Clinical trial NCT04367298: Chronoprevention in Hospital Falls of Older People
Official title: Chronoprevention in Hospital Falls of Older People: A Nursing Intervention CHRONOFALLS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accidental Fall
Keywords: accidental falls
older people
nursing care
nursing
temporal patterns
prevention
circadian rhythms
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Andalusian Regional Ministry of Health
First posted: 2020-04-29
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 65 years who suffer one/several fall/s during their hospital admission to four hospital (one teaching and three non-teaching hospitals)

Brief summary: 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: -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.

Eligibility criteria: Inclusion Criteria in patients:

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

Exclusion Criteria in patients:

* Do not accept and sign the informed consent

Inclusion Criteria in healthcare professionals:

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

Exclusion Criteria in patients:

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

Primary outcomes:
measure: Number of Participant with Hospital falls
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: Chronotype of patient
timeFrame: Through study completion, an average of 1 month
measure: Quality of life of patient
timeFrame: Through study completion, an average of 1 month
measure: General health status of patient
timeFrame: Through study completion, an average of 1 month
measure: Sleep pattern of the healthcare professionals
timeFrame: Through study completion, an average of 1 month
measure: Chronotype of the healthcare professionals
timeFrame: Through study completion, an average of 1 month
measure: Quality of life of the healthcare professionals
timeFrame: Through study completion, an average of 1 month
measure: General health status of the healthcare professional
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Maimónides Biomedical Research Institute of Córdoba
Study officials:
affiliation: Maimónides Biomedical Research Institute of Córdoba
name: Pablo Jesús López Soto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.