Falls - Tailoring Interventions for Patient Safety (Falls TIPS)
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 8, 2008 | ||||||||
| Last Updated Date | July 22, 2010 | ||||||||
| Start Date ICMJE | September 2007 | ||||||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The outcome measure will be rate of patients falls per 1000 patient days [ Time Frame: 1/2009-6/2009 ] [ Designated as safety issue: Yes ] Specific Aim: To evaluate the effectiveness of the FPTK prototype on reducing patient falls.
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| Original Primary Outcome Measures ICMJE |
The outcome measure will be the number of fall prevention measures applied to each individual patient of the 30% random sample of admitted patients within each unit on the site visit day [ Time Frame: 2007-2009 ] [ Designated as safety issue: Yes ] | ||||||||
| Change History | Complete list of historical versions of study NCT00675935 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
falls with injury as a secondary outcome measure. [ Time Frame: 2007-2009 ] [ Designated as safety issue: Yes ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Falls - Tailoring Interventions for Patient Safety | ||||||||
| Official Title ICMJE | Translating Fall Risk Status Into Interventions to Prevent Patient Falls: Falls TIPS (Tailoring Interventions for Patient Safety) | ||||||||
| 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. |
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| 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).
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.
Phase 4 Specific Aim: To evaluate satisfaction with the FPTK prototype and to generate recommendations for improvement.
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Patient Falls | ||||||||
| Intervention ICMJE | Other: Fall Prevention Tool Kit prototype using a randomized design
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.
Other Name: FPTK |
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| Study Arm (s) |
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| 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 2000 | ||||||||
| Completion Date | August 2009 | ||||||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00675935 | ||||||||
| Other Study ID Numbers ICMJE | 62572 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Patricia C. Dykes RN, DNSc, Partners HealthCare | ||||||||
| Study Sponsor ICMJE | Brigham and Women's Hospital | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Brigham and Women's Hospital | ||||||||
| Verification Date | July 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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