Falls with InjuriesNCT06698315
Evidence-based Approach to Reduce Falls in Adult Patients
An observational study of Falls with Injuries, run by Methodist Health System at 1 site in United States.
Trial summary
The project aims to promote patient safety and quality care by reducing preventable falls and falls with injuries using an evidence-based solution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Falls with Injuries
- What is being tested?
- Observation
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with psychiatric conditions and cognitive impairments will be excluded from the project. This assessment is routine.
Who may be able to join
- Adult (≥18 years) inpatients admitted for various medical-surgical conditions in 3 Medical unit at MRMC. All patients will be included in the project except those diagnosed with psychiatric conditions and cognitive impairments.
Who cannot join
- Patients with psychiatric conditions and cognitive impairments will be excluded from the project. This assessment is routine.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Methodist Dallas Medical Center- Clinical Research Institute
Dallas, Texas, 75203
Jeff Wilson, BS, 2149471279, JeffreyWilson@mhd.com
ELIZABETH D AARON, MSN
About this study
Official title: Tailored Interventions for Patient Safety: an Evidence-based Approach to Reduce Falls in Adult Patients
The project aims to promote patient safety and quality care by reducing preventable falls and falls with injuries using an evidence-based solution.
Read the detailed description
The project aims to promote patient safety and quality care by reducing preventable falls and falls with injuries using an evidence-based solution: the Fall Tailoring Interventions for Patient Safety (TIPS) intervention. The three objectives include: (a) developing personalized fall prevention interventions for high-risk patients, (b) engaging patients and families in fall prevention initiatives, and (c) promoting effective communication among teams using a bedside visual tool.
- Conditions
- Falls with Injuries
- Being tested
- Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Medical Records Chart Review
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if the Fall TIPS initiative is effective at reducing falls at MRMC.
Data will be collected from Verge and EPIC reports. To ensure intervention effectiveness, monitoring will be done through chart audits and staff reporting. EPIC slicer dicer generates customized reports, enhancing EHR effectiveness (Ayaad et al., 2022).
Measured: through study completion, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start23 Jul 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falls with InjuriesStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ELIZABETH D AARON, MSN, Principal investigator, METHODIST RICHARDSON MEDICAL CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698315
- Sponsor's protocol ID
- 011.NUR.2024.R
- Status last verified
- Aug 2024
- First submitted
- 18 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Interventions for Patient Safety: an Evidence-based Approach to Reduce Falls in Adult Patients
- ClinicalTrials.gov ID
- NCT06698315
- Acronym / sponsor ID
- 011.NUR.2024.R
- Conditions
- Falls with Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 20 Nov 2024 (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 project aims to promote patient safety and quality care by reducing preventable falls and falls with injuries using an evidence-based solution.
Detailed description
The project aims to promote patient safety and quality care by reducing preventable falls and falls with injuries using an evidence-based solution: the Fall Tailoring Interventions for Patient Safety (TIPS) intervention. The three objectives include: (a) developing personalized fall prevention interventions for high-risk patients, (b) engaging patients and families in fall prevention initiatives, and (c) promoting effective communication among teams using a bedside visual tool.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with psychiatric conditions and cognitive impairments will be excluded from the project. This assessment is routine.
Key inclusion criteria (1 listed)
- Adult (≥18 years) inpatients admitted for various medical-surgical conditions in 3 Medical unit at MRMC. All patients will be included in the project except those diagnosed with psychiatric conditions and cognitive impairments.
Key exclusion criteria (1 listed)
- Patients with psychiatric conditions and cognitive impairments will be excluded from the project. This assessment is routine.
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 |
|---|---|---|
| ObservationMedical Records Chart Review | Other | – |
Primary outcome
Determine if the Fall TIPS initiative is effective at reducing falls at MRMC.
Time frame: through study completion, up to 18 months
Data will be collected from Verge and EPIC reports. To ensure intervention effectiveness, monitoring will be done through chart audits and staff reporting. EPIC slicer dicer generates customized reports, enhancing EHR effectiveness (Ayaad et al., 2022).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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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.
ELIZABETH D AARON, MSN principal investigator
METHODIST RICHARDSON MEDICAL CENTER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Falls with Injuries, run by Methodist Health System at 1 site 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 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: status not confirmed, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeff Wilson, BS (2149471279, JeffreyWilson@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if the Fall TIPS initiative is effective at reducing falls at MRMC. (time frame: through study completion, up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2024.