# INTENDED PURPOSE
To summarize the available evidence regarding provider tools for ACP or GoCD.

# INTENDED USERS
Healthcare providers who engage in ACP or GoCD with their patients or should engage in ACP or GoCD with their patients and administrators who wish to provide ACP or GoCD training to providers within their institution.
This evidence summary was developed by a Working Group, consisting of three family physicians that have an interest in palliative care and who hold palliative care positions within their communities, one family physician who practices comprehensive family medicine, one family physician with clinical focus areas in both emergency and hospitalist medicine, one clinician engagement lead, and one health research methodologist, at the request of CCO"s former Palliative Care Program.
The Working Group was responsible for reviewing the identified evidence and drafting the summary. Conflict of interest declarations for all authors are summarized in Appendix 1, and were managed in accordance with the PEBC Conflict of Interest Policy.
This evidence review was conducted in two planned stages, including a search for systematic reviews followed by a search for primary literature. These stages are described in subsequent sections.

# Search for Existing Guidelines and Systematic Reviews
A search was conducted for existing guidelines and systematic reviews from 2010 onwards. The MEDLINE (2010 to June 2015) and EMBASE (2010 to week 26,2015) databases were searched using the literature search strategy found in Appendices 2 and 3. Guidelines and systematic reviews were included if they were published in English, were directly related to one or more of the guideline questions, and reported at least one outcome of interest.
Identified systematic reviews were evaluated based on their clinical content and relevance. Relevant systematic reviews were assessed using the 11-item Assessment of Multiple Systematic Reviews (AMSTAR)  tool to determine whether or not existing systematic reviews met a minimum threshold for methodological quality and could be considered for inclusion in the evidence base.

# Search for Primary Literature
A search strategy was developed and implemented that captured the primary literature in the following databases: MEDLINE, EMBASE, and American Society for Clinical Oncology (ASCO) Palliative Care Symposium meeting abstracts.

# Literature Search Strategy
The MEDLINE (1998 to September 2015) and EMBASE (1998 to week 37, 2015) databases were searched using the literature search strategies found in Appendix 4. In addition, ASCO Palliative Care Symposium for 2014 and 2015 were also searched using the following terms: advance care planning or ACP, goals of care or GoC, advance directives or AD, terminal care, and patient care planning. Reference lists of included studies were also searched.

# Study Selection Criteria and Process Inclusion Criteria
- English language  Patients living with chronic illnesses and/or their substitute decision makers OR simulated patients  Healthcare provider tools (as opposed to patient tools)  Includes at least one outcome of interest (see Appendix 5)  Comparative data (randomized trials, cohort, case-controlled, historically controlled trials, etc.) if available  Non-comparative data  Minimum study size of 30 patients

# Exclusion Criteria
- Case studies, commentaries, editorials A review of the titles and abstracts that resulted from the search was conducted independently by one reviewer (RC). For items that warranted full-text review, one reviewer (RC) reviewed each item independently. However, if there was any uncertainty regarding a particular paper, the Working Group was consulted.

# Data Extraction and Assessment of Study Quality and Potential for Bias
Data from the included studies were extracted by one member of the Working Group (RC). All extracted data and information were audited by an independent auditor.
Randomized controlled trials (RCTs) were assessed using the Cochrane Risk of Bias tool (chapter 8.5) (/) and all non-RCTs were assessed using the Cochrane Risk Of Bias In Non-Randomized Studies -of Interventions (ROBINS-I) tool (/).

# Synthesizing the Evidence
Meta-analysis was not planned as the studies included in this systematic review were quite varied and included some non-comparative data.

# Search for Existing Guidelines and Systematic Reviews
A search for guidelines uncovered 1701 documents. Of these, 82 papers (73 adult and nine pediatric) underwent full-text review. No adult guidelines were retained and one pediatric guideline was retained.
A search for systematic reviews yielded 824 documents. Of these, 55 papers (47 adult and eight pediatric) underwent full-text review. No adult systematic reviews were retained and one pediatric systematic review was retained.

# Search for Primary Literature
A search for primary literature was conducted for all guideline questions.

# Literature Search Results
A search for primary studies yielded 31,105 documents. Of these, 353 (313 adult and 40 pediatric) underwent full text-review. From this, 34 adult studies represented by 36 papers and three pediatric primary studies represented by four papers were retained. In addition, the abstracts from the 2014 and 2015 ASCO Palliative Care in Oncology symposia were searched, resulting in the retention of one abstract of adult ACP. A search of the reference lists of included studies led to the inclusion of a further seven adult studies. For a summary of the full literature search results (including guidelines and systematic reviews), please refer to Figure 1, which is a flow diagram depicting the inclusion and exclusion of all studies for this evidence document. A summary of all included studies can be found in Table 1.
Of the 42 included adult primary studies, 10 were RCTs, seven were pre/post designs and four were controlled trials. There were three studies each of the following types of designs: repeated measures, qualitative, chart reviews, and non-comparative studies. There was one or two each of various other study types including one systematic review, which was identified from the search for primary studies and not the search for systematic reviews. Of the three included pediatric primary studies, one was a RCT, one was a survey, and one was a chart review.  

# ADULT STUDIES
Boettcher 2015  Respecting Choices Repeated Measures Davis 2015  Conversation Project Qualitative Evaluation Hickman 2015  POLST Systematic Review Kadlec 2015  Practice Support Program -EOL Module Repeated Measures Detering 2014  Next Steps Pre/Post Study Paladino 2014  abstract Serious Illness Conversation Guide Cluster RCT Pecanac 2014  Respecting Choices Chart Review Slort 2014a  ACA Controlled Trial Slort 2014b  ACA Controlled Trial Wheeler 2014  Foundation in EOL/Palliative Care Pre/Post Study Wilson 2014  HCM Non-comparative Abel 2013  Planning Ahead Retrospective Cohort Levi 2013  MYWK Qualitative Evaluation Millington-Sanders 2013  Coordinate My Care Non-comparative Slort 2013  ACA Controlled Trial Wilson 2013  EpicCare HER Chart Review Au 2012  NA Cluster-RCT Clayton 2012  PREPARED Pre/Post Study Colville 2012  NA Descriptive Qualitative Study Green 2011  MYWK RCT Resnick 2011  NA Survey Detering 2010  Respecting Choices RCT Hammes 2010  Respecting Choices Chart Review Kirchhoff 2010/2012  PC-ACP RCT Szmuilowicz 2010  NA RCT Newton 2009  Preferred 

# Study Design and Quality
Various study designs are included in this guidance document. All systematic reviews were assessed using AMSTAR  (see Table 2). Randomized controlled trials were assessed using the Cochrane Risk of Bias tool (chapter 8.5) (/) (see Table 3) and all non-RCTs were assessed using Risk Of Bias In Non-Randomized Studies -of Interventions (ROBINS-I) tool (/) (see Table 4).
No suitable guideline was identified.

# Systematic Reviews
All systematic reviews used in this guidance document were assessed using the AMSTAR tool. Both systematic reviews provided an a priori design, conducted duplicate study selection and data extraction, performed a comprehensive literature search, provided the characteristics of each included study, combined the findings of the included studies appropriately (e.g., by not combining), and provided conflict of interest statements. (Table 2). 

# Randomized Controlled Trials
Eleven RCTs reported in 14 papers 39,40,44,47,48,50,51] were included in this guidance document and were assessed using Cochrane"s Risk of Bias tool (chapter 8.5) (/) (Table 3). Paladino et al.  was only available in abstract form; therefore, risk of bias was unclear because the needed information was not available in the abstract. Six other trials  had overall high risks of bias owing to several items being rated as either high risk of bias or unclear risk of bias. Unclear risk of bias may only be a reporting issue; however, it is impossible to know. This tool assesses each trial on seven domains of bias (Table 4) as well as an overall assessment of risk of bias. Almost all of the studies 24,25,27,32,45,46,49,53] had a moderate risk of bias, three studies had low risk of bias and five studies had a serious risk of bias. 

# Initiating and Facilitating ACP or GoCD Adult Studies
No clear distinction has been made between clinical tools that either introduce or facilitate both ACP and GoCDs and, as such, these two search criteria were combined.
The ACP provider tool most often encountered in the literature is Respecting Choices or tools based on the Respecting Choices program (e.g., patient-centred ACP, Honoring Choices Minnesota) (see Table 5). A key feature of this program is the use of trained facilitators for the ACP process. All studies addressing the Respecting Choices program describe various patient outcomes. In general, exposure to a Respecting Choices type of intervention, compared with controls, can result in: increased AD completion ; increased appointment of a surrogate ; more involvement in EOL decisions ; increased consistency between patient wishes and medical interventions undertaken at EOL ; increased patient and surrogate satisfaction with care received ; increased ACP knowledge ; fewer symptoms of anxiety and depression in family members of decedents ; decreased decisional conflict ; and increased consistency between wishes of patients and their surrogates. Only one study described provider outcomes. This study reported that case managers trained and certified by Respecting Choices demonstrated increased motivation, confidence, preparedness, and skill in facilitating ACP discussions at three months post-training compared with immediately after training. However, no p-values are reported.
Although there are different views on its relationship with GoCD, a commonly used provider tool is the Physician Orders for Life Sustaining Treatment (POLST) form. POLST is a standardized form containing medical orders that reflect a patient"s treatment preferences. One recent systematic review of this tool that included 23 studies was identified. It may be prepared by a non-physician facilitator and then reviewed and signed by a physician. Healthcare providers report that POLST expresses patient preferences reliably, guides care, improves communication, and helps in initiating EOL care discussions. POLST has challenges as well including the following difficulties: explaining the form, obtaining physician signatures, and transferring the form between settings, as well as issues regarding the time needed to complete the form. Overall, it has been reported that there is high consistency between code status and treatment received by patients as well as between antibiotic use and wishes of patients. There is general consistency between artificial nutrition use and patient wishes. There are mixed results in terms of the consistency between the level of medical intervention requested and received by patients.
Three studies of the Availability, Current Issues and Anticipation (ACA) tool were identified. ACA training is an eight-step program that takes approximately six hours to complete over a six-month time period. Briefly, it is an iterative process of roleplaying and simulated patient interviews, followed by feedback and revision of learning goals. When tested in simulated and real palliative care patients, there were no significant differences between intervention and control groups on any of the outcomes measured (Table 5).
Two studies of the Making Your Wishes Known (MYWK) tools were identified. MYWK is an interactive, online decision aid to help adults complete an AD. Providers use the decision aid to facilitate ACP with older patients. Green et al.  compared the effectiveness of the MYWK tool with a standard ACP planning package in medical students learning to facilitate ACP discussion with patients. Each student helped an adult aged 50 years old engage in ACP discussions. Compared with controls, students in the MYWK intervention group had significantly higher confidence in engaging in ACP and intervention patient-participants were significantly more satisfied with their ACP planning method (Table 5).
There were also many one-off-type tools identified, some of which were named and others not. They all measured different and varied outcomes. In general, these various tools resulted in positive patient and provider outcomes (see Table 5 for more detail) including achieving preferred place of death when an ACP document is available.

# Pediatric Studies
Only a few pediatric ACP (pACP) studies were identified  (Table 5). Lyon et al.  compared the Family-Centered Advance Care Planning (FACE) intervention with a control group that received current standard of care in teens with cancer and their surrogates. This RCT included 17 intervention and 13 control dyads. FACE consists of three sessions: a survey that assesses the values, beliefs, and experiences with EOL care in patients and their surrogates; a Respecting Choices interview customized for adolescents; and completion of Five Wishes document (an AD document) customized for adolescents with a trained facilitator. Quality of communication was not different between groups. However, treatment preference congruence between control dyads was low for all scenarios tested whereas treatment preference congruence between intervention dyads was statistically significant for five of the six scenarios. Intervention adolescents thought they were significantly better informed regarding EOL decisions than did control adolescents (p=0.007). Moreover, intervention families all rated the three FACE sessions as worthwhile. Intervention adolescents had significantly lower depression scores at baseline and at the three-month follow-up compared with controls (p=0.0268). There were not significant differences in quality of life between intervention and control adolescents. More intervention than control adolescents completed ADs (100% vs. 0%).
A systematic review by Lotz et al.  uncovered only three pACP programs: FACE, Footprints, and Respecting Choices. A review of these interventions revealed that many people are supportive of ADs for children although parents report discomfort of emergency personnel with ADs for children. Parents and adolescents find pACP interventions helpful for ensuring good care, providing time for decision making, facilitating communication among caregivers, and in providing peace of mind. They also found that fears about increasing distress in patients undertaking pACP are unfounded. However, some families do have difficulties thinking about a dismal future (Table 5).
A survey conducted by Mitchell et al.  found that 58% of pediatric intensive care units (PICUs) in the United Kingdom use a pACP document. All such documents were developed locally.
Finally, Walter et al.
 evaluated prognostic, goals-of-care conversations (PGOCC) in a review of 645 charts of children in the top decile for risk of mortality upon admission to the PICU in a children"s hospital in Michigan. A documented PGOCC was found in 200 (31%) of charts. Patient characteristics significantly associated with a documented PGOCC were length of stay (p<0.001) and cancer diagnosis (p<0.001) (Table 5).  o No significant differences between the groups with respect to the mean number of ACA issues (current or anticipated) discussed. o Significant differences between the groups with respect to only 3 types of affective utterances. No other significant differences with respect to quality of communication   Computer generated reminders 2x2 factorial RCT  Comparison of computer-generated reminders to discuss one or both types of ADs vs. no reminders to increase AD discussions and completion in outpatients  

# Documenting ACP or GoCD Adult Studies
Evidence regarding the documentation of ACP or GoCD is sparse. Overall, storage of ACP documents is varied and inconsistent and the documents can be quite difficult to find even when they exist (Table 6). Wilson et al.  conducted a chart review to identify the location of ACP in the electronic health record (EHR) of patients at least 65 years old who were known to have an ACP document in their EHR. Most ACP, POLST, and ADs were not scanned into the EHR. Of those that were, they could be scanned, scanned and in progress notes, scanned and in the problem list, or all three. Patients had a mean of four scanned documents per year but the maximum was 231. Therefore, it was often extremely difficult to locate the ACP documents among them.
Colville et al. in a qualitative evaluation, demonstrate the need to document ACP plans such that all providers of care for a given patient have access to them. Resnick et al.  surveyed a sample of home, health, and hospice agencies in the USA and found that AD storage varied. Most ADs were stored with the patient"s record at the agency (94.4%), many were stored at the patient"s residence (48.8%), and a few were stored in a special AD file at the agency (3.3%).
Bricker et al.  describe the development of an AD documentation process within an electronic medical record (EMR). They cite three options for creating an electronic AD: scanning the existing AD into the EMR; dictating an AD note using the existing telephone transcription service; and typing the AD note directly into the EMR. In all cases, the AD note was then highlighted within the list of EMR documents for ease of access. Moreover, singlepage AD forms were developed for ease of completion and ease of scanning into the EMR. All personnel, from healthcare providers to transcriptionists, were made aware of this new system. The result was an increase in the number of completed electronic AD notes. A further benefit was that the patient preferences were accessible throughout the healthcare system.
Finally, Pauls et al.  describe a model for transferring ADs from a long-term care (LTC) facility to an emergency department (ED). The model consists of three parts: the form, completing the form, and using the form. The form itself is only one or two pages employing simple language and providing a choice of three or four levels of care from which to choose. In terms of form completion, LTC residents and their families were given education sessions regarding ACP and ADs as soon as they entered LTC. The forms are reviewed annually or when there have been changes in a patient"s health. The completion of the forms involves various healthcare providers and they are remunerated. With respect to using the forms, they are kept in an accessible and consistent location and are printed on coloured paper for ease of transferability to the ED via paramedics.

