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| Name | Class |
|---|---|
| Quality Insights | UNKNOWN |
| Renal and Transplant Associates of New England, PC | OTHER |
| Mountain Kidney and Hypertension Associates | UNKNOWN |
| University of Pittsburgh |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coaching | Experimental | Receives printed advance care planning (ACP) materials. Receives advance care planning coaching session. May receive followup coaching session, typically by telephone. |
|
| Enhanced Control | Active Comparator | Receives printed advance care planning materials only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Medical decision maker documented in EHR | Proportion of participants with medical decision maker documented in EHR | 16 weeks after baseline |
| ACP conversation with nephrologist documented in EHR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dale E Lupu, PhD, MPH | The George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Renal & Transplant Associates of New England |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34648897 | Derived | 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. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| OTHER |
| Medstar Health Research Institute | OTHER |
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.
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| 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. |
|
Proportion of participants with documentation in EHR of ACP conversation with nephrologist
| 16 weeks after baseline |
| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |