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

Advance Care Planning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04730986
• Other study ID #: 2020P002934
• Secondary ID: K76AG064434
• Status: Completed
• Phase: N/A
• Start date: January 29, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Advance Care Planning
• Emergencies
• Emergency Department
• Motivational Interviewing

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Cambia Health Foundation, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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