Decision Aid for Renal Therapy



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:70 - Any
Updated:9/15/2018
Start Date:May 30, 2018
End Date:December 1, 2020
Contact:Daniel E Weiner, MD
Email:dweiner@tuftsmedicalcenter.org
Phone:6176365070

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Decision Aid for Renal Therapy: Promoting Knowledge and Autonomy in Chronic Kidney Disease Patients and Their Care-Partners

Good communication among patients, their families and loved ones, and their medical care
providers is important when figuring out how to treat chronic diseases like kidney disease. A
lot of people may not know all of their choices for how to treat kidney disease, and this can
lead to rushed decisions or even a sense that there weren't any choices to make. In this
study, the investigators are trying to find out if a decision-aid program on a computer can
help people with kidney disease have more confidence in their decisions and have better
agreement about their decisions with their families and loved ones.

The DART study will be conducted at four sites in different areas of the country: Boston,
Massachusetts; Portland, Maine; Chicago, Illinois; and San Diego, California. The study will
enroll a total of 400 people with kidney disease at these four sites.

Aligning patient preferences (goals of care and values) with treatment is essential for
quality health care. Treatment of life-limiting illness is especially preference-sensitive,
where high-intensity care often offers marginal survival benefit but can worsen quality of
life. Elderly persons with advanced chronic kidney disease (CKD) may face a choice between
high-intensity dialysis and low-intensity conservative management (CM). This decision is of
special import because it is often irreversible as dialysis itself can diminish residual
kidney function. In adults over 70 years-old with advanced CKD, dialysis on average confers
only marginally better survival than medical management while reducing independence and
mobility and increasing medical procedures. Poor communication about benefits and risks of
treatment options available to these patients results in decisional conflict: a state of
uncertainty associated with making a choice that best reflects values and preferences.
However, it is unclear how to best educate patients and their care-partners about their
treatment choices and the importance of advance care planning.

The objective of this trial is to compare the effectiveness of two widely used strategies,
in-person education alone versus in-person education plus an interactive web-based decision
aid, in: 1) reducing decisional conflict and empowering patients and care-partners to select
treatment aligned with patient preferences; and 2) improving care-partners' ability to
confidently and accurately express patients' preferences when patients are unable (proxy
decision-making).

The hypothesis is that, compared to traditional in-person education, use of the Decision Aid
for Renal Therapy (DART) will decrease decisional conflict, increase completion of advance
directives, improve patient and caregiver satisfaction with treatment (quantitative
outcomes), and contribute to greater patient engagement, satisfaction with decision-making,
and care-partner concordance (qualitative and quantitative outcomes).

DART is a web-based multimedia decision-aid that is designed to be accessible to individuals
with limited health literacy. The investigators will evaluate whether use of DART results in
greater patient understanding of options, leading to better discussions with care providers,
and ultimately lower decisional conflict and greater completion of advanced directives
compared with the comparator, in-person education. DART is replicable, consistent, can be
shared with care-partners, and can be viewed in the comfort of the patient's home.

This randomized clinical trial targeting 400 older adults with advanced kidney disease and as
many as 400 of their care-partners compares the effectiveness of DART plus in-person
education to in-person education alone for reducing decisional conflict and increasing
completion of advance care plans (ACPs) among older adults with advanced CKD and their
care-partners. Patients and patient-care-partner pairs will be surveyed at baseline for goals
of care, life goals, health literacy, patient activation, end-of-life (EOL) preferences and
baseline scores on other study outcome measures, and followed at 3- to 6-month intervals for
up to 18 months, censoring at dialysis, death or study end, to collect data on decisional
conflict and completion of advance directives as well as QOL, satisfaction, dyad concordance
and medical events, such as dialysis initiation.

Inclusion Criteria:

- CKD stages 4 or 5 (non-dialysis) without an established dialysis start or transplant
date within three months of expected randomization;

- Age >70 (with no upper limit);

- English speaking;

- Willingness to be randomized to DART; and

- Able to sign informed consent.

Exclusion Criteria:

- death, dialysis initiation or transplant deemed highly likely within the next three
months by the patient's nephrologist
We found this trial at
4
sites
22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Principal Investigator: Ana Rossi, MD
Phone: 207-396-8240
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Daniel E Weiner, MD
Phone: 617-636-4877
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Elisa Gordon, PhD
Phone: 312-503-1808
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San Diego, California 92093
Principal Investigator: Dena Rifkin, MD
Phone: 619-471-0592
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San Diego, CA
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