Siderails as a Measure of Physical Restraint. GERBAR Trial (GERBAR)

Perception of Users and Healthcare Professionals on Siderails Prescription as a Measure of Physical Restraint

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.

Study Overview

• Status: Recruiting
• Conditions: Aged; Patient Safety; Aged, 80 and Over; Restraint, Physical

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.

• Study Type: Observational
• Enrollment (Estimated): 355

Contacts and Locations

• Study Contact: Name: Oscar Macho Perez, MD; Phone Number: 6243 +34 938960025; Email: omacho@csapg.cat
• Study Contact Backup: Name: César Gálvez-Barrón, PhD; Phone Number: +34 938960025; Email: cgalvez@csapg.cat

Study Locations

• Spain
  • Barcelona
    • Sant Pere De Ribes, Barcelona, Spain, 08880
      • Recruiting
      • Consorci Sanitari d'Alt Penedès i Garraf
      • Contact: Oscar Macho-Perez; Email: omacho@csapg.cat
      • Contact: Cesar Galvez-Barron; Email: cgalvez@csapg.cat
      • Principal Investigator: Oscar Macho-Perez
      • Sub-Investigator: Cesar Galvez-Barron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 120 years (Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Users Group; Patients admitted to any Hospitalization Unit belonging to Geriatrics Department
Health Professionals Group; All health professionals working at some Hospitalization Unit belonging to CSAPG Institution

What is the study measuring?

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	Baseline
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	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors associated to prescription of siderails by health professionals	Factors associated to prescription of siderails by health professionals	Hospital discharge (assessed up to day 180)
Factors associated to prescription of siderails by hospitalized patients	Factors associated to prescription of siderails by hospitalized patients	Hospital discharge (assessed up to day 180)

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
• Investigators: Principal Investigator: Oscar Macho Perez, MD, Consorci Sanitari d'Alt Penedès i Garraf

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CSAPG-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
• IPD Sharing Time Frame: After publication of main results of the study.
• IPD Sharing Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No