Shared Decision Making and Renal Supportive Care
Shared Decision Making and Renal Supportive Care
This year, 90,000 Americans with end-stage renal disease (ESRD) will die and questions will
 legitimately be raised as to whether terminal treatment and location of death adequately
 represented their preferences. These concerns are linked by a failure on the part of patients
 and staff to discuss prognosis and share in end-of-life (EOL) planning. The rate of hospice
 use among patients dying with ESRD is half that of the national average and one-quarter the
 rate for patients with terminal cancer. In other patient populations when meaningful EOL
 conversation occurs this is associated with increased hospice referral and improved quality
 of the dying.

 Patients receiving hemodialysis (HD) often desire but rarely communicate with staff about
 prognoses, know little about availability of community hospice resources, or how to complete
 advance directives. Nephrologists are not trained to have these conversations, and although
 accustomed to relying on interdisciplinary teams, they are unaccustomed to collaborating with
 community hospices. Our preliminary research began by using focus groups, created and
 validated the first clinically useful HD prognostic tool, and developed a prototype for
 Shared Decision Making and Renal Supportive Care (SDM-RSC). This is a novel multimodal
 intervention that familiarizes patients, families, and dialysis staff with community hospice
 resources, emphasizes dialysis social work support, conveys information about terminal care
 issues, and encourages advance care planning.

 The proposed study tests the central hypothesis that EOL care can be improved by relying on
 patients and stakeholders to enhance SDM-RSC for HD patients who are most likely to die. It
 will test whether an intervention that targets communication deficiencies can alter EOL
 outcomes and achieve the goal of matching patient preferences with terminal treatments.
This year, 90,000 Americans with end-stage renal disease (ESRD) will die and questions will
 legitimately be raised as to whether terminal treatment and location of death adequately
 represented their preferences. These concerns are linked by a failure on the part of patients
 and staff to discuss prognosis and share in end-of-life (EOL) planning. The rate of hospice
 use among patients dying with ESRD is half that of the national average and one-quarter the
 rate for patients with terminal cancer. In other patient populations when meaningful EOL
 conversation occurs this is associated with increased hospice referral and improved quality
 of the dying.

 Patients receiving hemodialysis (HD) often desire but rarely communicate with staff about
 prognoses, know little about availability of community hospice resources, or how to complete
 advance directives. Nephrologists are not trained to have these conversations, and although
 accustomed to relying on interdisciplinary teams, they are unaccustomed to collaborating with
 community hospices. Our preliminary research began by using focus groups, created and
 validated the first clinically useful HD prognostic tool, and developed a prototype for
 Shared Decision Making and Renal Supportive Care (SDM-RSC). This is a novel multimodal
 intervention that familiarizes patients, families, and dialysis staff with community hospice
 resources, emphasizes dialysis social work support, conveys information about terminal care
 issues, and encourages advance care planning.

 The proposed study tests the central hypothesis that EOL care can be improved by relying on
 patients and stakeholders to enhance SDM-RSC for HD patients who are most likely to die. It
 will test whether an intervention that targets communication deficiencies can alter EOL
 outcomes and achieve the goal of matching patient preferences with terminal treatments.

 Specific Aims:

 1. To determine whether SDM-RSC impacts the use of hospice services, location of death, and
 EOL planning. The RSC intervention will be employed at the HD clinics with patients who
 are in the highest quintile of mortality.

 Hypothesis: SDM-RSC will increase a) hospice use, b) deaths at home (vs. in
 institutions), and c) completion of advance directives.

 2. To determine the effect of SDM- RSC on quality of life/death and caregiver satisfaction
 with patient care in the last week of life. Validated instruments reflecting values and
 priorities of patient and caregiver will be collected by interviewers.

 Hypothesis: SDM-RSC will significantly improve quality of life/death while also increasing
 caregiver satisfaction.

 The proposed work addresses recommendations by the Renal Physician's Association for EOL care
 and the Institute of Medicine for patient-centered healthcare. The novel communication
 intervention is relevant to not only ESRD but also other high-mortality disorders.

 Scope of the Problem:

 A match between patient goals and the care received should be the gold standard for quality
 medical management. Meaningful end-of-life (EOL) conversations are associated with increased
 hospice referral, less aggressive and expensive medical treatment, and improved satisfaction
 on the part of families. However, a survey of ESRD patients reported less than 10% having a
 conversation about any EOL issues with their nephrologist in the previous year, and more than
 90% endorsed that none of their physicians had ever discussed how much time they had to live.
 It is not known whether an intervention that targets deficiencies in communication and
 terminal care planning can improve EOL outcomes. This is an area that has been neglected in
 ESRD research, yet should have tremendous importance to patients, families, and
 policy-makers.

 Over 600,000 Americans have ESRD at a cost to society of more than $42 billion a year, and
 patients over the age of 75 constitute the fastest growing segment of the ESRD population in
 the United States. Up to one-third of these elderly patients have four or more comorbid
 chronic health conditions, and hemodialysis (HD) does not always substantially prolong their
 lives. This year, Wong and associates reported that 49% of elderly long-term HD patients
 spent time in an ICU in their final month of life, compared with 24% of cancer patients,
 suggesting intensity of care at the EOL is substantially higher in ESRD than that received by
 other Medicare beneficiaries with life-limiting illnesses. According to analyses from the
 United States Renal Data System, these decisions may have important economic ramifications.
 This figure demonstrates that the costs of care in the last week of life for those using
 hospice and withdrawing from dialysis was approximately half the cost of those who did
 neither. In light of the substantial prevalence of symptoms, costs, and high mortality rates,
 it is time to reconsider the care, and especially the EOL care, offered to the ESRD
 population with advancing age.

 Communication of prognosis is a key step in EOL planning, but occurs infrequently or
 extremely late in the dying process among patients with ESRD. Most ESRD patients want to
 learn about EOL issues, and according to Davison, the most valued components are being
 informed about prognosis, treatment options (including withdrawal from dialysis) and planning
 for death. In two studies, 95% and 97% of patients with ESRD preferred to be given
 life-expectancy information-even if their prognosis was poor-and patients specifically wanted
 their physician to disclose this information without prompting. Nevertheless, nephrologists
 and dialysis staff infrequently discuss EOL issues with patients and families, although they
 repeatedly face difficult determinations about treatment options, including whether to
 discontinue renal replacement therapies or to consider referral for hospice services. Despite
 national guidelines and an explicit recommendation by the Renal Physicians Association and
 American Society of Nephrology, patients and their family members or surrogate decision
 makers are often not provided with available information. This may help explain why only
 one-in-five dying dialysis patients currently receive hospice care-about half that of
 national figures for overall deaths in the United States and one-fourth that of people dying
 from cancer.

 Both uncertainty regarding individual prognosis and a lack of training in communicating has
 limited EOL discussions between nephrologists and ESRD patients. Instruments to identify
 individuals undergoing maintenance HD who are at highest risk for death have only recently
 been shown to be reliable predictive models for clinical use. Integrated prognostic models
 now take into account laboratory values, comorbidities, changes in comorbidity score over
 time, functional status/fragility, quality of life (QOL), and sometimes either the patient's
 or clinician's prediction of survival. Drs. Cohen and Germain have developed a practical and
 reliable instrument that is available online (http://touchcalc.com/calculators/sq), as a free
 application for mobile devices and it is being increasingly cited for its potential value in
 the literature. In addition to the barriers of providing a reliable prognosis, communication
 has been highlighted as a barrier in a qualitative study of elderly ESRD patients and
 nephrologists.

 Communication of prognosis may be an essential ingredient in the acceptance of life-limiting
 conditions, completion of advance directives, do-not-resuscitate orders, and the delineation
 of goals of care. However, nephrologists and dialysis staff have lacked training to
 meaningfully participate in these complex but much needed conversations. In recent years,
 guidelines have become available to assist medical personnel in communicating 'bad news' and
 introducing hospice and other EOL resources to patients and families in an honest and
 compassionate manner. Patients who talk with their physicians about approaching death are
 more satisfied with care than those who do not, and they also frequently request deaths take
 place at home. These results are consistent with other studies, suggesting that EOL
 communication between patients and physicians is associated with better outcomes, less
 expensive medical care, and decreased anxiety and depression on the part of the bereaved
 survivors.

 We have identified a major barrier in the management of dialysis patients: the dearth of
 communication between staff and patients about prognosis and EOL considerations. Without
 these conversations, this population will continue to receive overly demanding and expensive
 treatments, infrequent referrals for hospice services, and a diminished quality of life and
 death. The extensive preliminary work preceding this study, which began with focus groups
 involving patients and families, has allowed us to develop and validate an accurate
 prognostic instrument for the identification of HD patients with poor short-term survival
 expectancy. The multimodal SDM-RSC intervention takes advantage of the existing
 interdisciplinary team approach that is the bedrock of HD practice, and it empowers the
 social worker to engage in EOL communication with the patients and their loved ones. The
 SDM-RSC intervention is designed to be practical, adaptable to existing staff, and easily
 replicated in dialysis facilities throughout the country. Additional involvement of
 patient-partners from two distinct sections of the country will greatly improve the protocol.

 Renal supportive care holds the promise of becoming an increasingly important and desirable
 aspect of patient-centered care in ESRD. The principal elements of SDM-RSC include:
 identification of high-mortality patients, initiating discussions with them and families,
 sharing decision-making and advance care planning to establish agreed level of care, and when
 appropriate changing the emphasis from curative to palliative treatments, such as withdrawal
 of dialysis and referral for hospice services. This study intends to challenge the current
 paradigm of EOL care of ESRD patients and establish whether delivery of prognostic
 information, encouragement of advance directives, and sensitive discussion of terminal
 treatment options, e.g. hospice services, by nephrologists and dialysis social workers, can
 together meaningfully alter the last remaining portion of patient lives and the care they
 receive. The trial will confront the issue of overuse-when an appropriate service, e.g. HD,
 continues to be provided under circumstances in which the potential for harm may exceed the
 possible benefit. Furthermore, the proposed trial may significantly improve the QOL of
 patients and provide the opportunity for higher quality care.

 Brief Overview of SDM-RSC Study Design:

 The study utilizes a prospective intervention period and a retrospective control period at
 the same dialysis units, in order to balance efficacy, power, and accuracy. The intervention
 will be implemented at the unit level and is intended to impact not only the specific
 patients enrolled in the study but also other patients receiving care in these units. The
 design avoids the contamination effect and inadvertent cross-overs that would be present with
 an individual participant randomization design. Because we expect perceptions and practices
 to be changed among care providers other designs, e.g. cross-over designs, would also be
 unusable. Cluster randomization may also not be practical given the variation between units
 in practice patterns and logistics involved in conducting a study with a sufficient number of
 dialysis to maintain internal validity. The design may be open to potential selection bias
 and secular trends. Adjustments for these are discussed in the data analysis section.

 This study will test whether the SDM-RSC intervention compared to usual care improves EOL
 care, including: increased hospice use, enhanced EOL planning, and improved patient and
 caregiver satisfaction. The multi-modal SDM-RSC intervention communicates prognosis in a
 face-to-face encounter, uses an algorithm-based social work intervention, and provides
 hospice outreach. This study will be recruiting subjects from 16 dialysis units associated
 with 2 clinical centers-Baystate-Tufts (8), University of New Mexico (8). The study sample
 will be selected using a validated prognostic tool to enrich the pool of patients who have a
 high risk of mortality and are most likely to benefit from the SDM-RSC intervention. Subjects
 will be recruited over 6 months and enrolled subjects will be treated and followed for at
 least 18 months.
Inclusion Criteria:

 -  High-risk patients, as defined by falling within the high-risk category of our
 validated prognostic instrument and have approximately 50% 18-month mortality.

 -  English- and Spanish-speaking patients will be included (estimated to be 95% of this
 population).

 -  Patients who receive hemodialysis at one of our 16 research dialysis sites during the
 data collection period.

 -  Patients must be willing and able to sign the consent form.

 -  Patients who are lack the capacity to meaningfully participate in medical decisions
 must have a surrogate who is willing to sign the informed consent.

 Exclusion Criteria:

 -  Children 18 years of age. Children constitute 2% of the dialysis population, and our
 preliminary survey of the study sites found no children were active patients. In any
 case, the renal and other physical factors of children with ESRD are not directly
 comparable to those of adults.

 -  Does not belong to the population's high-mortality risk quintile according to our
 prognostic instrument

 -  Severe psychiatric disorders including schizophrenia, bipolar disorder which would
 interfere with participation in the study (severity determined by psychiatric
 hospitalization in the past month or actively suicidal)

 -  Active substance abuse (active abuse is defined as using alcohol or recreational drugs
 in the past 30 days in a way that interferes with their ability to function in daily
 life)

 -  Expectation of native kidney recovery

 -  History of poor adherence to thrice-weekly hemodialysis (poor adherence defined by
 missing 4 treatments in the past month)

 -  Unable to communicate in English or Spanish

 -  Scheduled for living donor kidney transplant, conversion to peritoneal dialysis, or
 plans to relocate to another hemodialysis unit

 -  Current pregnancy or actively planning to become pregnant

 -  Currently a prisoner

 -  Unable or unwilling to follow the study protocol

 -  Unable or unwilling to provide informed consent or sign Institutional Review Board
 (IRB)-approval or lack of a surrogate/proxy

 -  Exclusion by primary nephrologist or social worker due to risk of harm