Video Decision Aid for Chronic Kidney Failure

(VIDEO-KD Trial)

Recruiting at 8 trial locations

Overseen By Michael Paasche-Orlow, MD MPH

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Kidney transplant, Dialysis, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 months

456 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Advance Care Planning Video Decision Aid for chronic kidney failure?

Research shows that video decision aids can help older patients with advanced chronic kidney disease (CKD) better understand their treatment options, including supportive kidney care and advance care planning, leading to more informed decisions and care that aligns with their goals. ^{1 2 3 4 5}

Is the Video Decision Aid for Chronic Kidney Failure safe for humans?

The research articles do not provide specific safety data for the Video Decision Aid, but they focus on its use in helping patients make informed decisions about their care. Generally, decision aids like this are considered safe as they are educational tools designed to improve understanding and support decision-making. ^{1 2 5 6 7}

How is the Advance Care Planning Video Decision Aid treatment different from other treatments for chronic kidney failure?

The Advance Care Planning Video Decision Aid is unique because it uses video to help patients with chronic kidney failure understand their treatment options and make informed decisions about their care, including supportive kidney care and end-of-life preferences. This approach is different from traditional treatments as it focuses on enhancing patient knowledge and involvement in decision-making, rather than directly treating the disease itself. ^{1 2 4 6 7}

What is the purpose of this trial?

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.

Research Team

Michael Paasche-Orlow, MD, MPH

Principal Investigator

Tufts Medical Center

Eligibility Criteria

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.

Inclusion Criteria

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

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

I am 65-69, have advanced CKD not due to AKI, and my doctor thinks I may not live more than 2 years.

Exclusion Criteria

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

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

I am currently on or have been on dialysis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a video decision aid intervention to explore advance care planning options for end-stage renal disease

12 months

Surveys every 2 months

Follow-up

Participants are monitored for changes in CKD care preferences, quality of life, and ACP engagement

12 months

Treatment Details

Interventions

• Advance Care Planning Video Decision Aid

Trial Overview 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.

Participant Groups

Group I: Video Decision Aid Experimental Treatment 1 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 Care Active Control 1 Intervention

Usual clinical care

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

A study involving 100 older patients with advanced chronic kidney disease (CKD) found that both verbal and video education significantly increased knowledge of supportive kidney care, but there was no difference in effectiveness between the two methods.

Despite the lack of difference in knowledge or preferences for supportive kidney care between the education types, the video decision aid was highly accepted, with 96% of participants feeling comfortable with it and finding it helpful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Supportive Kidney Care Video Decision Aid in Older Patients: A Randomized Controlled Trial. Eneanya, ND., Percy, SG., Stallings, TL., et al.[2021]

The study aims to evaluate the effectiveness of a video intervention designed to improve advance care planning (ACP) and treatment preferences in 600 older patients with advanced chronic kidney disease (CKD) over a 5-year period across 10 sites.

This randomized controlled trial will assess how well a CKD-related video decision aid and personal video declarations can help patients make informed decisions about their care, potentially improving their quality of life and aligning end-of-life care with their personal goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video Images about Decisions for Ethical Outcomes in Kidney Disease (VIDEO-KD): the study protocol for a multi-centre randomised controlled trial. Eneanya, ND., Lakin, JR., Paasche-Orlow, MK., et al.[2022]

A predictive model for 12-month mortality in patients with advanced chronic kidney disease (CKD) was developed using data from 749 patients in Massachusetts and validated with 437 patients in West Virginia, showing good accuracy with a c-statistic of 0.80 in the derivation cohort and 0.74 in the validation cohort.

Key factors in predicting mortality included the response to the Surprise Question, Karnofsky Performance Score, and age, which can help nephrologists guide patients in making informed decisions about treatment options like dialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Derivation and validation of a prognostic model to predict mortality in patients with advanced chronic kidney disease. Schmidt, RJ., Landry, DL., Cohen, L., et al.[2021]

The study developed an advance care planning intervention for patients with chronic kidney disease, emphasizing a collaborative approach that involved patients, families, and healthcare professionals to address their needs and preferences.

Key components of the intervention include a conversation process that focuses on everyday life, illness, and treatment, along with an advance care planning tool designed to improve communication and support shared decision-making among all stakeholders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance care planning to patients with chronic kidney disease and their families: An intervention development study. Frandsen, CE., Dieperink, H., Trettin, B., et al.[2023]

The study aims to improve knowledge about conservative kidney management and advance care planning among older patients with advanced chronic kidney disease (CKD) through a pilot educational intervention called COPE, focusing on patients aged 70 and older or with poor functional status.

This randomized controlled trial will assess the effectiveness of the COPE intervention in enhancing patient knowledge and communication preferences regarding kidney management options, with outcomes measured at multiple time points over 12 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial. Stallings, TL., Temel, JS., Klaiman, TA., et al.[2021]

The CPR video decision aid (VDA) significantly improved knowledge about CPR among patients with end-stage renal disease (ESRD), with scores increasing from an average of 4.8 to 7.5 out of 9 after viewing the video.

The use of the CPR-VDA led to a shift in patient preferences regarding CPR, with a decrease in those wanting CPR from 86% to 57%, indicating enhanced clarity in decision-making and alignment with personal values.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the CPR video decision aid with patients with end stage renal disease. Kapell Brown, C., Kryworuchko, J., Martin, W.[2023]

The OPTIONS decision support intervention significantly improved participants' knowledge about the risks and benefits of dialysis in older adults with advanced kidney disease, enhancing their ability to make informed treatment choices.

While the intervention did not show significant differences in decision conflict or regret at the initial follow-up, it did lead to lower decisional conflict at a later time point, indicating its potential effectiveness in facilitating shared decision-making over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial testing a decision support intervention for older patients with advanced kidney disease. Brown, L., Gardner, G., Bonner, A.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Use of a Supportive Kidney Care Video Decision Aid in Older Patients: A Randomized Controlled Trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Video Images about Decisions for Ethical Outcomes in Kidney Disease (VIDEO-KD): the study protocol for a multi-centre randomised controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Derivation and validation of a prognostic model to predict mortality in patients with advanced chronic kidney disease. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Advance care planning to patients with chronic kidney disease and their families: An intervention development study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of the CPR video decision aid with patients with end stage renal disease. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial testing a decision support intervention for older patients with advanced kidney disease. [2020]