Shared Decision Making and Renal Supportive Care


Condition: Chronic Kidney Disease

Intervention:

  • Behavioral: advance care planning

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02405312

Sponsor: Baystate Medical Center

Primary Outcome Measures:

  • Measure: hospice use (documented in administrative data)
  • Time Frame: 2 years prior to study initiation to 1 year post initiation
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: location of death (site of death (home) as documented in administrative data)
  • Time Frame: 12 months post enrollment
  • Safety Issue:
  • Measure: completion of advanced directives (documented in administrative data)
  • Time Frame: 12 months post enrollment
  • Safety Issue:
  • Measure: depressive symptoms (Patient Health Questionnaire-9 Scores)
  • Time Frame: Change from baseline over 12 months of follow-up or until subject death, whichever came first
  • Safety Issue:
  • Measure: Caregiver Satisfaction (Famcare Scores)
  • Time Frame: Change from baseline over 12 months of follow-up or until subject death, whichever came first
  • Safety Issue:

Estimated Enrollment: 320

Study Start Date: September 2014

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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

Contact:

  • Michael Germain, MD
  • 4137942604

Location:

  • Fresenius Medical Corporation Dialysis Clinics
  • Springfield Massachusetts 01199 United States

View trial on ClinicalTrials.gov