- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04919941
A Guide to Conservative Care
A Pilot Study of A Guide to Conservative Care
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System
-
Seattle, Washington, United States, 98198
- University of Washington Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Decision aid
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.
|
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.
|
NO_INTERVENTION: Control
Did not receive the decision aid.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Preference
Time Frame: 3 months
|
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
|
Treatment Goals
Time Frame: 3 months
|
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
|
Guide Questionnaire
Time Frame: 2 weeks
|
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
|
Guide Interview
Time Frame: 3 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan P Wong, MD, University of Washington
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00010555
- Pilot/Exploratory Grant (OTHER_GRANT: National Palliative Care Research Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on End Stage Renal Disease
-
Outset MedicalCompletedAcute Kidney Injury | End Stage Renal Disease (ESRD) | End Stage Renal Disease on DialysisUnited States
-
University of Illinois at ChicagoWithdrawnObesity | End-Stage Renal Disease | Renal Disease, End-Stage | Renal Failure, End-StageUnited States
-
Bioconnect Systems, IncCompletedEnd-stage Renal Disease | End-stage Kidney DiseaseUnited States
-
Iperboreal Pharma SrlWithdrawnEnd-Stage Renal Disease
-
Cubist Pharmaceuticals LLCCompleted
-
Medical University of GrazWithdrawnEnd-stage Renal DiseaseAustria
-
Janssen Research & Development, LLCBayerCompleted
-
Chulalongkorn UniversityCompletedEnd-stage Renal DiseaseThailand
-
University of KansasCompletedEnd-Stage Renal Disease
-
Eisai Co., Ltd.CompletedEnd-Stage Renal DiseaseJapan
Clinical Trials on A Guide to Conservative Care
-
University of NottinghamNORTHAMPTONSHIRE HEALTHCARE NHS FOUNDATION TRUSTCompleted
-
University of Modena and Reggio EmiliaCompletedLiver Cirrhosis | Coagulation Disorder
-
Oregon Center for Applied Science, Inc.Completed
-
MTI UniversityCompletedAmputation; Traumatic, Leg, LowerEgypt
-
Thomas Wright, MDTactile MedicalCompletedLipedema | LipolymphedemaUnited States
-
Yale UniversityIcahn School of Medicine at Mount SinaiCompletedFamily CaregiversUnited States
-
Prof. Dr. Martin WabitschCharite University, Berlin, Germany; University of Leipzig; University of Witten... and other collaboratorsActive, not recruiting
-
Oregon Center for Applied Science, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedReproductive HealthUnited States
-
Abant Izzet Baysal UniversityCompleted
-
Hasan Kalyoncu UniversityCompletedSubacromial Impingement Syndrome | Morphologic ChangeTurkey