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OpenTrials
Completed

NCT Number: NCT03506087

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Washington Hospital Center, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Advance care planning coaching session.

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

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.

Primary outcomes

  1. Advance directive in EHR

    Time frame: 16 weeks after baseline

    Proportion of participants with advance directive or POLST/MOLST in EHR

  2. ACP readiness score

    Time frame: 14 weeks after baseline

    Mean ACP readiness score at follow-up survey

Secondary outcomes

  1. Medical decision maker documented in EHR

    Time frame: 16 weeks after baseline

    Proportion of participants with medical decision maker documented in EHR

  2. ACP conversation with nephrologist documented in EHR

    Time frame: 16 weeks after baseline

    Proportion of participants with documentation in EHR of ACP conversation with nephrologist

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • Medstar Health Research Institute
  • Mountain Kidney and Hypertension Associates
  • Quality Insights
  • Renal and Transplant Associates of New England, PC
  • University of Pittsburgh

Registry information

Official study title

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

Acronym: MY WAY

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 23, 2018
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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