Authors
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The Palliative Care Clinical Studies Collaborative (PaCCSC) -More
Category
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Primary study
Registry of Trials»Australian New Zealand Clinical Trials Register
Year
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2017
INTERVENTION: 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. Engagement of site interdi CONDITION: Advanced cancer Delirium PRIMARY OUTCOME: Adherence to the intervention, measured as completed domains according to data collected from patient medical records via case report form. 4. Any clinician or manager employed at an intervention site and involved in implementing the intervention and/or delirium measures w 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. SECONDARY OUTCOME: Complaints related to the intervention, measured by study incident reporting process. 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. 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. ; Sustainability of the intervention via data collected from patient medical records.. The number of oncology/palliative care units interested in participating in such a trial, via a site recruitment log. 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. ; Delirium severity measured at first onset using the DRS‐R‐98. 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. 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. 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. 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. Number of falls related to the intervention, measured by study incident reporting process. 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. Percentage completion of all study measures 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.
Epistemonikos ID: e4ed0e39ba075a4c78fe39ffd2439e8820f63bcb
First added on: Aug 24, 2024