Proxy Decision Research Articles

Transparent reporting of recruitment and informed consent approaches in clinical trials recruiting children with minor parents in sub-Saharan Africa: a secondary analysis based on a systematic review

BackgroundStandardised checklists of items to be addressed in clinical study protocols and publications are promoting transparency in research. However, particular specifications for exceptional cases, such as children with minor parents are missing. This study aimed to examine the level of transparency regarding recruitment and informed consent approaches in publications of clinical trials recruiting children with minor parents in sub-Saharan Africa. We thereby focused particularly on the transparency about consenting persons (i.e. proxy decision-makers) and assessed the need to expand reporting guidelines for such exceptional cases.MethodsWe conducted a secondary analysis of clinical trial publications previously identified through a systematic review. Multiple scientific databases were searched up to March 2019. Clinical trial publications addressing consent and potentially recruiting children with minor parents in sub-Saharan Africa were included. 44 of the in total 4382 screened articles met our inclusion criteria. A descriptive analysis was performed.ResultsNone of the included articles provided full evidence on whether any recruited children had minor parents and how consent was obtained for them. Four proxy decision-maker types were identified (parents; parents or guardians; guardians; or caregivers), with further descriptions provided rarely and mostly in referenced clinical trial registrations or protocols. Also, terminology describing proxy decision-makers was often used inconsistently.ConclusionsReporting the minimum maternal age alongside maternal data provided in baseline demographics can increase transparency on the recruitment of children with minor mothers. The CONSORT checklist should require clinical trial publications to state or reference exceptional informed consent procedures applied for special population groups. A standardized definition of proxy decision-maker types in international clinical trial guidelines would facilitate correct and transparent informed consent for children and children with minor parents.Study registrationCRD42018074220.

"I decide myself"- A qualitative exploration of end of life decision making processes of patients and caregivers through Advance Care Planning.

BackgroundThe Singapore national Advance Care Planning (ACP) programme was launched in 2011 with the purpose of ensuring that healthcare professionals are fully aware of patients’ treatment preferences. There is little research assessing the performance of such programmes in ethnically diverse Asian countries; hence, the purpose of this study was to qualitatively examine patients and caregivers’ experiences with the ACP programme.MethodWe conducted interviews with 28 participants, thirteen of whom identified as proxy decision makers (PDMs) and the remainder as patients. Interviews focused on respondents’ experiences of chronic illness and of participating in the ACP programme. Textual data was analysed through a framework analysis approach.ResultsParticipants’ narratives focused on four major themes with 12 subthemes: a) Engagement with Death, factors influencing respondents’ acceptance of ACP; b) Formation of Preferences, the set of concerns influencing respondents’ choice of care; c) Choice of PDM, considerations shaping respondents’ choice of nominated health spokesperson; and d) Legacy Solidification, how ACP is used to ensure the welfare of the family after the patient passes. These findings led to our development of the directive decision-making process framework, which delineates personal and sociocultural factors influencing participants’ decision-making processes. Respondents’ continual participation in the intervention were driven by their personal belief system that acted as a lens through which they interpreted religious doctrine and socio-cultural norms according to their particular needs.ConclusionThe directive decision-making process framework indicated that ACP could be appropriate for the Asian context because participants displayed an awareness of the need for ACP and were able to develop a concrete treatment plan. Patients in this study made decisions based on their perceived long-term legacy for their family, who they hoped to provide with a solid financial and psychological foundation after their death.

Is there a particular pediatric otolaryngology ethic?

ObjectivesThis paper proposes that there is a specific pediatric otolaryngology ethic. MethodsIn support of this contention, traditional ethical frameworks are considered, before ethical issues specific to pediatric otolaryngology are addressed. ResultsFirst, there is a difference between child flourishing and family flourishing, parents have parental virtue (as parents), and where autonomy as a moral agent is vested, is contested. Parents act as both proxy decision-makers and as autonomous decision-makers for our patients. We are aware of the open future of a child. We worry about unvoiced and unvoicable concerns and distress in children. Second, we treat the not-yet-born and the recently born, so we need a philosophical understanding of what is a person, and when we become one. Third, traditional approaches to decision-making in medical ethics in Western settings are based upon the frameworks of duty and rules, or of consequences and outcomes, or are virtue-based. In our contemporary era, characterized by pronounced value pluralism, these ethical approaches no longer provide sufficient guidance in the complex milieu of our pediatric otolaryngology practice. In contemporary pediatric otolaryngology, a moral philosophical approach is needed to add meaning and normativity (a sense of oughtness or shouldness) to decision-making amongst the stakeholders in the clinical consultation. ConclusionDetermining the virtuous balance between a priori rules and empirical consequences is a possible solution. This is put into clinical practice via the process of dialogic consensus – an inclusive, non-coercive and reflective dialogue, aimed at reaching a consensual decision as how to maximize the good of our young patients and their family. Based upon differing ethical and moral considerations, and specific issues around children and their families, there is a particular pediatric otolaryngology ethic.

