Chronoprevention in Hospital Falls of Older People

NCT04367298 | Completed

• 1 other identifier: PI-0360-2017
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Accidental Fall

Keywords

accidental falls; older people; nursing care; nursing; temporal patterns; prevention; circadian rhythms

Outcome Measures

Primary Outcomes (1)

• Number of Participant with Hospital falls

  Records of falls coded in the International Classification of Diseases (ICD-10) between codes W00-W19.9

  Through study completion, an average of 1 month

Secondary Outcomes (7)

• Chronotype of patient

  Through study completion, an average of 1 month

• Quality of life of patient

  Through study completion, an average of 1 month

• General health status of patient

  Through study completion, an average of 1 month

• Sleep pattern of the healthcare professionals

  Through study completion, an average of 1 month

• Chronotype of the healthcare professionals

  Through study completion, an average of 1 month

Study Arms (1)

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.

Behavioral: Chronoprevention

Interventions

Chronoprevention BEHAVIORAL

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

Chronoprevention in hospital falls

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• Do not accept and sign the informed consent
• Nurses in charge of the care of patients who suffer a fall
• Accept and sing the informed consent
• Nurses who do not care for a patient suffering a fall
• Do no accept and sign the informed consent

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead
• Andalusian Regional Ministry of Health: collaborator

Study Sites (1)

Maimónides Biomedical Research Institute of Córdoba

Córdoba, 14004, Spain

Location

Related Publications (2)

• 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.

  PMID: 34092223 BACKGROUND

• 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.

  PMID: 37143072 DERIVED

Study Officials

• Pablo Jesús López Soto, PhD

  Maimónides Biomedical Research Institute of Córdoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 34 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 29, 2020
• Study Start: January 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: June 1, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

ES (1)