Decision-Aid for Renal Therapy Pilot Trial (DART Pilot Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tufts University
- Enrollment
- 31
- Locations
- 4
- Primary Endpoint
- Completion of advance directives at 3 months.
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Usual care
Participants receive an educational pamphlet from the National Kidney Foundation, "Choosing a Treatment for Kidney Failure."
Intervention: Choosing a Treatment for Kidney Failure (Behavioral)
DART
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.
Intervention: DART (Behavioral)
DART
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.
Intervention: Choosing a Treatment for Kidney Failure (Behavioral)
Outcomes
Primary Outcomes
Completion of advance directives at 3 months.
Time Frame: Assessed at 3 months
Participants will be asked if they have completed an advance directive.
Change in baseline Decisional Conflict Scale score at 3 months.
Time Frame: Assessed in patients at 3 months.
Measures personal perceptions of: a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Secondary Outcomes
- Congruence in patient-caregiver goals of care(Assessed in patients and caregivers at 6 months.)
- Change in baseline overall patient satisfaction score from the Canadian Health Care Evaluation Project (CANHELP) questionnaire at 3 months.(Assessed in patients at 3 months.)
- Change in baseline overall caregiver satisfaction score from the Canadian Health Care Evaluation Project (CANHELP) questionnaire at 3 months.(Assessed in caregivers at 3 months.)
Investigators
Keren Ladin
Assistant Professor
Tufts University