A Pilot Study to Test the Acceptability and Feasibility of Brief Motivational Interview Intervention to Help Patients Formulate Their Goals for Medical Care in the Emergency Department
Phase: NA
Conditions: Emergency Service, Hospital, Motivational Interviewing, Advance Care Planning
Sponsor: Brigham and Women's Hospital

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Detailed Protocol 
Title: A pilot study to test the acceptability and feasibility of brief motivational 
interview intervention to help patients formulate their goals for medical care in the 
emergency department 
Principal Investigator: Kei Ouchi, MD, MPH 
Funding: National Institute of Health & Emergency Medicine Foundation Career 
Development Award 
Version Date: 6/7/2018 
NCT03208530 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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I. BACKGROUND AND SIGNIFICANCE 
The majority (75%) of older adults with serious illnesses visit the ED during the last 
six months of life. 1 ED visits often mark an inflection point in these patients’ illness 
trajectories, signaling a more rapid rate of decline. 2,3 Many of these patients have 
not formulated and communicated their goals for end-of-life care, 4 and the majority 
(56 to 99%) of older patients do not have advance directives available at the time of 
ED presentation. 5 Most of these patients have priorities other than simply to live as 
long as possible, 6 yet without alternative plans in place, they may receive aggressive 
care that does not align with their goals. 7 Therefore, the ED provides a point in time 
and a location to identify and empower patients who would benefit from formulating 
and communicating their goals for future medical care.  
Emergency medicine (EM) physicians recognize this opportunity and have expressed 
interest in engaging older adults with serious illnesses in a discussion of their end-of-
life care; 8 however, the time-pressured ED environment discourages physicians from 
conducting in-depth conversations with these patients. 4 There is not yet a suitable 
brief intervention that is acceptable in the ED environment for physicians without 
extensive training in serious illness communication. Lack of a feasible method to 
intervene in the ED constrains our current clinical practice. 
We propose to close this gap with a practical method to empower them to formulate 
their goals for end-of-life medical care. We are currently developing and refining the 
BMI intervention for serious illness communication (Table1). The BMI method allows 
physicians to engage patients in thinking about the importance of addressing a 
chronic care issue without conducting a time-consuming, sensitive conversation in 
the time-pressured ED environment. The BMI methods have been demonstrated 
robustly to improve outcomes for ED patients with alcohol and opioid abuse by 
helping patients understand the obstacles to and reasons for their medical care. 9-12 
We are developing a BMI intervention to engage older adults in thinking about the 
importance of establishing care goals. 
In this protocol, we will pilot test (Part I) the intervention to demonstrate its 
acceptability and feasibility in the ED, then collect patient-centered outcomes (Part 
II) on older adults with serious illness being discharged from the ED. This study will 
inform the study design of a future randomized clinical trial using this intervention. 
 
 

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Table 1 Brief Motivational Interview ED Intervention to Facilitate Serious Illness Communication 
1) Open 
I’d like to talk about what is ahead with your illness after leaving the ED. Is that ok? 
2) Prognostic 
    Awareness 
What is your understanding of your ______ (serious illness)? 
3) Information 
& 
Feedback 
Elicit (Ask) 
 
Provide (Tell) 
 
 
 
 
Elicit (Ask) 
 
 
Have you thought about preparing for your care in the future? 
 
In the ED, we care for patients in the moment and also help them prepare for what’s 
ahead after leaving the ED. 
Preparation helps patients and their caregivers adapt to an uncertain situation and relieve 
difficult decision making for caregivers. 
 
How you think about these ideas of preparing about the future?  
 
4) Assess 
Importance 
 
 
 
 
Reinforce 
positives 
 
Ask about lower 
# 
How important is it to prepare and think ahead about your future care? 
 
 
You think it is __ (very / not very) important to think about this. That’s great! 
 
 
Why did you choose that number and not a lower one like a 1 or a 2? 
 
5) Worries 
&Strength 
 
 
 
Reflect & 
Summarize 
What are your worries about planning for your future medical care? 
 
What strengths in your life can you turn to for support in working through these questions 
about the future? 
 
You are worried about ___, AND ___ gives you strength to plan for your future medical 
care. 
6) Action Plan 
Make a 
recommendation 
 
 
 
 
 
 
 
 
 
 
 
 
 
Thank patient 
Based on what you said, 
a. NOT ready (1-2) 
“This isn’t the right time for you to think about your future care. I will recommend that your 
doctor asks you about this topic again at your next visit. Here is an information sheet that 
you may find helpful to read at home before your next visit with your doctor.” 
b. Somewhat ready (3-9) 
“I recommend that you explore what is important to you using Prepareforyourcare.org before 
your next visit with your doctor.” 
c. Completely ready (10) 
“I will work with your doctor about documenting your goals and preferences with your doctor 
on a medical record.” 
 
Let me write down steps that I would recommend for you and notify your doctor to let 
him/her know about your visit to the ED and our conversation today, to help him/her know 
where you are in your planning process. Is that okay? 
 
Thank you for talking with me today. 
Not Important 
 
 
 
Very Important 

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II. SPECIFIC AIM 
Test the acceptability and feasibility of our brief motivational interview intervention 
to facilitate advance care planning (ACP) conversation on older adults with serious 
co-morbid illness being discharged from the emergency department (ED) and 
interview the participants to understand their perception and collect patient-reported 
outcomes data after leaving the ED.  
Hypotheses 
a) ≥80% of clinicians will find it acceptable to conduct this interview in the ED for 
appropriate patients; 
b) ≥80% of patients will find the interview respectful to patient-oriented needs;  
c) ≥25% of participants will have reported completing ACP conversation with their 
primary outpatient clinician at one month (28 days) after leaving the ED.  
Methodology 
We will pilot test (Part I) the intervention to ED patients and interview 15 to 25 
participants (depending on theme saturation) immediately following the intervention 
to explore how they perceived the intervention. After the intervention is 
administered, they will be asked to complete a Likert scale survey about 
acceptability. Additionally, we will collect pre-/post-intervention patient-centered 
outcome data (Part II) using a set of surveys in-person before the intervention and 
via phone/mail at 7±3 days, and one month (28±7 days) after the ED visit for 100 
patients. 
III. SUBJECT SELECTION 
Trained RAs will recruit the subjects using the inclusion and exclusion criteria (Table 
2). We will use convenience sampling for this study. Each morning when a trained 
EM physician evaluates patients in the ED or ED observation unit, the trained RAs will 
ask the physician to identify potential subjects based on inclusion and exclusion 
criteria.  
Table 2 Subject Criteria 
Inclusion 
Exclusion 
1. 
≥65 years of age AND ≥1 Serious illness* 
OR 
ED clinician would not be surprised if patient 
died in the next 12 months 
2. 
English-speaking 
3. 
Capacity to consent 
 
1. 
Acute physical or emotional distress 
2. 
Determined by EM physician not to be appropriate 
3. 
Clearly documented goals for medical care** 
(Unless the treating clinician recommends that the patient 
needs the intervention) 
4. 
Delirium (assessed using 3D-CAM Inattention Item) 
5. 
Already enrolled in this study 
6. 
Unable/unwilling to schedule follow-up outcome 
assessment survey 
*New York Heart Association stage 3 or 4 heart 
failure, oxygen-dependent chronic obstructive 
lung disease, chronic kidney disease on dialysis, 
or metastatic cancer 
**MOLST, medical order for life sustaining treatment. 
 

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IV. SUBJECT ENROLLMENT 
 
Picture 1. Study Flowchart 
  
 
There are two subject types in this study – ED clinicians and ED patients. ED 
clinicians (attending physicians and physician assistants) will be recruited to train in 
and administer the proposed intervention on ED patients. After the intervention is 
administered, they will be asked to complete a Likert scale survey about 
acceptability. Clinicians will be asked to participate voluntarily. The PI will make an 
announcement at the faculty / physician assistant meetings and hand out the study 
information sheet. ED patients will be recruited to be interviewed after the 
intervention to learn their perception of the intervention. Upon identification of the 
potential subject, the trained RAs will approach the potential subject to explain the 
study and ask about their willingness to participate. Once the eligible subject agrees 
to participate, the PI or co-investigator (licensed physician assistants or physicians) 
will consent the patient to enroll. After the trained RAs explain the study, the 
subjects will have time to think about the enrollment until the PI or co-investigator 

