Advance Care Planning Coaching for Patients With Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

— MY WAY  

Official title:

Impact of Advance Care Planning Coaching for Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506087
• Other study ID #: GW091617
• Status: Completed
• Phase: N/A
• Start date: May 15, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: July 2020
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: March 31, 2020
• Est. primary completion date: October 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• 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.
• Printed advance care planning materials
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.

Locations

Country	Name	City	State
United States	Mountain Kidney & Hypertension Associates	Asheville	North Carolina
United States	University of Pittsburgh Medical Center Kidney Clinic	Pittsburgh	Pennsylvania
United States	Renal & Transplant Associates of New England	Springfield	Massachusetts
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (6)

Lead Sponsor	Collaborator
George Washington University	Mountain Kidney and Hypertension Associates, Quality Insights, Renal & Transplant Associates of New England, University of Pittsburgh, Washington Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Advance directive in EHR	Proportion of participants with advance directive or POLST/MOLST in EHR	16 weeks after baseline
Primary	ACP readiness score	Mean ACP readiness score at follow-up survey	14 weeks after baseline
Secondary	Medical decision maker documented in EHR	Proportion of participants with medical decision maker documented in EHR	16 weeks after baseline
Secondary	ACP conversation with nephrologist documented in EHR	Proportion of participants with documentation in EHR of ACP conversation with nephrologist	16 weeks after baseline