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ACP Intervention in the ED - A Pilot RCT (ED GOAL RCT)

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ClinicalTrials.gov Identifier: NCT05209880
Recruitment Status : Recruiting
First Posted : January 27, 2022
Last Update Posted : June 27, 2022
Sponsor:
Information provided by (Responsible Party):
Kei Ouchi, Brigham and Women's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Metastatic Cancer Chronic Kidney Disease Requiring Chronic Dialysis Chronic Obstructive Pulmonary Disease Behavioral: ED GOAL Not Applicable

Detailed Description:
ED GOAL, a 6-minute motivational interview conducted in the emergency department (ED), which engages participants to address advance care planning (ACP) conversations with their outpatient clinicians and avoids a time-consuming, sensitive conversation in the time-pressured ED environment. This study is designed to determine the preliminary efficacy of ED GOAL on increasing ACP engagement (by self-report and in the electronic medical record) one month after leaving the ED.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Advance Care Planning Intervention in the Emergency Department: a Pilot Randomized Controlled Trial
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Arm
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.
Behavioral: ED GOAL
The emergency department clinician-led, behavioral intervention (ED GOAL) is designed to engage seriously ill yet clinically stable older adults in the emergency department to address their values and preferences towards end-of-life care with their outpatient clinicians. The intervention consists of an interview to discuss participants' values and preferences for end-of-life care. The participants will receive coaching on how to initiate/re-introduce discussions about end-of-life wishes with their loved ones and outpatient clinicians. The participants' outpatient clinicians will also receive a summary of what participants disclosed via email or mailed letter.

No Intervention: Control Arm
No intervention will be conducted (standard of care).



Primary Outcome Measures :
  1. Change in advance care planning (ACP) engagement with clinicians at one month [ Time Frame: 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: 10.1016/j.jpainsymman.2016.10.367. Epub 2016 Dec 29. PMID: 28042072; PMCID: PMC5730058.



Secondary Outcome Measures :
  1. Feeling heard and understood survey [ Time Frame: Baseline & 1, 3, and 6 months ]

    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 and Understood: A Patient-Reported Quality Measure for the Inpatient Palliative Care Setting. J Pain Symptom Manage. 2016 Feb;51(2):150-4. doi: 10.1016/j.jpainsymman.2015.10.018. Epub 2015 Nov 17. PMID: 26596879.


  2. Quality of communication survey [ Time Frame: Baseline & at 1, 3, and 6 months ]

    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.


  3. Healthcare utilization [ Time Frame: 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.

  4. Mortality [ Time Frame: At 1, 3, and 6 months ]
    The electronic medical records will be reviewed to find the patients' vital status.

  5. Qualitative benefits and obstacles of advance care planning (ACP) conversations after ED GOAL [ Time Frame: 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.

  6. Electronic medical record documentation of advance care planning (ACP) conversations [ Time Frame: At 1, 3, and 6 months ]
    The electronic medical record will be reviewed to find clinician documentation of ACP conversations.

  7. Change in advance care planning (ACP) engagement with clinicians at three months [ Time Frame: 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: 10.1016/j.jpainsymman.2016.10.367. Epub 2016 Dec 29. PMID: 28042072; PMCID: PMC5730058.


  8. Change in advance care planning (ACP) engagement with clinicians at six months [ Time Frame: 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: 10.1016/j.jpainsymman.2016.10.367. Epub 2016 Dec 29. PMID: 28042072; PMCID: PMC5730058.


  9. Participant-reported completion of advance care planning (ACP) conversations [ Time Frame: At 1, 3, and 6 months ]
    Participants are asked if they had completed ACP conversations with their loved ones and clinicians.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥50 years of age AND ≥1 Serious illness* OR ED clinician would not be surprised if patient died in the next 12 months (a validated prognostic sign)
  2. English-speaking
  3. Capacity to consent

    1. Patient with mild cognitive impairment or mild dementia with capacity to consent (requires a caregiver/study partner to enroll)
    2. Caregiver of patient with moderate/severe dementia with capacity to consent

(*) 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 will be included if recent hospitalization in the last 12 months exists.

Exclusion Criteria:

  1. Acute physical or emotional distress
  2. Determined by treating or study clinician not to be appropriate
  3. Clearly documented goals for medical care** (Unless the treating or study clinician recommends that the intervention is clinically indicated)
  4. Delirium (assessed using 3D-CAM)
  5. Already enrolled in this study
  6. Unable/unwilling to schedule the follow-ups on the calendar
  7. Receive both the outpatient care for serious illness and primary care outside of the Mass General Brigham health system

(**)e.g., MOLST, medical order for life-sustaining treatment, documented serious illness conversations in clinician notes within the last 3 months, etc.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05209880


Contacts
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Contact: Kei Ouchi, MD, MPH 6177325640 kei_ouchi@dfci.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kei Ouchi, MD, MPH       kei_ouchi@dfci.harvard.edu   
Principal Investigator: Kei Ouchi, MD, MPH         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Kei Ouchi, MD, MPH Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Kei Ouchi, Brigham and Women's Hospital:
Additional Information:
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Responsible Party: Kei Ouchi, Assistant Professor of Emergency Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT05209880    
Other Study ID Numbers: 2021P003093
First Posted: January 27, 2022    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kei Ouchi, Brigham and Women's Hospital:
Advance Care Planning
Palliative Care
Goals of Care
ED GOAL
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Kidney Diseases
Renal Insufficiency, Chronic
Heart Failure
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Urologic Diseases
Renal Insufficiency