Detailed patient-level outcomes will be measured by systematic sampling across participating wards throughout the pilot trial as part of a prospective observational sub-study. One patient per ward per month will be recruited from all six included wards (n = 84) and we will collect data through a combination of self-report and continuous monitoring, the details of which are described under the ‘outcome measures’ section of this protocol. Written consent will be secured prior to participant recruitment. Patient eligibility will be established by the study research officer (RO) in consultation with the ward nurse manager or shift coordinator at each recruitment point. The RO will be responsible for securing participant consent. Some inclusion/exclusion criteria will apply to recruitment. We will exclude patients who have been admitted for longer than 30 days or are due to be discharged within the following 3 days. Patients that have been recruited to the current study in a previous month will also be ineligible for recruitment. Patients with known cognitive impairment will be excluded, as an important element of this sub-study is to capture data on participant subjective experiences and this would be infeasible among cognitively impaired patients. Due to lack of multi-language versions of the scales used in this study, we will also exclude patients who are not fluent in English. We will exclude patients who are unstable or deemed too unwell to participate. Finally, patients aged less than 65 years on the day of recruitment will also be considered ineligible for recruitment.
Prior to the start of the study, the principal investigator (PI) will produce 84 sets of computer-generated random integer sequences ranging from ‘1’ to the maximum number of bed locations in any ward, for example, ‘35’. These will then be printed and placed in sealed opaque unmarked envelopes and handed over to a RBWH Safety and Quality Unit (SQU) staff member who is not involved with the study. At each recruitment point, the RO will identify, in consultation with ward nursing managers, patients who are eligible to be approached for the study and a list of eligible bed numbers will be compiled and communicated to the nominated SQU staff member. The staff member will then open one envelope and will generate the order of recruitment as per the number sequence in the envelope. This list will be provided to the RO for commencement of recruitment. The PI will monitor recruitment to ensure adherence to the recruitment protocol. The RO will approach the first bed number on the recruitment order; if a patient does not consent to participate in the study, this process will continue until a patient is successfully recruited. This process will be replicated for each ward at every recruitment point.
Prior to the start of the study, the principal investigator (PI) will produce 84 sets of computer-generated random integer sequences ranging from ‘1’ to the maximum number of bed locations in any ward, for example, ‘35’. These will then be printed and placed in sealed opaque unmarked envelopes and handed over to a RBWH Safety and Quality Unit (SQU) staff member who is not involved with the study. At each recruitment point, the RO will identify, in consultation with ward nursing managers, patients who are eligible to be approached for the study and a list of eligible bed numbers will be compiled and communicated to the nominated SQU staff member. The staff member will then open one envelope and will generate the order of recruitment as per the number sequence in the envelope. This list will be provided to the RO for commencement of recruitment. The PI will monitor recruitment to ensure adherence to the recruitment protocol. The RO will approach the first bed number on the recruitment order; if a patient does not consent to participate in the study, this process will continue until a patient is successfully recruited. This process will be replicated for each ward at every recruitment point.
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