Rater’s Guide v1.4€¦ · Web view2020. 3. 26. · Communication with families of patients in the ICU is an important issue. We are conducting a related research study, approved

The effect of documenting prognosis on the information provided to ICU proxies: A randomized trial

Alison E. Turnbull, DVM, MPH, PhDMargaret M. Hayes, MDRoy G. Brower, MDElizabeth Colantuoni, PhDPragyashree Sharma Basyal, BSDouglas B. White, MD, MASJ. Randall Curtis, MD, MPHDale M. Needham, FCPA, MD, PhD

Supplemental Digital Material

1 of 51

Table of Contents....................................................................................................................................p. 2

I Recruitment materials.…………………………………………………………………………………………………………...p. 3

II Study website.………………………………………………………………………………………………………………………..p. 5

III Physician screening survey and demographic data collection……..………………………………………….p. 8

IV Clinical scenario (patient case).…………………………………………………………………………………….……….p. 11

V Pre-simulation prompting questions for physiciansControl………………………………………………………………………………………………….………………………………p. 22Intervention………………………………………………………………………………………….……………………………...p. 23

VI Script development.………………………………………………………………………………………………………..……p. 24

VII Actor training……………………………………………………………………………………………………….……………….p. 26

VIII Quality assurance process...………………………………….…………………………………………….……..………...p. 27

IX Outcome Instrument - Physician Self-Report…………………..……………………..……………………….……p. 29

X Outcomes Rater's Guide v1.4……..………………………………………………………………………………….….….p. 34

XI Intensivist characteristics by treatment group………………………………….………………………….……….p. 41

XII Interim analysis plan……………………..……………………………………………………………………………………..p. 42

XIII Intensivist-perceived conflict during simulations………………………………………………………….……...p. 43

XIV Realism of simulations as rated by intensivists……………………………..…………….…………………….…p. 44

XV Outcomes stratified by actor.…………………………………………………………..………………….…………..….p. 48

XVI Sensitivity analyses……….....………………………………….…………………………………………….……..………...p. 50

2 of 51

RECRUITMENT MATERIALS

RECRUITMENT E-MAIL

Re: Participating in the Simulated Communication with ICU Proxies (SCIP) study

Dear Dr. __________________,

Communication with families of patients in the ICU is an important issue. We are conducting a related research study, approved by the Johns Hopkins IRB (IRB00082272, PI: Turnbull). We need your help to find ICU physicians to participate in this study. The study is being conducted in a state-of-the-art simulation center at the Johns Hopkins Outpatient Clinic.

Physicians will receive $500 and a parking voucher in appreciation of their effort and time in driving to Johns Hopkins and participating in this very important study.

Study participation involves:1. A brief online survey 2. One visit to the Simulation Center at Johns Hopkins Hospital in Baltimore, MD at a pre-

scheduled time (evenings and weekend times are available). During this visit, you would: a. Review the medical chart of a hypothetical patient b. Answer 8 questions about how the patient should be clinically managedc. Meet with an actor playing the role of a family member of the hypothetical patient d. Provide feedback on the simulated meeting with the family member

Completing all study activities will require 30 - 75 minutes. Funding for this study is provided by the non-profit Gordon and Betty Moore Foundation.

Physicians interested in participating should take this brief survey: hyperlinked survey

If you need more information about the study, please e-mail [email protected].

Please share this information with any other ICU physicians who may be interested. We are hoping for strong participation from intensivists in the region.

I hope to hear from you soon.

Dale M. Needham, FCPA, MD, PhD ProfessorDivision of Pulmonary & Critical Care MedicineMedical Director, Critical Care Medicine & Rehabilitation Program Johns Hopkins University

3 of 51

4 of 51

STUDY WEBSITE – WWW.ICUSTUDY.COM

This IRB-approved research study (IRB 00082272, PI: Turnbull) aims to quantify variability in the management of critically ill patients and communication with their families. Physicians who complete the study receive $500 in appreciation of their effort and time traveling to Johns Hopkins. Completing all study activities usually requires 30-75 minutes. Physicians who primarily practice in the United States and spent at least 4 weeks attending in an adult ICU setting during the past 12 months are eligible to participate. Funding for this study is provided by the non-profit Gordon and Betty Moore Foundation.

Study participation involves:

1. A brief online survey

2. One visit to the Simulation Center at Johns Hopkins Hospital in Baltimore, MD at a pre-

scheduled time. Evening and weekend times are available. During this visit, participants:

Review the medical chart of a hypothetical patient

Answer up to 8 questions about how the patient should be clinically managed.

Meet with an actor playing the role of a family member of the hypothetical patient

Provide feedback on the simulated meeting with the family member

5 of 51

Frequently Asked Questions

Who can participate in this study?Physicians who primarily practice in the United States and spent at least 4 weeks attending in the adult ICU setting during the past 12 months are eligible to participate.

Can fellows, NPs, or PAs participate?No, not at this time.

When will I receive the $500?When you complete the study at The Simulation Center you will immediately receive $500 in appreciation of your time. Both cash and check are available.

What days or times can I do this? We recognize that intensivists are very busy. We are available on weekends and evenings as well as during business hours. The brief online survey asks you to suggests days and times that are convenient to your schedule. We'll review the survey and reserve a time in the simulation center that works for you.

Is there parking? Will it be validated?Yes and yes! If you're driving to Johns Hopkins and are not a Johns Hopkins employee there is a garage immediately adjacent to The Simulation Center and we will validate your parking. The Simulation Center is also easily accessible from the Johns Hopkins stop on the subway.

Do I need to do any sort of preparation before I arrive?No.

Will I get to see the study results?Absolutely. We will contact all participants by e-mail when we finish recruitment and when the study results are published.

What happens at the Simulation Center if I join this study? If you provide your written consent to participate you'll be asked to:

1. Review the medical chart of a hypothetical patient,2. Answer up to 8 questions about how you think the patient should be clinically managed,3. Meet with an actor playing the role of a family member of the hypothetical patient, and4. Provide feedback on the simulated meeting with the family member

Who's running this study?Alison E. Turnbull, DVM, MPH, PhD is the principal investigator and an assistant professor in the Division of Pulmonary and Critical Care Medicine at Johns Hopkins.

Who's funding this study? Funding for this study is provided by the non-profit Gordon and Betty Moore Foundation.

How will my data be used? Participants provide data by answering the online survey, providing written answers about patient management, participating in a simulated family meeting which is audio and video recorded, and

6 of 51

providing feedback on the simulation. If you complete the study, the recordings will be used for the purposes of this research and will not be published or shared for any other reason.

Where's the Simulation Center? How do I get there?Once an appointment has been scheduled we'll send you a map and directions.

How many intensivists can participate in this study?We need to recruit 116 intensivists. Please tell your colleagues and help us spread the word!

Is this IRB-approved?Yes, this study was approved by the Johns Hopkins Medicine Institutional Review Board (IRB 00082272).

I have another question. Who should I contact?Please contact the principal investigator at [email protected].

R E A D Y T O T A K E T H E N E X T S T E P ?

Complete a brief survey and let us know what days and times are convenient for you.To the survey! →

7 of 51

PHYSICIAN SCREENING SURVEY AND DEMOGRAPHIC DATA COLLECTION

Thank you for your interest in participating in the Simulated Communication with ICU Proxies study. Please answer a few questions about yourself.

How old are you? (Years)

What is your gender?Male

Female

Prefer not to answer

Do you practice primarily in the United States?Yes

No

How many weeks have you worked in the ICU setting during the past 12 months?

How do you identify your race? (Select one)American Indian/Alaska Native

Native Hawaiian or Other Pacific Islander

White

Asian

Black or African American

More than one race


How do you identify your ethnicity? (Select one)Hispanic or Latino

Not Hispanic or Latino


8 of 51

What is your present religion, if any?Protestant Christian

Roman Catholic

Other Christian

Jewish

Agnostic/Atheist/No religion

Other:


How important is religion in your life?Extremely important

Very important

Moderately important

Slightly important

Not at all important


Do you have specialty training in one or more of the following? (You may select more than one)Medical

Surgical

Emergency

Anesthesiology

Other, please explain:

What year did you complete your first residency?

Have you completed a critical care fellowship in the United States?Yes

No

What year did you complete your critical care fellowship?

9 of 51

In what state did you complete your critical care fellowship? (Please use 2-letter abbreviation)

What type of ICU do you work in?

What type of hospital are you currently working for? (Select more than one, if you work in more than one type of hospital)

For profit

Non-profit

What is the academic status of the hospital where you currently work? (You may select more than one if you work in more than one hospital)

10 of 51


Trauma

Mixed Medical and Surgical

Surgical

Medical


CLINICAL SCENARIO (PATIENT CASE)Patient Scenario Development

The hypothetical patient was created to have a high probability of in-hospital death or impaired functional recovery that would prevent the patient from returning to independent living in the community. The simulated patient case documents, including flow sheets, physical examination findings, past medical history, laboratory values, ventilator settings, radiology report, and summary assessment and plans from the first three days of ICU admission, are adapted (in a de-identified manner) from the medical record of an actual patient. The simulated patient scenario was developed by those with expertise in critical care end-of-life research then reviewed by practicing critical care attending physicians and critical care fellows to ensure a high degree of realism and sufficient data to inform a family meeting.

The probability of in-hospital death was calculated at ICU admission using APACHE III and the probability of in-hospital death after 72 hours of treatment was calculated using the Mortality Probability Model II-72 hours. All risk prediction scores were calculated using the data provided in the hypothetical patient’s case documents. Risk scores were not provided to study participants.

11 of 51


Non-teaching

Non-University Teaching

University

INSTRUCTIONS FOR SCIP STUDY PARTICIPANTS(Leave this page with participants during simulation)

Background

It is the afternoon of Saturday, June 6th, 2015. Mr. Clyde Samuel is an 81-year-old who was admitted to your ICU via the emergency room late on Wednesday, June 3 rd.

You have been Mr. Samuel’s attending doctor throughout his ICU stay. Although Mr.

Samuel’s family has visited regularly, today is the first time that you are meeting them.

Instructions

1. Please review the clinical information provided about Mr. Samuel. Then, answer the

questions on the computer screen in front of you and click the button labeled “Submit

checklist.”

2. After submitting your responses, the computer will say “Wait for an announcement

before entering the Exam Room.” Ignore this statement on the computer screen. When you have completed the questions on the computer and are ready to meet with

the patient’s family, knock on the door and then immediately enter the room. Please act as you would in a real family meeting in your ICU.

3. When you have finished meeting with Mr. Samuel’s family, please return to this desk

and answer the next questions on the computer screen. After you submit your answers,

we will know that you have completed the study and we will return to provide you $500

compensation. We can also provide a parking voucher if needed unless you are a JHU

employee.

Are there any questions I can answer for you at this time?

12 of 51

Flowsheet Print Request

Patient: Samuel, Clyde DMRN: 8971563

Vitals 6/3/201515:00 in ER

6/4/20159:07 am in ICU

6/5/20153:58 pm

6/6/20153:43 pm

Temperature (C) 38.6 38.7 39.5 39.0

Heart Rate (bpm) 83 102 110 115

Respirations (breaths/min) 38 35 30 32

SpO2 99% 94% 93% 91%

Arterial Systolic (mmHg) 112 106 100 90

Arterial Diastolic (mmHg) 70 54 53 48

MAP (from device interface) 84 72 68 62

Max 24hrTemp (C) 39.1 40.3 39.6 39.1

Respiratory Devices/Method Endotracheal tube Endotracheal tube Endotracheal tube Endotracheal tube

Urine (24 hr) NA 350 50 75

Vent SettingsMode Volume Control Volume Control Volume Control Volume Control

TV (mL) 310 310 310 310

Set Resp Rate (/min) 30 30 35 35

FiO2 (%) 50 50 60 70

PEEP (cmH20) 8 8 10 14

Measured DataActual Resp Rate (/min) 35 32 35 36

Minute Ventilation (L/min) 10.8 10 10.8 11

Peak Pressure (cm H2O) 25 26 28 33

Plateau Pressure (cm H2O) 20 22 24 30

Date Range: 6/3/2015 – 6/6/2015

.

13 of 51

Flowsheet Print RequestPatient: Samuel, Clyde DMRN: 8971563

Date Range: 6/3/2015 – 6/6/2015Laboratory 6/3/2015 6/5/2015 6/6/2015Blood Gases (arterial) pH (7.35-7.45) 7.36 7.33 7.29PCO2 (35-45 mmHg) 24 47 51PO2 (75-100 mmHg) 66 60 56HCO3 (18-22 mmol/L) 13 24 25SO2 % 95 88 86Lactate, Whole Blood (0.5-1.6 mmol/L) 3.1 4.1 5.5

Common Chem Na (135-145 mmol/L) 137 136 138K (3.5-5 mmol/L) 6.3 5.5 4.9Cl (95-105 mmol/L) 102 97 95CO2 (23-29mmol/L) 13 18 22BUN (8-21 mg/dL) 45 45 45Cr (0.8-1.3 mg/dL) 3.2 3.1 2.9Glucose (65-110 mg/dL) 231 150 180Ca (adjusted) (8-10 mg/dL) 7.1 7.6 7.8Mg (1.5-2 mEq/L) 1.7 1.9 1.8Phosphate (3.5-5 mmol/L) 5.4 5.3 5.1Albumin (3.5-5 g/dL) 2.8 3.5 3.4Anion gap (8-16 mEq/L) 19 15 18Total Protein (6-8 g/dL) 5 4.5 4.8Bili, Total (0.3-1.9 mg/dL) 0.3 0.2 0.4Bili, Direct (0-0.3 mg/dL) 0.1 0.2 0.1ALT/SGPT (5-30 U/L) 19 20 21AST/SGOT (5-30 U/L) 35 37 38Alk Phos (50-100 U/L) 64 62 63Hematology WBC (4-10 x 10^9/L) 24 18.1 19.3RBC (4.7-6.1 million/uL) 2.9 2.47 2.51Hgb (12-15 g/dL) 9.6 7.4 5.7Hct (36%-47%) 25.6 21.2 22.5MCV (80-100 fL) 88.3 85.8 89.6MCH (27-33 pg/cell) 27.6 30 30.3MCHC (30-35 g/dL) 31.3 34.9 33.8RDW (11.5%-14.5%) 13.9 17.1 18Platelets (150-400 x 10^9/L) 167 121 84Bands % (< 1 x 10^9/L) 4 5 6Neutrophils % (35-80) 89 87 82.7Lymphs % (18-44) 3 3 6.7Monocytes % (4.7-12.5) 4 6 6.7Eosinophils % (0-4) 0 0.2 1Basophils % (0-1.2) 0 0.1 0PT (11-14 sec) 12.5 15.9 23.1INR (0.9-1.2) 1.2 1.6 2.4PTT (20-40 sec) 34.9 41.1 59.8

