Chronoprevention in Hospital Falls of Older People

NCT ID: NCT04367298

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-06-01

Brief Summary

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Accidental falls in hospitals are serious events concerning the safety of the patients. Recent studies demonstrated that the time of falls is a key factor to be considered in prevention. It has been shown that the time of day, the day of the week and the month of the year impact on the occurrence of falls.

The aim of this project is to know the effect of the application of a program of preventive measures based on the temporal patterns of the risk factors on the hospital fall occurrence. A mixed method research design will be conducted. Three phases will be carry out: 1) Longitudinal prospective study in two parts: a) audits and seminars of health professionals focused on an effective and efficient hospital falls register. Cosinor and Multi-Component analyses will be performed to obtain temporal patterns of the hospital falls and their related variables. b) Implementation of a based-temporal patterns, multidimensional prevention program. 2) Retrospective study of falls registered in institutional databases. 3) Qualitative study based on focus groups (physicians, nurses and nursing assistants).

It is imperative to study temporal patterns of hospital falls to effectively and comprehensively define the etiology of falls, and therefore, design preventive strategies. A reduction of the number of in-hospital falls and related injuries is expected, as well as, an improvement of the quality of life of patients. Considering temporal patterns, and levels of mood and sleep of healthcare professionals will achieve an improvement of patient safety.

Detailed Description

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-Design

A mixed-method research will be carried out. Three different study design will be used:

Phase 1. Prospective longitudinal study in 2 steps:

* A first step, of 18 months, in which a first intervention of audits and seminars in health professionals will be carried out, focused on an effective and efficient registry of hospital falls in older people. This first phase is crucial to identify temporal patterns of falls in relation to specific intrinsic and extrinsic risk factors among hospitalized older people; as well as the levels of fatigue/sleepiness, attention and cognitive functionality of the health professionals who attend to an in-hospital fall.
* A second step, of application of a multidimensional prevention program for 15 months focused on organizational, educational and behavioral elements; applied to admitted older people and health professionals.

Phase 2. Retrospective study of the fall records found in the institutional databases of the study centers, in the period between January 2018 - September 2020. This period covers the first (January 2018 - May 2019) and the second phase (June 2019 - September 2020) of the project, previously indicated.

Phase 3. Descriptive exploratory study with a qualitative approach, focus groups made up of health professionals: doctors, nurses and nursing assistants who provide and have provided their professional services in the field of study, in the periods in which the studies have been carried out. longitudinal and retrospective previously mentioned.

Conditions

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Accidental Fall

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronoprevention in hospital falls

Implementation of a hospital preventive measures program: adjusted to the identification of temporal patterns of falls and relative risk factors of falls.

Chronoprevention

Intervention Type BEHAVIORAL

Preventive measures will be focused on organizational, educational and behavioural elements related to older people and healthcare professionals

Interventions

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Chronoprevention

Preventive measures will be focused on organizational, educational and behavioural elements related to older people and healthcare professionals

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients who suffer a hospital fall
* Accept and sing the informed consent


* Nurses in charge of the care of patients who suffer a fall
* Accept and sing the informed consent

Exclusion Criteria

* Do not accept and sign the informed consent


* Nurses who do not care for a patient suffering a fall
* Do no accept and sign the informed consent
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Andalusian Regional Ministry of Health

OTHER_GOV

Sponsor Role collaborator

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pablo Jesús López Soto, PhD

Role: PRINCIPAL_INVESTIGATOR

Maimónides Biomedical Research Institute of Córdoba

Locations

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Maimónides Biomedical Research Institute of Córdoba

Córdoba, , Spain

Site Status

Countries

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Spain

References

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Lopez-Soto PJ, Lopez-Carrasco JC, Fabbian F, Minarro-Del Moral RM, Segura-Ruiz R, Hidalgo-Lopezosa P, Manfredini R, Rodriguez-Borrego MA. Chronoprevention in hospital falls of older people: protocol for a mixed-method study. BMC Nurs. 2021 Jun 6;20(1):88. doi: 10.1186/s12912-021-00618-y.

Reference Type BACKGROUND
PMID: 34092223 (View on PubMed)

Lopez-Soto PJ, Rodriguez-Cortes FJ, Minarro-Del Moral RM, Medina-Valverde MJ, Segura-Ruiz R, Hidalgo-Lopezosa P, Manfredini R, Rodriguez-Borrego MA; CHRONOFALLS project collaborators. CHRONOFALLS: A multicentre nurse-led intervention in the chronoprevention of in-hospital falls in adults. BMC Nurs. 2023 May 5;22(1):149. doi: 10.1186/s12912-023-01322-9.

Reference Type DERIVED
PMID: 37143072 (View on PubMed)

Other Identifiers

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PI-0360-2017

Identifier Type: -

Identifier Source: org_study_id

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