Video Decision Aid for Chronic Kidney Failure

(VIDEO-KD Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist older adults with chronic kidney disease (CKD) in planning their medical care using an educational tool called the Advance Care Planning Video Decision Aid. The video guides patients through options such as different dialysis treatments or managing the condition without dialysis, and it also covers CPR choices. Participants will record their care preferences in a video or audio format. This trial suits older adults with advanced CKD who have not consulted a kidney specialist in the past year. As an unphased trial, it offers participants the opportunity to actively engage in planning their care preferences and to enhance their understanding of CKD management options.

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 prior data suggests that this video decision aid is safe for patients with chronic kidney disease?

In previous studies, the Advance Care Planning Video Decision Aid has been used with patients who have kidney disease. Research has shown that this video tool is well-received. For example, one study tested a similar video with kidney patients and their families and found no serious side effects. The video helps patients understand their care options, such as dialysis or other treatments, without causing harm.

This trial is in a "Not Applicable" phase, indicating existing evidence of its safety. This phase typically applies to interventions with minimal risk. Overall, the video decision aid appears to be a safe way to help patients make informed decisions about their medical care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Video Decision Aid for chronic kidney failure because it offers a fresh way to support patients with end-stage renal disease (ESRD) in making informed choices about their care. Unlike standard treatments that focus solely on medical interventions like dialysis or medication, this approach uses a video-based tool to guide patients through their options, including hemodialysis, peritoneal dialysis, and medical management without dialysis. The unique aspect is that patients can record their care preferences, ensuring their voices are heard and respected. This method empowers patients with clear, personalized information, potentially improving satisfaction with care decisions and aligning treatments with their personal values.

What evidence suggests that this video decision aid is effective for chronic kidney disease?

Research shows that videos can help patients with chronic kidney disease (CKD) better understand their options. In this trial, participants in the Video Decision Aid arm will use a video intervention that explores advance care planning (ACP) options for medical care for end-stage renal disease (ESRD), including hemodialysis, peritoneal dialysis, and medical management without dialysis. It also reviews cardiopulmonary resuscitation (CPR). Previous studies have shown that older patients learned more about supportive kidney care by watching a video, and videos about planning for future care helped patients and their caregivers make better treatment choices. Additionally, patients with end-stage kidney disease who watched a video about CPR understood the procedure better. These findings suggest that video aids can help CKD patients make more informed decisions about their treatment. ^{2 4 6 7 8}

Who Is on the Research Team?

Michael Paasche-Orlow, MD, MPH

Principal Investigator

Tufts Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7543741/

Use of a supportive kidney care video decision aid in older ... We tested the efficacy of a video decision aid on knowledge of supportive kidney care among older patients with advanced chronic kidney disease.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814337

Effectiveness of an Advance Care Planning Intervention in ... Results of this trial demonstrated that the advance care planning intervention by health care workers at dialysis centers improved patient and surrogate ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/12/4/e059313.full.pdf

Video Images about Decisions for Ethical Outcomes in ... Hope and advance care planning in patients with end stage renal disease: qualitative interview study. BMJ 2006;333:886. 7 Brinkman ...

4. pcori.org pcori.org/research-results/2017/does-decision-aid-help-older-adults-chronic-kidney-disease-choose-treatment-dart-study

Does a Decision Aid Help Older Adults with Chronic ... In this study, the research team compared two ways to help patients and their care partners choose a treatment.

5. researchgate.net researchgate.net/publication/327652999_Evaluation_of_the_CPR_video_decision_aid_with_patients_with_end_stage_renal_disease

(PDF) Evaluation of the CPR video decision aid with ... In a study conducted with patients with end-stage renal disease, it was observed that the majority of patients before learning how the CPR procedure is ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8996022/

Video Images about Decisions for Ethical Outcomes in Kidney ... Video images about decisions for ethical outcomes in kidney disease (VIDEO-KD): the study protocol for a multi-centre randomised controlled trial.

7. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-018-1018-y

Evaluation of the CPR video decision aid with patients with ... The objectives of this research was to design, test, and analyze a novel CPR video decision aid (VDA) with nephrology patients and their families in a clinical ...

8. researchgate.net researchgate.net/publication/343644716_Use_of_a_Supportive_Kidney_Care_Video_Decision_Aid_in_Older_Patients_A_Randomized_Controlled_Trial

Use of a Supportive Kidney Care Video Decision Aid ... We tested the efficacy of a video decision aid on knowledge of supportive kidney care among older patients with advanced CKD. Methods: ...