Advance Care Planning Coaching for Patients With Chronic Kidney Disease

NCT ID: NCT03506087

Last Updated: 2020-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2020-03-31

Brief Summary

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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

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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

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Coaching

Receives printed advance care planning (ACP) materials. Receives advance care planning coaching session. May receive followup coaching session, typically by telephone.

Group Type EXPERIMENTAL

Advance care planning coaching session.

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Enhanced Control

Receives printed advance care planning materials only.

Group Type ACTIVE_COMPARATOR

Printed advance care planning materials

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Quality Insights

UNKNOWN

Sponsor Role collaborator

Renal & Transplant Associates of New England

UNKNOWN

Sponsor Role collaborator

Mountain Kidney and Hypertension Associates

UNKNOWN

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

Medstar Health Research Institute

OTHER

Sponsor Role collaborator

George Washington University

OTHER

Sponsor Role lead

Responsible Party

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Dale Lupu

Associate Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dale E Lupu, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

The George Washington University

Locations

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MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Renal & Transplant Associates of New England

Springfield, Massachusetts, United States

Site Status

Mountain Kidney & Hypertension Associates

Asheville, North Carolina, United States

Site Status

University of Pittsburgh Medical Center Kidney Clinic

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34648897 (View on PubMed)

Other Identifiers

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GW091617

Identifier Type: -

Identifier Source: org_study_id

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