Legionella Antigen (urine)Positive for Legionella pneumophilla serogroup I antigen

Blood culture No growth No growth Positive for Klebsiella

14 of 51

MRN: 8971563Visit: 205678945Age: 81 y (06/13/1934)

Samuel, Clyde D Gender: Male

Baltimore Mid-Atlantic HospitalCurrent Location: 5West-063-B

Admission History and Physical - Critical Care [Charted Location: MICU-063-B] [Authored: 06/04/2015 7:17]- for Visit: 205678945, Final, Revised, Signed in Full, General

History of present illness:

Mr. Samuel is an 81 year old African-American male with a history of ESRD secondary to long-standing uncontrolled HTN and DM-II status post deceased donor renal transplant in April 2009 with deterioration of allograft function who now presents to the ED with hypoxemic respiratory failure. In the ED, Mr. Samuel presented with worsening shortness of breath for two days, coughing up yellow sputum and fever of 39.4 Celsius. He was found to be tachypneic and hypoxic to 88% on RA. He denied any chest pain at home and also denied weight loss, chills, or fevers. Due to concern for acute decompensation, the patient was intubated and transferred to MICU.

In the ED, Mr. Samuel's VS were: t=39.5 Celcius, HR = 80-101, RR = 24-42, BP: 106/59 - 162/77, saturating 86-100% initially on 3L NC, then on BiPAP, then on the ventilator. Prior to intubation, he was confused but opening his eyes on command and withdrawing from pain. He was given: piperacillin/tazobactam, azithromycin, vancomycin, acetaminophen, propofol, succinylcholine, rocuronium, fentanyl and midazolam. WBC count was elevated to 24k with lactate of 3.1, hemoglobin of 9.6, UA with 3+ protein and 2+ blood. ABG showed a pH of 7.36, pCO2 of 24, pO2 of 66, HCO3 of 13. Chest X-ray was performed and he was found to have bilateral consolidations, which were thought to be secondary to infiltrate or mass or both.

Past Medical/Surgical/Psychiatric History:

- ESRD secondary to long-standing uncontrolled HTN and DM2

- Hypertension

- Diabetes mellitus type 2, unknown baseline Hb A1C

15 of 51

Social History:

The patient does not smoke, use alcohol, or use illicit drugs. Patient lives independently in the community with assistance from daughter.

Family History:

Unknown/unavailable.

Allergies/Intolerances:

None

Home Medications:

1- Ranitidine 150mg daily2- Extended release Nifedipine 60mg daily3- Clonidine 0.3mg TID4- Metoprolol Tartrate 200mg BID5- Losartan 50mg daily6- Cellcept 1g BID7- Prograf 5mg in the PM, 6mg in the AM 8- Prednisone 5mg dosage 9- Lantus 24 units daily.

Imaging Findings:

Chest X-ray: There is bilateral consolidation. Normal heart size. Blunted left costophrenic angle. Degenerative changes of the spine. Small left effusion.

EKG Findings:

EKG with sinus tachycardia, left atrial enlargement, and evidence of LVH.

Physical Exam:

General: Elderly man, resting in bed and intubated.

HEENT: small, equal, bilaterally reactive pupils.

Lungs: coarse breath sounds bilaterally.

Heart: regular rate and rhythm, no m/r/g. Non-distended jugular veins.

Abdomen: + Abdominal scars. Soft, non-tender and non-distended abdomen.

Extremities: Cool legs, good capillary refill. Trace peripheral edema. Left arm fistula.

Neuro: Sedated, currently unable to follow commands. Intact gag and cough.

16 of 51

Summary Assessment and Plan:

1. Respiratory: SpO2 99% on FiO2 0.5 and PEEP 8.ARDS: I reviewed his CXR - large bilateral infiltrates and ETT in adequate position,

- Continue mechanical ventilation on ARDS protocol - on 6 ml/kg PBW.

