Improving Medical Decision Making for Older Patients With End Stage Renal Disease
VIDEO-KD
2 other identifiers
interventional
456
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedStudy Start
First participant enrolled
June 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
ExpectedMarch 17, 2026
March 1, 2026
4.8 years
April 11, 2020
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Advance Care Planning (ACP) in Electronic Health Record (EHR) Documentation
Documentation in the electronic health record reflecting an ACP conversation (any of the following: completion of advance directive or physician order for life sustaining treatment (POLST); code status documentation; provider note reflecting ACP discussion).
Baseline, 12 months
Secondary Outcomes (9)
Change in ACP Engagement
baseline, 12 months
Change in ACP Preferences
Baseline, 12 months
Change in ACP Conversations
Baseline, 12 months
Change in Kidney Disease (KD) Specific Quality of Life (QOL)
Baseline, 12 months
Change in Health Related Quality of Life (QoL)
Baseline, 12 months
- +4 more secondary outcomes
Study Arms (2)
Usual Care
NO INTERVENTIONUsual clinical care
Video Decision Aid
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Medical Centerlead
- National Institute on Aging (NIA)collaborator
Study Sites (9)
VA Palo Alto Health Care System
Palo Alto, California, 94034-1290, United States
Stanford University
Palo Alto, California, 94034, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115-6110, United States
Massachusetts General Hospital
Boston, Massachusetts, 02118-2908, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Renal and Transplant Associates of New England, PC
Springfield, Massachusetts, 01107-1381, United States
The University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131-0001, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6205, United States
University of Washington
Seattle, Washington, 98195-9472, United States
Related Publications (1)
Eneanya ND, Lakin JR, Paasche-Orlow MK, Lindvall C, Moseley ET, Henault L, Hanchate AD, Mandel EI, Wong SPY, Zupanc SN, Davis AD, El-Jawahri A, Quintiliani LM, Chang Y, Waikar SS, Bansal AD, Schell JO, Lundquist AL, Tamura MK, Yu MK, Unruh ML, Argyropoulos C, Germain MJ, Volandes A. Video Images about Decisions for Ethical Outcomes in Kidney Disease (VIDEO-KD): the study protocol for a multi-centre randomised controlled trial. BMJ Open. 2022 Apr 8;12(4):e059313. doi: 10.1136/bmjopen-2021-059313.
PMID: 35396311DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Paasche-Orlow, MD, MPH
Tufts Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2020
First Posted
April 15, 2020
Study Start
June 21, 2021
Primary Completion
March 31, 2026
Study Completion (Estimated)
May 31, 2027
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Outcome data will be deposited into Open Science Framework repository as soon as possible but no later than within one year of the completion of the funded project period for the parent award or upon acceptance of the data for publication, or public disclosure of a submitted patent application, whichever is earlier. Data will remain available for a period of 5 years.
- Access Criteria
- Data and supporting information will be shared with investigators working in accordance to guidelines set by the data repository. Meta-analysis data and associated phenotypic data, along with data content, format, and organization, will be made available to investigators through the Open Science Framework data repository.
The phenotypic data associated with enrolled participants will be shared by depositing these data in the Open Science Framework data repository. Additional data documentation and de-identified IPD including demographics, diagnoses, and outcomes will be deposited. Resources such as study protocols and statistical analysis codes will also be made available.