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Decision Aid for Renal Therapy (DART)

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ClinicalTrials.gov Identifier: NCT03522740
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Tufts University

Brief Summary:

Good communication among patients, their families and loved ones, and their medical care providers is important when figuring out how to treat chronic diseases like kidney disease. A lot of people may not know all of their choices for how to treat kidney disease, and this can lead to rushed decisions or even a sense that there weren't any choices to make. In this study, the investigators are trying to find out if a decision-aid program on a computer can help people with kidney disease have more confidence in their decisions and have better agreement about their decisions with their families and loved ones.

The DART study will be conducted at four sites in different areas of the country: Boston, Massachusetts; Portland, Maine; Chicago, Illinois; and San Diego, California. The study will enroll a total of 400 people with kidney disease at these four sites.


Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Kidney Failure, Chronic Other: Decision Aid for Renal Therapy Not Applicable

Detailed Description:

Aligning patient preferences (goals of care and values) with treatment is essential for quality health care. Treatment of life-limiting illness is especially preference-sensitive, where high-intensity care often offers marginal survival benefit but can worsen quality of life. Elderly persons with advanced chronic kidney disease (CKD) may face a choice between high-intensity dialysis and low-intensity conservative management (CM). This decision is of special import because it is often irreversible as dialysis itself can diminish residual kidney function. In adults over 70 years-old with advanced CKD, dialysis on average confers only marginally better survival than medical management while reducing independence and mobility and increasing medical procedures. Poor communication about benefits and risks of treatment options available to these patients results in decisional conflict: a state of uncertainty associated with making a choice that best reflects values and preferences. However, it is unclear how to best educate patients and their care-partners about their treatment choices and the importance of advance care planning.

The objective of this trial is to compare the effectiveness of two widely used strategies, in-person education alone versus in-person education plus an interactive web-based decision aid, in: 1) reducing decisional conflict and empowering patients and care-partners to select treatment aligned with patient preferences; and 2) improving care-partners' ability to confidently and accurately express patients' preferences when patients are unable (proxy decision-making).

The hypothesis is that, compared to traditional in-person education, use of the Decision Aid for Renal Therapy (DART) will decrease decisional conflict, increase completion of advance directives, improve patient and caregiver satisfaction with treatment (quantitative outcomes), and contribute to greater patient engagement, satisfaction with decision-making, and care-partner concordance (qualitative and quantitative outcomes).

DART is a web-based multimedia decision-aid that is designed to be accessible to individuals with limited health literacy. The investigators will evaluate whether use of DART results in greater patient understanding of options, leading to better discussions with care providers, and ultimately lower decisional conflict and greater completion of advanced directives compared with the comparator, in-person education. DART is replicable, consistent, can be shared with care-partners, and can be viewed in the comfort of the patient's home.

This randomized clinical trial targeting 400 older adults with advanced kidney disease and as many as 400 of their care-partners compares the effectiveness of DART plus in-person education to in-person education alone for reducing decisional conflict and increasing completion of advance care plans (ACPs) among older adults with advanced CKD and their care-partners. Patients and patient-care-partner pairs will be surveyed at baseline for goals of care, life goals, health literacy, patient activation, end-of-life (EOL) preferences and baseline scores on other study outcome measures, and followed at 3- to 6-month intervals for up to 18 months, censoring at dialysis, death or study end, to collect data on decisional conflict and completion of advance directives as well as QOL, satisfaction, dyad concordance and medical events, such as dialysis initiation.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Decision Aid for Renal Therapy: Promoting Knowledge and Autonomy in Chronic Kidney Disease Patients and Their Care-Partners
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: Decision Aid for Renal Therapy
Usual Care as in the 'no intervention arm' below plus access to an web-based decision aid, the Decision Aid for Renal Therapy to patients and their care-partners
Other: Decision Aid for Renal Therapy
DART is a web-based decision aid that informs older adults with advanced kidney disease of kidney disease treatment options and prompts them to consider their preferences and raise questions to discuss with their kidney disease providers.

No Intervention: Usual Care
In-person education as would be done at study sites plus 'Choosing a Treatment for Kidney Failure', an educational booklet published by the National Kidney Foundation



Primary Outcome Measures :
  1. Change in score for patient-participants on the Decisional Conflict Scale, Low Literacy Version [ Time Frame: 3 months ]

    The decisional conflict scale (DCS) measures personal perceptions of:

    1. Uncertainty in choosing options; and
    2. Modifiable factors contributing to uncertainty.

    The low literacy version of the DCS contains 10 items scored on a 3 point scale, with 0 points given for an answer of yes, 2 for an answer of unsure, and 4 for an answer of no.

    The total DCS score is the sum of the 10 items, multiplied by 2.5. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)

    The DCS can be conceptualized as subscores, which will be examined as a part of this study, and are normalized to a 0 to 100 score as above. These include the following:

    1. Uncertainty subscore: 2 items (questions 9 and 10)
    2. Informed subscore: 3 items (questions 1, 2, and 3)
    3. Values clarity subscore: 2 items (questions 4 and 5)
    4. Support subscore: 3 items (questions 6, 7, and 8)

    Reference: https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf



Secondary Outcome Measures :
  1. Change in score for patient-participants on the Decisional Conflict Scale, Low Literacy Version [ Time Frame: Up to 18 months ]

    The decisional conflict scale (DCS) measures personal perceptions of:

    1. Uncertainty in choosing options; and
    2. Modifiable factors contributing to uncertainty.

    The low literacy version of the DCS contains 10 items scored on a 3 point scale, with 0 points given for an answer of yes, 2 for an answer of unsure, and 4 for an answer of no.

    The total DCS score is the sum of the 10 items, multiplied by 2.5. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)

    The DCS can be conceptualized as subscores, which will be examined as a part of this study, and are normalized to a 0 to 100 score as above. These include the following:

    1. Uncertainty subscore: 2 items (questions 9 and 10)
    2. Informed subscore: 3 items (questions 1, 2, and 3)
    3. Values clarity subscore: 2 items (questions 4 and 5)
    4. Support subscore: 3 items (questions 6, 7, and 8)

    Reference: https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf


  2. Advance Directive Completion [ Time Frame: 3 months ]
    Completion of an advance directive, Physician Orders for Life-Sustaining Treatment (POLST), or both among patient-participants ascertained by participant query and/or chart review.

  3. Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Patients [ Time Frame: 3 months ]

    Change in score on the CANHELP Lite Patient Questionnaire version 11 Nov 2014 for patient-participants.

    The CANHELP Lite Patient Questionnaire includes 21 items. One is a general question while the other 20 items inform 5 domains:

    Domain #1: Relationship with doctors: Questions 2, 3, and 4 Domain #2: Illness Management: Q5 - 13 Domain #3: Communication: Q13 - 16 Domain #4: Decision Making: Q17 - 20 Domain #5: Feeling at Peace: Q21 Questions are scored on a 5-point scale, ranging from 'Not at All' to 'Completely'. The Overall Score is the unweighted average of all answered questions. Individual domain scores are the unweighted average of non-missing questions specific to each domain. All scores are subsequently re-scaled to range between 0 (worst possible value) and 100 (best possible value). The Overall Score will be the focus of analyses.

    Ref: Heyland et al. J Pain Symptom Manage. 2013


  4. Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Carepartners [ Time Frame: 3 months ]

    Change in score on the CANHELP Lite Caregiver Questionnaire 11 Nov 2014 for carepartner participants.

    The CANHELP Lite Caregiver Questionnaire includes 23 items. Two are general questions while the remaining 21 items inform 5 domains:

    Domain #1: Relationship with doctors: Questions 3 - 5 Domain #2: Characteristics of Doctors and Nurses: Q6-7 Domain #3: Illness Management: Q8-16 Domain #4: Communication and Decision Making: Q17-20 Domain #5: Your Involvement: Q21-23

    Questions are scored on a 5-point scale, ranging from 'Not at All' to 'Completely'. The Overall Score is the unweighted average of all answered questions. Individual domain scores are the unweighted average of non-missing questions specific to each domain. All scores are subsequently re-scaled to range between 0 (worst possible value) and 100 (best possible value). The Overall Score will be the focus of analyses.

    Ref: Heyland et al. J Pain Symptom Manage. 2013


  5. Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Patients [ Time Frame: Up to 18 months ]

    Change in score on the CANHELP Lite Patient Questionnaire version 11 Nov 2014 for patient-participants.

