Clinical trial NCT04919941: A Guide to Conservative Care
Official title: A Pilot Study of A Guide to Conservative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Decision Aid
Patient Engagement
Dialysis
End-of-life Care
Keywords: conservative care
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 92
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Test feasibility and acceptability of a patient decision aid
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* Patients

  * 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

Primary outcomes:
measure: Questionnaire on patient-provider discussions of conservative care .
timeFrame: 3 months
measure: Attrition
timeFrame: 3 months
Secondary outcomes:
measure: Treatment Preference
timeFrame: 3 months
measure: Treatment Goals
timeFrame: 3 months
measure: Guide Questionnaire
timeFrame: 2 weeks
measure: Guide Interview
timeFrame: 3 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
city: Seattle
country: United States
facility: University of Washington Medicine
state: Washington
Study officials:
affiliation: University of Washington
name: Susan P Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: