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NCT Number: NCT03454022

Decision-Aid for Renal Therapy Pilot Trial

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.

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Key information

Conditions

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

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center, Boston, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Choosing a Treatment for Kidney Failure

Behavioral

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • Saint Elizabeth's Medical Center
  • Tufts Medical Center

Registry information

Official study title

Decision-Aid for Renal Therapy Pilot Trial (DART Pilot Trial)

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 5, 2018
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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