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A pilot study to determine the feasibility and acceptability of a non-pharmacological intervention to prevent delirium for people with advanced cancer in hospital.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001070325
Acronym
The PRESERVE pilot study: Prevent delirium through Eating and drinking, Sleep, Exercise, Reorientati
Enrollment
65
Registered
2017-07-24
Start date
2018-05-16
Completion date
2018-09-12
Last updated
2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 Disord

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

Sponsors

The Palliative Care Clinical Studies Collaborative (PaCCSC)
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 22, 2026