Advance Care Planning Coaching for Patients With Chronic Kidney Disease
MY WAY
Impact of Advance Care Planning Coaching for Patients With Chronic Kidney Disease
1 other identifier
interventional
288
1 country
4
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2018
CompletedFirst Posted
Study publicly available on registry
April 23, 2018
CompletedStudy Start
First participant enrolled
May 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedJuly 9, 2020
July 1, 2020
1.5 years
April 13, 2018
July 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Advance directive in EHR
Proportion of participants with advance directive or POLST/MOLST in EHR
16 weeks after baseline
ACP readiness score
Mean ACP readiness score at follow-up survey
14 weeks after baseline
Secondary Outcomes (2)
Medical decision maker documented in EHR
16 weeks after baseline
ACP conversation with nephrologist documented in EHR
16 weeks after baseline
Study Arms (2)
Coaching
EXPERIMENTALReceives printed advance care planning (ACP) materials. Receives advance care planning coaching session. May receive followup coaching session, typically by telephone.
Enhanced Control
ACTIVE COMPARATORReceives printed advance care planning materials only.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Chronic Kidney Disease (CKD) Stage 3-5
- Age 55 or older
- English speaking
- Patient at participating CKD clinic
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- George Washington Universitylead
- Quality Insightscollaborator
- Renal & Transplant Associates of New Englandcollaborator
- Mountain Kidney and Hypertension Associatescollaborator
- University of Pittsburghcollaborator
- Medstar Health Research Institutecollaborator
Study Sites (4)
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Renal & Transplant Associates of New England
Springfield, Massachusetts, 01107, United States
Mountain Kidney & Hypertension Associates
Asheville, North Carolina, 28801, United States
University of Pittsburgh Medical Center Kidney Clinic
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
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.
PMID: 34648897DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dale E Lupu, PhD, MPH
The George Washington University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Research Professor
Study Record Dates
First Submitted
April 13, 2018
First Posted
April 23, 2018
Study Start
May 15, 2018
Primary Completion
October 28, 2019
Study Completion
March 31, 2020
Last Updated
July 9, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share