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Advance Care Planning Intervention for Serious Illness (ED GOAL RCT Trial)
N/A
Recruiting
Led By Kei Ouchi, MD, MPH
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Caregiver of patient with moderate/severe dementia with capacity to consent
Capacity to consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1, 3, and 6 months
Awards & highlights
ED GOAL RCT Trial Summary
This trial will study whether the ED GOAL intervention can help increase advance care planning engagement for older adults with serious illness.
Who is the study for?
This trial is for adults over 50 with serious illnesses like advanced heart failure, lung disease on oxygen, kidney disease on dialysis, or metastatic cancer. It's also open to those who've been hospitalized recently for milder stages of these conditions and patients with mild cognitive issues if they have a caregiver.Check my eligibility
What is being tested?
The study tests 'ED GOAL', an intervention aimed at increasing advance care planning among older adults after emergency department visits. The trial will randomly assign participants to two groups and compare outcomes one month later using interviews and electronic health records.See study design
What are the potential side effects?
Since 'ED GOAL' is not a medication but an intervention focused on care planning, it does not have traditional side effects. However, discussing end-of-life plans may cause emotional discomfort or distress.
ED GOAL RCT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a caregiver for someone with moderate to severe dementia who can consent.
Select...
I am able to understand and agree to the study's requirements.
ED GOAL RCT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1, 3, and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1, 3, and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in advance care planning (ACP) engagement with clinicians at one month
Secondary outcome measures
Change in advance care planning (ACP) engagement with clinicians at six months
Change in advance care planning (ACP) engagement with clinicians at three months
Electronic medical record documentation of advance care planning (ACP) conversations
+6 moreED GOAL RCT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
The intervention will take place in the emergency department or days after an emergency department visit at home/hospital virtually using zoom or phone by our trained clinicians. At the time of follow-up assessments, participants may also receive additional counseling by our trained clinicians as needed.
Group II: Control ArmActive Control1 Intervention
No intervention will be conducted (standard of care).
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,470,710 Total Patients Enrolled
Kei Ouchi, MD, MPHPrincipal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
115 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently experiencing severe stress or emotional pain.You do not show signs of delirium when assessed using 3D-CAM.I am a caregiver for someone with moderate to severe dementia who can consent.I have mild memory problems but can make decisions, and I have someone to help me with the study.You receive treatment for a serious illness and primary care from a healthcare system other than Mass General Brigham.I am 50 or older and have a serious illness or doctors think I might not survive the next year.I am able to understand and agree to the study's requirements.I have severe heart failure, lung disease requiring oxygen, kidney disease needing dialysis, or advanced cancer.For example, if your doctor has had a serious discussion with you about your illness and documented it in their notes in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Arm
- Group 2: Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there available slots for prospective participants in this trial?
"According to clinicaltrials.gov, this medical trial has resumed recruitment of participants since its initial post on March 1st 2022 and the last update was on August 19th 2022."
Answered by AI
Could you provide me with an estimate of the sample size for this experiment?
"Afirmation. The information hosted on clinicaltrials.gov indicates that this research study is currently recruiting volunteers, with the initial post made on March 1st 2022 and most recent changes taking place August 19th 2022. This project requires 120 participants from a single location."
Answered by AI
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