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Shared Decision Making and Renal Supportive Care (SDMRSC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02405312
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : July 6, 2017
University of New Mexico
Northeastern University
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Lewis Cohen, MD, Baystate Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Behavioral: advance care planning Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Shared Decision Making and Renal Supportive Care
Study Start Date : September 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hospice Care

Arm Intervention/treatment
Experimental: advance care planning
nephrologist empowers social worker to meet with patient and family.
Behavioral: advance care planning
patient and family meeting with dialysis social worker and nephrologist with discussion of advance care planning and hospice resources

Primary Outcome Measures :
  1. hospice use (documented in administrative data) [ Time Frame: 2 years prior to study initiation to 1 year post initiation ]
    Hospice use as documented in administrative data

Secondary Outcome Measures :
  1. location of death (site of death (home) as documented in administrative data) [ Time Frame: 12 months post enrollment ]
    site of death (home) as documented in administrative data

  2. completion of advanced directives (documented in administrative data) [ Time Frame: 12 months post enrollment ]
    completion of advanced directives as documented in administrative data

  3. 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 ]
    Patient Health Questionnaire-9 Scores

  4. Caregiver Satisfaction (Famcare Scores) [ Time Frame: Change from baseline over 12 months of follow-up or until subject death, whichever came first ]
    Famcare Scores

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02405312

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United States, Massachusetts
Fresenius Medical Corporation Dialysis Clinics
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Baystate Medical Center
University of New Mexico
Northeastern University
Patient-Centered Outcomes Research Institute
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Principal Investigator: Lewis Cohen, MD Baystate Health

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lewis Cohen, MD, Psychiatrist, Baystate Medical Center Identifier: NCT02405312     History of Changes
Other Study ID Numbers: 630092
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Keywords provided by Lewis Cohen, MD, Baystate Medical Center:
palliative care
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency