End Stage Renal DiseaseNCT04919941
A Guide to Conservative Care
A study testing A Guide to Conservative Care in people with End Stage Renal Disease and Decision Aid, run by University of Washington at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Disease, Decision Aid, Patient Engagement
- What is being tested?
- A Guide to Conservative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Aug 2020to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- -Patients and Close Person
- Unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Puget Sound Health Care System
Seattle, Washington, 98108
University of Washington Medicine
Seattle, Washington, 98198
About this study
Official title: A Pilot Study of A Guide to Conservative Care
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.
Read the 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.
- Being tested
- A Guide to Conservative Care
- Keywords
- conservative care
- Medical subject headings
- Kidney Failure, Chronic, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Guide to Conservative CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision aid | Experimental | 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. Receives: Other: A Guide to Conservative Care |
| Control | No intervention | Did not receive the decision aid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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.
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 2 weeks
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start31 Aug 2020
- Primary completion31 Jan 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Test feasibility and acceptability of a patient decision aid
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Wong, University of Washington
- Investigators
- Susan P Wong, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919941
- Sponsor's protocol ID
- STUDY00010555
- Other IDs
- Pilot/Exploratory Grant
- Status last verified
- Jun 2021
- First submitted
- 28 May 2021
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified individual participant data collected and study protocols will be shared immediately following publication and ending 5 years following article publication with researchers who provide a written request and sound research proposal. Interested researchers can contact the principal investigator directly.
Publications
Wong SPY, Oestreich T, Prince DK, Curtis JR. A Patient Decision Aid About Conservative Kidney Management in Advanced Kidney Disease: A Randomized Pilot Trial. Am J Kidney Dis. 2023 Aug;82(2):179-188. doi: 10.1053/j.ajkd.2022.12.007. Epub 2023 Feb 4.
PubMed 36740038
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of A Guide to Conservative Care
- ClinicalTrials.gov ID
- NCT04919941
- Acronym / sponsor ID
- STUDY00010555
- Keywords
- conservative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Test feasibility and acceptability of a patient decision aid
| Arm | Type | Receives |
|---|---|---|
| Decision aid | Experimental | Other: A Guide to Conservative CareThe 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. |
| Control | No intervention | –Did not receive the decision aid. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Patients
- Close persons
Key exclusion criteria (2 listed)
- -Patients and Close Person
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Guide to Conservative CareThe 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. | Other | Decision aid |
Primary outcome
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.
4 secondary outcomes
Treatment Preference
Time frame: 3 months
Treatment Goals
Time frame: 3 months
Guide Questionnaire
Time frame: 2 weeks
Guide Interview
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Derived from this study: PubMed 36740038Wong SPY, Oestreich T, Prince DK, Curtis JR. A Patient Decision Aid About Conservative Kidney Management in Advanced Kidney Disease: A Randomized Pilot Trial. Am J Kidney Dis. 2023 Aug;82(2):179-188. doi: 10.1053/j.ajkd.2022.12.007. Epub 2023 Feb 4.
- Individual participant dataSharing planned: Yes. All de-identified individual participant data collected and study protocols will be shared immediately following publication and ending 5 years following article publication with researchers who provide a written request and sound research proposal. Interested researchers can contact the principal investigator directly.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan P Wong, MD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Guide to Conservative Care in people with End Stage Renal Disease and Decision Aid, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire on patient-provider discussions of conservative care . (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04919941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022; AzTrials last refreshed its copy on 26 Oct 2026.