Siderails as a Measure of Physical Restraint. GERBAR Trial

Study Overview
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Brief Summary
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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
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Aim: to know the perception of older patients and health professionals regarding bedrails using as a method of physical restraint. Additionally, we will evaluate if the health professsional's knowledge on patient´s desire regarding bedrails using produce a change on that using. Design: quasi-experimental study (before-after). Duration: 18 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: During month 1 a measurement of the use of bedrails at the Geriatric Hospitalization Units will be performed. In the sample of health professionals, a single online survey questionnaire is expected in month 2 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. In the sample of hospitalized older patients, 4 evaluations are expected. 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. Finally, a clinical, functional, and mental assessment will be performed at discharge. During the trial, using bedrails at the Geriatric Hospitalization Units will be registered in 3 different moments of the study: at the beginning of the study, after health professional's interviews, and finally after the period of patients' recruitment. For this, one of the collaborating researchers (external to the nursing team) of each hospitalization unit will proceed to count the number of beds using siderails, number of occupied beds, and number of free beds available in the corresponding unit, and the user's position (at bed or chair) will be recorded at the time of assessment. This counting will be done one day a week, first thing in the morning and before users start to get up. 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.

Official Title
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Perception of Users and Healthcare Professionals on Siderails Prescription as a Measure of Physical Restraint, and Perception's Impact on Using of Siderails

Conditions
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Restraint, Physical, Aged, Aged, 80 and Over, Patient Safety

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group 1 (Healthcare professionals): a. Any health professional (nursing assistant, nurse, or doctor) who works at any Hospitalization Unit belonging to CSAPG Institution. Group 2 (Users): Patient aged 65 or more years admitted to one of the participating Hospitalization Units belonging to Geriatrics Department. Exclusion Criteria: Group 1 (Healthcare professionals): a. Refusal to participate in the study. Group 2 (Users): Users in palliative sedation or with short /very short life expectancy. Inability to consent and absence of a legal representative. Refusal to participate in the study.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Users Group<br>Patients admitted to any Hospitalization Unit belonging to Geriatrics Department | |
| Health Professionals Group<br>All health professionals working at some Hospitalization Unit belonging to CSAPG Institution | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients considering siderails as a physical restraint method | Proportion of older patients (regard to all of hospitalized older patients) who consider siderails as a physical restraint's method | 9 months | 
| Proportion of health professionals considering siderails as a physical restraint method | Proportion of health professionals (regard to all health professionals working at the hospital) who consider siderails as a physical restraint's method | 1 month | 
| Change at the use of siderails | Difference on the proportion of hospitalized older patients using siderails at the starting and ending of the trial | 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated to using of siderails by older hospitalized patients | Factors associated to using of siderails by older hospitalized patients | 1 year | 
| Factors associated to prescription of siderails by health professionals | Factors associated to prescription of siderails by health professionals | 1 year |