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Decision-Aid for Renal Therapy Pilot Trial

Primary Purpose

Renal Insufficiency, Chronic, Kidney Failure, Chronic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DART
Choosing a Treatment for Kidney Failure
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Renal Insufficiency, Chronic

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tufts Medical Center
  • St. Elizabeth's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care

DART

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Completion of advance directives at 3 months.
Participants will be asked if they have completed an advance directive.
Change in baseline Decisional Conflict Scale score 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 Outcome Measures

Congruence in patient-caregiver goals of care
Patients and caregivers are each administered a questionnaire to determine what the patient's goals of care are at the end of life. The congruence (agreement) between the stated preferences of the patient and caregiver will be assessed at 6 months.
Change in baseline overall patient satisfaction score from the Canadian Health Care Evaluation Project (CANHELP) questionnaire at 3 months.
A survey instrument that evaluates satisfaction with care for older patients with life threatening illnesses, and their family members. The overall CANHELP Lite satisfaction score is calculated as the unweighted average of all answered questions. The score is then rescaled to range between 0 (worst possible value) to 100 (best possible value).
Change in baseline overall caregiver satisfaction score from the Canadian Health Care Evaluation Project (CANHELP) questionnaire at 3 months.
A survey instrument that evaluates satisfaction with care for older patients with life threatening illnesses, and their family members. The overall CANHELP Lite satisfaction score is calculated as the unweighted average of all answered questions. All scores are rescaled to range between 0 (worst possible value) to 100 (best possible value).

Full Information

First Posted
January 16, 2018
Last Updated
September 10, 2018
Sponsor
Tufts University
Collaborators
Tufts Medical Center, Saint Elizabeth's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03454022
Brief Title
Decision-Aid for Renal Therapy Pilot Trial
Official Title
Decision-Aid for Renal Therapy Pilot Trial (DART Pilot Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 16, 2017 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
Collaborators
Tufts Medical Center, Saint Elizabeth's Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic, Kidney Failure, Chronic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Participants receive an educational pamphlet from the National Kidney Foundation, "Choosing a Treatment for Kidney Failure."
Arm Title
DART
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
DART
Intervention Description
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
Intervention Name(s)
Choosing a Treatment for Kidney Failure
Intervention Description
This is an educational pamphlet published by the National Kidney Foundation.
Primary Outcome Measure Information:
Title
Completion of advance directives at 3 months.
Description
Participants will be asked if they have completed an advance directive.
Time Frame
Assessed at 3 months
Title
Change in baseline Decisional Conflict Scale score at 3 months.
Description
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).
Time Frame
Assessed in patients at 3 months.
Secondary Outcome Measure Information:
Title
Congruence in patient-caregiver goals of care
Description
Patients and caregivers are each administered a questionnaire to determine what the patient's goals of care are at the end of life. The congruence (agreement) between the stated preferences of the patient and caregiver will be assessed at 6 months.
Time Frame
Assessed in patients and caregivers at 6 months.
Title
Change in baseline overall patient satisfaction score from the Canadian Health Care Evaluation Project (CANHELP) questionnaire at 3 months.
Description
A survey instrument that evaluates satisfaction with care for older patients with life threatening illnesses, and their family members. The overall CANHELP Lite satisfaction score is calculated as the unweighted average of all answered questions. The score is then rescaled to range between 0 (worst possible value) to 100 (best possible value).
Time Frame
Assessed in patients at 3 months.
Title
Change in baseline overall caregiver satisfaction score from the Canadian Health Care Evaluation Project (CANHELP) questionnaire at 3 months.
Description
A survey instrument that evaluates satisfaction with care for older patients with life threatening illnesses, and their family members. The overall CANHELP Lite satisfaction score is calculated as the unweighted average of all answered questions. All scores are rescaled to range between 0 (worst possible value) to 100 (best possible value).
Time Frame
Assessed in caregivers at 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keren Ladin, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
St. Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Decision-Aid for Renal Therapy Pilot Trial

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