Emergency DepartmentNCT04730986
A Nurse-led, Advance Care Planning Intervention in the Emergency Department
A study testing ED GOAL Nursing in people with Emergency Department and Motivational Interviewing, run by Brigham and Women's Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Department, Motivational Interviewing, Advance Care Planning
- What is being tested?
- ED GOAL Nursing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
- ≥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
Who cannot join
- 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
Show all 15Show fewer
- Unable/unwilling to schedule the follow-up outcomes assessment on the calendar.
- Part 2.
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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.
- Being tested
- ED GOAL Nursing
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED GOAL NursingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | This is a single-arm study with all enrolled patients receiving the same ED GOAL Nursing intervention Receives: Behavioral: ED GOAL Nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: One month after the intervention
Secondary outcomes (2)
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).
Measured: 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.
Measured: Before and one month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start29 Jan 2021
- Primary completion31 Dec 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency DepartmentStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Cambia Health Foundation
- Responsible party
- Principal investigator, Kei Ouchi, Brigham and Women's Hospital
- Investigators
- Kei Ouchi, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730986
- Sponsor's protocol ID
- 2020P002934
- Other IDs
- K76AG064434
- Status last verified
- Jun 2022
- First submitted
- 4 Dec 2020
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nurse-led, Advance Care Planning Intervention in the Emergency Department: a Pilot Study
- ClinicalTrials.gov ID
- NCT04730986
- Acronym / sponsor ID
- 2020P002934
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Cambia Health Foundation
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: ED GOAL NursingThis is a single-arm study with all enrolled patients receiving the same ED GOAL Nursing intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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
- ≥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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ED GOAL NursingA brief (<7minutes) interview by an emergency department nurse to empower patients to formulate and communicate their goals for medical care with patients' outpatient clinicians. | Behavioural | Intervention Arm |
Primary outcome
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.
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.
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.
2 secondary outcomes
Patient-reported ACP conversation after the intervention
Time frame: One month after the intervention
Documentation of new ACP in the electronic health records
Time frame: Before and one month after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kei Ouchi principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ED GOAL Nursing in people with Emergency Department and Motivational Interviewing, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Intervention Fidelity (time frame: Immediately after the the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.