Decision-Aid for Renal Therapy Pilot Trial

Tufts University

Status: Completed

Conditions: Kidney Failure, Chronic; Renal Insufficiency, Chronic

Treatments: Behavioral: Choosing a Treatment for Kidney Failure; Behavioral: DART

Study type: Interventional

Funder types: Other

Identifiers

NCT03454022

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Details and patient eligibility

About

Successful communication between patients, caregivers, and physicians can improve how patients feel about their treatment. Our recent studies of older dialysis patients find, however, that many patients do not engage in this type of communication about treatment options. This study aims to determine whether the Decision-Aid for Renal Therapy (DART), a web-based program, can improve shared decision-making (decisions where patients are actively engaged) among patients, caregivers, and physicians, and improve certainty and satisfaction in treatment decisions.

Full description

Successful end-of-life communication between patients, caregivers, and physicians is associated with superior psychosocial outcomes, less intensive treatment, greater satisfaction, and higher likelihood of death at home. The Decision-Aid for Renal Therapy (DART) is an interactive web-based decision-aid that can empower patients and caregivers to select the treatment choice for chronic kidney disease that best suits them. DART was developed using a rigorous, validated, patient-engaged process and helps clarify decision-points and tradeoffs by providing individualized information about outcomes that matter most to patients. DART is designed to promote shared decision-making between patients, caregivers, and physicians and align preferences with treatment received.

Although proven effective and in current use in the general population, DART's effectiveness in an older population is unclear. The purpose of this project is to conduct a pilot study of DART's feasibility and effectiveness to improve end-of-life planning and shared decision-making among older end-stage renal disease patients.

Enrollment: 31 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic kidney disease stages 4 or 5, not currently on dialysis
• Age >=70
• English-speaking
• Willingness to be randomized to DART
• Able to sign informed consent
• 5-year kidney failure risk probability > 15% using [www.kidneyfailurerisk.com]
• Glomerular filtration rate (GFR) < 30

Exclusion criteria

• Non-English speaking

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups

Usual care

Active Comparator group

Description:

Participants receive an educational pamphlet from the National Kidney Foundation, "Choosing a Treatment for Kidney Failure."

Treatment:

Behavioral: Choosing a Treatment for Kidney Failure

DART

Experimental group

Description:

Participants receive an educational pamphlet from the National Kidney Foundation, "Choosing a Treatment for Kidney Failure." They also receive a link to access the web-based decision-aid program, Decision-Aid for Renal Therapy (DART). Participants may access this program using a computer at home throughout the duration of the trial. Those who do not have a computer with web access at home are assisted in watching the program in the clinic.

Treatment:

Behavioral: Choosing a Treatment for Kidney Failure

Behavioral: DART