Study protocol for Video Images about Decisions to Improve Ethical Outcomes with Palliative Care Educators (VIDEO-PCE): a pragmatic stepped wedge cluster randomised trial of older patients admitted to the hospital

Introduction
Despite the known benefit to patients and families, discussions about goals, values and preferences for medical care in advancing serious illness often do not occur. Many system and clinician factors, such as patient and clinician reticence and shortage of specialty palliative care teams, contribute to this lack of communication. To address this gap, we designed an intervention to promote goals-of-care conversations and palliative care referrals in the hospital setting by using trained palliative care educators and video decision aids. This paper presents the rationale, design and methods for a trial aimed at addressing barriers to goals-of-care conversations for hospitalised adults aged 65 and older and those with Alzheimer’s disease and related Dementias, regardless of age.

Methods and analysis
The Video Image about Decisions to Improve Ethical Outcomes with Palliative Care Educators is a pragmatic stepped wedge, cluster randomised controlled trial, which aims to improve and extend goals-of-care conversations in the hospital setting with palliative care educators trained in serious illness communication and video decision aids. The primary outcome is the proportion of patients with goals-of-care documentation in the electronic health record. We estimate that over 9000 patients will be included.

Ethics and dissemination
The Institutional Review Board (IRB) at Boston Medical Center will serve as the single IRB of record for all regulatory and ethical aspects of this trial. BMC Protocol Number: H-41482. Findings will be presented at national meetings and in publications. This trial is registered at ClinicalTrials.gov.

Trial registration number
NCT04857060; ClinicalTrials.gov

Leggi
Luglio 2022

Ethical challenges in palliative sedation of adults: protocol for a systematic review of current clinical practice guidelines

Introduction
This study aims to identify the full spectrum of ethical challenges of all forms of palliative sedation for adults as presented in current clinical practice guidelines (CPGs) and to determine whether CPGs specify ethical challenges of this therapy for patients with cancer and non-cancer and, if so, how exactly they do this. To the best of our knowledge, no studies have yet investigated this topic. The purpose is purely descriptive; our aim is not to make any kind of normative judgements on these challenges. Nor is our aim to assess the quality of the CPGs.

Methods and analysis
We will perform a systematic review of CPGs on palliative sedation for adults via five electronic databases, grey literature search tools, citation tracking and contact with palliative care experts. Current CPGs accredited by an international, national or regional authority, published in English, German, French, Italian or Polish, from 2000 to the date of the search, will be subjected to content analysis at the textual, linguistic and thematic levels.

Ethics and dissemination
This is a protocol for a systematic review and no human will be involved in this research. Therefore, ethics approval and consent to participate are not applicable to this context. This study protocol is reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis for Protocols criteria and registered on PROSPERO. Moreover, the integral version of this study protocol is published as a preprint on Research Square. The results of this study will be actively disseminated through peer-reviewed journals and books, international, national and local conference presentations, social media and media in general.

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Luglio 2022

Addressing palliative care and end-of-life issues in patients with advanced cancer: a systematic review of communication interventions for physicians not specialised in palliative care

Objective
To identify and summarise evaluated interventions aiming to improve the communication of palliative care (PC) and end-of-life (EoL) issues in physicians caring for cancer patients. Such interventions are needed with regard to the aim of an earlier communication of those issues in oncology daily practice, which is associated with a range of benefits for patients and caregivers but is often impeded by physicians’ communication insecurities.

Design
Systematic review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources
Relevant publications were systematically searched in MEDLINE, PsycINFO, CINAHL and Web of Science databases in September 2020 with an update in July 2021.

Eligibility criteria
We included publications reporting a quantitative evaluation of a communication intervention on one or more PC/EoL issues with a communication-related main outcome. Target group had to be physicians caring for cancer patients non-specialist in PC.

Data extraction and synthesis
Two independent raters extracted intervention characteristics, publication characteristics and publication quality. Results were narratively synthesised.

Results
24 publications reporting 22 interventions were included. 13 publications reported randomised controlled trials. A majority of the interventions addressed one specific PC/EoL issue, most often breaking bad news. Teaching strategies mostly involved role-plays. Target group were mainly oncologists. In addition to self-reported outcome measurements for evaluation, most publications also reported the use of external rating data. All but one publication reported significant intervention effects on at least one outcome parameter. Publication quality was overall moderate.

Conclusions
The empirically tested communication interventions on PC/EoL issues seem to effectively improve physicians’ communication. Future interventions should focus on other issues than breaking bad news, such as preparing for the future. Target group should also be organ-specific oncologists, as all primary caring physicians are responsible for timely communication. Our risk-of-bias assessment revealed some weaknesses, indicating that more high-quality studies for evaluation are needed.

PROSPERO registration number
CRD42020191054.

Leggi
Giugno 2022

Understanding the implementation strategy of a secondary care tobacco addiction treatment pathway (the CURE project) in England: a strategic behavioural analysis

Objectives
The Conversation, Understand, Replace, Experts and evidence-based treatment (CURE) project implemented an evidence-based intervention that offers a combination of pharmacotherapy and behavioural support to tobacco-dependent inpatients. Understanding key characteristics of CURE’s implementation strategy, and identifying areas for improvement, is important to support the roll-out of nationwide tobacco dependence services. This study aimed to (1) specify key characteristics of CURE’s exiting implementation strategy and (2) develop theoretical-informed and stakeholder-informed recommendations to optimise wider roll-out.

Design and methods
Data were collected via document review and secondary analysis of interviews with 10 healthcare professionals of a UK hospital. Intervention content was specified through behaviour change techniques (BCTs) and intervention functions within the Behaviour Change Wheel. A logic model was developed to specify CURE’s implementation strategy and its mechanisms of impact. We explored the extent to which BCTs and intervention functions addressed the key theoretical domains influencing implementation using prespecified matrices. The development of recommendations was conducted over a two-round Delphi exercise.

Results
We identified six key theoretical domains of influences: ‘environmental context and resources’, ‘goals’, ‘social professional role and identity’, ‘social influences’, ‘reinforcement’ and ‘skills’. The behavioural analysis identified 26 BCTs, 4 intervention functions and 4 policy categories present within the implementation strategy. The implementation strategy included half the relevant intervention functions and BCTs to target theoretical domains influencing CURE implementation, with many BCTs focusing on shaping knowledge. Recommendations to optimise content were developed following stakeholder engagement.

Conclusions
CURE offers a strong foundation from which a tobacco dependence treatment model can be developed in England. The exiting strategy could be strengthened via the inclusion of more theoretically congruent BCTs, particularly relating to ‘environmental context and resources’. The recommendations provide routes to optimisation that are both theoretically grounded and stakeholder informed. Future research should assess the feasibility/acceptability of these recommendations in the wider secondary-care context.

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Giugno 2022

Understanding patient views and experiences of the IDENTIfication of PALLiative care needs (IDENTI-Pall): a qualitative interview study protocol

Introduction
More people are living with multimorbidity, defined as two or more long-term physical or mental health conditions. Multimorbidity is associated with poor quality of life and high treatment burden. Palliative care identification tools have been developed for use in primary care to seek out patients who could benefit from a palliative approach to their care. There has been little evaluative research on such tools; patient perspectives on the process of identifying their palliative care needs is a significant gap. The aim of this research is to provide new understanding into patient perspectives of the experience of having their palliative care needs identified, and the impact on their healthcare.

Methods and analysis
This qualitative study will employ semistructured interviews to elicit the views of participants. We will purposively sample 10–12 adults with advanced serious illness who have been identified by their primary care team as having palliative care needs, and/or are receiving care from specialist palliative care services. A family member or carer may be included in an interview at the participant’s request. A descriptive, thematic analysis will be carried out using the data analysis software NVivo.

Ethics and dissemination
Ethical approval has been granted by the North of Scotland Research Ethics Committee. Study findings will be disseminated in peer-reviewed journals and through conference presentations. Other activities include the development of patient-centred outcomes for clinical practice and policy in relation to the use of palliative care identification tools.

Trial registration number
National Institute for Health Research (NIHR) Clinical Studies Portfolio, UK Clinical Research Network (UKCRN) Study number 51296.

Leggi
Giugno 2022