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(licensed physician assistants or physicians) physically arrives in the ED. The PI or 
co-investigator (licensed physician assistants or physicians) will review all study 
elements again with the subjects to ensure understanding of the study. After 
obtaining verbal consent and providing the study fact sheet to the subject, the 
trained RAs will use validated tools to assess delirium (3D-CAM Inattention Item) 
and cognitive impairment (MiniCog™) to further determine subject’s eligibility for 
enrollment. Assessments will be administered with the subject. Based on the results 
of these assessments, the patient may be deemed ineligible (if delirium is present) 
or enrolled into either the Normal Cognition Group OR Cognitive Impairment or 
Mild/Moderate Dementia Group (see Picture 1). Screening subjects for cognitive 
impairment is deemed necessary to provide deeper understanding into whether 
subjects will such condition would require more assistance in engaging in 
conversation about the importance of establishing goals of care. Patient with severe 
dementia will be excluded because they lack the capacity to consent ealier on this 
enrollment algorithm. Upon enrollment, the trained physician responsible for the care 
of the patient will administer the intervention. When a trained physician is not on 
duty in the ED or ED observation unit, the PI or trained clinician will administer the 
intervention. 
 
There will be no other methods of recruiting for this study. Subjects assigned to any 
group will receive the same intervention and follow-up procedures. 
V. STUDY PROCEDURES 
There will be two distict parts of the study: acceptability study (Part I) using 
qualitative interviews to explore the patient’s perception of the intervention and 
quantitative assessment of clinician’s acceptability rating, and feasibiltiy study to 
measure patient-reported outcomes (Part II) after leaving the ED for future 
randomized clinical trial. The timing of proposed data collection is shown on Table 3.  
Table 3. Timing of Proposed Data Collection and Instruments 
Study 
Part 
Subjects 
Screening 
Assessments/
Group 
Assignment 
Pre-Intervention 
Post-Intervention 
7-Day  
Follow-Up 
(7 ± 3 Days) 
One-Month  
Follow-Up 
(28 ± 7 Days) 
Part 1 
Clinicians 
 
 
Acceptability Survey 
 
 
Patients 
 
 
Qualitative Interview 
 
 
Part 2 
Patients 
- 3D-CAMa 
- MiniCog™b 
- ACP-Ec  
- QUAL-Ed 
 
- 4 Questionse 
- IES-Rf 
- 4 Questions 
- ACP-E 
- QUAL-E 
a. 
3D-CAM 
: 3-minute diagnostic assessment for Confusion Assessment Method (CAM)-defined delirium 
b. 
MiniCog™ 
: 3-minute instrument for the detection of cognitive impairment in older adults 
c. 
ACP-E 
: The Advance Care Planning (ACP) Engagement survey 
d. 
QUAL-E 
: The Quality of Live at the End of Life (QUAL-E) scale 
e. 
4 Questions : Four open-ended questions to assess subjects’ decision to speak with their doctors and family members 
f. 
IES-R 
: The Impact of Event Scale – Revised 
 
Part I: Acceptability Study 

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We will conduct in-depth, semi-structured interviews to understand patient’s 
perception of the intervention after its administration by a trained ED clinician. We 
anticipate to interview 15 to 25 patients, until thematic saturation of their perception 
is reached. Further, we will assess clinician acceptability by administering a Likert 
scale survey.  
Measurements 
Patient Perception Assessment: The PI and the trained RA will conduct the semi-
structured interviews. The following domains will be explored: beliefs about 
formulating and communicating goals of care, experience of the ED intervention, and 
attitude towards further patient education about how to formulate goals of care. Both 
the administration of BMI intervention by a clinician and subsequent qualitative 
interview of the participants will be video-recorded to ensure fidelity of the 
intervention administration and accurate capturing of their inputs. 
Clinician Acceptability Assessment: Immediately after the clinician completes the 
encounter, we will ask to fill out an in-person survey to rate acceptability (Likert 
scale, 1 – not acceptable, 2 – somewhat unacceptable, 3 – neutral, 4 – somewhat 
acceptable, and 5 – acceptable).  
Outcome Our primary outcome for the patient perception assessment of the study is 
to identify a recurring theme that illustrates the patient perception of the 
intervention. Our primary outcome for the physician assessment of the study is the 
proportion of administering clinicians who found the rating to be somewhat 
acceptable (4) or acceptable (5). Secondary outcomes are the time to administer the 
intervention and how often the 4 intervention components are appropriately 
completed. 
Part II: Feasibility Study 
We will collect pre-/post-intervention data to demonstrate the intervention’s 
feasibility to improve patient-reported outcomes using a set of surveys. We will 
measure patient-reported outcomes before the intervention (in-person), as well as 7 
(±3) days, and one month (28±7 days) after leaving the ED. After the collection of 
10 IES-R surveys (as part of the 7-Day Follow-Up), the investigator will analyze the 
impact of the intervention. If the IES-R is proven insignificant (p > 0.05), collection 
of this assessment and all 7 (±3) day follow-up procedures will be discontinued. At 
this point, the one month (28±7 days) follow-up procedures will instead be 
completed after 3 weeks of the intervention (21±7 days). 
Participants will be provided with a certificate of completion (see attached) and a 
compensation of $5 at the time of enrollment.  
Post-Intervention Outcome Surveys: 
Participants will have three ways to complete the outcome survey: i. over the phone; 
ii. by mailed survey with a return postage; or iii. in-person by a research assistant at 
the next doctor’s appointment on campus at BWH/BWFH (we will ask permission to 
look through their medical records for future scheduled hospital visits). At the time of 
enrollment, we will ask the participants which option is most feasible for them.  
We will exclude the subjects if they are unable/unwilling to schedule follow-up 
outcome assessments in the reasonable time.  

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In addition, we will send a “Thank You” postcard (see attached) and a total of $10 to 
all participants at the time of outcome survey (a total compensation of the entire 
study is $15). For patients who choose to complete the follow-up survey over the 
phone with a research assistant, verbal consent will be obtained to audio-record the 
conversation prior to administration of the questionnaires. If the patient elects to 
complete the surveys by mail, we will place a reminder call/voicemail at the 7-day 
and 1-month follow-up timepoints. In addition, we will obtain verbal consent to send 
email and text message reminders to subjects to complete the assessments. We will 
assess the proportion of participating older adults who self-reported having spoken 
to their primary outpatient physician and/or caregivers about their goals for end-of-
life medical care following the intervention. We will use validated instruments to 
measure quality of life (QUAL-E), 13 ACP engagement behavior (ACP Engagement 
Survey), 14 and potential subjective distress caused by the intervention (a potentially 
traumatic event). 15  
Measurements 
After obtaining verbal consent, but prior to enrolling the subject, several validated 
instruments will be used to assess delirium and cognitive impairment. Before all 
enrollment procedures, a trained RA will administer the 3D-CAM Inattention Item to 
assess delirium. In the absence of delirium, the trained RA will administer the 
MiniCog™ to the subject. Based on the results of these assessments, the patient may 
be deemed ineligible (if delirium is present) or enrolled into either the Normal 
Cognition Group OR Cognitive Impairment or Mild/Moderate Dementia Group (see 
Picture 1). We will train the research assistants to administer these tools by 30-
minute didactic on the concepts of delirium, cognitive impairment, and dementia, as 
well as bedside practice administration with the PI until competency is demonstrated 
(PI will self-record the responses next to the research assistant administering the 
instrument and compare the results. We will repeat this process with new patient 
volunteers until there is no discrepancy). In case of equivocal findings on these 
assessments administered by research assistants, physician backup will be available. 
Prior to the screening assessments, study staff will offer a personal sound amplifier 
as a hearing-assistive device to subjects who, in the opinion of the study staff, will 
benefit from its use, e.g., subjects with hearing impairment issue. From our 
experience, given that the setting is in the busy and noisy ED, the subjects 
sometimes have difficulties following our instructions or answering our questions. 
Therefore, we believe that the hearing aids will help them respond to our 
prompts/instructions more appropriately. 
We will measure the proportion of patients who self-report having had the 
conversation with their outpatient physician. We will also use QUAL-E, a validated 
instrument to measure quality of life of patients with a range of diseases (cancer, 
congestive heart failure, chronic obstructive pulmonary disease, and end-stage renal 
disease). 13 This instrument is particularly suited to measuring the quality of life of 
patients who may or may not have acknowledged the terminal nature of their 
disease, but who, nevertheless, are dealing with end-of-life issues. In addition, we 
will use the ACP Engagement Survey, a validated instrument developed based on 
Social and Behavior Change Theory, and it measures the full range of self-reported 

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processes involved in ACP (e.g. changes in knowledge, contemplation, self-efficacy 
and readiness) as well as actions associated with ACP behavior. 14 To evaluate 
whether the ED intervention itself increases patient stress, we will also measure 
posttraumatic stress disorder symptoms using the Impact of Event Scale – Revised 
(IES-R). 15 IES-R is a validated scale to assess subjective distress caused by 
traumatic events. The trained RAs will administer these instruments (see Appendix) 
immediately before the intervention, and again by phone one month (28±7 days) 
after leaving the ED. IES-R will only be used for the 7-day (7±3 days) follow-up 
phone call. After the collection of 10 IES-R surveys, the investigator will analyze the 
impact of the intervention. If the IES-R is proven insignificant (p > 0.05), collection 
of this assessment and all 7 (±3) day follow-up procedures will be discontinued. At 
this point, the one month (28±7 days) follow-up procedures will instead be 
completed after 3 weeks of the intervention (21±7 days). During each follow-up, we 
will ask participants open-ended questions about their decisions to speak with their 
primary care physicians and family members (please refer to the 7-day and 1-month 
questionnaires). The subject can opt to complete the post-intervention surveys by 
mail. Return postage will be provided. 
Outcomes 
The primary outcome is the proportion of patients self-reporting having spoken to 
their primary outpatient physician regarding their preferences for end-of-life medical 
care one month after leaving the ED. The secondary outcomes are quality of life, ACP 
behavior change, posttraumatic stress disorder symptoms, proportion of subjects 
with documented ACP conversation on medical records one month after leaving the 
ED. We will also track the rate of patients being lost-to-follow-up to aid in 
appropriate design of a future randomized clinical trial. 
VI. BIOSTATISTICAL ANALYSIS 
Variables to be collected 
We will collect demographic information of our subjects from the electronic health 
records, including age, gender, prior ACP documentation, co-morbid medical 
conditions, and ED diagnosis. Both the administration of BMI intervention by a 
clinician and subsequent qualitative interview of the participants will be video-
recorded to ensure fidelity of the intervention administration and accurate capturing 
of their inputs. We will also administer the validated survey instruments (ACP 
Engagement Survey, QUAL-E, IES-R) and self-reported completion of ACP 
conversation one month after leaving the ED. 
Study Endpoint 
Part I – Acceptability Study 
The study will conclude when 15 to 25 participants are enrolled and thematic 
saturation of the qualitative analysis is reached. 
Part II – Feasibility Study 
The study will conclude when 100 participants are enrolled and one month post 
intervention data is collected over the phone. 
Statistical Methods 

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Part I Analysis 
We will employ a modified phenomenological approach to code for themes that 
illustrate patient’s perception of the intervention. We selected phenomenology as our 
qualitative research strategy since it is particularly suited to explore how individuals 
experienced our intervention. The PI and the trained RA will immerse themselves in 
the text by reading and re-reading for content, quality, and patterns. During this 
time, the audit trail of notes will be kept by individual coders to be reviewed in a 
subsequent discussion group. After independent coding of 5 initial transcripts, the PI 
and the trained RA will determine the standard labeling for common patient 
perception themes; and these will be organized into a code book. We will iteratively 
re-organize the code book until the consensus is reached among the coders. If there 
are disagreements between the coders on a particular theme, we will employ a third 
coder to aid in judgment of the codes. The coders are purposefully not blinded to the 
study questions because they need to decide what is pertinent to answer the study 
question at hand. The coders will use the code book to independently code the 
remaining transcripts. We will use Nvivo software to organize and manage our data. 
The study will conclude when new themes no longer emerge (thematic saturation is 
reached), based on agreement between the coders. If not, we will continue to recruit 
more subjects until thematic saturation is reached. The themes will be categorized 
and coders will decide with group consensus which quotes will be included as the 
representative quotes in the final manuscript. If there are disagreements, an 
additional researcher from the ED will be asked to review the quotes and themes. 
Part II Analysis 
We will calculate descriptive statistics of the patient-reported outcomes before and 
after the intervention. We will use one sample binomial exact test of proportions for 
categorical outcomes (e.g. proportion of patients reporting ACP conversations with 
their physicians), and Wilcoxon signed ranks test for ordinal outcomes (e.g. QUAL-E) 
at baseline and one month. We will use a p-value of 0.05 as the significance 
threshold.  
Sample Size 
Part I: 
We propose to enroll 10 to 25 subjects in Part I. In prior qualitative studies, this is 
the general number that a study like this takes to reach thematic saturation. We 
may enroll more than 25 subjects if we find that thematic saturation has not 
reached. We will submit an amendment to change the enrollment number should 
that occur.  
Part II: 
We propose to enroll 100 subjects in Part II. A recent meta-analysis of advance 
directive documentation studies demonstrated improvement in ACP completion rate 
ranging from 2 to 44% with an intervention. 16 We assume that the baseline rate of 
ACP completion rate is <10% to be conservative. Based on prior similar studies, we 
assume our intervention will result in 25% increase in the rate of conversation above 
10%. A sample of 100 subjects will afford us 97% power (two-tailed alpha of 0.05) 
to detect a difference of the conversation completion rates of 10% before the 
intervention versus 30% after the intervention. Power is also expected to be strong 

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for the ACP behavioral change scale outcomes (our secondary outcome, similar 
preliminary data demonstrated a pre-to-post improvement of 0.5 SD). 17 With a 
conservative assumption, we will have 85–98% power with our sample size.  
 
VII. RISKS AND DISCOMFORTS 
There is no risks and discomforts associated with procedures, drugs, devices, or 
radiation in this study. 
Psychosocial Risks (Uncommon) 
The participants will be introduced or re-initiated on the topic of ACP. Some patients 
with serious illness do not wish to discuss ACP because they feel uncomfortable with 
the topic. This potential discomfort, however, is a part of the routine practice of EM. 
Many ED clinicians discuss ACP with patients routinely, and the study does not add 
additional discomfort that is different from the routine clinical practice. Further, PI is 
trained in serious illness communication and will be available to manage patients’ 
anxiety and other emotions as needed. 
VIII. POTENTIAL BENEFITS 
Potential Benefits to Participating Individuals 
It is our hope that the proposed intervention will empower patients to engage in ACP 
discussions with their primary outpatient clinician ≥25% of the time one month after 
the ED visit. Further, this intervention may also improve other patient-reported 
outcomes without causing significant harm.  
Potential Benefits to Society 
We hope that our intervention will allow EM clinicians to reach many older adults 
with serious illness presenting to the ED and guide them to formulate their goals for 
medical care. Such intervention will allow clinicians to align the future medical care 
towards end of life to match patients’ values and preferences. 
IX. MONITORING AND QUALITY ASSURANCE 
The PI will be solely responsible for monitoring of safety, adverse events, protocol 
deviations, and outcomes. The data safety will be monitored by the PI on weekly 
basis, who is solely responsible for determining whether the research should be 
altered or stopped. The PI will be aware of every patient who is recruited and 
enrolled in the study. All data obtained in this study (video-recorded interviews of 
the participants and responses to the surveys by both clinicians and participants) will 
be stored in a secure Partners shared drive of the PI. As soon as the opportunity is 
available, the obtained data will be anonymized and removed of personal health 
information. All participants and clinicians will be de-identified and assigned research 
subject IDs (e.g. clinician 1). Only the study staff will have access to information that 
can link the subject IDs with the personal health information, which will be saved in 
the secure shared drive. 
The PI will be aware of every subject enrolled in this study. Therefore, he is able to 
monitor for adverse events, such as unexpected emotional distress, and address 
them clinically using his clinical communication skills. Further, the PI will inform the 
IRB of any adverse events using standard procedures. 

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As stated earlier, the PI will be solely responsible for the adherence to the IRB-
approved protocol. The PI will be checking the adherence on every enrollment 
(especially because he will physically be there).  
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