2. Cardiovascular: MAP 84 HR 83 lactate rising - avoiding LR since high K and using NS, off all anti-HTN meds - so having relative hypotension- if BP drops then will consider stress dose steroids due to home steroid use.

3. Renal: K = 6.3 and giving shift therapy, renal transplant service consulted for renal management and immunosuppression. Metabolic acidosis due to AKI - will consider HCO3 to assist (may also help with hyperkalemia), holding Cellcept until renal team assesses. Keep Foley for careful I&O.

4. ID: Tmax 40.3. PIV only to prevent CLABSI. Urine legionella positive - will ask transplant ID to consult. Continues to be febrile.

- Legionella pneumonia: transplant ID consult, continue zosyn, vancomycin, and axithromycin.

5. GI: NPO - will consult nutrition service and start feeds.

6. Heme: DVT ppx with S.C. heparin.

7. Endo: Continue prednisone 5 mg daily.

8. Neuro: RASS -1 cam positive Fentanyl infusion off and on prn dosing. Goal RASS 0.

9. MSK/Rehab: PT and OT are ordered

17 of 51

Progress Note -- Critical Care [Charted Location: MICU-063-B] [Authored: 06/05/2015 12:03]-

for Visit: 205678945, Final, Revised, Signed in Full, General

Mr. Samuel is an 81 year old man with a history of ESRD secondary to long-standing uncontrolled HTN and DM-II, s/p deceased donor renal transplant in April 2009 with deterioration of allograft function, who presents with hypoxemic respiratory failure 2/2 legionella PNA.

MICU day 2.

- MAPs in lower 70s, bolused 1 liter normal saline with fair response- Started tube feeds - Hb drop since admission, no clinical signs of bleeding

Summary Assessment and Plan:#Respiratory: unable to attempt SBT due to high O2 requirement- ARDS protocol: 310/35/60/10. Pplat: 25.

#Cardiovascular:- Lower MAPs, ongoing infection, MAP goal >65, will start levophed if not meeting goal.

#ID:*Legionella PNA with Increasing WBC. -On zosyn, vancomycin, and azithromycin, awaiting further ID recommendations-Standing acetaminophen for fever. -Avoid cooling blanket given shivering.

#Renal:-Appreciate recs from renal transplant team.-Awaiting renal US-Tacro 6 mg qAM, 5 mg qPM. Goal 4 - 6.

#Neuro:-Continuous sedation with fentanyl.

#GI:-Nepro tube feeds.-Lansoprazole.

#Endocrine:-A1C 6.2 %-Insulin gtt given difficult to control BG with SSI-Will consider adding stress dose steroids given down trending BP and prior home steroid use

18 of 51

MRN: 8971563Visit: 205678945Age: 81 y (06/13/1934)

Samuel, Clyde D Gender: Male

Baltimore Mid-Atlantic HospitalCurrent Location: 5West-063-B

Progress Note -- Critical Care [Charted Location: MICU-063-B] [Authored: 06/06/2015 06:11]-

for Visit: 205678945, Final, Revised, Signed in Full, General

Mr. Samuel is an 81 year old man with a history of ESRD secondary to long-standing uncontrolled HTN and DM-II, s/p deceased donor renal transplant in April 2009 with deterioration of allograft function, who now presents with hypoxemic respiratory failure 2/2 legionella PNA. Now complicated by Klebsiella sepsis. MICU day 3.

- Started on Levophed, currently at 0.5 mcg/Kg/min to maintain MAP > 65- Added moxifloxacin per ID recs; zosyn/vancomycin continued- Started oral bicarb per renal recommendations- Abdominal x-ray with adynamic ileus; continues to tolerate tube feeds and have BMOvernight:- Received 1 unit pRBCs for Hgb 5.7 (repeat Hgb 7.8)- Cellcept held per Renal recommendations- He does not open eyes but did withdraw from pain

Summary Assessment and Plan:#Respiratory: Unable to attempt SBT due to high O2 requirement- ARDS in the setting of legionella pneumonia

- Continue ARDS protocol: 310/35/70/14. Pplat: 28.

#Cardiovascular:- Septic shock requiring vasopressors

- Continue levophed for MAP goal >65 - Will consider adding stress dose steroids given down trending BP and prior home steroid use

#ID:*Legionella PNA now c/b blood culture positive for Klebsiella- Increasing WBC. -Moxi x 14 days, zosyn and vancomycin continued-Standing acetaminophen for fever. -Avoid cooling blanket given shivering. - Transplant ID following

- repeat blood cultures

#Renal:-Appreciate recs from renal transplant team.

19 of 51

-renal US done and pending results-Tacro 6 mg qAM, 5 mg qPM. Goal 4 - 6.

#Neuro:-Continuous sedation with fentanyl.

