Chronic Kidney Disease Clinical Trial
— SDMRSCOfficial title:
Shared Decision Making and Renal Supportive Care
Verified date | July 2017 |
Source | Baystate Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 172 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Fresenius Medical Corporation Dialysis Clinics | Springfield | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Baystate Medical Center | Northeastern University, Patient-Centered Outcomes Research Institute, University of New Mexico |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hospice use (documented in administrative data) | Hospice use as documented in administrative data | 2 years prior to study initiation to 1 year post initiation | |
Secondary | location of death (site of death (home) as documented in administrative data) | site of death (home) as documented in administrative data | 12 months post enrollment | |
Secondary | completion of advanced directives (documented in administrative data) | completion of advanced directives as documented in administrative data | 12 months post enrollment | |
Secondary | depressive symptoms (Patient Health Questionnaire-9 Scores) | Patient Health Questionnaire-9 Scores | Change from baseline over 12 months of follow-up or until subject death, whichever came first | |
Secondary | Caregiver Satisfaction (Famcare Scores) | Famcare Scores | Change from baseline over 12 months of follow-up or until subject death, whichever came first |
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