A Guide to Conservative Care

End Stage Renal Disease Clinical Trial

Official title:

A Pilot Study of A Guide to Conservative Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04919941
• Other study ID #: STUDY00010555
• Secondary ID: Pilot/Explorator
• Status: Completed
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Decision Aid
• Dialysis
• End Stage Renal Disease
• End-of-life Care
• Kidney Failure, Chronic
• Patient Engagement

Intervention

Other:
• A Guide to Conservative Care
The intervention is receipt of a patient decision aid on conservative care, entitled A Guide to Conservative Care. This is 12-page printed handout that provides an overview of conservative care. Participants assigned to the intervention group are mailed a copy of the Guide after their initial baseline visit (T1). Participants keep the Guide throughout the duration of the study.

Locations

Country	Name	City	State
United States	University of Washington Medicine	Seattle	Washington
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire on patient-provider discussions of conservative care .	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.	3 months
Primary	Attrition	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.	3 months
Secondary	Treatment Preference	Preference for dialysis or conservative care will be assessed using the Decision Conflict Scale (DCS) at each study visit. The DCS is a16-item survey to assess their level of difficulty in choosing between dialysis vs. conservative care based on uncertainty, values clarity and feeling informed and supported in decision-making. Each item is rated from 0-4 (higher scores indicating greater conflict). For close persons, their preference for dialysis or conservative care for the patient will also be assessed using the Decision Conflict Scale at each study visit.	3 months
Secondary	Treatment Goals	For each patient at each study visit, patients about their preference for either extending life, preserving comfort or unsure using a validated survey question. Close persons will also be asked the same question about what they perceive the patients' healthcare goals are at each study visit.	3 months
Secondary	Guide Questionnaire	For participants randomized to receive the intervention, at T2, they will complete a survey inquiring whether they reviewed the Guide, the time it took to review the Guide and whether they had made any notes in the Guide.	2 weeks
Secondary	Guide Interview	For participants randomized to receive the intervention, at T2 and T3, they will complete a qualitative interview inquiring their likes/dislikes about the Guide, what they found useful/not useful about the Guide, what they found difficult about the Guide, suggestions to improve the Guide, and whether the Guide helped to support discussions about conservative care with others and their healthcare providers.	3 months