2691 Delirium Communications Delirium Communications 2959-104X European Delirium Association Website: Delirium 94808 10.56392/001c.94808 Articles Driving quality in delirium care through a patient-centered monitoring system in palliative care: Protocol for the two-staged exploratory sequential mixed methods MODEL-PC study https://orcid.org/0000-0001-9380-2739 van Oosterom Nameer 1 https://orcid.org/0000-0002-6756-6119 Agar Meera R. 2 https://orcid.org/0000-0002-0177-1777 Walpole Grace 3 https://orcid.org/0000-0003-1206-9294 Casey Penelope 4 https://orcid.org/0000-0003-0662-5266 Moffat Paula 5 https://orcid.org/0009-0005-1934-2814 Bradley Keiron 6 https://orcid.org/0000-0002-1758-6496 Cook Angus 7 https://orcid.org/0000-0001-9190-8441 Johnson Claire 8 9 https://orcid.org/0000-0003-1506-9572 Chye Richard 10 Oehme Jacqueline 11 Senatore Maria 11 https://orcid.org/0000-0003-3945-0749 Virdun Claudia 12 https://orcid.org/0000-0001-7628-7421 Pearson Mark 13 https://orcid.org/0000-0002-9042-7600 Featherstone Imogen 14 https://orcid.org/0000-0001-7319-1395 Lawlor Peter G. 15 16 17 https://orcid.org/0000-0001-8907-1283 Bush Shirley H. 15 16 17 https://orcid.org/0000-0001-8039-8749 Daveson Barb 18 https://orcid.org/0000-0001-5993-6768 Clapham Sabina 18 https://orcid.org/0000-0002-9656-7823 Campbell Kimberley 2 https://orcid.org/0000-0003-1674-2124 Hosie Annmarie 1 19 20 School of Nursing & Midwifery The University of Notre Dame Australia https://ror.org/02stey378 IMPACCT University of Technology Sydney https://ror.org/03f0f6041 Wantirna Palliative Care Unit Eastern Health https://ror.org/00vyyx863 School of Nursing & Midwifery Deakin University https://ror.org/02czsnj07 Palliative Care Bethesda Hospital, Perth Palliative Care Bethesda Hospital https://ror.org/01kpm8k86 School of Population and Global Health University of Western Australia https://ror.org/047272k79 Palliative Aged Care Outcomes Program University of Wollongong https://ror.org/00jtmb277 Nursing and Midwifery Monash University https://ror.org/02bfwt286 Sacred Heart Palliative Care Service St Vincent’s Health Network Sydney Palliative Care, St Joseph’s Hospital St Vincent’s Health Network Sydney Flinders Research Centre for Palliative Care, Death, and Dying Flinders University https://ror.org/01kpzv902 Wolfson Palliative Care Research Centre, Hull York Medical School University of Hull https://ror.org/04nkhwh30 Mental Health and Addiction Research Group University of York https://ror.org/04m01e293 Department of Medicine (Division of Palliative Care) University of Ottawa https://ror.org/03c4mmv16 Research Institute Ottawa Hospital https://ror.org/03c62dg59 Bruyère Research Institute Palliative Care Outcomes Collaboration University of Wollongong https://ror.org/00jtmb277 Cunningham Centre for Palliative Care St Vincent’s Health Network Sydney IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation University of Technology Sydney https://ror.org/03f0f6041 8 5 2024 94808 25 2 2024 7 3 2024 http://creativecommons.org/licenses/by/4.0 This is an open access article distributed under the terms of the Creative Commons Attribution License (4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Introduction Delirium is a serious acute neurocognitive condition that is common in palliative care units and yet under-addressed. To improve delirium care in this setting, we will develop and pilot a monitoring system that integrates the Delirium Clinical Care Standard, Palliative Care Outcomes Collaboration (PCOC) methods, and perspectives of patients, carers and staff.

Methods This paper reports the protocol for a two-stage, exploratory, sequential mixed-methods implementation study. Stage 1 data collection includes Delirium Standard-aligned process mapping and clinical audits, and Critical Incident Technique interviews with patients, carers and staff with a recent experience of delirium. We will present integrated stage 1 findings to stakeholders then collaboratively develop a delirium monitoring system that aligns with the Delirium Standard and PCOC methods. In stage 2, we will pilot the new system and repeat stage 1 data collection and analyses, adding PCOC and adverse event measures. Implementation principles and strategies such as audit and feedback and education will be applied. We developed simplified participants information sheets and consent forms for interview and process mapping participants, who will provide written informed consent; and waiver of consent to collect clinical audit, PCOC and adverse event data from patients’ medical records is approved. At study end, we will report implementation, effectiveness and safety outcomes, including systemic utility of the delirium monitoring system for wider testing and use to meet the Delirium Standard in palliative care units. Quantitative data analyses will include descriptive and inferential statistics and qualitative analyses will incorporate thematic content analysis aligned to the Critical Incident Technique. Mixed methods data integration will be at the end of each stage.

Discussion This protocol paper describes the mixed methods, systems integration, and innovative measures and study processes of the MODEL-PC study. We also share data collection tools and a simplified information sheet and consent form for patients.

 carers delirium feedback health personnel implementation inpatients monitoring mixed methods palliative care standards This research is funded by a National Health and Medical Research Council (NHRMC) Ideas Grant (2021/GNT2010701). Introduction

Delirium is an acute neurocognitive condition affecting up to half of patients in palliative care units.1,2 The condition involves acute and fluctuating changes in attention, awareness, and cognition,3 with common precipitants being dehydration, infection, and psychotropic medications.4,5 Delirium increases risk of falls and pressure injuries, prolonged admission and physical and cognitive deterioration.2,6 Patients find delirium symptoms and associated emotions such as fear and anger difficult, and carers and clinicians experience distress witnessing them.5,7,8 Timely recognition and response to delirium symptoms depend on knowledgeable clinicians, routine structured screening, and effective teamwork.9 Yet delirium is under-addressed in many hospital settings.10

Clinical care standards for delirium are in place in some countries.9,11 In Australia, the Delirium Clinical Care Standard (‘Delirium Standard’) covers delirium prevention, early diagnosis, treatment and concomitant care via eight quality statements and 12 quality indicators, with patient-centredness the overarching principle.9 This Standard has become the key quality framework for delirium care in Australian hospitals.

There are gaps in how palliative care units in Australia have implemented the Delirium Standard, with areas for improvement including systems, practice, clinician understanding, and provision of information for patients and carers.12 Delirium prevention may be possible for around a third of patients, but prevention strategies are under-utilised.13,14 Managing delirium is challenging in this setting because its reversibility near the end of life can be uncertain, addressing all causes may not be possible for dying patients, and there are no interventions proven to safely relieve delirium symptoms.15–17 Palliative care clinicians also use antipsychotics and benzodiazepines for delirium more often than clinicians working elsewhere.18

Implementing the Delirium Standard would improve the safety and quality of delirium care in palliative care units. We plan to support this implementation by integrating the Standard with a national symptom monitoring program, the Palliative Care Outcomes Collaboration (PCOC). PCOC aims to improve patient and carer outcomes in palliative care using patient and proxy reported measures.19 These measures include the PCOC Symptom Assessment Scale, a numerical rating scale of 0 (absent) to 10 (worst possible) for patients’ level of distress from common symptoms such as pain and fatigue.20 The measures are routine and inform clinical care. Six-monthly PCOC national and site-specific reports support review and benchmarking of clinical outcomes.21 Observational data indicates that PCOC is feasible, valid and effective in improving palliative care outcomes.20,22,23

The current PCOC collection has no delirium measure. We designed the ‘Monitoring Delirium in Palliative Care’ (MODEL-PC) study to inform such an addition.

MODEL-PC study objectives are to:

Collaboratively develop a new delirium monitoring system (Text box 1) for palliative care units that integrates the Delirium Standard, PCOC methods, and patient, carer and staff perspectives.

Pilot the new delirium monitoring system and measure implementation, effectiveness and systemic utility (feasibility, acceptability and appropriateness) outcomes to determine whether it can be more widely tested and used to meet the Delirium Standard in palliative care units, +/- via PCOC.

 Definition of the proposed delirium monitoring system

A comprehensive process to systematically monitor the occurrence of delirium, related distress, clinical care and outcomes (prevention, assessment, treatment, communication) within a health care service and potentially across health care services.

 Methods Design

This is a two-stage multicentre exploratory sequential mixed methods implementation study. The new delirium monitoring system will be developed in stage 1 then piloted in stage 2 (Figure 1). ‘Exploratory’ signifies initial prioritisation and positioning of qualitative methods/data (‘QUAL/quant’) over quantitative (QUANT/qual), an appropriate sequential ordering when developing a new process or measure and our rationale for using mixed methods.24 The MODEL-PC study sits within the “adaptation, preparation, feasibility and piloting” stage of implementation research, as articulated in the Standards for Reporting Implementation Studies (StaRI) Statement.25

225062 Two-stage exploratory sequential mixed methods study design

Code: QUAL and qual = qualitative, Quant and QUANT = quantitative (capitalisation denotes relative prioritisation)

PCOC = Palliative Care Outcomes Collaboration

 Setting

Palliative care units (PCUs) in Australia are multidisciplinary services specialising in prevention and relief of suffering for inpatients with life-limiting illness and their carers. Four PCUs from metropolitan New South Wales, Victoria, and Western Australia will be included. Patients in this setting have a mean age of around 75 years26; and around 65% die during admission, with delirium occurring more often for this group compared to discharged patients.

 Participants

Participants include adult patients, carers, and staff of participating PCUs.

Eligibility

Patients eligible for an interview will be adult (aged 18 years or older), admitted to a participating PCU, English speaking or have a health care interpreter available, experienced delirium in the preceding week, and willing and able to consent and participate. Patients in the terminal phase (last days to hours of life) will not be asked to participate in an interview. Patient’s medical records will be audited if they are aged 18 years or older and admitted for more than 24 hours. PCOC data will be obtained from all PCU inpatients in stage 2.

Carers eligible for an interview will be an adult family member or friend of an admitted patient, present when the patient had delirium in the preceding week, English speaking or with a health care interpreter available, and willing and able to consent and participate. Carers will not be asked to participate in an interview if the patient is in the terminal phase, although those who previously consented and wish to continue may do so.

Staff eligible for process mapping and interviews will be adults employed in a clinical or unit-level managerial role who are willing to consent. Interview participants must have cared for a patient with delirium in the preceding week.

 Data collection and entry

Site research staff will collect data, with senior clinicians contributing to clinical auditing. Most patient items are routinely collected in clinical practice. Research staff will enter data into a study-specific REDCap database.27

Stage 1 data collection includes:

Process mapping, a systematic, collaborative and rapid method to map PCUs clinical policy and processes against the Delirium Standard.28 Researchers will facilitate between 1-3 sessions with key staff from each PCU, record discussions and enter data in REDCap (Supplementary file 1). Results will be presented to key PCU staff for verification before finalisation.

Clinical audits of patients’ medical records (N=240, 60 per PCU) to obtain data on documented delirium practices and outcomes. The audit tool aligns with the Delirium Standard and contains predominantly Yes/No responses plus optional free text on application/relevance for individual patients (Supplementary file 2).

Semi-structured interviews (N=80, 20 per PCU: 5 patients, 5 carers, 10 staff) will align with the critical incident technique (CIT), a research method that gathers detailed first-hand reports about satisfactory and unsatisfactory execution of a task in order to refine it.29,30 The focused, brief and storytelling CIT interview method is ideal for unwell patients and hard-pressed carers and staff. Site research staff will be trained in CIT, with the interview schedule (Supplementary file 3) designed to obtain recounts of delirium care in the preceding week. Staff participants will be additionally asked how recalled incident/s might inform practice alignment with the Delirium Standard and PCOC.

Stage 2 data collection will mirror stage 1, with additional measures, different time points, and nuances reflective of stage 2 objectives, as follows:

Process mapping: end of the stage, to allow sufficient time for change in delirium care.

Clinical audits: monthly results rapidly fed back to PCU teams.

Semi-structured interviews: additional focus on receipt or delivery of the new PCOC measure/s and other changes in delirium care.

New PCOC delirium measure/s: completed by clinical staff and collected by research staff from every medical record. PCOC data will include completion (Yes/No), reporter (patient, carer and/or clinician) and scores.

Adverse events, to capture potential study harms and/or the new delirium monitoring system to patients, carers, staff or organisations.

Data items are outlined in Supplementary file 4.

 Implementation strategies

MODEL-PC study implementation strategies include:

Overall alignment with key principles for successful health systems integration as identified in a systematic review by Sutor et al,31 with six explicitly applied (Text box 2).

At the end of stage 1, outcomes will be presented to study investigators, key PCU staff and other stakeholders, including in an online workshop where those involved will co-design a new delirium monitoring system that addresses the Delirium Standard, articulates the new PCOC measurement for delirium, and specifies activities, tools, time points and persons required. Within these prerequisites, PCUs will be free to vary how they apply the new monitoring system and meet the Delirium Standard e.g., choice of validated screening tool.

Stage 2:

Two-week run-in for new PCOC measurement when research staff will seek clinical staff feedback on the process.

Data feedback of monthly audit results to key PCU staff, who will asked to disseminate these to their wider team.32

Staff training in the Delirium Standard and PCOC measurement, tailored to/by PCUs based on stage 1 and emerging results and preferences for mode e.g., one-on-one, inservices.

 MODEL-PC application of six key principles for successful health systems<xref ref-type="bibr" rid="ref-307247"><sup>31</sup></xref>

Patient focus: patients’ needs at an individual and population level will be central to study endeavours; patients’ dignity and perspectives will be respected; explicit efforts to engage and support patients to participate will be made.

Organisational culture and leadership: health policy makers’ and site managers’ support will be sought and visionary leaders who inspire strong, cohesive PCU team engagement involved.

Physician integration: research and clinical physicians will be considered pivotal to developing and piloting the new delirium monitoring system.

Performance management: investigator, project and site team commitment to respect for all involved in the project, and quality services, evaluation and continuous quality improvement by linking delirium care to clinical outcomes.

Standardised care delivery through inter-professional teams: PCU teams will collaborate to develop and deliver the evidence- and Delirium Standard-based delirium monitoring system.

Information systems: PCOC will be utilised to routinely capture delirium data to inform clinical processes and quality improvement in and across the PCUs, with a focus on improving outcomes.

 Outcomes

Stage 1 and 2 outcomes are outlined in Tables 1 and 2.

225063 Stage 1 Outcomes
Process outcomes Corresponding QIs9 Patient/participant inclusion decision tree
i Degree of achievement of clinical and reporting policy and procedures as per the Delirium Standard (Yes/No/Partial) 1a, 2, 4b NA
ii Proportion of older patients (≥65 years, or ≥45 years if Aboriginal or Torres Strait Islander) in the PCU screened for cognitive impairment using a validated tool within 24 hours of presentation to hospital (+ description of the tool/s) 1b All older patients
iii Proportion and characteristics of patients who had interventions to prevent delirium in the PCU, +/- involvement of family carers 2 All
iv Frequency of delivery of strategies to prevent delirium (i.e., natural sleep-wake cycle, vision, hearing, physical activity, nutrition and hydration, orientation, pain management, patient and family engagement) 2 All
v Proportion and characteristics of patients screened/assessed for delirium using a validated tool in the PCU (+ description of the tool/s) 4a All
vi Proportion and characteristics of patients with delirium in the PCU comprehensively assessed to investigate the root cause/s 5a All with delirium
vii Proportion and characteristics of patients with delirium in the PCU who received interventions to treat identified cause/s 5b All with delirium
viii Proportion and characteristics of patients with delirium assessed for risk of other hospital complications (functional decline, dehydration, malnutrition, falls and pressure injuries) 6a All with delirium
ix Proportion and characteristics of patients with delirium in the PCU who did not/did receive antipsychotic (or benzodiazepine) medicines for delirium symptoms 7 All with delirium
x Proportion and characteristics of patients with current or resolved delirium in the PCU with an individualised comprehensive discharge plan re delirium 8a All with delirium + discharged
Participant outcomes
xi

Rates of delirium:

n (%) patients with prevalent delirium (defined as present on admission to the PCU)

n (%) patients with incident delirium (defined as occurring after admission to the PCU)

 		4b All
xii

Proportions and characteristics of patients with delirium in the PCU:

With dehydration or malnutrition, a fall resulting in fracture or intracranial injury, or pressure injury

Readmitted to hospital for delirium within 10 days of discharge

 		6b8b All with deliriumAll with delirium + discharged
xiii Key stakeholders’ perspectives of delirium care and communication (current and potential) in the PCUs (qualitative) 1-8 Had delirium or cared for a patient with delirium in the preceding week

Code: PCU = palliative care unit(s); QIs = Delirium Standard quality indicators

 225064 Stage 2 Outcomes
Implementation outcomes Corresponding Qis9
i Reach:
N, % and characteristics of staff who received training/education on the Delirium Standard and the delirium monitoring system 1, 2, 4
Patient and family carer perspectives of the appropriateness, acceptability, and feasibility of the delirium monitoring system 3
N, %, and representativeness* of recipients (patients and family carers) of the delirium monitoring system 4b
ii Adoption:
N, %, representativeness* of PCUs that pilot the delirium monitoring system NA
Adaptation of the delirium monitoring system 4b
Completion of the new PCOC delirium item (n, %, overall, per palliative care phase) 4b
Patient- versus proxy-reported (family carer, clinician) of new PCOC delirium item for patients with delirium (n, %, overall, per palliative care phase) 4b
Staff perspectives of the appropriateness, acceptability, feasibility of the new delirium monitoring system 4b
Effectiveness outcomes
iii Meeting the Delirium Standard:
Maintenance of Delirium Standard QIs that were met in stage 1 (n, type, range/sites) 1-8
Achievement of Delirium Standard QIs that were not met in stage 1 (n, type, range/sites) 1-8
An increase of 10% or more in Delirium Standard compliance across domains applicable to individual admitted patients as per decision tree between stage 1 and stage 2 1-8
iv Anticipatory care of patients with absent-mild PCOC delirium item (n, %, overall, per palliative care phase) 2
v Responsive care of patients with moderate-severe PCOC delirium item (n, %, overall, per palliative care phase, and with sustained midpoint RASS-PAL levels of +1 (Restless but not aggressive), 0 (Alert and Calm) or -1 (Drowsy but has sustained awakening to voice for ≥10 seconds)) in the subsequent phase 5a, 5b, 6b, 7
vi Concordance of >85% for identification of delirium in clinical audits vs PCOC 4a
vii Adverse effects (patient, family carer, staff, organisation) 3, 6a, 6b, 7, 8b
Systemic utility outcome
viii Combined key stakeholder perspectives of the appropriateness + acceptability + feasibility of the delirium monitoring system for wider testing and use, including in PCOC, to meet the Delirium Standard in PCUs 1-8

Code: PCU = palliative care unit(s); QIs = Delirium Standard quality indicators; RASS-PAL = Richmond Agitation-Sedation Scale - Palliative Version33; *Representativeness = similarity/differences between recipients and participating PCUs and non-recipients and non-participating PCUs

 Sample sizes

For clinical audits, each PCU is considered an independent site with probable low (<2%) current complete compliance to the Delirium Standard (based on previous audits at two sites). To detect changes in estimated proportion of compliance for eligible patients (determined by a decision tree incorporating delirium present yes/no and deceased vs discharged) of at least 10% between stages with an assumed intracluster correlation coefficient (ICC) = 0.01, alpha = 0.05 and power = 0.8 will require 120 clinical audits per site (60 per stage), thus an overall total of 480.

PCOC delirium items will be collected from approximately 1,000 patients; with the mean of 2.2 palliative care phases34 per admitted patient, this will potentially give >2000 data entries for analysis, providing at least 2.5% level of precision in estimating frequency of delirium-related events in the overall study population, with 95% confidence and assuming a conservative 35% likelihood of delirium diagnosis during admission.

Qualitative interview sample sizes will be determined from number of incidents rather than participants, as per CIT. Adequate data collection will be when an additional 100 critical incidents identify no more than two additional relevant behaviours, which we will determine at 50, 150 incidents, etc. in each stage. Using this calculus, we anticipate needing at least 80 participants in each stage (N=160). A minimum quota of 40 patient interviews will address their under-representation in qualitative studies of delirium in palliative care.12

 Analyses

Quantitative data analysis will use descriptive statistics (means and standard deviations, medians, interquartile ranges, frequencies) to summarise participants’ characteristics and implementation study outcomes. Where appropriate, standard tests for normality will be conducted and outliers assessed for numerical variables. In stage 2 clinical audit data analysis, a multiple logistic regression model will be used to assess predictors of achievement versus non-achievement of the Delirium Standard. Results will be compared across study sites and potential reasons for disparities in patient characteristics, admission patterns and outcomes explored. Missing data will be assessed for any non-random patterns.

Qualitative data will be recounted incidents with an antecedent, a clear description of the incident, and an outcome, congruent with CIT.29,30 We will perform thematic content analysis framed against the Delirium Standard with inquiry focused on its feasibility, acceptability and appropriateness in the PCUs.35,36 A sub-set of investigators with qualitative analysis experience will perform initial analysis and develop preliminary themes and sub-themes, then present these to the full investigator team for refinement before finalisation.

Data integration through triangulation of quantitative and qualitative summary data will occur at the end of each stage and reported in narrative and diagrammatic summaries and joint displays.37

 Ethical considerations Recruitment, enrolment and consent

For interviews and process mapping, we developed brief and simplified participant information sheets and consent forms with 13-point font and lay language resulting in a Flesch Kincaid reading ease score of 8.3 (equivalent to 8th grade student standard) for the patient version (Supplementary file 5). Site research staff will recruit eligible people, rather than site investigators who may have clinical or managerial responsibility for some who asked to participate. People eligible for interviews or process mapping will be given sufficient time to make participation decisions. Research staff will endeavour to avoid undue research burden on patients and carers by prioritising their individual needs and wishes over recruitment targets. Patients will be free to consult with trusted others and undertake the interview in their presence if they wish. Participants will confirm their consent in writing. Research staff will record participants’ names and details in a participant master log, assigning each person a unique participant identification number (PID). Research staff will be trained in study-specific consent and interview processes and experience of delirium from patients’ perspectives.8,12

Waiver of consent to audit medical records and use PCOC data was approved by the Human Research Ethics Committee (HREC), with patients or their proxies able to opt out. An opt-out approach was ethically justified because inclusion of routinely collected clinical data on delirium care and outcomes carries no more than low risk to patients, project validity requires most eligible patients be included, potential study benefits outweigh risks, and data will be maintained in accordance with relevant security standards.38,39

 Potential risks and their mitigation

The MODEL-PC study involves patients who are highly dependent on medical care, near the end of life, experiencing distress, and many with cognitive impairment. We will minimise potential risks to patients, carers, staff, participating organisations and the project as outlined in Table 3.40

225065 Potential risks and their mitigation strategies
Risks* Risk Mitigation Strategies and Counterbalances
All participant groups
Interviews: Inconvenience, tiredness, psychological discomfort or distress

Informed and voluntary consent

Brief and ‘storytelling’ CIT method.

Trained study personnel with insight and experience in palliative care or end of life care

Patients may participate with a carer present.

Interviewers will seek to establish trust and rapport, prioritise participants’ safety and wellbeing, and respond to signs of discomfort and distress with compassion, with request for treating team follow up where required and agreed by the patient or carer.

Participants will be free to withdraw from a question, interview or the study.

Counterbalance: Potential therapeutic benefit for participants to share experiences of delirium and delirium care and contribute to improving clinical practice.41,42
Privacy and confidentiality: Re-identification of personal, sensitive or health information

Participants/enrolled patients given a PID and identifiable information such as names or medical record numbers stored only in Master participant logs.

Secure data storage and management with access restricted to research and regulatory staff.

Site investigators/research staff certified in International Council for Harmonisation Good Clinical Practice.43

Summary reporting of participants/enrolled patients’ characteristics and outcomes.
COVID-19 transmission

Social distancing and personal protective equipment.

Researcher compliance with governmental/organisational COVID-19 requirements.

Interviews may be conducted virtually if acceptable to the participant.
Patients
Inconvenience or fatigue related to Delirium Standard care or new PCOC measure/s

Delirium Standard care is tailored to the individual patient’s needs and wishes.9

PCOC measures may be completed by proxies (carers or staff), where required.20

Counterbalance: Potential for improved delirium prevention to reduce other hospital complications such as falls.44
Psychological harm, including stigma, related to increased clinical identification of delirium

Provision of patient-centred information and support is part of the Delirium Standard (QS 3).

Counterbalance: Qualitative evidence from diverse settings is consistent that patients and family carers want and appreciate information about delirium from clinicians.8,12,15

Changes in antipsychotic and benzodiazepine use for delirium in stage 2:

Increased, due to increased monitoring of patients’ delirium and related distress14 OR

Decreased use to meet the Delirium Standard may have unintended consequences

Study processes attend to the whole Delirium Standard.

Regular audit and feedback to PCU teams.

Combined measurement and monitoring of delirium-related distress, related psychotropic medication use, and agitation and sedation scores.*
PCU staff/organisations

Stage 2:

Increased documentation burden due to new PCOC measures and other changes

Lack of motivation if complex clinical processes become a ‘tick-box’ exercise

Psychological discomfort with previous delirium practice or practice change

Opportunity to recount experiences of the new delirium monitoring system in an interview.

Site investigators and research staff active listening to staff concerns and complaints.

Staff complaints about the study or new clinical processes will be reported as an adverse event.*

Counterbalance: The study is explicitly designed to minimise duplication of delirium care processes (including documentation) for staff
Reputational/professional harm to participating organisations if the Delirium Standard is not met.

Site-specific data confidential to the site and available to them for actioning.

Study outcomes reported in accordance with a mutually agreed dissemination plan.
Audits or interviews may identify serious breach of professional standards

Research staff will inform the site investigator of any observed breaches of professional practice, who will consult with the PCU’s Nurse Unit Manager for his/her consideration and actioning.
Research staff
Psychological discomfort or distress or physical harm through interactions with patients with life-limiting illness and recent delirium, their carers and staff

Research staff checking with clinical team about approaching patients and carers for research purposes.