#GI:-Nepro tube feeds at goal rate as per nutrition consult.-Lansoprazole for GI ppx

#Endocrine:-A1C 6.2 %-Insulin gtt given difficult to control BG with SSI; 3 more recent ACC check values (q1 hr): 171, 192, 168

#Heme:SC Heparin held due to rising INR

20 of 51

Radiology Report Print Request

Patient: Samuel, Clyde DMRN: 8971563

Department of RadiologyAnd Radiological Science

Baltimore Mid-Atlantic Hospital

Samuel, Clyde D Exam Date: 06/06/2015 11:39 ORD #8971563 Accession #189153453History Number: 8971563 Age: 81Y. Sex: M Race: B

Exam 1: CBZ 5800 - CT CHEST WO CONTRAST - Jun 06, 2015 11:39

Acc#:4564861263

RESULT: History: worsening fever and dyspnea with new development of sepsis.

Technique: CT of the chest performed without IV contrast.

Findings: Endotracheal tube tip is at the distal trachea just above the carina. NG tube distal tip in the stomach, incompletely visualized. Sub centimeter nodule in the left thyroid lobe. Coarsely calcified atherosclerotic plaques at the coronary arteries. Annular calcification of the mitral valve. Bilateral mid-sized pleural effusions and dependent atelectasis and/or consolidation in the both lower lobes. Patchy consolidations in both upper lobes. Calcified granuloma in the right middle lobe. Upper abdomen: Status post cholecystectomy. Atrophic native kidneys, incompletely visualized. Skeletal structures: Spondyloarthropathy.

Impression: Bilateral consolidation/atelectasis in both lower lobes and patchy consolidations in both upper lobes, with pleural effusions suggestive of acute respiratory distress syndrome.

21 of 51

PRE-SIMULATION PHYSICIAN PROMPTING QUESTIONS

Control

1. What is your fluid goal for this patient today? Fluid Goal:

2. What is your sedation goal for this patient today? Sedation Goal:

3. Would you like to make any other changes in management today?

No changes needed

Changes needed. Describe the changes:

4. Are there any consults that you would like to order for this patient today? Select all that apply.

Cardiology

Physical Therapy

Palliative care

Other

None

When finished, please text/call the research team member.

22 of 51

Intervention

1. What is your fluid goal for this patient today? Fluid Goal:

2. What is your sedation goal for this patient today? Sedation Goal:

3. Would you like to make any other changes in management today? (Choose one)

No changes needed

Changes needed. Describe the changes:

4. Are there any consults that you would like to order for this patient today? (Select all that apply)

Cardiology

Physical Therapy

Palliative Care

Other

None

5. What do you believe is this patient's most likely outcome 3 months from now?

6. Do you expect this patient to survive to hospital discharge?

Yes

No

7. If this patient survives his current hospitalization, what do you believe is his most likely outcome 3 months from now?

Able to live independently; No physical or cognitive decline

Able to live independently; Some physical or cognitive decline

Dependent in at least one ADL; Unable to live independently

Dependent in all ADLs; Unable to live independently

Deceased

When finished, please text/call the research team member

23 of 51

SCRIPT DEVELOPMENTThe study script provided instructions for the actors portraying the hypothetical patient’s daughter (Dorothy) during the simulated family meeting. To foster realistic performances, examples of verbal family responses during actual family meetings recorded in a prospective cohort study in six U.S. medical centers1 were provided as examples. The actors, who were all local residents, were asked to review the script and make suggestions to foster authenticity for the Baltimore-metro region. Examples from the resulting script are provided below in eTable 1.

Script elements included:

Background information about the hypothetical patient’s life including age, residence, marital status, spirituality, employment history, activities of daily living, instrumental activities of daily living, and preferred leisure activities.

Background information about the patient’s daughter including age, residence, marital status, family structure and support systems, spirituality, employment, education, relationship with her father, understanding of her father’s medical history, previous experiences with critical illness and disability.

Scripted responses to expected actions, questions, and statements by participating physicians that are always the same regardless of physician behavior.

Examples of 1)vague physician statements implying a poor prognosis, 2)clear physician statements that a patient may die despite treatment, and 3)clear physician explanations that a patient is unlikely to regain independence if he survives.

Responses to difficult questions if the participating physician has made a vague statement implying a poor prognosis.

Responses to difficult questions if the participating physician has made a clear statement that the hypothetical patient may die despite treatment.

Responses to difficult questions if the participating physician has clearly explained that the hypothetical patient is unlikely to regain independence if he survives.

1. Chiarchiaro J, Ernecoff NC, Scheunemann LP, et al. Physicians Rarely Elicit Critically Ill Patients’ Previously Expressed Treatment Preferences in Intensive Care Units. Am J Respir Crit Care Med. 2017;196(2):242-245.

24 of 51

eTable 1: Responses and examples from the study scriptPhysician action, question, or statement

Dorothy's response or reaction

Recorded examples from actual ICU family meetings

Doctor asks an open-ended question about Clyde's health before coming to the hospital.

"Can you tell me a little about how Clyde was doing before he got sick? Does he get around ok? Does he take care of himself?"

State that Clyde generally seems well and takes care of himself. Mention a couple of the activities that you help with (shopping, transportation to appointments, laundry). Acknowledge that he's "slowed down" a bit in recent years.

"I know that she was weak before this also she even though she used to get very tired. And uh, but her activities were just like, you know, mmm, like going to the bathroom or watching TV or reading Holy Book or just a little walk here and there. But talk over the phone with her daughters at home …… with her friends and all of that. That was, you know, she didn’t expect much, you know"

Doctor provides emotional support. "I want you to know that everyone here in the ICU cares about you and your family, and we will do whatever we can to help you through this."

Express gratitude. Thank the doctors and nurses for their hard work.

"I know you guys have taken really good care of him and I appreciate that."

"Well, thank you. Again, I just express my thanks. Again, to everybody, the great care she’s getting. I can see it. I really appreciate it."

Doctor explains surrogate decision making. "Because Clyde's on the breathing machine and can't talk right now we need your help. Your role is to help us understand your father's values, goals, and preferences so that we know what kind of treatment is best for him."

You accept this responsibility.

You feel confident that you know your father well.

"And I can make decisions, based on what I think [patient] would say."

Doctor asks about Clyde as a person.

"Can you tell me a bit about your father? What kind of person is he? What does he like to do?"

Mention any of the activities described in the leisure section of Clyde’s background.

Please use one of the following words: Stubborn, strong, independent.

"Irritable. As soon as he wakes up, he’s going to want to leave and he’s not going to want to lie helpless. He’s pretty stubborn and [first name] and I were talking about that, this morning because [first name] is about having to leave before he wakes up and come back later. Uhm, we think that, once he is awake … He’ll be tellin’ us all to get outta here. He’s very stubborn. He’ll want to be better.”

25 of 51

ACTOR TRAINING Overview

Three paid, African-American actors of similar age portrayed the patient’s daughter. A detailed study script was developed, including actor responses to expected statements and questions from intensivists.1 To foster a high degree of realism, the script included example statements made by actual ICU proxies recorded during a previous study.2 To ensure fidelity to the script, each simulation was independently reviewed by two members of the research team tasked with identifying all actor errors (eTable 2). Actors received feedback after each simulated family meeting, were informed of all errors, and participated in 4 review sessions, during the course of study, in which previous simulations were reviewed and discussed to achieve high fidelity to the script across all 3 actors.

Actor Recruitment and Training

The Johns Hopkins Simulation Center identified and referred actors of similar age and race (50 to 70 years old, African American female) with experience portraying medical patients and their family members. We auditioned and interviewed recommended actors about their availability, commitment to attend rehearsals, compensation, and previous experiences as both a medical patient and a patient proxy in the hospital setting. Actors invited to a second audition received feedback on their initial performance and were given time to demonstrate they could incorporate feedback into their performances. Three actors were hired to help ensure maximal availability throughout the duration of the trial which included evening and weekend enrollment.

Initial trainings prior to physician enrollment and start of trial:

90 minute read-through and discussion of the script 1st rehearsal in the Simulation Center with ineligible physicians 2nd rehearsal in the Simulation Center with ineligible physicians 3rd rehearsal in the Simulation Center with ineligible physicians 90 minute review of rehearsal videos and feedback

26 of 51

QUALITY ASSURANCE PROCESS

Quality Assurance Team: The Quality Assurance Team members are tasked with ensuring the study actors provide consistent performances with high fidelity to the study script. Team members also assist with clinical scenario development, script development, and actor training.

Both members of the quality assurance team independently review the audio and the video recording as well as the written transcription of each simulated family meetings in the trial. After reviewing each simulation, team members independently complete a Research Electronic Data Capture (REDCap) form with questions about actor performance (eTable 2). Discrepancies in actor performance evaluations are identified using the Data Comparison Tool for Double Data Entry in REDCap by the Research Study Coordinator and then discussed by the Quality Assurance Team, Principal Investigator and Research Study Coordinator. Each error is categorized by whether it could have influenced the behavior of the physician participating in the study. For example, answering a physician question about the hypothetical patient’s hobbies or employment history is unlikely to significantly impact physician behavior. In contrast, expressing doubt or disbelief about information provided by the physician (either verbally or through body language) is very likely to affect physician behavior during the simulation.

