Purpose

The overall objective of this study is to reduce the burden of chronic kidney disease (CKD) and its consequences for an aging U.S. population. To accomplish this, the investigators propose to conduct a multi-center randomized trial of an advance care planning (ACP) video intervention (vs. usual care) among older patients with CKD.

Conditions

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients age ≥70 are eligible if they have EITHER Advanced CKD defined as ONE eGFR value ≤ 30 ml/min/1.73m2 in the past 12 months NOT determined to be a result of AKI OR Have a diagnosis of CKD and less than a two-year prognosis from any cause, defined by the clinician answering "NO" to the Surprise Question ("Would you be surprised if this patients died in the next two years?") - Patients age 65-69 are eligible if they have BOTH Advanced CKD defined as ONE eGFR value ≤ 30 ml/min/1.73m2 NOT determined to be a result of AKI AND Have less than a two-year prognosis, defined by the clinician answering "NO" to the Surprise Question ("Would you be surprised if this patients died in the next two years?") - Patients who have not had a nephrology visit in the past 12 months can be recruited from non-Nephrology Clinics per the above eligibility criteria

Exclusion Criteria

  • listed for kidney transplantation or previous transplant recipient - already on or previously on dialysis (including emergent dialysis) - new patient visit - visually impaired beyond 20/200 corrected - psychological state not appropriate for ACP discussions as determined by the primary nephrologist - cognitive impairment

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Usual Care
Usual clinical care
Experimental
Video Decision Aid
The video intervention consists of a video decision aid along with a video declaration (ViDec), which is recorded by the patient. The video decision aid explores ACP options for medical care for end-stage renal disease (ESRD) and reviews hemodialysis, peritoneal dialysis, as well as medical management without dialysis; it also reviews cardiopulmonary resuscitation (CPR). Patients will also audio- or video-record their preferences using a tablet.
  • Behavioral: Advance Care Planning Video Decision Aid
    The video decision aid explores ACP options for medical care for end-stage renal disease (ESRD) and reviews hemodialysis, peritoneal dialysis, as well as medical management without dialysis; it also reviews cardiopulmonary resuscitation (CPR). Patients will also audio- or video-record their preferences using a tablet.

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Lori Henault, MPH
617-414-6935
lori.henault@bmc.org

More Details

Status
Recruiting
Sponsor
Tufts Medical Center

Study Contact

Michael Paasche-Orlow, MD MPH
617-636-1029
michael.paasche-orlow@tuftsmedicine.org

Detailed Description

The video intervention consists of a video decision aid along with a video declaration (ViDec), which is recorded by the patient. The video decision aid explores ACP options for medical care for end-stage renal disease (ESRD) and reviews hemodialysis, peritoneal dialysis, as well as medical management without dialysis; it also reviews cardiopulmonary resuscitation (CPR). Patients will also audio- or video-record their preferences using a tablet. The video will be shared with their nephrologist. The patient will have a copy of the video to take with them and share with their loved ones. Patients will answer survey questions about their preferences, knowledge, decisional conflict, and ACP engagement. They will be surveyed every two months for one year or death (if they die before one year). Potential participants will be recruited from 10 nephrology clinics: Massachusetts General Hospital (n=75), Brigham and Women's Hospital (n=75), University of Pittsburgh (n=75), University of Pennsylvania, Stanford University, Palo Alto Veterans Institute for Research, University of Washington, Renal & Transplant Associates of New England, University of New Mexico and Boston Medical Center.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.