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Completed

NCT Number: NCT04730986

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

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

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.)

Treatment and study plan

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.

Primary outcomes

  1. Measurement of Intervention Fidelity

    Time frame: Immediately after the the intervention

    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.

  2. Measurement of change in ACP conversations before and after the intervention

    Time frame: Before and one month 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.

  3. Identification of key care coordination components from outpatient clinicians.

    Time frame: One month after the intervention

    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.

Secondary outcomes

  1. Patient-reported ACP conversation after the intervention

    Time frame: One month 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).

  2. Documentation of new ACP in the electronic health records

    Time frame: Before and one month after the intervention

    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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Cambia Health Foundation
  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 29, 2021
Registry last updated
Jun 24, 2022

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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