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Clinical Trials/NCT04919941
NCT04919941
Completed
N/A

A Pilot Study of A Guide to Conservative Care

University of Washington2 sites in 1 country92 target enrollmentAugust 31, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
End Stage Renal Disease
Sponsor
University of Washington
Enrollment
92
Locations
2
Primary Endpoint
Questionnaire on patient-provider discussions of conservative care .
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This is a randomized pilot study to test the feasibility and acceptability of a patient decision aid on conservative care among older patients with advanced CKD and their close persons.

Detailed Description

Conservative care is an important therapeutic option for patients with advanced chronic kidney disease (CKD) who do not wish to pursue maintenance dialysis. However, most patient educational materials on treatment options for advanced CKD do not include information. This study is a randomized pilot study to test the acceptability and feasibility of a novel patient decision aid on conservative care, entitled A Guide to Conservative Care, among older patients with advanced CKD and their close persons. The investigators hypothesize that the Guide will be feasible and acceptable to patients and families as reflected in greater discussion of conservative care with health care providers following receipt of the Guide as compared with usual care. The study will enroll 92 patients aged 75 years and older with advanced CKD and up to 92 of their close persons from University of Washington Medicine and Veterans Affairs Puget Sound Health Care System. Enrolled patients are invited but not required to nominate a close person (defined as a person who assists the patient with his/her advanced CKD) to also participate in the study. Patients and their close persons will be randomized together in a 1:1 fashion to receive either the Guide (i.e. intervention) or usual care (i.e. control). Data from participants will be collected at the time of enrollment, 2-week follow-up and 3-month follow-up. As a reflection of acceptability and feasibility, the primary outcome measure is difference in rates of discussion of conservative care with a healthcare provider at 3-month follow-up. Increased motivation for patients to discuss of conservative care with their health care providers would reflect that the Guide is acceptable to patients and can be feasibly incorporated by them into their care planning. The investigators will also collect completion and attrition rates at the second and third study visits as additional measures of acceptability and feasibility. Furthermore, the investigators will collect feedback on the Guide and experiences with using the Guide from participants who received the Guide using qualitative interviews at 2-week and 3-month follow-up. The investigators will also explore treatment goals and preferences for advanced CKD using standardized surveys at each study visit. The investigators will use the information gathered during the study towards further refining the Guide so that it will be ready for distribution at participating study sites and future testing in broader patient populations.

Registry
clinicaltrials.gov
Start Date
August 31, 2020
End Date
April 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susan Wong

Assistant Professor, School of Medicine: Nephrology

University of Washington

Eligibility Criteria

Inclusion Criteria

  • Adults aged ≥75 years
  • Diagnosis of advanced CKD as defined as having at least 2 outpatient measures of eGFR \<25 ml/min/1.73m2 separated by \>90 days in the prior year and with at least 1 of these measures of eGFR \<20 ml/min/1.73m2
  • Must be english-speaking
  • Close persons
  • Adults aged ≥18 years
  • Must assist patient with their kidney disease care
  • Must be English-speaking

Exclusion Criteria

  • Patients and Close Person
  • Unable to provide informed consent

Outcomes

Primary Outcomes

Questionnaire on patient-provider discussions of conservative care .

Time Frame: 3 months

Using a questionnaire, patients will be asked whether they had discussed conservative care with any of their healthcare providers prior to T1 and by T3. Possible responses are "yes", "no" or "unsure." Greater motivation to discuss conservative care with their care providers at T3 after would indicate that the Guide is acceptable to patients and can be feasibly incorporated by them into their care planning.

Attrition

Time Frame: 3 months

The proportion of participants in each study arm who withdraw from the study and the reasons why at T2 and T3. Study withdrawal would indicate that the Guide and/or study is unacceptable or burdensome to the participant.

Secondary Outcomes

  • Guide Interview(3 months)
  • Guide Questionnaire(2 weeks)
  • Treatment Goals(3 months)
  • Treatment Preference(3 months)

Study Sites (2)

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