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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

Tracking Information
First Submitted Date  ICMJE January 16, 2018
First Posted Date  ICMJE March 5, 2018
Last Update Posted Date September 11, 2018
Actual Study Start Date  ICMJE March 16, 2017
Actual Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
  • 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.
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Decision-Aid for Renal Therapy Pilot Trial
Official Title  ICMJE Decision-Aid for Renal Therapy Pilot Trial (DART Pilot Trial)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Renal Insufficiency, Chronic
  • Kidney Failure, Chronic
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Usual care
    Participants receive an educational pamphlet from the National Kidney Foundation, "Choosing a Treatment for Kidney Failure."
    Intervention: Behavioral: Choosing a Treatment for Kidney Failure
  • 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.
    Interventions:
    • Behavioral: DART
    • Behavioral: Choosing a Treatment for Kidney Failure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2018)
31
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2018)
62
Actual Study Completion Date  ICMJE July 1, 2018
Actual Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03454022
Other Study ID Numbers  ICMJE 12345
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Keren Ladin, Tufts University
Study Sponsor  ICMJE Tufts University
Collaborators  ICMJE
  • Tufts Medical Center
  • Saint Elizabeth's Medical Center
Investigators  ICMJE
Principal Investigator: Keren Ladin, PhD Tufts University
PRS Account Tufts University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP