Decision-Aid for Renal Therapy Pilot Trial

NCT03454022 | Completed

• 1 other identifier: 12345
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (2)

• Completion of advance directives at 3 months.

  Participants will be asked if they have completed an advance directive.

  Assessed at 3 months

• 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).

  Assessed in patients at 3 months.

Secondary Outcomes (3)

• Congruence in patient-caregiver goals of care

  Assessed in patients and caregivers at 6 months.

• Change in baseline overall patient satisfaction score from the Canadian Health Care Evaluation Project (CANHELP) questionnaire at 3 months.

  Assessed in patients at 3 months.

• Change in baseline overall caregiver satisfaction score from the Canadian Health Care Evaluation Project (CANHELP) questionnaire at 3 months.

  Assessed in caregivers at 3 months.

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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

Behavioral: Choosing a Treatment for Kidney Failure

DART

EXPERIMENTAL

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; Behavioral: Choosing a Treatment for Kidney Failure

Interventions

DART BEHAVIORAL

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.

DART

Choosing a Treatment for Kidney Failure BEHAVIORAL

This is an educational pamphlet published by the National Kidney Foundation.

DART; Usual care

Eligibility Criteria

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

You may qualify if:

• 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
• year kidney failure risk probability \> 15% using \[www.kidneyfailurerisk.com\]
• Glomerular filtration rate (GFR) \< 30

You may not qualify if:

• Non-English speaking

Sponsors & Collaborators

• Tufts University: lead
• Tufts Medical Center: collaborator
• Saint Elizabeth's Medical Center: collaborator

Study Sites (2)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

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

Study Officials

• Keren Ladin, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: March 5, 2018
• Study Start: March 16, 2017
• Primary Completion: November 1, 2017
• Study Completion: July 1, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

US (2)