Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000661572
Ethics application status
Approved
Date submitted
3/05/2024
Date registered
23/05/2024
Date last updated
23/05/2024
Date data sharing statement initially provided
23/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sleep for hospital inpatients: Evaluation of the Implementation of routine sleep assessment and a sleep protocol
Scientific title
Sleep for hospital inpatients: Evaluation of the Implementation of routine sleep assessment and a sleep protocol
Secondary ID [1] 312080 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep quality 333705 0
Condition category
Condition code
Public Health 330386 330386 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implementation science interventions to encourage uptake by health professionals of the 'getting it right for sleep at night' guideline and routine sleep assessment to improve sleep for hospital inpatients.
The 'getting it right for sleep at night' guideline (TAG NSW) is evidence-based containing all interventions which may help promote and maintain sleep for hospital patients including and not limited to environmental controls, behaviour change (sound reduction at night and light levels conducive to circadian rhythm), avoidance of new prescriptions of sedative and hypnotic medications, assessment of sleep quality, provision of eye masks and ear plugs, clustering care at night and prioritising sleep over non-essential care/treatments at night.
The brief 5 point Likert sleep scale ('very good' to 'very poor') was validated using the Richards Campbell Sleep Questionnaire (https://onlinelibrary.wiley.com/doi/10.1111/jocn.16348) and will be further validated in the pre-implementation phase of the current study. This scale has a drop down field to select the relevant descriptor of sleep and is designed for any health care worker to use and takes approximately 2 minutes to administer via the electronic medical record. Clinicians will ask the patient "Please describe your sleep last night on a scale of 'very good to very poor' ". Reference text is available to guide the assessment and a comment box is available to record qualitative information about the patient's sleep. A link to the 'Getting It right for sleep at night' guideline TAG NSW website is also provided in the electronic medical record, It is not diagnostic but rather provides a means to follow trends in patient's sleep quality and provides a gauge of the effectiveness of interventions designed to promote and maintain their sleep.
Implementation will be predominately delivered by an experienced clinical nurse researcher in the study wards with input from the investigator team of clinicians and will include:
*One to one academic detailing with health professionals (nurses, medical doctors) including a standardised script i.e., a brief summary of the 'getting it right for sleep at night' guideline, availability and location of eye covers and ear plugs, location of sleep assessment scale in the electronic medical record and how to use it (location of reference text). This will be delivered in the clinical setting while shadowing individual clinicians. The total time spent with each clinician will not exceed 5 minutes (depending on individual need).
*Email communications using unit / ward based email list serves (bi-monthly) outlining usage rates of the sleep assessment and reminders about the 'getting it right for sleep at night' guideline.
*Face to face 20- 30 minute education sessions with small groups of nurses in the ward setting (bimonthly) including a summary of the study methods, the guideline, location of ear plugs and eye covers and location of the sleep assessment scale and how to use it and progress with uptake of the scale. In addition information about sleep and shift work will be provided to assist nurses with their own sleep hygiene. Sessions will be provided on site in a room close the clinical setting and information will be delivered using PowerPoint slides.
*Posters and visual information available from the 'Getting it right for sleep at night' website tool kit will be displayed in the clinical setting in areas frequently attended by clinicians e.g., doors of store rooms, education notice boards.
*Feedback about the usage of the sleep scale (aggregate frequency) will be obtained using an electronic medical record audit (number of patients and number of scales completed downloaded) and will be the main measure of adoption (adherence) and will be provided to health care professionals (as described above).
The implementation phase will be conducted over 6 - 12 months.
Intervention code [1] 328520 0
Behaviour
Comparator / control treatment
This is a before and after implementation study. Sleep quality and a number of other outcomes will be measured in the month (and sleep data for 50 patients in each phase is completed) before and after the implementation of the 'getting it right for sleep at night' guideline and routine sleep assessment.
Data collection will be prospective and involve direct data entry via electronic tablets. Nurse researchers will perform data collection.
Control group
Active

Outcomes
Primary outcome [1] 338149 0
Completion rates of sleep assessment (occasions of routine sleep assessment in patient electronic record)
Timepoint [1] 338149 0
Trends in the rate that the sleep assessment is recorded will be examined weekly during the implementation period (6 to 12 months)
A primary endpoint is not specified
Secondary outcome [1] 434710 0
Patient reported sleep quality
Timepoint [1] 434710 0
50 patients will report their sleep quality during phase 1 before the implementation phase and after implementation 50 (different) patients will be asked to report their sleep quality
Patients will report their sleep quality (and barriers and facilitators of sleep) for one night after first providing informed written consent.

Eligibility
Key inclusion criteria
Patient participants
*Adult patients (age 18 years or older)
*Any diagnosis
*Treated in the study ward for more than one night (and >24 hours)
*Sufficient English language comprehension to complete the sleep assessment instruments
Nurse participants
*Permanently employed registered and enrolled nurses working a rotating roster i.e., both day and night shifts providing direct care to patients in the study ward
Medical doctor participants
*Working in the speciality provided in the study ward
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient participants
*Documented pre-existing sleep disorder
*Cognitive impairment (assessed using the Confusion Assessment Method)
*Glasgow Coma Scale score is <14
Nurse participants
*Nurses working during the day only
*Students
*Temporarily deployed/employed
Medical doctor participants
*Temporarily employed

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Before and after implementation study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistical analyses will be performed; means and standard deviations for normally distributed data and medians and interquartile ranges for non-normally distributed data. Dichotomous data will be described using frequencies and percentages. The study data for phase 1 will be mapped to the COM-B Behaviour Change Wheel to identify intervention functions. Inferential analyses will be used to compare sleep quality for the two study phases as appropriate for the data e.g., student t and McNemar tests and patient outcomes e.g., Fishers exact test. We will assess test-retest validity of 5-CILS with a Kappa coefficient, and the congruent validity by the correlation (Kendall rank) of 5-CILS with the RCSQ. Validation of the 5-CILS will include Receiver Operator Curve analyses. Content analysis will be performed on patient participant responses to open-ended items.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/06/2023
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
100
Accrual to date
50
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316439 0
Charities/Societies/Foundations
Name [1] 316439 0
North Foundation
Country [1] 316439 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 318609 0
University
Name [1] 318609 0
University of Technology Sydney
Address [1] 318609 0
Country [1] 318609 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315231 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315231 0
Ethics committee country [1] 315231 0
Australia
Date submitted for ethics approval [1] 315231 0
02/02/2022
Approval date [1] 315231 0
27/04/2023
Ethics approval number [1] 315231 0
2023/ETH00231

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134066 0
A/Prof Rosalind Elliott
Address 134066 0
Intensive care unit, Royal North Shore Hospital, Pacific Highway, St Leonards NSW 2065
Country 134066 0
Australia
Phone 134066 0
+61 2 9463 2682
Fax 134066 0
Email 134066 0
[email protected]
Contact person for public queries
Name 134067 0
Rosalind Elliott
Address 134067 0
Intensive care unit, Royal North Shore Hospital, Pacific Highway, St Leonards NSW 2065
Country 134067 0
Australia
Phone 134067 0
+61 2 9463 2682
Fax 134067 0
Email 134067 0
[email protected]
Contact person for scientific queries
Name 134068 0
Rosalind Elliott
Address 134068 0
Intensive care unit, Royal North Shore Hospital, Pacific Highway, St Leonards NSW 2065
Country 134068 0
Australia
Phone 134068 0
+61 2 9463 2682
Fax 134068 0
Email 134068 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not applied for or approved by HREC


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.