Decision Aid for Renal Therapy

NCT03522740 | Completed

• 1 other identifier: 12890
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Kidney Diseases; Kidney Failure, Chronic

Keywords

Chronic Kidney Disease; Chronic Kidney Failure; Palliative Care; Dialysis; End-of-life care; Decision making

Outcome Measures

Primary Outcomes (1)

• Change in score for patient-participants on the Decisional Conflict Scale, Low Literacy Version

  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

  3 months

Secondary Outcomes (6)

• Change in score for patient-participants on the Decisional Conflict Scale, Low Literacy Version

  Up to 18 months

• Advance Directive Completion

  3 months

• Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Patients

  3 months

• Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Carepartners

  3 months

• Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Patients

  Up to 18 months

Other Outcomes (2)

• Instability of Patient Preferences

  Up to 18 months

• Patient/Care-Partner Concordance

  Up to 18 months

Study Arms (2)

Decision Aid for Renal Therapy

ACTIVE COMPARATOR

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

Usual Care

NO INTERVENTION

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

Interventions

Decision Aid for Renal Therapy OTHER

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.

Decision Aid for Renal Therapy

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tufts University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (4)

University of California San Diego

San Diego, California, 92103, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (3)

• Gonzales KM, Koch-Weser S, Kennefick K, Lynch M, Porteny T, Tighiouart H, Wong JB, Isakova T, Rifkin DE, Gordon EJ, Rossi A, Weiner DE, Ladin K. Decision-Making Engagement Preferences among Older Adults with CKD. J Am Soc Nephrol. 2024 Jun 1;35(6):772-781. doi: 10.1681/ASN.0000000000000341. Epub 2024 Mar 22.

  PMID: 38517479 DERIVED

• Ladin K, Tighiouart H, Bronzi O, Koch-Weser S, Wong JB, Levine S, Agarwal A, Ren L, Degnan J, Sewall LN, Kuramitsu B, Fox P, Gordon EJ, Isakova T, Rifkin D, Rossi A, Weiner DE. Effectiveness of an Intervention to Improve Decision Making for Older Patients With Advanced Chronic Kidney Disease : A Randomized Controlled Trial. Ann Intern Med. 2023 Jan;176(1):29-38. doi: 10.7326/M22-1543. Epub 2022 Dec 20.

  PMID: 36534976 DERIVED

• Porteny T, Gonzales KM, Aufort KE, Levine S, Wong JB, Isakova T, Rifkin DE, Gordon EJ, Rossi A, Di Perna G, Koch-Weser S, Weiner DE, Ladin K; Stakeholder Advisory Board. Treatment Decision Making for Older Kidney Patients during COVID-19. Clin J Am Soc Nephrol. 2022 Jul;17(7):957-965. doi: 10.2215/CJN.13241021. Epub 2022 Jun 7.

  PMID: 35672037 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Daniel E Weiner, MD

  Tufts Medical Center and Tufts University

  PRINCIPAL INVESTIGATOR

• Keren Ladin, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 11, 2018
• Study Start: May 30, 2018
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)