Chronic Kidney Disease Requiring Chronic Dialysis, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, Metastatic Cancer
Conditions
Keywords
Advance Care Planning, Palliative Care, Goals of Care, ED GOAL
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.
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.
Interventions
BEHAVIORALED 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.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month | 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
| Measure | Time frame | Description |
|---|---|---|
| Feeling Heard and Understood Survey | 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 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. |
| Quality of Communication Survey | 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. |
| Healthcare Utilization | 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. |
| Mortality | At 1, 3, and 6 months | The electronic medical records will be reviewed to find the patients' vital status. |
| Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL | 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. |
| Electronic Medical Record Documentation of Advance Care Planning (ACP) Conversations | At 1, 3, and 6 months | The electronic medical record will be reviewed to find clinician documentation of ACP conversations. |
| Change in Advance Care Planning (ACP) Engagement With Clinicians at Three Months | 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. |
| Change in Advance Care Planning (ACP) Engagement With Clinicians at Six Months | 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. |
| Participant-reported Completion of Advance Care Planning (ACP) Conversations | At 1, 3, and 6 months | Participants are asked if they had completed ACP conversations with their loved ones and clinicians. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKei Ouchi, MD, MPH
Brigham and Women's Hospital
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 70 |
| Control Arm No intervention will be conducted (standard of care). | 71 |
| Total | 141 |
Baseline characteristics
| Characteristic | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Age, Continuous Mean (SD) | 65.6 years STANDARD_DEVIATION 8.7 | 67.8 years STANDARD_DEVIATION 9.62 | 66.7 years STANDARD_DEVIATION 9.21 |
| Age, Customized Median [Min, Max] | 66.0 years | 68.0 years | 66.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 70 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 15 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 50 Participants | 53 Participants | 103 Participants |
| Region of Enrollment United States | 70 participants | 71 participants | 141 participants |
| Serious Illness CHF (NYHA Class III/IV) or recent hospitalization | 16 Participants | 13 Participants | 29 Participants |
| Serious Illness CKD on dialysis or recent hospitalization | 10 Participants | 4 Participants | 14 Participants |
| Serious Illness COPD on home oxygen or recent hospitalization | 3 Participants | 5 Participants | 8 Participants |
| Serious Illness ED Clinician would not be surprised if patient died in the next 12 months | 2 Participants | 3 Participants | 5 Participants |
| Serious Illness Solid tumor cancer with metastases or recent hospitalization | 39 Participants | 46 Participants | 85 Participants |
| Sex: Female, Male Female | 35 Participants | 38 Participants | 73 Participants |
| Sex: Female, Male Male | 35 Participants | 33 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 70 | 4 / 71 |
| other Total, other adverse events | 0 / 70 | 0 / 71 |
| serious Total, serious adverse events | 0 / 70 | 0 / 71 |
Outcome results
Primary
Change in Advance Care Planning (ACP) Engagement With Clinicians 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.
Time frame: Change from baseline ACP engagement at one month
Population: Some participants did not complete the 1-month follow-up survey. Thus, the number analyzed is different at baseline compared to the 1-month mark.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month | Baseline | 2.84 score on a scale | Standard Deviation 1.29 |
| Intervention Arm | Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month | 1-Month | 3.37 score on a scale | Standard Deviation 1.07 |
| Control Arm | Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month | Baseline | 2.87 score on a scale | Standard Deviation 1.4 |
| Control Arm | Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month | 1-Month | 3.32 score on a scale | Standard Deviation 1.28 |
p-value: 0.5835Wilcoxon (Mann-Whitney)
Secondary
Change in Advance Care Planning (ACP) Engagement With Clinicians 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.
Time frame: Change from baseline ACP engagement at six months
Secondary
Change in Advance Care Planning (ACP) Engagement With Clinicians 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.
Time frame: Change from baseline ACP engagement at three months
Secondary
Electronic Medical Record Documentation of Advance Care Planning (ACP) Conversations
The electronic medical record will be reviewed to find clinician documentation of ACP conversations.
Time frame: At 1, 3, and 6 months
Secondary
Feeling Heard and Understood Survey
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.
Time frame: Baseline & 1, 3, and 6 months
Secondary
Healthcare Utilization
Electronic medical records will be reviewed to find the number of urgent care visits, ED visits, hospitalizations, hospice visits, and outpatient visits.
Time frame: At 6 and 12 months before and 1, 6, 12 months after enrollment
Secondary
Mortality
The electronic medical records will be reviewed to find the patients' vital status.
Time frame: At 1, 3, and 6 months
Secondary
Participant-reported Completion of Advance Care Planning (ACP) Conversations
Participants are asked if they had completed ACP conversations with their loved ones and clinicians.
Time frame: At 1, 3, and 6 months
Secondary
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
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.
Time frame: At 1, 3, and/or 6 months
Secondary
Quality of Communication Survey
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.
Time frame: Baseline & at 1, 3, and 6 months