# Pediatric Studies
No pediatric studies regarding the documentation of ACP or GoCD were identified.

# Ongoing, Unpublished, or Incomplete Studies
None. NA Descriptive  Development of an AD documentation process within one healthcare system  Specifically developed an electronic AD note within the EMR  Developed short instructional video to increase patient understanding of the importance of ADs  3 options for creating electronic AD o Scan the existing AD document into the EMR o Dictate AD note using existing telephone transcription service o Type AD note directly into EMR  The AD note was then highlighted within the list of EMR documents for easy access  Single page forms developed for ease of completion of AD and for ease of scanning into EMR  Everyone in the system from healthcare providers to transcriptionists had to be aware of the new system  Number of completed electronic AD notes increased and continues to increase  Informal polling of healthcare providers indicates that they like that patient preferences are available throughout this healthcare system 
Recently, considerable attention has been given to the important role for ACP conversations and GoCD in decision making for patients not only in the setting of serious illness, but also when there is no illness. Currently, no consensus exists as to the tools or processes clinicians should use to inform or guide ACP and GoCD. The purpose of this evidence summary was to identify existing tools that could be used for each of these clinical encounters. The specific questions that shaped this review were intended to reflect the elements clinicians find particularly challenging, i.e., introducing, facilitating, and documenting both ACP and GoCD. Although a number of studies reported positive findings, there is a lack of consistent patient outcomes evidence to support any one clinical tool for use in either ACP or GoCD. However, despite this, the evidence points to important elements for clinicians to consider when reflecting on their practice around ACP and GoCD. Also, certain evidence emerged that is important for healthcare leaders and system planners to consider. Of note, no clear distinction has been made between clinical tools that either introduce or facilitate both ACP and GoCDs and, as such, these two search criteria were combined.
There are common challenges providers encounter in clinical practice relating to ACP and GoCD. There continues to be a lack of widespread agreement on the definitions of ACP and GoCD, their critical elements, and desired outcomes. For example, in some studies and in practice, ACP has been equated with determining a person"s resuscitation status, whereas others define it differently. This is problematic on several levels. However, for the purpose of this review, the lack of standard definitions prevents a unified approach to studying ACP and GoCD and contributes to great difficulty interpreting and comparing the findings among different studies. Improving a shared understanding of these concepts as described in this review is an essential step to establishing evidence for best practice. Similarly, consensus on outcomes are needed. The ideal ACP outcomes may include adequate understanding of the person"s health status by the patient and their SDM, and the SDM understanding the patient"s values, beliefs, and wishes as they relate to the patient"s healthcare. The ideal GoCD outcome would be that current healthcare decisions are informed by the person"s goals and values. This can occur at any point along the illness journey, but will always occur in relation to current, not future, healthcare decisions. Addressing these discrepancies will be beneficial for clinicians, for the development of tools and to guide evidence-informed best practices.
A second challenge in attempting to identify tools for clinicians is clarifying what might be considered appropriate tools for the contexts of introducing and facilitating these conversations. Additionally, different tools may be more or less effective for clinicians with varying expertise and competency in advanced communication skills, EOL communication skills, and values-based conversations. Finally, development and evaluation of tools must take into account the relationship of ACP and GoCD with regional laws on capacity, consent, and substituted decision making. It is important to note that tools structured for use by patients or caregivers without immediate clinical support were excluded from this review.
Finally, synthesizing evidence for ACP and GoCD is challenging owing to the nature of these two clinical encounters as each has inherent limitations to standardization. ACP is considered to be a process over time, which can lead to a lack of clarity and inconsistent practices around what could or what should be documented for any given clinical encounter. For GoCDs, there are different understandings of the expected outcomes or products of the clinical encounter and one standard approach has yet to be proposed or studied.
The majority of studies that met inclusion criteria address ACP-related processes (rather than GoCD), such as the occurrence of any kind of EOL conversation and documentation. Differences in the interpretations of the essential components of ACP are evident, with a key difference being the perceived importance of addressing specific treatments in the conversations. However, it is worth pointing out that the tool with the largest evidence base is Respecting Choices, which moves away from preferences for specific treatments and shifts toward a greater emphasis on patient values. Although this shift makes the desired outcome of the clinical interaction more challenging to capture, the evidence suggests values-based information is more likely to be help future SDMs than treatment-based or treatment-focused ACP conversations. Considering these emerging themes from the evidence suggests that tool development should focus on enabling healthcare providers to facilitate values-based discussions. Future studies with corresponding valuesbased outcome measures are needed to evaluate the impact on patient care.
Irrespective of how ACP effectiveness might be defined, the evidence suggests it is critical to think beyond singular ACP elements in order to meaningfully impact patient care. The evidence related to the Respecting Choices model outlines the high likelihood that a comprehensive, systematic approach to ACP is necessary. Ideal patient outcomes are unlikely to be achieved in the absence of broad systemic commitments to integrate and deliver ACP as part of routine care. A comprehensive approach to ACP includes community engagement, professional education, development of standard practices, monitoring of these practices through Quality Improvement initiatives, supporting policies and practices, and a technology infrastructures. This approach must be applied across public health and healthcare sectors to support the exchange of clinical information and will involve system-level coordination and planning. Addressing only one, or a few, of these elements creates the risks of leaving critical gaps that could prevent positive impacts on quality patient care.
The development of materials, clinical processes, and professional development experiences that improve communication skills, designed to enable clinicians to facilitate a discussion of a person"s values, must be embedded in a system-wide approach to ACP. Evidence from studies addressing the ACA tool serve as important examples of this. The associated education components of the intervention (i.e., simulation and direct feedback) are known to be highly effective from the perspectives of educational design and adult learning theory. However, high-quality education, although essential, on its own is unlikely to improve care or the patient experience in the absence of supporting systemic changes.
Important findings for the pediatric population mirror many of the early reports that address ACP in adults. The evidence outlines that, in general, children and their parents are supportive of ACP and find these discussions helpful to ensure good care, to facilitate communication among caregivers, and to provide peace of mind. Concerns that ACP discussions will cause distress in children and parents are not supported by the evidence. However, parents are aware of discomfort among clinicians attempting to navigate ACP discussions. This is an important area for further exploration and discovery.
Very few studies specifically address GoCDs and in large part this is likely due to GoCDs having been added to the healthcare lexicon relatively recently. There is a resultant lack of patient outcome evidence and many problematic elements in the research findings. These include a lack of widespread agreement on the expected outcomes, general approach, and components of GoCD. Detailed information regarding the specific clinical interaction was notably absent from studies involving the GoCD. Exploring the elements of GoCD that could be amenable to standardization would uncover important clinician tool-related information.
One specific element of the GoCD on which practices differ among clinicians is the perceived relationship with decision making. This ranges from considering GoCD to be separate and distinct from decision-making discussions to considering the two to be one and the same. These differing perspectives may parallel differences in how the POLST is viewed in relation to the GoCD. Some clinicians would likely view the POLST as a tool for use during the GoCD whereas others would not. For the purpose of this evidence review, we include POLST studies with the caveat that this not be considered endorsement for its use as a GoCD or ACP tool. We have chosen to include the POLST to highlight this challenge and enable further discussion.
It should be highlighted that the Ontario legal context should preclude the widespread use of tools like the POLST for ACP conversations. Regional variation exists with regard to the completion of orders sets in advance of receiving healthcare. Practitioners should be familiar with their regional laws surrounding consent, capacity, and healthcare decision making. In Ontario, direction and decision making for a person"s current care must come from a capable person (either the patient or their SDM if the patient is not capable), not a previously completed order set. In cases where the patient has been found incapable for a current decision, the SDM will rely on applicable previously expressed wishes or the person"s values. This underscores the importance of ACP conversations as preparation of the SDM for many eventualities of future decision making.
The involvement of interprofessional healthcare providers was identified as an important element of the ACP process in a number of positive studies. The shift toward emphasizing patient values in the ACP context has expanded the facilitation of such discussions to include non-physician providers. The Respecting Choices model demonstrates how the training of interested and willing clinicians, regardless of profession, may be a critical strategy for impacting patient outcomes. An example for GoCDs is the role of clinical nurse specialists and the communication skills they bring to the patient experience. Implementation of ACP as an interprofessional practice is an important consideration in addressing the concern of many physicians about not having adequate time for these discussions.
- Outcome evidence for ACP suggests the greatest impact is likely to be made by a system-wide approach to integrating ACP into practice, one that maximizes clinical skills of all interprofessional team members.  What is likely to be of greatest value for the GoCD context is to achieve widespread agreement on the specific outcomes that should be expected?  The most important patient-related outcome of any future planning or current care decision-making process is a patient receives the care that is wished for or desired.  Inconsistencies in definitions and desired outcomes for both ACP and GoCD need to be addressed to enable better understanding of effective healthcare provider tools.

# INTERNAL REVIEW
The evidence summary was reviewed by the Director of the PEBC. The Working Group is responsible for ensuring the necessary changes are made. 
The Palliative Care Program and the Working Group would like to thank the following individuals for their assistance in developing this report:
- Melissa Brouwers, Sheila McNair, Hans Messersmith, for providing feedback on draft versions.  Ruth Chau for conducting a data audit.  Sara Miller for copy editing.