search
Back to results

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

Primary Purpose

Emergency Department, Motivational Interviewing, Advance Care Planning

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ED GOAL Nursing
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Emergency Department

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
December 4, 2020
Last Updated
June 22, 2022
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Aging (NIA), Cambia Health Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT04730986
Brief Title
A Nurse-led, Advance Care Planning Intervention in the Emergency Department
Official Title
A Nurse-led, Advance Care Planning Intervention in the Emergency Department: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Aging (NIA), Cambia Health Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Department, Motivational Interviewing, Advance Care Planning

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
This is a single-arm study with all enrolled patients receiving the same ED GOAL Nursing intervention
Intervention Type
Behavioral
Intervention Name(s)
ED GOAL Nursing
Intervention Description
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 Outcome Measure Information:
Title
Measurement of Intervention Fidelity
Description
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.
Time Frame
Immediately after the the intervention
Title
Measurement of change in ACP conversations before and after the intervention
Description
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.
Time Frame
Before and one month after the intervention
Title
Identification of key care coordination components from outpatient clinicians.
Description
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.
Time Frame
One month after the intervention
Secondary Outcome Measure Information:
Title
Patient-reported ACP conversation after the intervention
Description
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).
Time Frame
One month after the intervention
Title
Documentation of new ACP in the electronic health records
Description
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.
Time Frame
Before and one month after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kei Ouchi
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs