Clinical trial NCT03454022: Decision-Aid for Renal Therapy Pilot Trial
Official title: Decision-Aid for Renal Therapy Pilot Trial (DART Pilot Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency, Chronic
Kidney Failure, Chronic
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Tufts Medical Center
name: Saint Elizabeth's Medical Center
First posted: 2018-03-05
Enrollment: 31
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants (patient-caregiver dyads) will be randomized to receive either usual care education (a pamphlet published by the National Kidney Foundation, "Choosing a Treatment for Kidney Failure," or usual care education plus DART.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Completion of advance directives at 3 months.
timeFrame: Assessed at 3 months
measure: Change in baseline Decisional Conflict Scale score at 3 months.
timeFrame: Assessed in patients at 3 months.
Secondary outcomes:
measure: Congruence in patient-caregiver goals of care
timeFrame: Assessed in patients and caregivers at 6 months.
measure: Change in baseline overall patient satisfaction score from the Canadian Health Care Evaluation Project (CANHELP) questionnaire at 3 months.
timeFrame: Assessed in patients at 3 months.
measure: Change in baseline overall caregiver satisfaction score from the Canadian Health Care Evaluation Project (CANHELP) questionnaire at 3 months.
timeFrame: Assessed in caregivers at 3 months.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Brighton
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Keren Ladin, PhD
role: PRINCIPAL_INVESTIGATOR
References: