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

NCT04730986 | Completed

• 2 other identifiers: 2020P002934K76AG064434
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emergency Department; Motivational Interviewing; Advance Care Planning

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Patient-reported ACP conversation after the intervention

  One month after the intervention

• Documentation of new ACP in the electronic health records

  Before and one month after the intervention

Study Arms (1)

Intervention Arm

EXPERIMENTAL

This is a single-arm study with all enrolled patients receiving the same ED GOAL Nursing intervention

Behavioral: ED GOAL Nursing

Interventions

ED GOAL Nursing BEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.
• ≥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
• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Aging (NIA): collaborator
• Cambia Health Foundation: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kei Ouchi

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: January 29, 2021
• Study Start: January 29, 2021
• Primary Completion: December 31, 2021
• Study Completion: June 1, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

US (1)