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Improving Medical Decision Making for Older Patients With End Stage Renal Disease (VIDEO-KD)

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Tufts University

Status

Active, not recruiting

Conditions

Decision Aids
Renal Disease, End Stage
Palliative Care

Treatments

Behavioral: Advance Care Planning Video Decision Aid

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04347629
H-39981
1R01AG066892 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

456 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

456 participants in 2 patient groups

Usual Care
No Intervention group
Description:
Usual clinical care
Video Decision Aid
Experimental group
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.
Treatment:
Behavioral: Advance Care Planning Video Decision Aid

Trial contacts and locations

9

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Central trial contact

Michael Paasche-Orlow, MD MPH

Data sourced from clinicaltrials.gov

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