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Decision-Aid for Renal Therapy Pilot Trial

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ClinicalTrials.gov Identifier: NCT03454022
Recruitment Status : Completed
First Posted : March 5, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborators:
Tufts Medical Center
Saint Elizabeth's Medical Center
Information provided by (Responsible Party):
Keren Ladin, Tufts University

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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Kidney Failure, Chronic Behavioral: DART Behavioral: Choosing a Treatment for Kidney Failure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Decision-Aid for Renal Therapy Pilot Trial (DART Pilot Trial)
Actual Study Start Date : March 16, 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : July 1, 2018

Arm Intervention/treatment
Active Comparator: Usual care
Participants receive an educational pamphlet from the National Kidney Foundation, "Choosing a Treatment for Kidney Failure."
Behavioral: Choosing a Treatment for Kidney Failure
This is an educational pamphlet published by the National Kidney Foundation.

Experimental: 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.
Behavioral: 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.

Behavioral: Choosing a Treatment for Kidney Failure
This is an educational pamphlet published by the National Kidney Foundation.




Primary Outcome Measures :
  1. Completion of advance directives at 3 months. [ Time Frame: Assessed at 3 months ]
    Participants will be asked if they have completed an advance directive.

  2. 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 Outcome Measures :
  1. Congruence in patient-caregiver goals of care [ Time Frame: Assessed in patients and caregivers at 6 months. ]
    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.

  2. Change in baseline overall patient satisfaction score from the Canadian Health Care Evaluation Project (CANHELP) questionnaire at 3 months. [ Time Frame: Assessed in patients 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).

  3. Change in baseline overall caregiver satisfaction score from the Canadian Health Care Evaluation Project (CANHELP) questionnaire at 3 months. [ Time Frame: Assessed in caregivers 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454022


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
St. Elizabeth's Medical Center
Brighton, Massachusetts, United States, 02135
Sponsors and Collaborators
Tufts University
Tufts Medical Center
Saint Elizabeth's Medical Center
Investigators
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Principal Investigator: Keren Ladin, PhD Tufts University
  Study Documents (Full-Text)

Documents provided by Keren Ladin, Tufts University:
Study Protocol  [PDF] October 5, 2017
Statistical Analysis Plan  [PDF] February 20, 2018
Informed Consent Form: Patient ICF  [PDF] August 24, 2017
Informed Consent Form: Caregiver ICF  [PDF] August 24, 2017

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Responsible Party: Keren Ladin, Assistant Professor, Tufts University
ClinicalTrials.gov Identifier: NCT03454022    
Other Study ID Numbers: 12345
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases