Developing Tools for Dialysis Decision Support

Not Applicable

Recruiting

• Conditions: Chronic Kidney Diseases

• Registration Number: NCT06597279
• Lead Sponsor: VA Palo Alto Health Care System

Brief Summary

The aim of this study is to evaluate the impact of a web-based dialysis decision support tool on decisional conflict, and values-treatment concordance and other decisional outcomes in individuals with advanced chronic kidney disease, and to assess the tool's acceptability and usability.

Detailed Description

This study employs a pre-post design to assess the impact of a web-based dialysis decision support tool on patients with advanced chronic kidney disease and their caregivers. Participants will complete baseline surveys assessing demographics, knowledge of kidney failure treatments, and decisional conflict during a nephrology clinic visit. Following the visit, participants will access the decision support tool, with follow-up support provided by the study coordinator. One to four weeks after the baseline visit, participants will complete follow-up surveys to re-evaluate knowledge, decisional conflict, values-treatment concordance, and the quality of shared decision-making. Additionally, telephone interviews will be conducted to explore participants' understanding of treatment options and gather feedback on the decision support tool.

Study Timeline

• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-11
• Study First Posted: 2024-09-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Study Start: 2024-11-21
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Age >=65
2. Estimated GFR <25 ml/min/1.73m2
3. English speaking
4. Not a candidate for kidney transplant based on nephrologist assessment.

Family/caregiver inclusion criteria:

1. age >=21
2. English speaking

Exclusion Criteria

a. Patients with cognitive impairment will be excluded; however their family member or caregiver is eligible to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Treatment choice	1 month	Proportion of patients who choose medical management without dialysis
Values treatment concordance	1 month	Change in values treatment concordance.
Confidence in treatment decision	1 month	Confidence in kidney failure treatment decision
Decisional Conflict Scale (DCS)	1 month	Change in the decisional conflict scale (DCS) score from baseline to follow-up. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\].

Trial Locations

Locations (2)

U.S. Department of Veterans Affairs - Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States

Stanford Health Care; 🇺🇸 Stanford, California, United States