Patient FallNCT03499717
Generalizability and Spread of an Evidenced-based Fall Prevention Toolkit: Fall TIPS
An observational study of Patient Fall, run by Brigham and Women's Hospital.
Trial summary
The goal of our project is to evaluate the effectiveness of the Fall TIPS program with regard to inpatient falls and fall-related injuries. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Patient Fall
- How many people
- 37,231 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 2022
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes all adult patients admitted to medical, surgical, neurology and oncology units at participating hospitals during the time of the study. Participating hospitals include the Partners Healthcare System, Montefiore Medical Center, and NewYork-Presbyterian/Columbia University Medical Center.
Who may be able to join
- All adult patients admitted to medical, surgical, neurology and oncology units at participating hospitals during the time of the study
Who cannot join
- Anyone who does not meet the inclusion criteria
About this study
Official title: Generalizability and Spread of an Evidenced-based Fall Prevention Toolkit: Fall TIPS (Tailoring Interventions for Patient Safety)
The goal of our project is to evaluate the effectiveness of the Fall TIPS program with regard to inpatient falls and fall-related injuries.
Read the detailed description
This study will explore the effectiveness of the Fall TIPS (Tailoring Interventions for Patient Safety) program in regard to inpatient falls and fall-related injuries in three large hospital systems with different Electronic Medical Records (EMRs). We will collect and evaluate data on the perceived effectiveness of the Fall TIPS implementation process along with stakeholders' views of the toolkit. We will use an interrupted time series approach for evaluation of pre and post-Fall TIPS data related to patient falls and injurious falls. We will systematically analyze the costs and benefits of the Fall TIPS program from two perspectives: (1) the hospital, and (2) society as a whole. The hospital perspective will assist other hospitals in evaluating the decision to invest in implementing and adopting the Fall TIPS program, while the societal perspective will be instructive from a public policy stance
By the end of the study, we will produce a set of recommendations to facilitate adoption, implementation, and maintenance of the Fall TIPS program, along with a manuscript that will answer the following research questions:
- Does Fall TIPS reduce the incidence of falls and injurious falls?
- Were there differences in Fall TIPS effectiveness among different healthcare systems and hospitals as well as variations associated with differing patient characteristics (gender, age, ethnic/racial), EMRs, and degrees of adherence with the Fall TIPS protocol?
- Do the benefits associated with Fall TIPS outweigh the costs from hospital and societal perspectives?
- What Fall TIPS components were most/least useful and what recommendations will improve the overall utility and ease of use of the Fall TIPS Toolkit?
- What aspects of the implementation model were most/least helpful for promoting Fall TIPS adoption and use?
- Conditions
- Patient Fall
- Keywords
- Fall Risk, Patient Falls, Fall Prevention, Patient Safety
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls
Prevalence of patient falls in the study population
Measured: 1/1/2014-12/31/2020
Secondary outcomes (1)
Falls with Injury
Prevalence of patient falls with injury in the study population
Measured: 1/1/2014-12/31/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start1 Jan 2014
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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 FallStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 37,231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Montefiore Medical Center, Partners HealthCare, Columbia University
- Responsible party
- Principal investigator, Patricia C. Dykes, Brigham and Women's Hospital
- Investigators
- Patricia C Dykes, MA,Ph.D,RN, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499717
- Sponsor's protocol ID
- 2017P000670
- Status last verified
- Jul 2023
- First submitted
- 9 Apr 2018
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dykes PC, Burns Z, Adelman J, Benneyan J, Bogaisky M, Carter E, Ergai A, Lindros ME, Lipsitz SR, Scanlan M, Shaykevich S, Bates DW. Evaluation of a Patient-Centered Fall-Prevention Tool Kit to Reduce Falls and Injuries: A Nonrandomized Controlled Trial. JAMA Netw Open. 2020 Nov 2;3(11):e2025889. doi: 10.1001/jamanetworkopen.2020.25889.
PubMed 33201236
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generalizability and Spread of an Evidenced-based Fall Prevention Toolkit: Fall TIPS (Tailoring Interventions for Patient Safety)
- ClinicalTrials.gov ID
- NCT03499717
- Acronym / sponsor ID
- 2017P000670
- Conditions
- Patient Fall
- Keywords
- Fall Risk, Patient Falls, Fall Prevention, Patient Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37,231 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Montefiore Medical Center, Partners HealthCare, Columbia University
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 Apr 2018 (actual)
- 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 evaluate the effectiveness of the Fall TIPS program with regard to inpatient falls and fall-related injuries.
Detailed description
This study will explore the effectiveness of the Fall TIPS (Tailoring Interventions for Patient Safety) program in regard to inpatient falls and fall-related injuries in three large hospital systems with different Electronic Medical Records (EMRs). We will collect and evaluate data on the perceived effectiveness of the Fall TIPS implementation process along with stakeholders' views of the toolkit. We will use an interrupted time series approach for evaluation of pre and post-Fall TIPS data related to patient falls and injurious falls. We will systematically analyze the costs and benefits of the Fall TIPS program from two perspectives: (1) the hospital, and (2) society as a whole. The hospital perspective will assist other hospitals in evaluating the decision to invest in implementing and adopting the Fall TIPS program, while the societal perspective will be instructive from a public policy stance
By the end of the study, we will produce a set of recommendations to facilitate adoption, implementation, and maintenance of the Fall TIPS program, along with a manuscript that will answer the following research questions:
- Does Fall TIPS reduce the incidence of falls and injurious falls?
- Were there differences in Fall TIPS effectiveness among different healthcare systems and hospitals as well as variations associated with differing patient characteristics (gender, age, ethnic/racial), EMRs, and degrees of adherence with the Fall TIPS protocol?
- Do the benefits associated with Fall TIPS outweigh the costs from hospital and societal perspectives?
- What Fall TIPS components were most/least useful and what recommendations will improve the overall utility and ease of use of the Fall TIPS Toolkit?
- What aspects of the implementation model were most/least helpful for promoting Fall TIPS adoption and use?
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes all adult patients admitted to medical, surgical, neurology and oncology units at participating hospitals during the time of the study. Participating hospitals include the Partners Healthcare System, Montefiore Medical Center, and NewYork-Presbyterian/Columbia University Medical Center.
Key inclusion criteria (1 listed)
- All adult patients admitted to medical, surgical, neurology and oncology units at participating hospitals during the time of the study
Key exclusion criteria (1 listed)
- Anyone who does not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Falls
Time frame: 1/1/2014-12/31/2020
Prevalence of patient falls in the study population
1 secondary outcome
Falls with Injury
Time frame: 1/1/2014-12/31/2020
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 27 Jul 2023.
- Results publication: PubMed 33201236Dykes PC, Burns Z, Adelman J, Benneyan J, Bogaisky M, Carter E, Ergai A, Lindros ME, Lipsitz SR, Scanlan M, Shaykevich S, Bates DW. Evaluation of a Patient-Centered Fall-Prevention Tool Kit to Reduce Falls and Injuries: A Nonrandomized Controlled Trial. JAMA Netw Open. 2020 Nov 2;3(11):e2025889. doi: 10.1001/jamanetworkopen.2020.25889.
- Evaluation of a Patient-Centered Fall-Prevention Tool Kit to Reduce Falls and Injuries: A Nonrandomized Controlled TrialLink provided by the sponsor.
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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.
Patricia C Dykes, MA,Ph.D,RN principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Fall, run by Brigham and Women's Hospital.
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 1 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Falls (time frame: 1/1/2014-12/31/2020). 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 NCT03499717, 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 27 Jul 2023.