Clinical trial NCT03506087: Advance Care Planning Coaching for Patients With Chronic Kidney Disease
Official title: Impact of Advance Care Planning Coaching for Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Advance Care Planning
Shared Decision Making
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Quality Insights
name: Renal & Transplant Associates of New England
name: Mountain Kidney and Hypertension Associates
name: University of Pittsburgh
name: Medstar Health Research Institute
First posted: 2018-04-23
Enrollment: 288
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Chronic Kidney Disease (CKD) Stage 3-5
* Age 55 or older
* English speaking
* Patient at participating CKD clinic

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Advance directive in EHR
timeFrame: 16 weeks after baseline
measure: ACP readiness score
timeFrame: 14 weeks after baseline
Secondary outcomes:
measure: Medical decision maker documented in EHR
timeFrame: 16 weeks after baseline
measure: ACP conversation with nephrologist documented in EHR
timeFrame: 16 weeks after baseline
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Springfield
country: United States
facility: Renal & Transplant Associates of New England
state: Massachusetts
city: Asheville
country: United States
facility: Mountain Kidney & Hypertension Associates
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Kidney Clinic
state: Pennsylvania
Study officials:
affiliation: The George Washington University
name: Dale E Lupu, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.