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Trial registered on ANZCTR


Registration number
ACTRN12617001070325
Ethics application status
Approved
Date submitted
30/06/2017
Date registered
24/07/2017
Date last updated
23/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to determine the feasibility and acceptability of a non-pharmacological intervention to prevent delirium for people with advanced cancer in hospital.
Scientific title
Phase 2 cluster randomized controlled trial of a multi-component non-pharmacological intervention to prevent delirium for hospitalized people with advanced cancer: The PRESERVE pilot study.
Secondary ID [1] 292242 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The PRESERVE pilot study: Prevent delirium through Eating and drinking, Sleep, Exercise, Reorientation, Vision and hearing, and Enabling family
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 303744 0
Advanced cancer 303745 0
Condition category
Condition code
Neurological 303117 303117 0 0
Other neurological disorders
Cancer 303118 303118 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Routine delirium screening and diagnostic assessment and a multi-component non-pharmacological delirium prevention intervention will be implemented in four oncology/palliative care inpatient units.

Bedside nurses will complete the Nursing Delirium Screening Scale (NuDESC) for all patients at admission and at the end of every shift. Within 24 hours of the patient assessed as having their first NuDESC score >2, the treating physician, will apply Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnostic criteria for delirium, operationalised by the Delirium Rating Scale-Revised-1998 (DRS-R-98). The DRS-R-98 will be completed by either a physician or nurse trained in its use. These processes are currently not routine in the setting and therefore are an addition to usual care.

The multi-component non-pharmacological delirium prevention intervention has five care domains and will be delivered to all patients from admission until discharge or death by members of the interdisciplinary team and volunteers. The domains and their associated strategies are:
1. Preserve natural sleep: Offer ear plugs to patients who have low risk of falls; Offer eye shades to patients who have low risk of falls; Reduce noise outside patient rooms during 21:00-06:00; Normal day-night variation in room and unit lighting; Exposure to natural light during daylight hours; Schedule care activities to allow uninterrupted sleep during the night; Avoid caffeine after 4pm.
2. Maintain optimal sensory perception: Assess hearing; Assist with and re-inforce use of hearing aids and special communication techniques; Ear wax clearing as needed; Assess need for visual aids (glasses, magnifying lenses); If needed, ask family to provide for the patient; Assist with and reinforce use of visual aids.
3. Optimise hydration; Encourage oral fluids; Physical assistance with drinks and meals, as required; Drinking aids, as required; Be alert and respond to reversible causes of poor oral intake within 24 hours e.g. nausea, vomiting, drowsiness, sore mouth.
4. Promote communication, orientation and cognition; Interpreter and translation for people with NESB; Greet the patient by name; Introduce self by name and role; Refer to person, time and place when talking with the patient; Time aids in room e.g. watch, personal or wall clock; wall, desk or electronic calendar; Update in-room whiteboards daily with date, day, place, reason for admission, team member names, schedule; Minimise number of transfers to other beds or rooms within the unit; Discuss current events with the patient; Encourage the patient to reminisce and talk; Encourage the patient to engage in cognitively stimulating activities.
5. Optimise mobility;Minimise use of tethers e.g. intravenous line, indwelling catheter, drain, oxygen; Minimise use of physical restraints e.g. bed rails, lock-in chair tables, vest restraints, limb restraints; Encourage and/or assist the patient to undertake physical activity throughout the day according to their capacity (Level 0: No activity planned (state reason), Level 1: Active range of movement exercises in bed and/or sitting position in bed (e.g. regular bed adjustment, assistance with re-positioning); Level 2: Assistance to sit on the side of the bed; Level 3: Sitting out of bed in a chair, standing, Level 4: Walking (marching in place, independent or assisted walking around room and unit), Level 5: Attend inpatient gym, walking outside of unit.
6. Family partnership: Ask family about the patient’s baseline cognition; Inform the patient and family about delirium risk; Inform the patient and family about delirium prevention strategies and invite participation.

Site teams will tailor the delivery of the intervention according to their human, material and environmental resources and capabilities. The intervention will be implemented at a site level and all patients with advanced cancer admitted to a participating site during the study period will be included in de-identified data collection, regardless of the intervention strategies received. The intervention will be embedded into routine daily clinical practice and tailored to each patient’s needs and preferences, using usual procedures of assessment and consent for clinical interventions. For example, while all patients will be assessed on admission for hearing and vision impairment, only those who require a sensory aid will receive that intervention. Likewise, family caregivers will be encouraged to be partners in care according to their capacity. Patients can therefore choose to opt-out of participating in any of the intervention elements; substitute decision makers may also opt out for patients with a cognitive impairment; and family caregivers can choose to not be involved in the ‘family partnership’ domain. The intervention phase will continue until data is collected for 40 patients overall with at least 20 in the intervention sites.

Engagement of site interdisciplinary teams will be guided by Michie’s Behaviour Change Wheel. Education and training of site team members relevant to delirium screening, diagnostic and non-pharmacological prevention will be interdisciplinary and based on Biggs’ educational model. Frequency, duration and mode of administration of education and training will be determined prior to implementation of delirium screening, diagnosis and prevention strategies in collaboration with participating sites, then standardised for each. Education and training will take place during a two month ‘training’ interval prior to the commencement of data collection. Staff and volunteer training will be evaluated through feedback about training and audit of delirium measure completion prior to commencement of data collection at each site.

Adherence and fidelity to the intervention are also study outcomes of this pilot trial. Site research nurses will collect data from the medical record on adherence to each strategy within the multicomponent delirium prevention intervention and record these in the case report form (CRF). If the patient received the strategy in the 24-hour period, a ‘Yes’ will be recorded. If the patient does not receive the intervention, a ‘No’ will be recorded, as will the reason according to the following categories:
• Not required
• Patient choice
• Not clinically appropriate
• Not possible with current resources
• Other





Intervention code [1] 298407 0
Prevention
Intervention code [2] 298408 0
Early detection / Screening
Intervention code [3] 298409 0
Diagnosis / Prognosis
Comparator / control treatment
Control sites will be waitlisted to implement only routine delirium screening and diagnostic assessment until data is collected for 40 patients overall with at least 20 in the intervention sites. Control sites will then implement the delirium prevention intervention, which will be modified should initial findings indicate that this is required.
Control group
Active

Outcomes
Primary outcome [1] 302498 0
Adherence to the intervention, measured as completed domains according to data collected from patient medical records via case report form.
Timepoint [1] 302498 0
During the first seven days of admission.
Secondary outcome [1] 336228 0
Coverage: the rate that the multi-component intervention is delivered to all consecutive eligible patients admitted to the unit, reasons why intervention was not delivered, weekend coverage, according to data collected from patient medical records via case report form.
Timepoint [1] 336228 0
During intervention phase.
Secondary outcome [2] 336229 0
Fidelity to delirium screening, diagnosis and the intervention: degree of alignment with standardised protocol, rationales for adaptation, rate of deviation from protocol without reasons, according to data collected from patient medical records via case report form.
Timepoint [2] 336229 0
During screening and interventions phases.
Secondary outcome [3] 336230 0
Methods, areas and levels of interdisciplinary involvement in delivery of the intervention, via baseline site assessment, interdisciplinary working group minutes and staff and volunteer surveys.
Timepoint [3] 336230 0
At baseline, during intervention phase and at intervention completion.
Secondary outcome [4] 336231 0
Feasibility and acceptability of study processes and measures, measured via semi-structured interviews with patients and caregivers and an online survey of staff and volunteers, designed specifically for this study.
Timepoint [4] 336231 0
Interviews will be conducted between days 3-7 of patient admission. The online survey will be conducted at the end of the intervention phase at each site (i.e. when all patient data collection is complete).
Secondary outcome [5] 336232 0
Sustainability of the intervention via data collected from patient medical records..
Timepoint [5] 336232 0
Adherence measured for all inpatients over one week, six months after commencement of data collection at the intervention sites.
Secondary outcome [6] 336233 0
The number of oncology/palliative care units interested in participating in such a trial, via a site recruitment log.
Timepoint [6] 336233 0
During the 6 month site recruitment phase.
Secondary outcome [7] 336234 0
Feasibility of the sample: percentage of participants included in data collection, reasons for non-inclusion, time to achieve sample size, according to data collected from patient medical records via case report form.
Timepoint [7] 336234 0
During intervention phase.
Secondary outcome [8] 336235 0
Number of people with advanced breast cancer admitted to the units, number of these who are in underserved populations (patients over 70, indigenous patients, and culturally and linguistically diverse backgrounds), and the number who experience an episode of delirium (total, and in under-served populations) via data from Palliative Care Outcome Collaborative (PCOC) site specific datasets and patient medical records.
Timepoint [8] 336235 0
During screening and intervention phases.
Secondary outcome [9] 336236 0
Percentage completion of all study measures
Timepoint [9] 336236 0
During screening and interventions phases.
Secondary outcome [10] 336237 0
Rate of patients with a positive delirium screen, measured according to a score of > or more on the NuDESC at least once during each 24-hour period.
Timepoint [10] 336237 0
During screening and interventions phases.
Secondary outcome [11] 336238 0
Delirium incidence, measured at first onset according to the patient meeting the DSM-5 diagnostic criteria for delirium within 24-hours of a positive delirium screen.
Timepoint [11] 336238 0
During screening and interventions phases.
Secondary outcome [12] 337007 0
Delirium severity measured at first onset using the DRS-R-98.
Timepoint [12] 337007 0
During screening and interventions phases.
Secondary outcome [13] 337008 0
Number of falls related to the intervention, measured by study incident reporting process.
Timepoint [13] 337008 0
During intervention phase.
Secondary outcome [14] 337106 0
Complaints related to the intervention, measured by study incident reporting process.
Timepoint [14] 337106 0
During intervention phase.

Eligibility
Key inclusion criteria
1. Sites will be Australian oncology or palliative care inpatient units that provide inpatient care for people with advanced cancer. Data will be collected for all admitted patients aged 18 years or older with a diagnosis of advanced cancer.

2. Patients who received the intervention, speak English or have availability of a health care interpreter, able to give fully informed written consent and participate in a brief semi-structured interview, will be eligible to participate in a qualitative sub-study.

3. Family caregivers of patients who received the intervention, aged 18 years or older, able to speak English or have a health care interpreter available, able to give fully informed written consent and participate in a brief semi-structured interview will be eligible to participate in a qualitative sub-study.

4. Any clinician or manager employed at an intervention site and involved in implementing the intervention and/or delirium measures will be eligible to participate in a survey.

5. Site volunteers aged 18 years or older, enrolled in a formal volunteer program at an intervention site and involved in implementing the intervention will be eligible to participate in a survey.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Data will not be collected for patients under 18 years of age or without a diagnosis of advanced cancer.

2. Patients who do not receive the intervention, or with an Australian Karnofsky Performance Status (AKPS) score less than 30 and/or are in the terminal phase will be excluded from the qualitative sub-study.


Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation of sites to intervention or waitlist control will be managed by the study coordination centre, the University of Technology Sydney (UTS).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A permuted block randomisation method with various block sizes will be used to allocate sites to the intervention or waitlist control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A cluster randomised controlled trial, with a waitlist control arm.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Primary outcome:
Adherence will be calculated as the rate to which patients have completed domains on a daily basis for the first seven days of admission. Degree of adherence to individual strategies will also be calculated as proportions, as will the reasons for patient non-eligibility or refusal. A rate of at least 60% of patients having at least four completed domains for at least five of the first seven days of admission will be considered minimum evidence that the intervention is feasible without need for major modification of the intervention or its delivery methods. Endpoints will at completion of the intervention and modified-intervention phases.

Secondary outcomes:
Data on all outcomes will be summarized with descriptive statistics including their distribution. Frequency and percentage will be used for summarizing categorical variables, and mean, standard deviation, median, and inter-quartile range for continuous variables. Delirium incidence and severity will be determined at both the intervention and control sites.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 8411 0
Greenwich Hospital - Greenwich
Recruitment hospital [2] 8412 0
Calvary Health Care Sydney Ltd - Kogarah
Recruitment hospital [3] 8466 0
Camden Hospital - Camden
Recruitment hospital [4] 8467 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 16483 0
2217 - Kogarah
Recruitment postcode(s) [2] 16484 0
2065 - Greenwich
Recruitment postcode(s) [3] 16550 0
2570 - Camden
Recruitment postcode(s) [4] 16551 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 296790 0
Charities/Societies/Foundations
Name [1] 296790 0
National Breast Cancer Foundation
Address [1] 296790 0
9/10 Barrack St, Sydney NSW 2000
Country [1] 296790 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Palliative Care Clinical Studies Collaborative (PaCCSC)
Address
Faculty of Health
University of Technology
Level 3, Building 10
235 Jones St., Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 295778 0
None
Name [1] 295778 0
Address [1] 295778 0
Country [1] 295778 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298050 0
SWSLHD Human Research Ethics Committee
Ethics committee address [1] 298050 0
Research and Ethics Office
Locked Bag 7103
LIVERPOOL BC NSW 1871
Ethics committee country [1] 298050 0
Australia
Date submitted for ethics approval [1] 298050 0
26/05/2017
Approval date [1] 298050 0
19/07/2017
Ethics approval number [1] 298050 0
HREC/17/LPOOL/224

Summary
Brief summary
This study aims to determine if a tailored multi-component non-pharmacological delirium prevention intervention is feasible and acceptable for people with advanced cancer in hospital.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have a diagnosis of advanced cancer, and are an inpatient at a participating Australian oncology or palliative care unit.

Study details
All participants in this study will undergo routine delirium screening and diagnostic assessment. In addition, patients being treated at sites allocated to the intervention will receive a multi-component delirium prevention intervention that includes six domains: preserve natural sleep, maintain optimal vision and hearing, optimise hydration, promote communication, orientation and cognition, optimise mobility and function, and family partnership. Intervention delivery will be tailored to the site, and strategies will be tailored to patient need. Patient, family caregivers, staff and volunteer perspectives about the feasibility and acceptability of the intervention will be obtained using interviews and surveys.

The primary outcome is adherence to the intervention, defined as the proportion of patients who achieve at least four completed domains for least five of the first seven days of admission, measured by medical record audit. Secondary outcomes relate to fidelity and feasibility, acceptability and sustainability of the study intervention, processes and measures in this patient population, using quantitative and qualitative measures.

The study will inform whether a multi-component non-pharmacological delirium prevention intervention in people with advanced cancer is feasible for testing in a subsequent phase 3 trial.
Trial website
Trial related presentations / publications
Public notes
Attachments [2] 1813 1813 0 0
Attachments [3] 1814 1814 0 0
Attachments [4] 1815 1815 0 0
Attachments [5] 1816 1816 0 0

Contacts
Principal investigator
Name 75730 0
Prof Meera Agar
Address 75730 0
IMPACCT
Faculty of Health
University of Technology Sydney
Level 3, 235 Jones St. Ultimo NSW 2007



Country 75730 0
Australia
Phone 75730 0
+61 2 9514 4243
Fax 75730 0
Email 75730 0
meera.agar@uts.edu.au
Contact person for public queries
Name 75731 0
Dr Annmarie Hosie
Address 75731 0
IMPACCT
Faculty of Health
University of Technology Sydney
Level 3, 235 Jones St. Ultimo NSW 2007
Country 75731 0
Australia
Phone 75731 0
+61 2 9514 4404
Fax 75731 0
Email 75731 0
annmarie.hosie@uts.edu.au
Contact person for scientific queries
Name 75732 0
Dr Annmarie Hosie
Address 75732 0
IMPACCT
Faculty of Health
University of Technology Sydney
Level 3, 235 Jones St. Ultimo NSW 2007
Country 75732 0
Australia
Phone 75732 0
+61 2 9514 4404
Fax 75732 0
Email 75732 0
annmarie.hosie@uts.edu.au

No information has been provided regarding IPD availability
Summary results
No Results