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NCT05209880

Advance Care Planning in the Emergency Department

Completed NA Results posted Last updated 13 March 2026
What this trial tests

NA trial testing ED GOAL in Congestive Heart Failure in 141 participants. Completed in 1 July 2024.

Timeline
1 March 2022
Primary endpoint
31 December 2023
1 July 2024

Quick facts

Lead sponsorBrigham and Women's Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment141
Start date1 March 2022
Primary completion31 December 2023
Estimated completion1 July 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Brigham and Women's Hospital

Who can join

18 and older, any sex, with Congestive Heart Failure or Metastatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month Primary · Change from baseline ACP engagement at one month

ACP engagement is a one-item question from the validated ACP engagement survey that measures participants' self-reported readiness to discuss their values and preferences with their doctors. The instrument is a 5-point Likert scale ranging from "I have never thought about it (1)" to "I have already done it (5)." A higher score indicates a better outcome. Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, Boscardin J, You JJ. Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. J Pain Symptom Manage. 2017 Apr;53(4):669-681.e8. doi: 10.101

Baseline
GroupValue95% CI
Intervention Arm2.84± 1.29
Control Arm2.87± 1.40
1-Month
GroupValue95% CI
Intervention Arm3.37± 1.07
Control Arm3.32± 1.28
Feeling Heard and Understood Survey Secondary · Surveys were done at baseline and once at 1, 3, or 6 months. If participants reported discussing end-of-life wishes with their doctor during a follow-up, the survey was given then or at 6 months, whichever came first. Follow-up results were summed.

A validated instrument for seriously ill patients to report how well they feel heard and understood about their wishes for end-of-life care. This instrument is a 5-point Likert scale: "not at all (1)," "slightly (2)," "moderately (3)," "quite a bit (4)," and "completely (5)." A higher score indicates a better outcome. Gramling R, Stanek S, Ladwig S, Gajary-Coots E, Cimino J, Anderson W, Norton SA; AAHPM Research Committee Writing Group, Aslakson RA, Ast K, Elk R, Garner KK, Gramling R, Grudzen C, Kamal AH, Lamba S, LeBlanc TW, Rhodes RL, Roeland E, Schulman-Green D, Unroe KT. Feeling Heard an

Baseline
GroupValue95% CI
Intervention Arm7
Control Arm6
Intervention Arm4
Control Arm6
Intervention Arm12
Control Arm12
Intervention Arm17
Control Arm15
Follow-up
GroupValue95% CI
Intervention Arm5
Control Arm4
Intervention Arm1
Control Arm3
Intervention Arm9
Control Arm7
Intervention Arm19
Control Arm11
Quality of Communication Survey Secondary · Baseline & 1, 3, or 6 months (same as Outcome 2). Additionally, the baseline questionnaire was asked with respect to the study clinician, whereas the follow-up was asked with respect to the primary doctor. Thus, only the follow-up value is reported.

A validated instrument to measure the quality of communication about end-of-life care. This instrument is a 10-point Likert scale ranging from "the very worse I could imagine (0)" to "the very best I could imagine (10)". A higher score indicates a better outcome. Engelberg RA, Downey L, Curtis JR. Psychometric characteristics of a quality of communication questionnaire assessing communication about end-of-life care. J Palliat Med. 2006 Oct;9(5):1086-98.

How good is doctor at talking about your FEELINGS concerning the possibility you might get sicker?
GroupValue95% CI
Intervention Arm8.80± 1.81
Control Arm8.53± 1.80
How good is doctor at talking about the DETAILS concerning the possibility you might get sicker?
GroupValue95% CI
Intervention Arm8.65± 1.54
Control Arm8.61± 1.87
How good is your doctor at talking to you about HOW LONG you might have to live?
GroupValue95% CI
Intervention Arm8.03± 2.11
Control Arm8.07± 2.48
How good is your doctor at talking with you about WHAT DYING MIGHT BE LIKE?
GroupValue95% CI
Intervention Arm6.69± 3.07
Control Arm7.75± 3.11
How good is doctor at involving you in DECISIONS ABOUT TREATMENTS you want if you get too sick?
GroupValue95% CI
Intervention Arm9.08± 1.62
Control Arm9.19± 1.41
How good is your doctor at asking about the things in life that are IMPORTANT TO YOU?
GroupValue95% CI
Intervention Arm8.52± 1.73
Control Arm7.79± 2.63
How good is your doctor at asking about your SPIRITUAL OR RELIGIOUS beliefs?
GroupValue95% CI
Intervention Arm8.67± 2.29
Control Arm7.40± 2.97
Healthcare Utilization Secondary · At 6 and 12 months before and 1, 6, 12 months after enrollment

Electronic medical records will be reviewed to find the number of urgent care visits, ED visits, hospitalizations, hospice visits, and outpatient visits.

Urgent Care Visits 6 Months Prior
GroupValue95% CI
Intervention Arm00 – 3
Control Arm00 – 3
Urgent Care Visits 12 Months Prior
GroupValue95% CI
Intervention Arm00 – 4
Control Arm00 – 4
ED Visits 6 Months Prior
GroupValue95% CI
Intervention Arm21 – 7
Control Arm21 – 7
ED Visits 12 Months Prior
GroupValue95% CI
Intervention Arm2.51 – 10
Control Arm21 – 9
Hospitalizations 6 Months Prior
GroupValue95% CI
Intervention Arm10 – 5
Control Arm10 – 5
Hospitalizations 12 Months Prior
GroupValue95% CI
Intervention Arm20 – 11
Control Arm20 – 11
ED Visits 1 Month After
GroupValue95% CI
Intervention Arm00 – 3
Control Arm00 – 3
ED Visits 6 Months After
GroupValue95% CI
Intervention Arm00 – 7
Control Arm00 – 7
Mortality Secondary · At 1, 3, and 6 months

The electronic medical records will be reviewed to find the patients' vital status.

1-Month
GroupValue95% CI
Intervention Arm1
Control Arm1
6-Month
GroupValue95% CI
Intervention Arm4
Control Arm4
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL Secondary · At 1, 3, and/or 6 months

Semi-structured interviews to assess the benefits of ED GOAL and obstacles participants faced in completing more ACP conversations with their outpatient clinicians and loved ones after ED GOAL.

Raised awareness/clarity about wishes
GroupValue95% CI
Intervention Arm16
Learned about ACP
GroupValue95% CI
Intervention Arm7
Encouraged to take action
GroupValue95% CI
Intervention Arm17
Making wishes known
GroupValue95% CI
Intervention Arm3
No effect on attitudes toward ACP
GroupValue95% CI
Intervention Arm15
Spoke with clinician
GroupValue95% CI
Intervention Arm17
Spoke with family/loved ones
GroupValue95% CI
Intervention Arm21
No action taken towards ACP
GroupValue95% CI
Intervention Arm16
Electronic Medical Record Documentation of Advance Care Planning (ACP) Conversations Secondary · At 1, 3, and 6 months

The electronic medical record will be reviewed to find clinician documentation of ACP conversations.

Baseline
GroupValue95% CI
Intervention Arm0
Control Arm0
1-Month
GroupValue95% CI
Intervention Arm10
Control Arm5
3-Month
GroupValue95% CI
Intervention Arm17
Control Arm7
6-Month
GroupValue95% CI
Intervention Arm22
Control Arm9
Change in Advance Care Planning (ACP) Engagement With Clinicians at Three Months Secondary · Change from baseline ACP engagement at three months

ACP engagement is a one-item question from the validated ACP engagement survey that measures participants' self-reported readiness to discuss their values and preferences with their doctors. The instrument is a 5-point Likert scale ranging from "I have never thought about it (1)" to "I have already done it (5)." A higher score indicates a better outcome. Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, Boscardin J, You JJ. Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. J Pain Symptom Manage. 2017 Apr;53(4):669-681.e8. doi: 10.101

Baseline
GroupValue95% CI
Intervention Arm2.84± 1.29
Control Arm2.87± 1.40
3-Month
GroupValue95% CI
Intervention Arm3.56± 1.11
Control Arm3.55± 1.25
Change in Advance Care Planning (ACP) Engagement With Clinicians at Six Months Secondary · Change from baseline ACP engagement at six months

ACP engagement is a one-item question from the validated ACP engagement survey that measures participants' self-reported readiness to discuss their values and preferences with their doctors. The instrument is a 5-point Likert scale ranging from "I have never thought about it (1)" to "I have already done it (5)." A higher score indicates a better outcome. Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, Boscardin J, You JJ. Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. J Pain Symptom Manage. 2017 Apr;53(4):669-681.e8. doi: 10.101

Baseline
GroupValue95% CI
Intervention Arm2.84± 1.29
Control Arm2.87± 1.40
6-Month
GroupValue95% CI
Intervention Arm3.73± 1.13
Control Arm3.70± 1.23
Participant-reported Completion of Advance Care Planning (ACP) Conversations Secondary · At 1, 3, and 6 months

Participants are asked if they had completed ACP conversations with their loved ones and clinicians.

1-Month
GroupValue95% CI
Intervention Arm12
Control Arm5
Intervention Arm33
Control Arm28
3-Month
GroupValue95% CI
Intervention Arm7
Control Arm5
Intervention Arm33
Control Arm37
6-Month
GroupValue95% CI
Intervention Arm9
Control Arm2
Intervention Arm30
Control Arm27

Sponsor's own description

This is a two-armed, parallel-design, pre-/post-intervention assessment study. The investigators will conduct a randomized controlled trial for ED GOAL on a cohort of 120 older adults with serious illness to collect patient-centered outcomes and determine preliminary efficacy on increasing advance care planning engagement (self-reported and/or in the electronic medical record) one month after leaving the emergency department. The investigators will also conduct qualitative interviews with participants of ED GOAL.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Emergency department-based, nurse-initiated, serious illness conversation intervention for older adults: a protocol for a randomized controlled trial.
    Prachanukool T, Block SD, Berry D, Lee RS, et al · · 2022 · cited 7× · PMID 36210436 · DOI 10.1186/s13063-022-06797-6
  2. Serious Illness Conversations in the Emergency Department for Older Adults With Advanced Illnesses: A Randomized Clinical Trial.
    Ouchi K, Block SD, Rentz DM, Berry DL, et al · · 2025 · cited 4× · PMID 40531532 · DOI 10.1001/jamanetworkopen.2025.16582
  3. Exploring Patients' Perceptions of an Advance Care Planning Intervention in the Emergency Department: A Qualitative Study.
    Shiozawa Y, Morton S, Shirai N, Oelschlager H, et al · · 2025 · PMID 40729413 · DOI 10.1111/acem.70109
  4. Emergency department-based, nurse-initiated, serious illness conversation intervention for older adults: a protocol for a randomized controlled trial
    Prachanukool T, Block SD, Berry D, Lee RS, et al · · 2022 · DOI 10.21203/rs.3.rs-1972016/v1

Verify or expand the search:

Other recruiting trials for Congestive Heart Failure

Currently open trials in the same condition.

Other Brigham and Women's Hospital trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05209880.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing