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Renal Disease, End StageVIDEO-KDNCT04347629

Improving Medical Decision Making for Older Patients With End Stage Renal Disease

A study testing Advance Care Planning Video Decision Aid in people with Renal Disease, End Stage and Palliative Care, run by Tufts Medical Center at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Advance Care Planning Video Decision Aid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
456 participants
Where
9 sitesUnited States
Study dates
21 Jun 2021to 31 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • The University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87131-0001

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115-6110

  • Massachusetts General Hospital

    Boston, Massachusetts, 02118-2908

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • VA Palo Alto Health Care System

    Palo Alto, California, 94034-1290

  • Stanford University

    Palo Alto, California, 94034

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-6205

  • University of Washington

    Seattle, Washington, 98195-9472

  • Renal and Transplant Associates of New England, PC

    Springfield, Massachusetts, 01107-1381

Other trials in United States

About this study

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.

Read the 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.

Being tested
Advance Care Planning Video Decision Aid
Keywords
video decision aid, video declaration, aging population
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Advance Care Planning Video Decision AidBehavioural

    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.

Study groups in NCT04347629
Study groupRoleWhat they receive
Usual CareNo interventionUsual clinical care
Video Decision AidExperimentalThe 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.
Receives: Behavioral: Advance Care Planning Video Decision Aid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline, 12 months

Secondary outcomes (9)

  1. Change in ACP Engagement

    4 investigator designed questions about actions patient has taken with regards to ACP

    Measured: baseline, 12 months

  2. Change in ACP Preferences

    survey assessment

    Measured: Baseline, 12 months

  3. Change in ACP Conversations

    3 investigator designed questions about conversations with family/friends about ACP

    Measured: Baseline, 12 months

  4. Change in Kidney Disease (KD) Specific Quality of Life (QOL)

    KD-QOL is a validated instrument to assess QOL that includes 36 questions with response options in likert scale format. The outcome measure is the difference in averaged scores between baseline and 12 months; It is calculated as (Score at visit 2 - Score at visit 1).

    QOL is assessed by three components; physical health score, mental health score and kidney disease health score. Physical health score, mental health score and kidney disease health score are averaged scores of sub-scales. The range of each score and each sub-scale are 0 - 100, and higher values indicate better QOL status.

    Measured: Baseline, 12 months

  5. Change in Health Related Quality of Life (QoL)

    Health related quality of life will be assessed using a validated instrument EuroQol-5D (EQ-5D) which has two components. There is a descriptive system with 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. the other component is a visual analogue scale (VAS) that records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.

    Measured: Baseline, 12 months

  6. Change in Decisional Conflict

    We will measure decisional conflict using the decisional conflict scale (DCS), which attempts to measure decisional uncertainty.

    Measured: Baseline, 12 months

  7. Acceptability of video intervention

    For those patients randomized to the video intervention, we will measure, via survey, acceptability of the decision aid using a modified version of the validated Yorkshire Dialysis Decision Aid Usefulness Scale. We will also ask questions regarding comfort viewing the video, which we have validated in our prior work.

    Measured: Baseline

  8. Change in CKD Care Preferences

    All patients will be asked their preferences for kidney failure care at baseline. We will then assess their follow-up preferences by chart review in the electronic medical record.

    Measured: Baseline, 12 months

  9. Healthcare Costs

    We will identify the major components of healthcare services used, including inpatient, pharmacy, outpatient, emergency department and dialysis. We will also examine utilization by subgroups with comorbidity of diabetes, heart failure and cardiovascular disease. We will use Medicare claims data to obtain the associated costs, including payments by Medicare and secondary payers (e.g., out-of-pocket payments).

    Measured: Baseline, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2020
  2. Study start21 Jun 2021
  3. Primary completion31 Mar 2026
  4. Study completion31 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
456 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04347629
Sponsor's protocol ID
H-39981
Other IDs
1R01AG066892
Acronym
VIDEO-KD
Status last verified
Oct 2026
First submitted
11 Apr 2020
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Volandes AE, Lakin JR, Chang Y, Lindvall C, Quintiliani LM, Lundquist AL, Liu A, Tamura MK, Unruh M, Wong SPY, Davis AD, Garde C, Henault L, Samarakoon U, Hanchate A, Mandel E, Green JA, Lawson K, Randa SN, Paasche-Orlow MK. Video Decision Support and Advance Care Planning in Older Adults With Advanced Kidney Disease: The VIDEO-KD Randomized Clinical Trial. JAMA Intern Med. 2026 Oct 22:e265989. doi: 10.1001/jamainternmed.2026.5989. Online ahead of print.

    PubMed 42911803

  • 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.

    PubMed 35396311

Questions about this trial

What is this clinical trial studying?

A study testing Advance Care Planning Video Decision Aid in people with Renal Disease, End Stage and Palliative Care, run by Tufts Medical Center at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Advance Care Planning (ACP) in Electronic Health Record (EHR) Documentation (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04347629, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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