tailoring Interventions for Patient Safety)
- ClinicalTrials.gov ID
- NCT00675935
- Acronym / sponsor ID
- Falls TIPS / 62572
- Conditions
- Patient Falls
- Keywords
- Patient falls, fall risk, fall prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,264 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Massachusetts General Hospital, North Shore Medical Center
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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?
- 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.
- Is the FPTK used to communicate fall risk status and facilitate adherence with the tailored patient safety plan of care recommendations?
- Is there a relationship between use of the FPTK and the incidence of falls (primary outcome measure) and fall-related injury (secondary outcome measure)?
- 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.
- Are the interdisciplinary team members, paraprofessionals, patients and family members satisfied with the FPTK?
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Fall Prevention Tool Kit prototype using a randomized designOne high-risk medical unit at each hospital will be randomly assigned to receive the fall prevention toolkit |
| 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Anyone who does not meet criteria above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fall Prevention Tool Kit prototype using a randomized designAlso: FPTKBased 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 | 1 |
Primary outcome
The outcome measure will be rate of patients falls per 1000 patient days
Time frame: 1/2009-6/2009
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)?
2 secondary outcomes
Falls with injury as a secondary outcome measure.
Time frame: 1/2009-6/2009
To evaluate the effectiveness of the FPTK prototype on documentation of planned and completed tailored interventions
Time frame: 1/2009-6/2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Derived from this study: PubMed 21045097Dykes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lana Tsurikova, MSc, MA study director
Partners Healthcare Sys
Patricia C. Dykes, RN, DNSc principal investigator
Partners Healthcare Sys
2 sites in 1 country: see every site and its status.
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.