Interviewers with communication and de-escalation skills and bound to site policy on patient and staff safety.

Research staff regular meet and debrief with site investigators and will report adverse events.
Travel risks for project staff during site visits

Project staff adherence to university travel policy
Project
Disruption/delays if stringent COVID-19 restrictions return

Multi-state study so delays at one site may be offset by increasing data collection at other sites.
Impaired communication between project and site teams due to long geographical distances

Lead investigator and project coordinator will visit PCUs at key time points.

Use of phone, email and virtual platforms for routine communication.

*Adverse events that will be routinely monitored and reported are outlined in Supplementary file 6

 Dissemination

Outputs will include the study protocol, stage 1 interview findings, stage 1 clinical audit results, stage 1 mixed methods integration, stage 2 interview findings, stage 2 PCOC results, and overall project mixed methods results, and corresponding conference presentations.

 Discussion

Delirium is a serious but under-addressed condition in Australian palliative care units, estimated to occur for around 22,000 patients annually.1,45 The MODEL-PC study will, for the first time, obtain patients’ perspectives of delirium and delirium care and their levels of distress in this setting.12 Patient recruitment processes align with the MORECare capacity statement, which focuses on maximising individual autonomy, allowing sufficient time and resources for participation, and recruitment strategies that anticipate and address patients’ varied capacities, including fluctuations in individual patients.46 This ‘supported decision-making’ approach privileges the person with a disability as the decision-maker and affords them equal rights, respect and necessary support for decision-making, without abuse or undue influence.47,48

Alignment and interlinking of the Delirium Standard with PCOC monitoring methods increases the likelihood that PCU staff will adopt the study processes, given the potential for measures and efficiencies that may help them to meet a hospital accreditation requirement. MODEL-PC study findings will inform the development of a funding proposal for a definitive implementation trial, as well as quality improvement in delirium care in palliative care settings in Australia and other jurisdictions with a delirium standard. The study will build understanding of how PCOC data can drive quality delirium care in PCUs and may inform future PCOC data linkage projects. It will provide PCOC and all registered palliative care services across Australia with exemplars of delirium care to use when they train clinicians in use of PCOC delirium items, thus aiding research translation. It will also aid service-level quality improvements and national surveillance and monitoring, which will be useful in helping to determine whether the Australian standards for delirium are being addressed in palliative care services.23

225061 List of Abbreviations
CIT Critical Incident Technique
HREC Human Research Ethics Committee
PCOC Palliative Care Outcomes Collaboration
PCU Palliative Care Unit
PID Participant Identification Number
QI Quality indicator/s of the Delirium Standard
QS Quality statement/s of the Delirium Standard
QUAL or qual Qualitative
QUANT or quant Quantitative
RASS-PAL Richmond Agitation-Sedation Scale - Palliative Version
Author Contributions

AH, MA, CJ, GW, PM, AC, RC, JO, MS, CV, MP, IF, SB, PL conceptualised and developed the study proposal and submitted it for grant funding in 2020. Full protocol development was led by AH with contributions from the remaining authors. NVO led the tailoring of the full protocol into this protocol manuscript. All authors approved the submitted manuscript.

 Ethics statement

This research was reviewed and approved by the St Vincent’s Hospita Human Research Ethics Committee (HREC) (approval number: 2022/ETH00110) on 27 May 2022), with Cross Institutional Ratification by the University of Notre Dame Australia HREC (reference number: 2022-096S) on 13 July 2022.

 Declarations of Interests

PL and SB receive an Academic Protected Time Award from the Department of Medicine, (Blinded for review).

Investigators AH, GW, PM, PC, KB, JO and MS have clinical and/or academic appointments at participating sites.

 Progress statement

Stage 1 data collection is complete, with analyses underway. One site withdrew from the study at the end of stage 1 due to complete closure of the hospital. Stage 2 data collection started at the remaining three sites in January 2024. The number of stage 2 audits per site will be adjusted to obtain the 240 required, pending ethical approval of this amendment.

 Supporting information Supplementary file 1_MODEL-PC study process mapping items Supplementary file 2 - MODEL-PC study Clinical Audit Tool Supplementary file 3 - MODEL-PC study Master Interview Schedule Supplementary file 4 -MODEL-PC study data items_variables Supplementary file 5 - MODEL-PC_Participant information sheet and consent form_patient Supplementary file 6_MODEL-PC study Adverse Effect Reporting Items Acknowledgements

We thank Mr Jonathon Lennon for his expertise and assistance as a project officer in the initial phase of the study; and Ms Clare Johnston, Research Development and Grants Coordinator, for her support in the grant application and management.

 The incidence and prevalence of delirium across palliative care settings: A systematic review Palliative Medicine Watt C. L. Momoli F. Ansari M. T.. 2019 33 865 877 10.1177/0269216319854944 https://doi.org/10.1177/0269216319854944 Delirium: diagnosis, prevention and management National Clinical Guideline Centre for Acute and Chronic Conditions 2010 2023-10-23 https://www.nice.org.uk/guidance/cg103 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) American Psychiatric Association American Psychiatric Publisher Arlington, VA 2013 10.1176/appi.books.9780890425596 Predisposing and Precipitating Factors Associated With Delirium: A Systematic Review JAMA Network Open Ormseth C. H. LaHue S. C. Oldham M. A.. 2023 6 e2249950 e2249950 10.1001/jamanetworkopen.2022.49950 https://doi.org/10.1001/jamanetworkopen.2022.49950 Risk factors for delirium in adult patients receiving specialist palliative care: A systematic review and meta-analysis Palliative Medicine Featherstone I. Sheldon T. Johnson M.. 2021 02692163211065278 10.1177/02692163211065278 https://doi.org/10.1177/02692163211065278 Economic impact of delirium in Australia: a cost of illness study BMJ Open Pezzullo L. Streatfeild J. Hickson J.. 2019 9 e027514 10.1136/bmjopen-2018-027514 https://doi.org/10.1136/bmjopen-2018-027514 Distress in delirium: causes, assessment and management European Geriatric Medicine Williams S.T. Dhesi J.K. Partridge J.S.L. 2020 11 63 70 10.1007/s41999-019-00276-z https://doi.org/10.1007/s41999-019-00276-z Delirium-related distress in the ICU: A qualitative meta-synthesis of patient and family perspectives and experiences International Journal of Nursing Studies Boehm L. M. Jones A. C. Selim A. A.. 2021 104030 10.1016/j.ijnurstu.2021.104030 https://doi.org/10.1016/j.ijnurstu.2021.104030 Delirium Clinical Care Standard Australian Commission on Safety and Quality in Health Care 2021 2021-10-19 https://www.safetyandquality.gov.au/our-work/clinical-care-standards/delirium-clinical-care-standard Improving recognition of delirium in clinical practice: a call for action BMC Geriatrics Teodorczuk A. Reynish E. Milisen K. 2012 12 55 10.1186/1471-2318-12-55 https://doi.org/10.1186/1471-2318-12-55 Delirium in adults - Quality standard National Institute for Health and Care Excellence NICE UK 2014 The experience of delirium in palliative care settings for patients, family, clinicians and volunteers: A qualitative systematic review and thematic synthesis Palliative Medicine Featherstone I. Hosie A. Siddiqi N.. 2021 35 988 1004 10.1177/02692163211006313 https://doi.org/10.1177/02692163211006313 A Multicomponent Nonpharmacological Intervention to Prevent Delirium for Hospitalized People with Advanced Cancer: A Phase II Cluster Randomized Waitlist Controlled Trial (The PRESERVE Pilot Study) Journal of Palliative Medicine Hosie A. Phillips J. Lam L.. 2020 23 1314 1322 10.1089/jpm.2019.0632 https://doi.org/10.1089/jpm.2019.0632 Stakeholder perspectives of a pilot multicomponent delirium prevention intervention for adult patients with advanced cancer in palliative care units: A behaviour change theory-based qualitative study Palliative Medicine Green A. Hosie A. Phillips J.L.. 2022 36 1273 1284 10.1177/02692163221113163 https://doi.org/10.1177/02692163221113163 The experiences of caregivers of patients with delirium, and their role in its management in palliative care settings: an integrative literature review Psycho-Oncology Finucane A. M. Lugton J. Kennedy C.. 2017 26 291 300 10.1002/pon.4140 https://doi.org/10.1002/pon.4140 A Scoping Review to Map Empirical Evidence Regarding Key Domains and Questions in the Clinical Pathway of Delirium in Palliative Care Journal of Pain and Symptom Management Lawlor P.G. Rutkowski N.A. MacDonald A.R.. 2019 57 661 681.e612 10.1016/j.jpainsymman.2018.12.002 https://doi.org/10.1016/j.jpainsymman.2018.12.002 Drug therapy for delirium in terminally ill adults Cochrane Database of Systematic Reviews Finucane A. M. Jones L. Leurent B.. 22 1 2020 2020 1 Cd004770 10.1002/14651858.CD004770.pub3 https://doi.org/10.1002/14651858.CD004770.pub3 Clinicians’ delirium treatment practice, practice change, and influences: A national online survey Palliative Medicine Hosie A. Agar M. Caplan G. A.. 2021 35 1553 1563 10.1177/02692163211022183 https://doi.org/10.1177/02692163211022183 Palliative Care Outcomes Collaboration 2020 2024-2-13 https://ahsri.uow.edu.au/pcoc/index.html The PCOC Symptom Assessment Scale (SAS): A valid measure for daily use at point of care and in palliative care programs PLOS ONE Daveson B. A. Allingham S. F. Clapham S.. 2021 16 e0247250 10.1371/journal.pone.0247250 https://doi.org/10.1371/journal.pone.0247250 Accrediation, Standards, Quality PCOC 2022 2023-10-3 https://www.uow.edu.au/ahsri/pcoc/palliative-care/accreditation-standards-quality/ Patient-reported outcome measurement of symptom distress is feasible in most clinical scenarios in palliative care: an observational study involving routinely collected data International Journal for Quality in Health Care Clapham S. Daveson B. A. Allingham S. F.. 2021 33 10.1093/intqhc/mzab075 https://doi.org/10.1093/intqhc/mzab075 Population-level, patient-reported outcomes: a case study regarding a public health intervention that involves patients with life-limiting illnesses Frontiers in Public Health Daveson B. Blanchard M. Clapham S.. 2023 11 10.3389/fpubh.2023.1232881 https://doi.org/10.3389/fpubh.2023.1232881 Designing and conducting mixed methods research Creswell J.W. Plano Clark V.L. SAGE Publications Thousand Oaks, California 2006 Standards for Reporting Implementation Studies (StaRI) Statement BMJ Pinnock H. Barwick M. Carpenter C. R.. 2017 356 i6795 10.1136/bmj.i6795 https://doi.org/10.1136/bmj.i6795 Palliative care services in Australia Australian Institute of Health and Welfare 2023 2024-2-13 https://www.aihw.gov.au/reports/palliative-care-services/palliative-care-services-in-australia/contents/summary-of-palliative-care-services-in-australia#Hospitalisation Research electronic data capture (REDCap)-a metadata-driven methodology and workflow process for providing translational research informatics support Journal of Biomedical Informatics Harris P.A. Taylor R. Thielke R.. 2009 42 377 381 10.1016/j.jbi.2008.08.010 https://doi.org/10.1016/j.jbi.2008.08.010 How to process map: Clinical Program Design and Implementation Agency for Clinical Innovation (ACI) 2015 The Critical Incident Technique Psychological Bulletin Flanagan J. C. 1954 51 10.1037/h0061470 Fifty years of the critical incident technique: 1954-2004 and beyond Qualitative Research Butterfield L. D. Borgen W. A. Amundson N. E.. 2005 5 475 497 10.1177/1468794105056924 https://doi.org/10.1177/1468794105056924 Ten key principles for successful health systems integration Healthc Q Suter E. Oelke N. D. Adair C. E.. 2009 13 Spec No 16 23 10.12927/hcq.2009.21092 https://doi.org/10.12927/hcq.2009.21092 Audit and feedback: effects on professional practice and healthcare outcomes Cochrane Database of Systematic Reviews Ivers N. Jamtvedt G. Flottorp S.. 2012 10.1002/14651858.CD000259.pub3 https://doi.org/10.1002/14651858.CD000259.pub3 The Richmond Agitation-Sedation Scale modified for palliative care inpatients (RASS-PAL): a pilot study exploring validity and feasibility in clinical practice BMC Palliative Care Bush S.H. Grassau P.A. Yarmo M.N.. 2014 13 17 17 10.1186/1472-684x-13-17 https://doi.org/10.1186/1472-684x-13-17 Palliative Care Phase: inter-rater reliability and acceptability in a national study Palliative Medicine Masso M. Allingham S.F. Banfield M.. 2015 29 22 30 10.1177/0269216314551814 https://doi.org/10.1177/0269216314551814 The qualitative content analysis process Journal of Advanced Nursing Elo S. Kyngas H. 21 3 2008 62 107 115 10.1111/j.1365-2648.2007.04569.x https://doi.org/10.1111/j.1365-2648.2007.04569.x Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness Nurse Education Today Graneheim U. H. Lundman B. 2004 24 105 112 10.1016/j.nedt.2003.10.001 https://doi.org/10.1016/j.nedt.2003.10.001 Achieving integration in mixed methods designs—principles and practices Health Services Research Fetters M.D. Curry L.A. Creswell J.W. 2013 48 2134 2156 10.1111/1475-6773.12117 24279835 PMC4097839 Management of Data and Information in Research: A guide supporting the Australian Code for the Responsible Conduct of Research National Health and Medical Research Council, Australian Research Council and Universities Australia Canberra PCOC Data Policy Palliative Care Outcomes Collaboration, University of Wollongong 10 2020 National Statement on Ethical Conduct in Human Research The National Health and Medical Research Council Australian Research Council Universities Australia Commonwealth of Australia Canberra 2007 What do palliative care patients and their relatives think about research in palliative care?-a systematic review Supportive Care in Cancer White C. Hardy J. 2010 18 905 911 10.1007/s00520-009-0724-1 https://doi.org/10.1007/s00520-009-0724-1 Older Persons' and Their Caregivers' Perspectives and Experiences of Research Participation With Impaired Decision-Making Capacity: A Scoping Review The Gerontologist Hosie A. Kochovska S. Ries N.. 2022 62 e112 e122 10.1093/geront/gnaa118 https://doi.org/10.1093/geront/gnaa118 Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice: E6(R2) International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) ICH 2016 Does delirium prevention reduce risk of in-patient falls among older adults? A systematic review and trial sequential meta-analysis Australasian Journal of Ageing He S. Rolls K. Stott K.. 2022 41 396 406 10.1111/ajag.13051 https://doi.org/10.1111/ajag.13051 National Report, Inpatient setting PCOC 1 2023 2023-10-23 https://documents.uow.edu.au/content/groups/public/@web/@chsd/@pcoc/documents/doc/uow275760.pdf Processes of consent in research for adults with impaired mental capacity nearing the end of life: systematic review and transparent expert consultation (MORECare_Capacity statement) BMC Medicine Evans C. J. Yorganci E. Lewis P.. 2020 18 221 10.1186/s12916-020-01654-2 https://doi.org/10.1186/s12916-020-01654-2 Equality, Capacity and Disability in Commonwealth Laws Australian Law Reform Commission 2014 2019-10-19 https://www.alrc.gov.au/publications/equality-capacity-disability-report-124 Supported decision-making in aged care: a policy development guideline for aged care providers in Australia Sinclair C. Field S. Blake M. Cognitive Decline Partnership Centre Sydney 2018