Supporting independence at home for people living with dementia: a qualitative ethnographic study of homecare

PurposeThe aim of this ethnographic study was to investigate how homecare workers support or inhibit independence in people living with dementia.MethodsWe undertook 100 h of participant observations with homecare workers (n = 16) supporting people living with dementia (n = 17); and 82 qualitative interviews with people living with dementia (n = 11), family carers (n = 22), homecare managers and support staff (n = 11), homecare workers (n = 19) and health and social care professionals (n = 19). We triangulated data and analysed findings thematically.ResultsWe developed three themes: (1) independence and the home environment, highlighting ongoing negotiations between familiarity, suitability and safety for care; (2) independence and identity, exploring how homecare workers’ understanding of their clients’ identity can enable active participation in tasks and meaningful choices; and (3) independence and empowerment, considering the important position of homecare workers to advocate for clients living with dementia while navigating authoritative power amongst proxy decision-makers.ConclusionWe consider that person-centred care should also be home-centred, respecting the client’s home as an extension of self. Homecare workers can use their understanding of clients’ identities, alongside skills in providing choice and developing relationships of interdependence to engage clients in everyday tasks. Homecare workers are well placed to advocate for their client’s voice within the care network, although their ability to do so is limited by their position within power structures.

Development of a decision support intervention for family members of adults who lack capacity to consent to trials

BackgroundInformed consent is required for participation in clinical trials, however trials involving adults who lack capacity to consent require different enrolment processes. A family member usually acts as a proxy to make a decision based on the patient’s ‘presumed will’, but these decisions can be challenging and families may experience an emotional and decisional burden. Decisions made on behalf of others are conceptually different from those made for ourselves. Innovations have been developed to improve informed consent processes for research, including a number of decision aids, however there are no interventions for proxies who are faced with more complex decisions. This article outlines the development of a novel decision aid to support families making decisions about research participation on behalf of an adult who lacks capacity to consent.MethodsDecision support interventions should be developed using rigorous and evidence-based methods. This intervention was developed using MRC guidance for the development of complex interventions, and a conceptual framework for the development and evaluation of decision aids for people considering taking part in a clinical trial. The intervention was informed by a systematic review and analysis of existing information provision. Previous qualitative research with families who acted as proxies enabled the development of a theoretical framework to underpin the intervention. The intervention was iteratively developed with the involvement of lay advisors and relevant stakeholders.ResultsPrevious research, theoretical frameworks, and decision aid development frameworks were used to identify and develop the intervention components. The decision aid includes information about the proxy’s role and utilises a values clarification exercise and decision support methods to enable a more informed and better-quality decision. Stakeholders, including those representing implementers and receivers of the intervention, contributed to the design and comprehensibility of the decision aid to ensure that it would be acceptable for use.ConclusionsFrameworks for the development of decision aids for people considering participating in a clinical trial can be used to develop interventions for family members acting as proxy decision-makers. The decision support tool is acceptable to users. Feasibility testing and outcome measure development is required prior to any evaluation of its effectiveness.

Family's Perception of Proxy Decision Making to Authorize Do Not Resuscitate Order of Elderly Patients in Long Term Care Facility: A Q-Methodological Study

This study aimed to distinguish and describe the types of perceptions of do not resuscitate (DNR) proxy decisions among families of elderly patients in a long-term care facility. This exploratory study applied Q-methodology, which focuses on individual subjectivity. Thirty-four Q-statements were selected from 130 Q-populations formed based on the results of in-depth interviews and literature reviews. The P-samples were 34 families of elderly patients in a long-term care hospital in Busan, Korea. They categorized the Q-statements using a 9-point scale. Using the PC-QUANL program, factor analysis was performed with the P-samples along an axis. The families' perceptions of the DNR proxy decision were categorized into three types. Type I, rational acceptance, valued consensus among family members based on comprehensive support from medical staff. Type II, psychological burden, involved hesitance in making a DNR proxy decision because of negative emotions and psychological conflict. Type III, discreet decisions, valued the patients' right to self-determination and desire for a legitimate proxy decision. Type I included 18 participants, which was the most common type, and types II and III each included eight participants. Families' perceptions of DNR proxy decisions vary, requiring tailored care and intervention. We suggest developing and providing interventions that may psychologically support families.

(Im)patience by proxy: Making intertemporal decisions for others

Decisions with consequences that play out over time are ubiquitous in business, policy, and family relations, and frequently the agent making such a decision is not the one who bears the consequences. We use a lab experiment to examine whether individuals make different intertemporal decisions for others of varying social distance than for themselves. Subjects make a series of intertemporal work time allocation decisions for themselves and for another individual, either a friend or a stranger. We find that if they do not receive information about the decision recipient, people choose more impatiently (moving more disutility cost into the future) for others than for themselves. In other words, a decision made for you by an uninformed proxy is more impatient than a decision you would make for yourself and thus is probably suboptimal. This result contrasts with some of the literature, a divergence that may be because most of those studies are in the benefit domain while ours is in the cost domain and because (as we find in a separate survey) people perceive procrastination as qualitatively different from other discounting decisions. We provide evidence that this bias in proxy decisions exists because benevolent decision-makers believe their decision recipients to be more impatient than they actually are. First, survey evidence suggests that uninformed individuals believe that they are more patient than other subjects. Second, when the decision-maker sees information about how patient the recipient believes herself to be, this impatience bias disappears if the recipient is a friend. Taken together, our results show that given limited information, proxy decision-makers choose more impatiently than principals would prefer, but information can mitigate this suboptimal choice if social distance is low. Our results also suggest that intertemporal choice may not be behaviorally the same over time as over money.

Implementing Psychiatric Advance Directives: The Transmitter and Receiver Problem and the Neglected Right to Be Deemed Incapable.

Psychiatric advance directives (PADs) can help adults with serious mental illnesses preserve their autonomy and avoid involuntary interventions during an incapacitating mental health crisis. A PAD is a legal document prepared while mentally competent and states the person's treatment preferences to be implemented during a future crisis, ideally with the advocacy of an authorized proxy decision maker. PADs have been available in the United States for more than three decades but have yet to be robustly implemented in practice. This Open Forum describes PADs metaphorically as a device for remote communication among the person with mental illness, a proxy decision maker, and health care providers. Barriers to PAD usage occur on both "transmitter" and "receiver" sides and must be addressed to advance PAD implementation.

Caregiver-Centered Communication: Engaging Family Caregivers

Older adults are often relying on a family member or other informal caregiver (friend or other) to jointly navigate the health care system and cope with the ramifications of serious illness; thus, the patient-caregiver dyad becomes the unit of care. The caregiving role becomes crucial in cases where patients are facing a condition that limits their cognitive and functional abilities and caregivers are called to act as proxy decision makers for significant treatment and symptom management decisions. Caregivers often report that they feel isolated and overwhelmed, and in some cases experience significant barriers in communicating with health care providers. It is important that clinicians communicate in a way that acknowledges and addresses caregivers’ preferences, needs and perspectives. Caregiver centered communication can facilitate a more effective adaptation throughout the illness course with better adherence to recommended treatment plans and greater satisfaction with care for both patients and families, as well as a more comprehensive response to their psychosocial needs. While health care organizations often aim to increase caregiver engagement and involvement in care processes, there is a lack of tools or strategies not only to more actively engage caregivers but also to assess how ongoing approaches perform in terms of facilitating meaningful and inclusive communication. This symposium will review existing tools and a new instrument to measure caregiver centered communication, challenges and opportunities in measuring the quality of communication with caregivers and highlight empirical data of communication quality in various health care settings including home care and hospice.

Profit for friends, fairness for strangers: Social distance reverses the endowment effect in proxy decision making

Buyers often price a product lower than sellers do, a pricing discrepancy known as the endowment effect. We investigated the way buyers and sellers change their pricing decisions as a function of social distance when making decisions on behalf of another person. In Study 1, the pricing discrepancy persisted when making a decision for a close social contact whereas the pattern was reversed when making a decision for a distant social contact. Study 2 replicated this reversed pattern using a social proximity manipulation, and this effect was mediated by participants’ prioritizing of fairness over immediate profit of the transaction. The current work suggests that people allocate different value to objects depending on the subjective closeness towards another for whom they make the pricing decision.

Psychiatric Advance Directives as an Ethical Communication Tool: An Analysis of Definitions

A psychiatric advance directive (PAD) is a communication tool that promotes patients' autonomy and gives capacitated adults who live with serious mental illnesses the ability to record their preferences for care and designate a proxy decision maker before a healthcare crisis. Despite a high degree of interest by patients and previous studies that recommend that clinicians facilitate the completion of PADs, the rate of implementation of PAD remains low. Research indicates that many clinicians lack the necessary experience to facilitate the completion of PADs and to use them, and, as a consequence, do not effectively engage patients about PADs. This study developed practical recommendations for clinicians to improve their ability to communicate and facilitate PADs. We (1) thematically analyzed definitions of PADs published in 118 articles across disciplines, and (2) presented our recommendations for enhanced communication in clinical practice that emphasizes patient-centeredness, usefulness, and clarity, aligned with evidence-based practices that put patients' autonomy and understanding first. While there is no one-size-fits-all script to engage patients in complex conversations, our recommended strategies include an emphasis on patients' autonomy, the adaptation of word choices, the use of metaphor not simile, and checking for patients' understanding as effective methods of clinical communication.

Oncologist- versus hospitalist-led service: Differences in hospital utilization for solid tumor patients.

53 Background: Hospitalists have been practicing alongside oncologists to provide high quality care for hospitalized cancer patients. We examined the differences in hospital utilization and outcomes among solid tumor patients admitted to oncologist-led teams (OT) versus hospitalist-led teams (HT). Methods: We performed a retrospective cohort study of patients with solid tumors admitted to the OT or HT at Mount Sinai Hospital from July to December 2019. We excluded patients less than 18 years of age, primary hematologic malignancies, or admission to intensive care or surgical units. We used the Activity Measure for Post Acute Care (AMPAC) and Charlson Comorbidity Index as a measure of functional ability and illness severity, respectively. We performed bivariate and multivariate analyses comparing differences in length of stay, ICU transfers, palliative care consults, healthcare proxy (HCP) decision, new DNR decision, readmission within 30 days and inpatient mortality by type of admitting service (OT vs HT). Results: A total of 544 patients were identified; 61% (334) admitted to HT. There were significant differences according to race and cancer type (p= 0.001 for both). HT patients had more functional impairment (p<0.0001) and poorer prognosis (p=0.0002). In bivariate analysis, HT had significantly more ICU transfers (OT, 2% vs HT, 8%; p=0.008), new DNR decisions (OT, 7% vs HT, 16%; p=0.002), and inpatient mortality (OT, 4% vs HT, 9%; p=0.02) while OT had significantly more palliative care consults (OT, 45% vs HT, 20%; p<0.0001). Multivariate analysis (Table) demonstrates HT had significantly more new DNR decisions (odds ratio [OR]: 0.46, 95% confidence interval [CI]: 0.23-0.93) and OT had significantly more palliative care consults (OR: 4.01, 95% CI: 2.51-6.43). Conclusions: At our academic hospital, inpatient cancer care led by hospitalists is comparable to that of oncologists despite HT caring for more severely ill oncology patients. From a value perspective, hospitalists facilitating care for hospitalized cancer patients will allow oncologists to maximize ambulatory time and focus on active cancer treatment. [Table: see text]

Ethics Consultations at a Major Academic Medical Center: A Retrospective, Longitudinal Analysis

Background Evidence suggests that healthcare professionals feel inadequately equipped to manage ethical issues that arise, resulting in ethics-related stress. Clinical ethics consultation, and preventive ethics strategies, have been described as ways to decrease ethics-related stress, however information is limited regarding specific sources of ethical concern. Methods The purpose of this study was to conduct a retrospective, longitudinal analysis of a comprehensive database of ethics consultations, at a major academic medical center in the Northeast United States in order to: (1) Discern major sources of ethical concern, (2) Evaluate how these have changed over time in their content and frequency, (2a) Evaluate trends in nurse versus physician-initiated requests. Results Six major reasons for requesting an ethics consult were identified: Conflict Over Goals of Care, Decisional Capacity, Withholding/Withdrawing Treatment, Proxy Decision Making, Communication, and Behavior. Themes were operationally defined by the study team. An increase in requests related to Conflict Over Goals of Care (β = 0.7, 95% CI = 0.2–1.2, p = 0.008) and Discharge Planning (β = 2.2, 95% CI = 1.4–3.1, p < 0.001), and a trend toward increased number of consults for behavior-related consults from nurses (median 6.5% versus 2.3%, p = 0.07) were noted. Nurses were significantly more likely than physicians to request ethics consultation for Communication (yearly median 10.4% of cases vs 1.3% of cases, p = 0.01), whereas, physicians were significantly more likely to request ethics consultation for Proxy Decision-Making than nurses (yearly median 26.0% of cases vs 13.0%, p = 0.005) and for Decision-Making Capacity (yearly median 7.5% of cases vs 4.0%, p = 0.04). Conclusions This study revealed several noteworthy and previously unidentified trends in consultation requests, and several important distinctions between the sources of ethical concern nurses identify versus those physicians identify. These findings can be used to develop future preventive-ethics frameworks.

Constructing authentic decisions: proxy decision making for research involving adults who lack capacity to consent

Research involving adults who lack capacity to consent relies on proxy (or surrogate) decision making. Proxy decisions about participation are ethically complex, with a disparity between normative accounts and empirical...

Article 5: The Role of Parents in the Proxy Informed Consent Process in Medical Research involving Children

Abstract Medical research involving child subjects has led to advances in medicine that have dramatically improved the lives, health and well-being of children. Yet, determining when and under what conditions a child should be enrolled in medical research remains an ethically vexing question in research ethics. At the crux of the issue is the free and informed consent of the child participant. A child, who is presumed legally incompetent, or lacks sufficient understanding to exercise autonomous decision-making, will not be able to express free and informed consent in the research setting. Rather than exclude all such children from medical research, a parent (or legal guardian) is designated as a proxy to consent on the child’s behalf. However, the concept of proxy informed consent and the framework for its implementation present practical and ethical challenges for researchers, particularly in navigating the relationship between proxy decision-makers and child subjects in the medical research setting. Article 5 of the uncrc may offer guidance on this point: (1) it places boundaries around how parental authority should be exercised; (2) it offers a model for parent-child decision-making that is participatory, collaborative and linked to the child’s enjoyment of rights under the uncrc; (3) it respects and supports the autonomy of child participants by recognising their evolving capacities to give informed consent. This paper concludes that greater consideration should be given to Article 5 as a complementary framework for researchers engaged in medical research involving children.

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)

BackgroundInvolving adults lacking capacity (ALC) in research on end of life care (EoLC) or serious illness is important, but often omitted. We aimed to develop evidence-based guidance on how best to include individuals with impaired capacity nearing the end of life in research, by identifying the challenges and solutions for processes of consent across the capacity spectrum.MethodsMethods Of Researching End of Life Care_Capacity (MORECare_C) furthers the MORECare statement on research evaluating EoLC. We used simultaneous methods of systematic review and transparent expert consultation (TEC). The systematic review involved four electronic databases searches. The eligibility criteria identified studies involving adults with serious illness and impaired capacity, and methods for recruitment in research, implementing the research methods, and exploring public attitudes. The TEC involved stakeholder consultation to discuss and generate recommendations, and a Delphi survey and an expert ‘think-tank’ to explore consensus. We narratively synthesised the literature mapping processes of consent with recruitment outcomes, solutions, and challenges. We explored recommendation consensus using descriptive statistics. Synthesis of all the findings informed the guidance statement.ResultsOf the 5539 articles identified, 91 met eligibility. The studies encompassed people with dementia (27%) and in palliative care (18%). Seventy-five percent used observational designs. Studies on research methods (37 studies) focused on processes of proxy decision-making, advance consent, and deferred consent. Studies implementing research methods (30 studies) demonstrated the role of family members as both proxy decision-makers and supporting decision-making for the person with impaired capacity. The TEC involved 43 participants who generated 29 recommendations, with consensus that indicated. Key areas were the timeliness of the consent process and maximising an individual’s decisional capacity. The think-tank (n = 19) refined equivocal recommendations including supporting proxy decision-makers, training practitioners, and incorporating legislative frameworks.ConclusionsThe MORECare_C statement details 20 solutions to recruit ALC nearing the EoL in research. The statement provides much needed guidance to enrol individuals with serious illness in research. Key is involving family members early and designing study procedures to accommodate variable and changeable levels of capacity. The statement demonstrates the ethical imperative and processes of recruiting adults across the capacity spectrum in varying populations and settings.

Palliative Care in Advanced Dementia.

Dementia syndrome is common and expected to increase significantly among older people and characterized by the loss of cognitive, psychological and physical functions. Palliative care is applicable for people with dementia, however they are less likely to have access to palliative care. This narrative review summarizes specifics of palliative care in advanced dementia. Most people with advanced dementia live and die in institutional care and they suffer a range of burdensome symptoms and complications. Shortly before dying people with advanced dementia suffer symptoms as pain, eating problems, breathlessness, neuropsychiatric symptoms, and complications as respiratory or urinary infections and frequently experience burdensome transitions. Pharmacological and nonpharmacological interventions may reduce symptom burden. Sensitive observation and appropriate assessment tools enable health professionals to assess symptoms and needs and to evaluate interventions. Due to lack of decisional capacity, proxy decision making is often necessary. Advanced care planning is an opportunity establishing values and preferences and is associated with comfort and decrease of burdensome interventions. Family carers are important for people with advanced dementia they also experience distress and are in need for support. Recommendations refer to early integration of palliative care, recognizing signs of approaching death, symptom assessment and management, advanced care planning, person-centered care, continuity of care, and collaboration of health care providers.

The Semantics of Autonomy, the Pathos of Decision, and Dispositifs of Representation at the End of Life

This article examines the slightly changing legal and ethical situation in Germany around so called end-of-life-decisions. Representation plays the complex role here of a ‘dispositif’ in the Foucauldian sense. Living wills first came into use 40 years ago: a very personal choice (how do I want to die?) could now be transferred to a proxy decision-maker. Some years later, various forms of presumed agreement gained acceptance, and today even merely hypothetical consent has become conceivable. Representation increasingly ceases to be representational at all. At the same time, concepts from Civil Law (Autonomy, Decision) have finally absorbed an older way of thinking that was based in Criminal Law. Beyond a biopolitical shift, according to the author’s thesis, these changes also correspond to a juridical shift.

End-of-life communication in advanced cancer: international trends (2009–2014)

ObjectiveTo examine trends in end-of-life communication with people with cancer in general practice.MethodsMortality follow-back survey among general practitioners (GPs) in representative epidemiological surveillance networks in Belgium (BE), the Netherlands (NL)...

Study on advance care planning in care dependent community-dwelling older persons in Germany (STADPLAN): protocol of a cluster-randomised controlled trial

BackgroundIn Germany, advance care planning (ACP) was first introduced by law in 2015. However, ACP is still uncommon in Germany and only few people have advance directive forms. This study aims to evaluate an ACP program in care dependent community-dwelling persons, compared to optimised usual care.MethodsA cluster-randomised controlled trial of 12 months duration will be conducted in 3 German study sites comparing the pretested ACP-counselling offered by trained nurses with a control group receiving optimised usual care. Using external concealed randomisation, 16 home care services each will be included in the intervention and the control group (30 participants per cluster; n = 960). Eligibility criteria for patients are: ≥60 years, somehow care dependent, adequate German language skills, assumed life-expectancy of ≥4 weeks, and cognitive ability for participation.ACP will be delivered by trained nurse facilitators of the respective home care services and communication will include proxy decision-makers. The primary endpoint will be patient activation, assessed by the Patient Activation Measure (PAM-13). Secondary endpoints include ACP-engagement, proportion of prepared advance directives, number and duration of hospitalisations, quality of life as well as depression and anxiety. Further, comprehensive economic and process evaluations will be conducted.DiscussionSTADPLAN is the first study in Germany that assesses an adapted ACP intervention with trained nurses in home care services and the first international study focusing on cost effectiveness of ACP in community-dwelling older persons. The results will help to improve the understanding and communicating of patients’ preferences regarding medical treatment and care and thereby contribute to patients’ autonomy.Trial registrationGerman Clinical Trials Register: DRKS00016886 (Date of registration: 04.06.2019).