Interventions for interpersonal communication about end of life care between health practitioners and affected people (Protocol)

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the e&ects of interventions designed to improve verbal interpersonal communication about EoL care between health practitioners and people a&ected by EoL. Interventions for interpersonal communication about end of life care between health practitioners and a ected people (Protocol) Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 1 Cochrane Library Trusted evidence. Informed decisions. Better health. Cochrane Database of Systematic Reviews


B A C K G R O U N D Description of the condition
Discussion about end of life (EoL) between health practitioners and a ected people can be a confronting experience for all parties involved.According to the Australian Medical Association, "Death, dying and bereavement are all an integral part of life; however, reflecting on, and discussing death, can be profoundly confronting and di icult.Open and frank discussion of death and dying including EoL care options, approach to futile treatment, caring and bereavement should be encouraged within the profession and in the wider community" (AMA 2014).EoL and EoL care can be defined in many di erent ways.For this review, we have adopted the following definitions, developed as part of a recent national (Australian) consensus statement on end of life care.
• End of life: "the period when a patient is living with, and impaired by, a fatal condition, even if the trajectory is ambiguous or unknown.This period may be years in the case of patients with chronic or malignant disease, or very brief in the case of patients who su er acute and unexpected illnesses or events, such as sepsis, stroke or trauma" (ACSQHC 2015, p. 33).• End of life care: "includes physical, spiritual and psychosocial assessment, and care and treatment delivered by health professionals and ancillary sta .It also includes support of families and carers, and care of the patient's body a er their death.People are 'approaching the end of life' when they are likely to die within the next 12 months.This includes people whose death is imminent (expected within a few hours or days) and those with: * advanced, progressive, incurable conditions; * general frailty and co-existing conditions that mean that they are expected to die within 12 months; * existing conditions, if they are at risk of dying from a sudden acute crisis in their condition; and * life-threatening acute conditions caused by sudden catastrophic events" (ACSQHC 2015, p. 33).
People involved in communication with health practitioners about EoL and EoL care may include the person at EoL and the family or carers of that person.Each of these people may have an important role in discussions about EoL care.For the purpose of this review, we need to define these di erent people in a way that is not ambiguous, given the multiplicity of terms that are used in di erent health systems for all parties.Further, although the term 'patient' is not always suitable for someone who may o en not be in a patient role, we needed to distinguish the person at EoL from that person's family member or carer.We therefore define a ected people as follows.
• Patient: identified as "the primary recipient of care" (ACSQHC 2015, p. 34).In many health systems and countries, terms other than 'patient' are preferred.However, in this review we use this term to distinguish clearly between people who are approaching the end of their life, or dying (and to whom discussions about prognosis, treatment, and care relate directly), and people to whom these discussions relate indirectly (i.e.discussions about EoL and EoL care related to a family member or person in whose care they are involved).• Family: this review takes the broadest possible view of family members, considered to represent "those who are closest to the patient in knowledge, care and a ection.This may include the biological family, the family of acquisition (related by marriage or contract), and the family and friends of choice" (ACSQHC 2015, p. 33).needs or concerns associated with administrative paperwork, formal documentation, dying or the choice for assisted dying (for jurisdictions where relevant); and death.The intervention may be tailored towards an individual or a small group, as long as the group includes patients and their family members or carers.

Description of the intervention
We will consider the full range of EoL communication interventions identified as eligible for this review, and their dispersion and application across studies may vary.The needs and circumstances of the people involved will be complex and highly varied.Accordingly, the elements of EoL and EoL care to be discussed will be tailored to specific EoL contexts.

How the intervention might work
Interventions to improve EoL verbal communication aim to provide more e ective general communication between practitioners and the people directly a ected by EoL and EoL care.Previous reviews have confirmed the highly complex and varied scope of EoL experiences and support the need for the study intervention to be fully described and to include EoL context, details of what the intervention entails, and related primary patient outcomes (Fawole 2012; Walczak 2016). We

O B J E C T I V E S
To assess the e ects of interventions designed to improve verbal interpersonal communication about EoL care between health practitioners and people a ected by EoL.

Types of studies
We will include randomised and cluster-randomised controlled trials (RCTs) and quasi-RCTs that evaluate the e ects of interventions intended to enhance communication between health practitioners and patients and families or carers about EoL care.We expect to find a limited number of RCTs on this topic and therefore plan to include quasi-RCTs (defined as trials attempting, but not achieving, random allocation of participants).

Types of participants
We will include the following participants.
• Patients with a life-limiting illness who are expected to die within 12 months (ACSQHC 2015).• Patients with cancer, end-stage pulmonary disease, end-stage cardiac failure, end-stage renal failure, motor neuron disease, or other chronic conditions (e.g.dementia), as reported in the study.
• Patients with a life-threatening acute condition caused by sudden catastrophic events (ACSQHC 2015).• Vulnerable groups of patients with a life-limiting illness, as reported in the study.For example, patients could be in a third world setting in which EoL is not explicitly defined.In such cases, researchers may use terms such as 'dying' and 'death', which can be used to identify the study as relevant.• Patients of any age from birth who meet one of the criteria listed above.
We will also include family or carers of a patient with a life-limiting illness, as defined by the study.We define family as "biological, family of acquisition (related by marriage or contract) and the family and friends of choice" (ACSQHC 2015, p. 33).We define a carer as "a person providing personal care, support and assistance for the patient with a life-limiting illness" (ACSQHC 2015, p. 32).
We will not exclude studies based on the setting of the communication or the person delivering the communication, although the communication must involve a health practitioner.We define health practitioners to be included in this review as follows.

Interventions for interpersonal communication about end of life care between health practitioners and a ected people (Protocol)
Copyright © 2018 The Cochrane Collaboration.Published by John Wiley & Sons, Ltd.

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Cochrane Database of Systematic Reviews
• Healthcare professionals may include doctors, nurses, midwives, allied health practitioners, social workers, and government healthcare workers.• The professional population could be identified as the healthcare team, the interdisciplinary team, or a group of healthcare providers, as reported in the study.• We may include lay health workers, who are not health practitioners as such but who are educated/trained to deliver the intervention (e.g. may be applicable in resource-poor/lowand middle-income country settings or within a specific cultural context to promote cultural safety).• We may include other community providers or volunteers, as reported in the study.

Types of interventions
We will include any interventions provided to promote or improve interpersonal communication between health practitioners and people a ected by EoL care versus usual care.We will also include comparisons of one form of communication intervention versus another.
The communication may focus on any aspect of EoL or EoL care, including the following.
• Knowledge of what might happen around the disease and what a possible disease trajectory might be for the patient (prognosis).• Understanding of the possibilities for treatment, pain management, symptom management, and treatment or care to relieve su ering.• Preferences for care and/or treatment (e.g.resuscitation, feeding), including wishes regarding the location of living until dying.• Needs or concerns related to supportive, spiritual, cultural, or palliative care.• Needs or concerns related to the role of the family or carer, including support for family members/carers.• Needs or concerns associated with administrative paperwork, formal documentation, and dying or the choice for assisted dying (for jurisdictions where relevant).
The intervention must involve interpersonal interaction between health practitioner(s) and the patient, family, and/or carers.We will include videoconferencing, remote video links, or Internet-enabled discussions only if the parties involved cannot be located physically together (e.g. in the case of patients living in rural, remote, or underserved areas).
The communication intervention might include one or more of the following aims: to inform or educate, support, skill, engage, or seek the participation of patients and their families and carers in a communication episode with professionals around EoL care.Interventions could be simple or complex; we will include interventions as long as the e ects of the communication element of any complex intervention can be isolated by inclusion of an appropriate comparison group.
We will exclude the following studies.
• Studies focusing on specific decisions -shared or otherwise.This review will focus on general communication between health practitioners and patients and their family members and carers.Such communication may be viewed as a necessary and fundamental precursor to more specific decisions about treatment and other choices, which may o en involve highly structured or specific communication tools (as described above).• Studies focusing on development or completion of an ACP or AD for which uptake or completion is the primary outcome.

Primary outcomes
Patient, family, and/or carer (a ected persons) outcomes

Adverse outcomes
• Any adverse outcomes or harms identified in the included studies.* These might include any negative e ects on the primary outcomes listed above.

Secondary outcomes
• Health practitioner knowledge and understanding of patient/ family/carer knowledge, wishes, or preferences.• Health practitioner evaluation of his or her communication performance, the overall communication encounter, or selfconfidence or preparedness to communicate.• Patient/family member/carer quality of life.

Health systems impacts relevant to the impacts of communication
• Costs of subsequent care.
• Hospital admissions and re-admissions (e.g.hospital bed days, intensive care unit (ICU) admissions).• Quality of EoL care (family/carer rated, practitioner rated).
• Ratings of concordance with patient preferences for EoL care.
We will not exclude studies that are otherwise eligible based on the outcomes reported, except for the situation described above, Cochrane Database of Systematic Reviews in which the intervention focuses on ACP/AD and the primary outcome sought is uptake or completion.

Main outcomes for the 'Summary of findings' tables
We will report the following outcomes.satisfaction, calmness or confidence about ability to manage the future, preparedness to plan for the future).• Evaluation of the communication -negative constructs (e.g.fear, anxiety, distress).

Adverse events
• These will be reported as any negative changes in the above outcomes associated with the intervention.
We will report findings for each of the primary outcomes in the 'Summary of findings' tables.
If multiple outcomes are reported in a given outcome category, we will collect information on all relevant outcomes.However, if the same outcome is assessed by two or more outcome measures in the same trial, two review authors will: • select the primary outcome measure that has been identified by the publication authors; • select the one specified in the sample size calculation when no primary outcome measure has been identified; and • rank e ect estimates (i.e.list them in order from largest to smallest) and select the median e ect estimate if no sample size calculations are reported.* When an even number of outcome measures is reported, the outcome measure whose e ect estimate is ranked n/2, where n is the number of outcome measures, will be selected.

Electronic searches
We will search the following electronic databases.
• Cochrane Central Register of Controlled Trials (CENTRAL; latest issue) in the Cochrane Library.• MEDLINE (OvidSP) (inception to present).
We will present the strategy for MEDLINE (OvidSP) in Appendix 1.
We will tailor strategies to other databases and report them in the review.
We will apply no language nor date restrictions.

Searching other resources
We will contact experts in the field and authors of included studies for advice as to other relevant studies.We will also search reference lists of relevant studies.We will search grey literature sources including World Wide Hospice Palliative Care Alliance, TROVE, ProQuest Dissertations & Theses, British Library Electronic Theses Online Service (EThOS), and the Networked Digital Library of Theses and Dissertations (NDLTD).We will search clinicaltrials.govto identify any relevant trials.

Selection of studies
Two review authors will independently screen all titles and abstracts identified through searches to determine which meet the inclusion criteria.We will retrieve in full text any papers identified as potentially relevant by at least one review author.Two review authors will independently screen full-text articles for inclusion or exclusion and will resolve discrepancies by discussion and by consultation with a third review author if necessary to reach consensus.We will list all potentially relevant papers excluded from the review at this stage as excluded studies and will provide reasons for exclusion in the 'Characteristics of excluded studies' table.We will also provide citation details and any available information about ongoing studies and will collate and report details of duplicate publications, so that each study (rather than each report) is the unit of interest in the review.We will report the screening and selection process in an adapted PRISMA flow chart (Liberati 2009).

Data extraction and management
Two review authors will extract data independently from included studies.We will resolve any discrepancies by discussion until consensus is reached, or through consultation with a third review author when necessary.We will develop and pilot a data extraction form using the Cochrane Consumers and Communication Group (CCCG) Data Extraction Template (available at http://cccrg.cochrane.org/author-resources).Data to be extracted will include the following items: details of the study (aim of intervention, study design, description of the intervention and the comparison group, outcomes, and data).One review author will enter all extracted data into RevMan (Review Manager 2014), and a second review author working independently will check the data for accuracy against the data extraction sheets.

