Clinical trial NCT04861025: Siderails as a Measure of Physical Restraint. GERBAR Trial
Official title: Perception of Users and Healthcare Professionals on Siderails Prescription as a Measure of Physical Restraint
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restraint, Physical
Aged
Aged, 80 and Over
Patient Safety
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 355
Sex: ALL
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All older patients admitted to Hospitalization Units belonging to Geriatrics Department.

All health professionals working at a Secondary Care Center.

Brief summary: There is a controversy about if siderails should be considered as a method of physical restraint in older hospitalized patients. This study aims to investigate the opinion of older patients and health professionals about this controversy.

Detailed description: Aim: to know the perception of older patients and health professionals regarding bedrails using as a method of physical restraint.

Design: quasi-experimental study ("before-after").

Duration: 13 months

Sample:

Two samples will be recruited: one from older patients who are hospitalized at Geriatric Hospitalization Units participating in the study, and the other one including all health professionals working at the 3 hospitals which belong to the Consorci Sanitari de l'Alt Penedès i Garraf.

Sample size:

Being the main objective of the study the estimation of a proportion (proportion of users who consider the siderails as a method of physical restraint), and having a preliminary estimation (65%) of this perception in older patients from a preliminary study, we calculated a sample size of 270 participants, considering a confidence level of 95% with a precision +/- 6%, and a necessary replacement rate of 10%. In the case of healthcare professionals, we calculated a sample size of 85 participants, considering an estimated proportion of 30%, a confidence level of 95% with a precision of +/- 10%, and a necessary replacement proportion of 5%.

Procedures:

In the sample of health professionals, a single online survey questionnaire is expected in month 1 with the purpose of knowing the health professional's perception of siderails as a method of physical restraint.

Once the health professionals' evaluations are finalized, the older patient recruitment will start. A baseline evaluation (interview) will be performed within days 0-2 of admission at the hospitalization unit. In this evaluation, basal data, the perception of bedrails as a method of physical restraint, and a register of patient's desire on using bedrails during their hospitalization will be collected. Then, two follow-up evaluations (days +1 and +2 from baseline evaluation) will be done to record the use of the siderails.

Participants' recruitment:

After the first register of use of bedrails at the Geriatric Hospitalization Units, the researchers will inform the health professionals about the objectives and design of the study, and compliance with the inclusion and exclusion criteria will be verified. If the health professional agrees to participate, the information sheet will be delivered and the informed consent will be collected. All health professionals will complete the survey questionnaire individually, anonymously, and in electronic format.

Older patient's recruitment and their baseline assessment will take place on the same day. The collaborating investigator of the study will invite all those users who undergo the clinical admission interview in the participating hospitalization unit to participate in the study, and within the first two days of admission. Once the study admission criteria have been confirmed, and the participant's informed consent has been obtained, the baseline interview will be carried out. In this interview, the user's perception of the bedrails and their willingness to use them during their hospitalization will be registered. Subsequently, the collaborator will communicate the patient's desire to the nursing team orally and registering the desire at the clinical record.

In the case of participants with Pfeiffer test ≥ 5 errors or a positive result for the Confusional Assessment Method test, a patient's relative or accompanying person will also be interviewed. In the event that the participant is not clinically stable to be interviewed according to the criteria of the interviewer, the interview will be carried out exclusively with the family member or accompanying person.

Eligibility criteria: Inclusion Criteria:

1. Group 1 (Healthcare professionals):

   a. Any health professional (nursing assistant, nurse, doctor...) who belons to CSAPG Institution.
2. Group 2 (Users):

   1. Patient aged 65 or more years admitted to one of the participating Hospitalization Units belonging to Geriatrics Department.

Exclusion Criteria:

1. Group 1 (Healthcare professionals):

   a. Refusal to participate in the study.
2. Group 2 (Users):

   1. Users in palliative sedation or with short /very short life expectancy.
   2. Inability to consent and absence of a legal representative.
   3. Refusal to participate in the study.

Primary outcomes:
measure: Proportion of patients considering siderails as a physical restraint method
timeFrame: Baseline
measure: Proportion of health professionals considering siderails as a physical restraint method
timeFrame: Baseline
Secondary outcomes:
measure: Factors associated to prescription of siderails by health professionals
timeFrame: Hospital discharge (assessed up to day 180)
measure: Factors associated to prescription of siderails by hospitalized patients
timeFrame: Hospital discharge (assessed up to day 180)
Other outcomes:
Locations:
city: Sant Pere De Ribes
country: Spain
facility: Consorci Sanitari d'Alt Penedès i Garraf
state: Barcelona
Study officials:
affiliation: Consorci Sanitari d'Alt Penedès i Garraf
name: Oscar Macho Perez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Macho-Perez O, Arroyo-Huidobro M, Gimenez Buendia MDC, Galvez-Barron C. [Does the healthcare user consider rails as physical subjugation?]. Rev Esp Geriatr Gerontol. 2021 Jan-Feb;56(1):59-60. doi: 10.1016/j.regg.2020.06.008. Epub 2020 Oct 17. No abstract available. Spanish.
citation: Galvez-Barron C, Gonzalez-De Luna A, Perez-Lopez C, Macho-Perez O. Cross-sectional survey of healthcare professionals' perceptions of bedrails as a measure of physical restraint in the hospital setting. Age Ageing. 2025 Jan 6;54(1):afaf002. doi: 10.1093/ageing/afaf002.