Clinical trial NCT04347629: Improving Medical Decision Making for Older Patients With End Stage Renal Disease
Official title: Improving Medical Decision Making for Older Patients With End Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Renal Disease, End Stage
Palliative Care
Decision Aids
Keywords: video decision aid
video declaration
aging population
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-04-15
Enrollment: 456
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Advance Care Planning (ACP) in Electronic Health Record (EHR) Documentation
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Change in ACP Engagement
timeFrame: baseline, 12 months
measure: Change in ACP Preferences
timeFrame: Baseline, 12 months
measure: Change in ACP Conversations
timeFrame: Baseline, 12 months
measure: Change in Kidney Disease (KD) Specific Quality of Life (QOL)
timeFrame: Baseline, 12 months
measure: Change in Health Related Quality of Life (QoL)
timeFrame: Baseline, 12 months
measure: Change in Decisional Conflict
timeFrame: Baseline, 12 months
measure: Acceptability of video intervention
timeFrame: Baseline
measure: Change in CKD Care Preferences
timeFrame: Baseline, 12 months
measure: Healthcare Costs
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Renal and Transplant Associates of New England, PC
state: Massachusetts
city: Albuquerque
country: United States
facility: The University of New Mexico Health Sciences Center
state: New Mexico
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Tufts Medical Center
name: Michael Paasche-Orlow, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.