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.|
|ClinicalTrials.gov Identifier: NCT02405312|
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : July 6, 2017
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
|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|
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
- 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
- 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
- completion of advanced directives (documented in administrative data) [ Time Frame: 12 months post enrollment ]completion of advanced directives as documented in administrative data
- 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
- Caregiver Satisfaction (Famcare Scores) [ Time Frame: Change from baseline over 12 months of follow-up or until subject death, whichever came first ]Famcare Scores
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 ClinicalTrials.gov identifier (NCT number): NCT02405312
|United States, Massachusetts|
|Fresenius Medical Corporation Dialysis Clinics|
|Springfield, Massachusetts, United States, 01199|
|Principal Investigator:||Lewis Cohen, MD||Baystate Health|