Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chronic Kidney Diseases
  • Kidney Failure Chronic
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 70 years and 125 years
Gender
Both males and females

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 ad...

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.

Tracking Information

NCT #
NCT03522740
Collaborators
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Daniel E Weiner, MD Tufts Medical Center and Tufts University Principal Investigator: Keren Ladin, PhD Tufts University