Clinical trial NCT03522740: Decision Aid for Renal Therapy
Official title: Decision Aid for Renal Therapy: Promoting Knowledge and Autonomy in Chronic Kidney Disease Patients and Their Care-Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Kidney Failure, Chronic
Keywords: Chronic Kidney Disease
Chronic Kidney Failure
Palliative Care
Dialysis
End-of-life care
Decision making
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2018-05-11
Enrollment: 400
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in score for patient-participants on the Decisional Conflict Scale, Low Literacy Version
timeFrame: 3 months
Secondary outcomes:
measure: Change in score for patient-participants on the Decisional Conflict Scale, Low Literacy Version
timeFrame: Up to 18 months
measure: Advance Directive Completion
timeFrame: 3 months
measure: Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Patients
timeFrame: 3 months
measure: Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Carepartners
timeFrame: 3 months
measure: Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Patients
timeFrame: Up to 18 months
measure: Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Carepartners
timeFrame: Up to 18 months
Other outcomes:
measure: Instability of Patient Preferences
timeFrame: Up to 18 months
measure: Patient/Care-Partner Concordance
timeFrame: Up to 18 months
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center and Tufts University
name: Daniel E Weiner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts University
name: Keren Ladin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Porteny T, Gonzales KM, Aufort KE, Levine S, Wong JB, Isakova T, Rifkin DE, Gordon EJ, Rossi A, Di Perna G, Koch-Weser S, Weiner DE, Ladin K; Stakeholder Advisory Board. Treatment Decision Making for Older Kidney Patients during COVID-19. Clin J Am Soc Nephrol. 2022 Jul;17(7):957-965. doi: 10.2215/CJN.13241021. Epub 2022 Jun 7.