A Nurse-led, Advance Care Planning Intervention in the Emergency Department

A Nurse-led, Advance Care Planning Intervention in the Emergency Department: a Pilot Study

ED GOAL is a 6-minute, motivational interviewing, advance care planning intervention.

In this study, the investigators will pilot test (Part I) ED GOAL by training research nurses to demonstrate its intervention fidelity and acceptability on older adults with serious illness in the emergency department (ED). Upon demonstrating the intervention fidelity of this intervention in Part I, the investigators will collect patient-centered outcomes (Part II) of 100 older adults with serious illness after leaving the ED. Further in Part III, the investigators will conduct a survey to the participants' outpatient clinicians to find out how to optimize the care coordination from the ED to the outpatient office to facilitate advance care planning conversations.

Study Overview

• Status: Completed
• Conditions: Motivational Interviewing; Emergency Department; Advance Care Planning
• Intervention / Treatment: Behavioral: ED GOAL Nursing

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Part 1.

Inclusion Criteria:

• ≥50 years of age AND ≥1 Serious illness* OR ED clinician would not be surprised if patient died in the next 12 months
• English-speaking
• Capacity to consent

Exclusion Criteria:

• Acute physical or emotional distress
• Determined by EM physician not to be appropriate
• Clearly documented goals for medical care** (Unless the treating clinician recommends that the patient needs the intervention)
• Delirium (assessed using 3D-CAM)
• Mild cognitive impairment or dementia (assessed using MiniCog or SBT)
• Already enrolled in this study
• Unable/unwilling to schedule the follow-up outcomes assessment on the calendar.

Part 2.

Inclusion Criteria:

• ≥50 years of age AND ≥1 Serious illness* OR ED clinician would not be surprised if patient died in the next 12 months
• English-speaking
• Patient with mild cognitive impairment or mild dementia with caregiver has a capacity to consent
• Caregivers of patients with moderate/severe dementia has a capacity to consent

Exclusion Criteria:

• Acute physical or emotional distress
• Determined by EM physician not to be appropriate
• Clearly documented goals for medical care** (Unless the treating clinician recommends that the patient needs the intervention)
• Delirium (assessed using 3D-CAM)
• Already enrolled in this study
• Unable/unwilling to schedule the follow-up outcomes assessment on the calendar.

(*NYHA Stage III/IV congestive heart failure, chronic obstructive lung disease on home oxygen, chronic kidney disease on dialysis, or metastatic solid tumor cancer. In addition, patients with NYHA Stage I/II congestive heart failure, chronic obstructive lung disease not on home oxygen, chronic kidney disease not on dialysis, solid tumor cancer without metastasis will be included if recent hospitalization in the last 12 months exists.) (**MOLST, medical order for life-sustaining treatment.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Arm; This is a single-arm study with all enrolled patients receiving the same ED GOAL Nursing intervention	Behavioral: ED GOAL Nursing; A brief (<7minutes) interview by an emergency department nurse to empower patients to formulate and communicate their goals for medical care with patients' outpatient clinicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Intervention Fidelity	Measure the intervention fidelity of ED GOAL Nursing administered by trained research nurses to seriously ill older adults or caregivers of patients with cognitive impairment in the ED (N=30). Trained research nurses will demonstrate intervention fidelity >70% on a prespecified checklist.	Immediately after the the intervention
Measurement of change in ACP conversations before and after the intervention	Conduct a pre-/post-intervention study (N=100) of ED GOAL Nursing on advance care planning (ACP) conversations one month (28 days) after leaving the ED (confirmed by EMR documentation of new/changes in ACP conversations, advance directive forms, or healthcare proxy, as well as changes in patient's or caregiver's self-reported ACP engagement). ≥25% of participants will have reported completing an ACP conversation, or changed advance directive forms or healthcare proxy, or change in patient's or caregiver's self-reported ACP engagement at one month after leaving the ED.	Before and one month after the intervention
Identification of key care coordination components from outpatient clinicians.	Conduct a survey on the outpatient clinicians of ED GOAL study participants one month (28 days) after the participating patients leave the ED to identify key care coordination components to maximize the intervention efficacy.	One month after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported ACP conversation after the intervention	Conduct a survey on the patients to ask if they report having new ACP conversation after the intervention. The outcome is dichotomous (yes or no).	One month after the intervention
Documentation of new ACP in the electronic health records	Conduct a chart review to find new documentation of advance care planning including new health care proxy form, new medical order for life-sustaining treatment, and new clinicians' free-text documentation of ACP conversations.	Before and one month after the intervention

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute on Aging (NIA); Cambia Health Foundation
• Investigators: Principal Investigator: Kei Ouchi, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2021
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): June 1, 2022

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (ACTUAL): January 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2020P002934; K76AG064434 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No