Decision-Aid for Renal Therapy Pilot Trial

NCT ID: NCT03454022

Last Updated: 2018-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-16

Study Completion Date

2018-07-01

Brief Summary

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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

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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.

Conditions

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Renal Insufficiency, Chronic Kidney Failure, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual care

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

Group Type ACTIVE_COMPARATOR

Choosing a Treatment for Kidney Failure

Intervention Type BEHAVIORAL

This is an educational pamphlet published by the National Kidney Foundation.

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.

Group Type EXPERIMENTAL

DART

Intervention Type BEHAVIORAL

A one-hour long web-based decision-aid program that explains treatment options for end-stage renal disease, including the benefits and risks of each treatment option.

Choosing a Treatment for Kidney Failure

Intervention Type BEHAVIORAL

This is an educational pamphlet published by the National Kidney Foundation.

Interventions

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DART

A one-hour long web-based decision-aid program that explains treatment options for end-stage renal disease, including the benefits and risks of each treatment option.

Intervention Type BEHAVIORAL

Choosing a Treatment for Kidney Failure

This is an educational pamphlet published by the National Kidney Foundation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tufts Medical Center

OTHER

Sponsor Role collaborator

Saint Elizabeth's Medical Center

UNKNOWN

Sponsor Role collaborator

Tufts University

OTHER

Sponsor Role lead

Responsible Party

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Keren Ladin

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keren Ladin, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Locations

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Tufts Medical Center

Boston, Massachusetts, United States

Site Status

St. Elizabeth's Medical Center

Brighton, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Patient ICF

View Document

Document Type: Informed Consent Form: Caregiver ICF

View Document

Other Identifiers

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12345

Identifier Type: -

Identifier Source: org_study_id

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