    The CANHELP Lite Patient Questionnaire includes 21 items. One is a general question while the other 20 items inform 5 domains:

    Domain #1: Relationship with doctors: Questions 2, 3, and 4 Domain #2: Illness Management: Q5 - 13 Domain #3: Communication: Q13 - 16 Domain #4: Decision Making: Q17 - 20 Domain #5: Feeling at Peace: Q21 Questions are scored on a 5-point scale, ranging from 'Not at All' to 'Completely'. The Overall Score is the unweighted average of all answered questions. Individual domain scores are the unweighted average of non-missing questions specific to each domain. All scores are subsequently re-scaled to range between 0 (worst possible value) and 100 (best possible value). The Overall Score will be the focus of analyses.

    Ref: Heyland et al. J Pain Symptom Manage. 2013


  6. Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Carepartners [ Time Frame: Up to 18 months ]

    Change in score on the CANHELP Lite Caregiver Questionnaire 11 Nov 2014 for carepartner participants.

    The CANHELP Lite Caregiver Questionnaire includes 23 items. Two are general questions while the remaining 21 items inform 5 domains:

    Domain #1: Relationship with doctors: Questions 3 - 5 Domain #2: Characteristics of Doctors and Nurses: Q6-7 Domain #3: Illness Management: Q8-16 Domain #4: Communication and Decision Making: Q17-20 Domain #5: Your Involvement: Q21-23

    Questions are scored on a 5-point scale, ranging from 'Not at All' to 'Completely'. The Overall Score is the unweighted average of all answered questions. Individual domain scores are the unweighted average of non-missing questions specific to each domain. All scores are subsequently re-scaled to range between 0 (worst possible value) and 100 (best possible value). The Overall Score will be the focus of analyses.

    Ref: Heyland et al. J Pain Symptom Manage. 2013



Other Outcome Measures:
  1. Instability of Patient Preferences [ Time Frame: Up to 18 months ]
    A reversal of the post-intervention decision (dialysis or conservative management) from the first visit after DART/3month follow-up and study completion

  2. Patient/Care-Partner Concordance [ Time Frame: Up to 18 months ]
    Goal concordance as assessed on the goals of care survey



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • CKD stages 4 or 5 (non-dialysis) without an established dialysis start or transplant date within three months of expected randomization;
  • Age >70 (with no upper limit);
  • English speaking;
  • Willingness to be randomized to DART; and
  • Able to sign informed consent.

Exclusion Criteria:

  • death, dialysis initiation or transplant deemed highly likely within the next three months by the patient's nephrologist

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): NCT03522740


Contacts
Contact: Daniel E Weiner, MD 6176365070 dweiner@tuftsmedicalcenter.org

Locations
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92103
Contact: Jack Degnan    619-471-0592    jdegnan@ucsd.edu   
Contact: Dena Rifkin, MD    858-552-2784    drifkin@ucsd.edu   
Principal Investigator: Dena Rifkin, MD         
Sub-Investigator: Danuta Trzebinska, MD         
Sub-Investigator: Tammy Rubenzik, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Carlos Martinez, CCRP    312-503-1808    Carlos.martinez@northwestern.edu   
Contact: Patrick Fox    312-503-1887    patrick.fox@northwestern.edu   
Principal Investigator: Elisa Gordon, PhD         
Sub-Investigator: Tamara Isakova, MD         
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Katrina Ferguson    207-396-8240    KFerguson@mmc.org   
Contact: Ana Rossi, MD    2077745222    arossi@mmc.org   
Principal Investigator: Ana Rossi, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Arushi Agarwal    617-636-4877    agarwal3@tuftsmedicalcenter.org   
Contact: Daniel E Weiner, MD    6176365070    dweiner@tuftsmedicalcenter.org   
Principal Investigator: Daniel E Weiner, MD         
Sponsors and Collaborators
Tufts University
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Daniel E Weiner, MD Tufts Medical Center and Tufts University
Principal Investigator: Keren Ladin, PhD Tufts University

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT03522740     History of Changes
Other Study ID Numbers: 12890
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tufts University:
Chronic Kidney Disease
Chronic Kidney Failure
Palliative Care
Dialysis
End-of-life care
Decision making

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases