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Video Decision Aid for Chronic Kidney Failure (VIDEO-KD Trial)

N/A

Recruiting

Led By Michael Paasche-Orlow, MD, MPH

Research Sponsored by Boston Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients age ≥70 with 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 patient died in the next two years?')

Patients age ≥70 with 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

Must not have

Visually impaired beyond 20/200 corrected

Listed for kidney transplantation or previous transplant recipient

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether an ACP video intervention can reduce the burden of CKD for older patients.

Who is the study for?

This trial is for older adults with advanced chronic kidney disease (CKD). Eligible participants are those aged 70+ with an eGFR ≤30 ml/min/1.73m2 or a prognosis of less than two years, and those aged 65-69 meeting both criteria. Excluded are new patients, those listed for transplant, on dialysis, visually impaired beyond correction, or cognitively impaired.

What is being tested?

The study tests whether an advance care planning video can help manage CKD in aging individuals compared to usual care. It's a multi-center randomized trial where some will watch the decision aid video and others will continue with their regular treatment without the video.

What are the potential side effects?

Since this intervention involves educational material rather than medication, traditional side effects aren't expected. However, emotional or psychological discomfort may arise from discussing end-of-life decisions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 70 or older with CKD and my doctor thinks I may not live more than two years.

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I am 70 or older with advanced kidney disease not due to a sudden injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My vision is worse than 20/200 even with glasses or contacts.

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I am on the kidney transplant list or have received a kidney transplant.

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I am currently on or have been on dialysis.

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I have difficulty with memory or thinking clearly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Advance Care Planning (ACP) in Electronic Health Record (EHR) Documentation

Secondary study objectives

Acceptability of video intervention

Change in ACP Conversations

Change in ACP Engagement

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Video Decision AidExperimental Treatment1 Intervention

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.

Group II: Usual CareActive Control1 Intervention

Usual clinical care

0 / 6Eligibility criteria met