Chronic Kidney DiseasesMY WAYNCT03506087
Advance Care Planning Coaching for Patients With Chronic Kidney Disease
A study testing Advance care planning coaching session. and Printed advance care planning materials in people with Chronic Kidney Diseases, run by George Washington University at 4 sites in United States.
Trial summary
This project will develop and test a model intervention for Advance Care Planning (ACP) for patients with advanced chronic kidney disease (CKD) cared for in nephrology clinics that have the capacity to consult with or refer to palliative care. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Advance care planning coaching session. and Printed advance care planning materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 May 2018to 31 Mar 2020
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Kidney Disease (CKD) Stage 3-5
- Age 55 or older
- English speaking
- Patient at participating CKD clinic
Who cannot join
- Receiving dialysis
- Kidney transplant recipient
- Cognitively impaired or otherwise not competent to participate (as deemed by treating nephrologist and research staff)
- Participation contra-indicated for patient's health (as deemed by treating nephrologist)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mountain Kidney & Hypertension Associates
Asheville, North Carolina, 28801
University of Pittsburgh Medical Center Kidney Clinic
Pittsburgh, Pennsylvania, 15213
Renal & Transplant Associates of New England
Springfield, Massachusetts, 01107
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Impact of Advance Care Planning Coaching for Patients With Chronic Kidney Disease
This project will develop and test a model intervention for Advance Care Planning (ACP) for patients with advanced chronic kidney disease (CKD) cared for in nephrology clinics that have the capacity to consult with or refer to palliative care. Specifically, we will compare the effectiveness of having a trained ACP coach meet in person with patients to discuss their goals and preferences vs. providing patients with a packet of material to review on their own and then discuss with their nephrologist at their initiation.
Hypothesis: In patients aged 55 or older with stage 3-5 Chronic Kidney Disease cared for in a CKD outpatient clinic, an advance care planning process that involves in-person meetings with a trained ACP coach will be more effective than providing patients with printed educational materials alone.
Read the detailed description
BASELINE VISIT: After obtaining written informed consent, research staff will administer a baseline survey to assess ACP readiness as well as participant physical and emotional health. The participant will then be randomized to one of the study arms: intervention or control. Research staff will provide participants in both study arms with the advance care planning educational materials and instruct them that they are encouraged to discuss their thoughts and questions with the nephrologist, at their own initiation. Participants will be further encouraged to bring their advance directives (ADs) to the clinic to be scanned into the electronic health record (EHR) if they currently have ADs or complete them in the future.
ADVANCE CARE PLANNING COACHING SESSION (intervention arm only): Participants in the intervention arm will receive a 60-minute in-person coaching session. The advance care planning coach, trained in motivational interviewing, will use a flexible script and checklist to assess the participant's readiness to engage in advance care planning and guide the participant forward in the process, proceeding at the participant's pace. Some participants may complete advance directives while others will not get that far. The coach will document the clinical aspects of the discussion in the participant's medical chart according to clinic protocol and the research aspects in the participant tracking instruments. The ACP coach may arrange for one or more follow-up sessions as needed, typically conducted by telephone.
FOLLOW-UP ASSESSMENT SURVEY (both study arms): Approximately 14 weeks after the baseline visit, research staff will contact the participant to administer a follow-up assessment survey.
FOLLOW-UP CHART REVIEW: Approximately 16 weeks after the baseline visit, research staff will review the participant's medical chart to assess documentation of advance care planning activities, medical and health outcomes, and use of medical and palliative care services.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Advance care planning coaching session., Printed advance care planning materials
- Keywords
- Advance Care Planning, Shared Decision Making
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance care planning coaching session.Behavioural
A 60-minute in-person coaching session. The advance care planning coach, trained in motivational interviewing, will use a flexible script and checklist to assess the participant's readiness to engage in advance care planning and guide the participant forward in the process, proceeding at the participant's pace. Some participants may complete advance directives while others will not get that far. Some participants may receive a follow-up session 2-4 weeks later. Typically this 20 to 30-minute conversation will be by phone, but it may be conducted at the clinic as indicated for the participant.
Printed advance care planning materialsBehavioural
Participants are provided with a folder containing an advance care planning guide developed by the Coalition for the Supportive Care of Kidney Patients for persons with Chronic Kidney Disease. The patient folder also contains the advance directive form used by the clinic that is appropriate to the state.
| Study group | Role | What they receive |
|---|---|---|
| Coaching | Experimental | Receives printed advance care planning (ACP) materials. Receives advance care planning coaching session. May receive followup coaching session, typically by telephone. Receives: Behavioral: Advance care planning coaching session.; Behavioral: Printed advance care planning materials |
| Enhanced Control | Active comparator | Receives printed advance care planning materials only. Receives: Behavioral: Printed advance care planning materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advance directive in EHR
Proportion of participants with advance directive or POLST/MOLST in EHR
Measured: 16 weeks after baseline
ACP readiness score
Mean ACP readiness score at follow-up survey
Measured: 14 weeks after baseline
Secondary outcomes (2)
Medical decision maker documented in EHR
Proportion of participants with medical decision maker documented in EHR
Measured: 16 weeks after baseline
ACP conversation with nephrologist documented in EHR
Proportion of participants with documentation in EHR of ACP conversation with nephrologist
Measured: 16 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start15 May 2018
- Primary completion28 Oct 2019
- Study completion31 Mar 2020
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 Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to an intervention arm or an enhanced control arm. Participants in the intervention group will receive printed educational materials plus one or more ACP coaching sessions. Participants in the enhanced control arm will receive printed materials only.
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Quality Insights, Renal and Transplant Associates of New England, PC, Mountain Kidney and Hypertension Associates, University of Pittsburgh, Medstar Health Research Institute
- Responsible party
- Principal investigator, Dale Lupu, George Washington University
- Investigators
- Dale E Lupu, PhD, MPH, Principal investigator, The George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506087
- Sponsor's protocol ID
- GW091617
- Acronym
- MY WAY
- Status last verified
- Jul 2020
- First submitted
- 13 Apr 2018
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lupu DE, Aldous A, Anderson E, Schell JO, Groninger H, Sherman MJ, Aiello JR, Simmens SJ. Advance Care Planning Coaching in CKD Clinics: A Pragmatic Randomized Clinical Trial. Am J Kidney Dis. 2022 May;79(5):699-708.e1. doi: 10.1053/j.ajkd.2021.08.019. Epub 2021 Oct 12.
PubMed 34648897
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Advance Care Planning Coaching for Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03506087
- Acronym / sponsor ID
- MY WAY / GW091617
- Conditions
- Chronic Kidney Diseases
- Keywords
- Advance Care Planning, Shared Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Quality Insights, Renal and Transplant Associates of New England, PC, Mountain Kidney and Hypertension Associates, University of Pittsburgh, Medstar Health Research Institute
- Study start
- 15 May 2018 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 23 Apr 2018 (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 project will develop and test a model intervention for Advance Care Planning (ACP) for patients with advanced chronic kidney disease (CKD) cared for in nephrology clinics that have the capacity to consult with or refer to palliative care. Specifically, we will compare the effectiveness of having a trained ACP coach meet in person with patients to discuss their goals and preferences vs. providing patients with a packet of material to review on their own and then discuss with their nephrologist at their initiation.
Hypothesis: In patients aged 55 or older with stage 3-5 Chronic Kidney Disease cared for in a CKD outpatient clinic, an advance care planning process that involves in-person meetings with a trained ACP coach will be more effective than providing patients with printed educational materials alone.
Detailed description
BASELINE VISIT: After obtaining written informed consent, research staff will administer a baseline survey to assess ACP readiness as well as participant physical and emotional health. The participant will then be randomized to one of the study arms: intervention or control. Research staff will provide participants in both study arms with the advance care planning educational materials and instruct them that they are encouraged to discuss their thoughts and questions with the nephrologist, at their own initiation. Participants will be further encouraged to bring their advance directives (ADs) to the clinic to be scanned into the electronic health record (EHR) if they currently have ADs or complete them in the future.
ADVANCE CARE PLANNING COACHING SESSION (intervention arm only): Participants in the intervention arm will receive a 60-minute in-person coaching session. The advance care planning coach, trained in motivational interviewing, will use a flexible script and checklist to assess the participant's readiness to engage in advance care planning and guide the participant forward in the process, proceeding at the participant's pace. Some participants may complete advance directives while others will not get that far. The coach will document the clinical aspects of the discussion in the participant's medical chart according to clinic protocol and the research aspects in the participant tracking instruments. The ACP coach may arrange for one or more follow-up sessions as needed, typically conducted by telephone.
FOLLOW-UP ASSESSMENT SURVEY (both study arms): Approximately 14 weeks after the baseline visit, research staff will contact the participant to administer a follow-up assessment survey.
FOLLOW-UP CHART REVIEW: Approximately 16 weeks after the baseline visit, research staff will review the participant's medical chart to assess documentation of advance care planning activities, medical and health outcomes, and use of medical and palliative care services.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to an intervention arm or an enhanced control arm. Participants in the intervention group will receive printed educational materials plus one or more ACP coaching sessions. Participants in the enhanced control arm will receive printed materials only.
| Arm | Type | Receives |
|---|---|---|
| Coaching | Experimental | Behavioral: Advance care planning coaching session., Behavioral: Printed advance care planning materialsReceives printed advance care planning (ACP) materials. Receives advance care planning coaching session. May receive followup coaching session, typically by telephone. |
| Enhanced Control | Active comparator | Behavioral: Printed advance care planning materialsReceives printed advance care planning materials only. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic Kidney Disease (CKD) Stage 3-5
- Age 55 or older
- English speaking
- Patient at participating CKD clinic
Key exclusion criteria (4 listed)
- Receiving dialysis
- Kidney transplant recipient
- Cognitively impaired or otherwise not competent to participate (as deemed by treating nephrologist and research staff)
- Participation contra-indicated for patient's health (as deemed by treating nephrologist)
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 |
|---|---|---|
| Advance care planning coaching session.A 60-minute in-person coaching session. The advance care planning coach, trained in motivational interviewing, will use a flexible script and checklist to assess the participant's readiness to engage in advance care planning and guide the participant forward in the process, proceeding at the participant's pace. Some participants may complete advance directives while others will not get that far. Some participants may receive a follow-up session 2-4 weeks later. Typically this 20 to 30-minute conversation will be by phone, but it may be conducted at the clinic as indicated for the participant. | Behavioural | Coaching |
| Printed advance care planning materialsParticipants are provided with a folder containing an advance care planning guide developed by the Coalition for the Supportive Care of Kidney Patients for persons with Chronic Kidney Disease. The patient folder also contains the advance directive form used by the clinic that is appropriate to the state. | Behavioural | Coaching, Enhanced Control |
Primary outcome
Advance directive in EHR
Time frame: 16 weeks after baseline
Proportion of participants with advance directive or POLST/MOLST in EHR
ACP readiness score
Time frame: 14 weeks after baseline
Mean ACP readiness score at follow-up survey
2 secondary outcomes
Medical decision maker documented in EHR
Time frame: 16 weeks after baseline
ACP conversation with nephrologist documented in EHR
Time frame: 16 weeks after baseline
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 9 Jul 2020.
- Derived from this study: PubMed 34648897Lupu DE, Aldous A, Anderson E, Schell JO, Groninger H, Sherman MJ, Aiello JR, Simmens SJ. Advance Care Planning Coaching in CKD Clinics: A Pragmatic Randomized Clinical Trial. Am J Kidney Dis. 2022 May;79(5):699-708.e1. doi: 10.1053/j.ajkd.2021.08.019. Epub 2021 Oct 12.
- Individual participant dataSharing planned: No
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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.
Dale E Lupu, PhD, MPH principal investigator
The George Washington University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance care planning coaching session. and Printed advance care planning materials in people with Chronic Kidney Diseases, run by George Washington University at 4 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 4 inclusion and 4 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 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Advance directive in EHR (time frame: 16 weeks after baseline). 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 NCT03506087, 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 9 Jul 2020.