Assessment of risk of bias in included studies
We will assess and report on the methodological risk of bias of included studies in accordance with the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011), as well as the guidelines of the Cochrane Consumers and Communication Review Group (Ryan 2013), which recommend explicit reporting of the following individual elements for RCTs: random sequence generation; allocation sequence concealment; blinding of participants and personnel; blinding of outcome assessment; completeness of outcome data; selective outcome reporting; and other sources of bias (baseline imbalances).We will consider blinding separately for di erent outcomes when appropriate (e.g.blinding may have the potential to di erently a ect subjective vs objective outcome measures).We will judge each item as being at high, low, or unclear risk of bias as set out in the criteria provided by Higgins 2011, and we will provide a quote from the study report and a justification for our judgement for each item in the risk of bias table.
Cochrane Database of Systematic Reviews We will judge studies to be at highest risk of bias if they are scored as at high or unclear risk of bias for either the sequence generation or the allocation concealment domain, based on growing empirical evidence that these factors are particularly important potential sources of bias (Higgins 2011).
In all cases, two review authors will independently assess the risk of bias of included studies and will resolve disagreements by discussion to reach consensus.We will contact study authors for additional information about the included studies, or for clarification of study methods as required.We will incorporate results of the risk of bias assessment into the review through standard tables and systematic narrative description and commentary about each of the elements, leading to an overall assessment of the risk of bias of included studies and a judgement about the internal validity of results of the review.
We will assess and report quasi-RCTs as being at high risk of bias on the random sequence generation item of the risk of bias tool.
For cluster-RCTs, we will also assess and report the risk of bias associated with an additional domain: selective recruitment of cluster participants.

Measures of treatment e ect
For dichotomous outcomes, we will analyse data based on the number of events and the number of people assessed in the intervention and comparison groups.We will use these numbers to calculate the risk ratio (RR) and the 95% confidence interval (CI).
For continuous measures, we will analyse data based on the mean, the standard deviation (SD), and the number of people assessed for both intervention and comparison groups to calculate the mean di erence (MD) and 95% CI.If the MD is reported without individual group data, we will use this information to report the study results.
If more than one study measures the same outcome using di erent tools, we will calculate the standardised mean di erence (SMD) and the 95% CI using the inverse variance method in Review Manager 5.

Unit of analysis issues
If cluster-RCTs are included, we will check for unit of analysis errors.If we find errors and su icient information is available, we will re-analyse the data using the appropriate unit of analysis, by taking account of the intracluster correlation (ICC).We will obtain estimates of the ICC by contacting authors of included studies, or we will impute them using estimates from external sources.If it is not possible to obtain su icient information to re-analyse the data, we will report e ect estimates and will annotate the unit of analysis error.

Dealing with missing data
We will attempt to contact study authors to obtain missing data (participant, outcome, or summary data).For participant data, we will, when possible, conduct analysis on an intention-to-treat basis; otherwise we will analyse data as reported.We will report on the levels of loss to follow-up and will assess this as a source of potential bias.
For missing outcome or summary data, we will impute missing data when possible and will report any assumptions in the review.We will investigate, through sensitivity analyses, the e ects of any imputed data on pooled e ect estimates.

Assessment of heterogeneity
When we consider studies similar enough (based on consideration of populations, interventions, or other factors) to allow pooling of data using meta-analysis, we will assess the degree of heterogeneity by visually inspecting forest plots and by examining the Chi test for heterogeneity.We will quantify heterogeneity by using the I statistic.We will consider an I value of 50% or more to represent substantial levels of heterogeneity, but we will interpret this value in the light of size and direction of e ects and strength of the evidence for heterogeneity, based on the P value derived from the Chi test (Higgins 2011).
When we detect substantial clinical, methodological, or statistical heterogeneity across included studies, we will not report pooled results from meta-analysis but will instead use a narrative approach to data synthesis.In this event, we will attempt to explore possible clinical or methodological reasons for this variation by grouping studies that are similar in terms of populations, intervention features, methodological features, or other factors to explore di erences in intervention e ects.

Assessment of reporting biases
We will assess reporting bias qualitatively based on the characteristics of included studies (e.g. if only small studies that indicate positive findings are identified for inclusion); we will do this if information that we obtain upon contacting experts and study authors or studies suggests that there are relevant unpublished studies.
If we identify su icient studies (at least 10) for inclusion in the review, we will construct a funnel plot to investigate small-study e ects, which may indicate the presence of publication bias.We will formally test for funnel plot asymmetry, a er choosing the test based on advice provided in Higgins 2011, and bearing in mind when interpreting study results that there may be several reasons for funnel plot asymmetry.

Data synthesis
We will decide whether to meta-analyse data based on whether interventions in the included trials are similar enough in terms of participants, settings, interventions, comparisons, and outcome measures to ensure meaningful conclusions from a statistically pooled result.Owing to anticipated variability in populations and interventions, and possibly other factors, of included studies, we will use a random-e ects model for meta-analysis.
If we are unable to pool the data statistically using meta-analysis, we will prepare a narrative synthesis of results.We will present major outcomes and results, organised by intervention categories according to major types and/or aims of identified interventions, or by other factors that we identify as key to e ects of the interventions.Depending on the assembled research, we may also explore the possibility of organising the data by population.Within the data categories, we will explore the main comparisons of the review.
• Intervention versus usual care.
• One form of intervention versus another.
When studies compare more than one intervention, we will compare each intervention separately versus no intervention/ Cochrane Database of Systematic Reviews control and versus another.If we are unable to pool the data statistically using meta-analysis, we will group data based on the category that best explores the heterogeneity of studies and makes the most sense to the reader (e.g. by interventions, populations, or outcomes).Within each category, we will present the data in tables and will narratively summarise and synthesise the results.

Subgroup analysis and investigation of heterogeneity
We do not anticipate including enough studies with quantitative data to warrant subgroup analyses, but we will attempt to explore potential e ects of the following factors through systematic grouping of studies and narrative synthesis when possible.

Sensitivity analysis
We do not expect to include enough studies in any one pooled analysis to justify conducting sensitivity analyses.However if we identify su icient studies, we will consider removing those rated as having highest risk of bias from the analysis and examining e ects on the pooled e ect estimate.

'Summary of findings' table
We will prepare a 'Summary of findings' table to present results for the main outcomes, based on the methods described in Chapter 11 of the Cochrane Handbook for Systematic Reviews of Interventions (Schünemann 2011).We will present the results of analysis for major comparisons of the review, for each of the major primary outcomes, including potential harms, as outlined in the Types of outcome measures section.We will provide a source and rationale for each assumed risk cited in the table(s), and we will use the GRADE system to rank the quality of evidence using GRADEprofiler (GRADEpro) so ware (GRADEpro GDT; Schünemann 2011).If metaanalysis is not possible, we will present results in a narrative 'Summary of findings' table format.

Ensuring relevance to decisions in health care
One of the co-authors (JB) is a consumer representative for the Healthcare Consumers' Association of the Australian Capital Territory.She will have input to the protocol and will review it at all stages.
We also plan to consult more widely about the consumer perspective with consumer groups, industry, and/or government agencies.
Subject to funding, we will conduct a focus group/s to evaluate the relevance of findings for practice.Participants could include representatives from stakeholders with content expertise in EoL care/practice.
A consumer will provide feedback on the protocol and the review as part of standard CCCG editorial processes.
) Copyright © 2018 The Cochrane Collaboration.Published by John Wiley & Sons, Ltd.
Patient, family, and/or carer (a ected persons) outcomes • Knowledge and understanding about what might happen (prognosis), what to do, or options.• Evaluation of the communication -positive constructs (e.g. • Carer: "a person who provides personal care, support and assistance to another individual who needs it because they have a disability, medical condition (including a terminal or chronic illness) or mental illness, or they are frail and aged.An individual is not a carer merely because they are a spouse, de facto partner, parent, child, other relative or guardian of an individual, or live with an individual who requires care" (ACSQHC 2015, p. 32).
(Barnes 2012lly, a large body of research is documenting di iculties noted in EoL communication between healthcare professionals and people a ected by EoL (i.e.patients, their families and carers) (Clayton 2007a; Fawole 2012; IoM 2014; NICE 2017; Walczak 2016).These di iculties include failure to communicate adequately with the person who is dying about his or her prognosis (Barnes 2006; Fawole 2012; Gott 2009; NICE 2017), or to provide understandable information on what the future holds and decisions that the person and family members and carers may need to make (Alsakson 2012; Anselm 2005; Barnes 2012; Gutierrez 2012; Selman 2007).It is also documented that EoL patients, or those closest to them, may not be given the opportunity to ask questions or to check their understanding of information that has been provided (Alsakson 2012; Clayton 2007a; Gutierrez 2012).People o en have misunderstandings about their prognosis and goals of treatment in the EoL period (Clayton 2007a; Gattellari 1999; Weeks 1998).Misunderstandings may also arise from conflicting information given by multiple practitioners involved in the patient's care.Additionally, the patient and family members or carers may have their own questions about EoL care but may be unaware of how or whom they should approach to find answers to these questions (Alsakson 2012; Anselm 2005; Gutierrez 2012; NICE 2017).Communicating e ectively about EoL is a di icult and complex task that is further complicated by uncertainty about the trajectory of the last stages of a person's life(Barnes 2012; Fawole 2012).
needs or concerns related to supportive, spiritual, cultural, or palliative care; needs or concerns related to the role of the family or carer, including support for family members/carers; EoL discussions are not limited to a specific healthcare setting, so it is important that this review is inclusive of EoL communication interventions applied irrespective of national, geographical, cultural, social, wealth, and healthcare access boundaries.Such diverse EoL experiences could be related to gender, ethnicity, race, religion, culture, refugee status, indigenous peoples, gender diversity, disability, socioeconomic status, education, poverty, and populations in lowand middle-income countries (Welch 2010).For this reason, this review will consider inequality and inequity issues as they relate to EoL communication interventions (Welch 2010).
To inform how EoL communication can be improved in future practice, one must gain an understanding of the e ectiveness of communication interventions in the EoL context and the impact these interventions can have on measurable outcomes for patients, families, and carers.The findings of this review should prove important in this endeavour.Improved and more e ective communication between health practitioners and people a ected by EoL has the potential to help practitioners address gaps in care, improve outcomes such as distress and poor quality of life associated with poor communication, and lay groundwork that will allow patients and others a ected by EoL events to participate in decisions about treatment and care.
(Oczkowski 2016the content of the EoL communication intervention above.Practitioners could use a variety of modalities to deliver the intervention and to guide or influence the discussion about EoL or EoL care.Examples could include prompts for patients to promote or guide discussions about EoL care (Clayton 2007b; Walczak 2017); web-based collaboration tools to facilitate communication between practitioners and people a ected by EoL (Voruganti 2017; Walczak 2016); nurse-led discussions about EoL care (Sulmasy 2017); or EoL family meetings (Agar 2017; Walczak 2016).Outcomes chosen to measure e ects of the interventions could reflect changes in the level of communication occurring (e.g.increasing the frequency and/or length of discussions between practitioners and patients and a ected people), improved structure of the communication taking place (e.g.providing prompts to assist patients, family members, and carers to ensure that key questions are raised with practitioners, thereby improving knowledge and understanding about EoL care), or specific outcomes related to patient's/a ected people's EoL care experiences and their experiences of the communication around EoL.Why it is important to do this reviewGeneral EoL communication guidelines are already available.For example, in 2007, Medical Journal of Australia published a supplement titled "Clinical practice guidelines for communicating prognosis and end of life issues with adults in the advance stages A systematic review and meta-analysis undertaken by Oczkowski in 2016 examined communication tools for EoL decision-making in ambulatory care settings(Oczkowski 2016).The Oczkowski review was focused on EoL decision-making and advance care planning and concluded that use of structured communication tools should be the preferred approach to EoL decision-making conversations(Oczkowski 2016).An existing Cochrane protocol -"Advance care planning for haemodialysis patients" -also has an indirect link with this review (Lim 2016).The current review will include discussions on the topic of advance care planning, but only when these conversations are taking place in the last 12 months of life, and only when uptake of advance care planning (ACP) or advance directives (AD) is not the primary goal of the study.Other Cochrane reviews -Chan 2016, "End-of-life care pathways for improving outcomes in caring for the dying"; Moore 2013, "Communication skills training for healthcare professionals working with people who have cancer"; and Shepperd 2016, "Hospital at home: home based end of life care" -have addressed issues related to EoL, but they have not addressed the interventions to improve communication that will be explored in this current review.

Interventions for interpersonal communication about end of life care between health practitioners and a ected people (Protocol)
Copyright © 2018 The Cochrane Collaboration.Published by John Wiley & Sons, Ltd.

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Type of EoL care: groupings might include palliative care, acute (emergency) care, and others.The rationale for considering e ects separately in such (or similar) groupings is that communication needs, opportunities to communicate, and information and decisions needed are likely very di erent across such di erent types of EoL care.• Type and/or aim of intervention: groupings might include those to inform and educate, those to support communication, and those to promote communication or decision-making skills.The rationale for separately considering these groupings is that interventions with di erent purposes have di erent underlying mechanisms of action.