Individual Performance Feedback: Actors receive individualized feedback two ways. First, the study team member running the simulation (principal investigator, research study coordinator, or research assistant) will watch and listen to the simulated meeting and provide immediately in-person general feedback to the actor after the performance. Second, the timing and nature of all performance errors identified after the simulated meeting has been reviewed by the quality assurance team are shared with actors via written report. Actors have the opportunity to discuss these errors with the Principal Investigator or Research Study Coordinator and to watch the video of their own performance, but actors do not interact with the quality assurance team.

Group Performance Review and Continuing Education: Periodically throughout the trial, all actors meet with the Principal Investigator and Research Study Coordinator to review issues that arise, additions or amendments to the study scrip, and trends or concerns identified by the Quality Assurance Team. These meetings also serve as an opportunity for actors to share their experiences with one another and discuss how to respond when physicians make statements or ask questions that are not covered by the study script.

27 of 51

Fields in the REDCap Quality Assurance Form Completed by Both Members of the Quality Assurance Team for Each Simulated Family Meeting

1 Unique ID # of study participant2 Video ID #3 Date of simulation4 SP portraying Dorothy (patient's daughter)5 Video auditor6 Date that video is being audited7 Did the MD make a vague statement implying a poor prognosis? 8 Did the SP respond appropriately?9 Time of 1st vague statement about prognosis10 Lines in transcript corresponding to 1st vague statement11 Did the MD explicitly state that Clyde may die during this hospitalization? 12 Time of 1st explicit statement about survival to hospital discharge13 Lines in transcript corresponding to explicit statement14 Was the explicit statement about survival prompted?15 Did SP respond appropriately?

16 Did the SP ask "What's most likely to happen?" at some point after the explicit statement about death?

17 Did the MD explain that Clyde has a poor functional prognosis? 18 When did the MD 1st address functional prognosis?19 Lines in transcript that correspond to functional prognosis statement20 Did the actor respond appropriately?21 First error22 Time of 1st error23 Corresponding lines in transcript24 2nd error25 Time of 2nd error26 Corresponding lines in transcript27 3rd error28 Time of 3rd error29 Corresponding lines in transcript30 4th error31 Time of 4th error32 Corresponding lines in transcript33 How many TOTAL errors in this simulation?34 How many errors that may have influenced MD behavior in this simulation?

28 of 51

OUTCOME INSTRUMENTS – PHYSICIAN SELF-REPORT

Select the response that best represents your thinking about questions 1-7.

1. How much disagreement, including conflicts and negative feelings, has there been between you and this proxy regarding this patient’s care? (Circle one number)0 No conflict12345678910 Most conflict possible

2. If you felt there was a disagreement between you and the family, to what extent was this disagreement similar to the type of disagreements that sometimes arise in ICUs about goals of care? (Circle one number or Select N/A)N/A0 Completely different12345678910 Almost identical

3. To what extent was this family conference similar to conversations you might have with families of ICU patients? (Circle one number)0 Completely different12345678910 Almost identical

29 of 51

4. To what extent were the actor portraying family members similar to family member(s) of patients with whom you have met? (Circle one number)0 Completely different12345678910 Almost identical

5. To what extent were the types of emotions expressed in this conference similar to those expressed during conferences with families of ICU patients? (Circle one number)0 Completely different12345678910 Almost identical

6. To what extent was the conference room similar to the environment where you usually meet with families of ICU patients? (Circle one number)0 Completely different12345678910 Almost identical

30 of 51

7. To what extent was the clinical information available through the electronic medical record similar to the information you usually review prior to a discussion with the family of an ICU patient? (Circle one number)0 Completely different12345678910 Almost identical

8. During the simulation, did you provide emotional support?(eg Acknowledge emotions, convey empathy, explore proxy’s concerns)Don't rememberDoneNot doneNot applicable

9. During the simulation, did you offer the support of social work or chaplaincy?Don't rememberDoneNot doneNot applicable

10. During the simulation, did you explain surrogate decision making?(eg Explain why proxy input is important; explain proxy’s role to promote patient’s values, goals, and preferences; explain substituted judgment)Don't rememberDoneNot doneNot applicable

11. During the simulation, did you identify the patient's legal healthcare proxy?Don't rememberDoneNot DoneNot applicable

12. Who do you believe is this patient's legal healthcare proxy?

___________________________________________________________

31 of 51

13. During the simulation, did you explain the patient’s current condition and treatments?Don't rememberDoneNot doneNot applicable

14. During the simulation, did you elicit the patient’s values, goals, and preferences?(ex. Elicit previously expressed treatment preferences (oral or written), elicit patient’s values about relevant health states, ask proxy what the patient would likely choose if he were able to speak for himself)Don't rememberDoneNot DoneNot applicable

15. During the simulation, did you convey prognosis for risk of death?Don’t rememberDoneNot DoneNot applicable

16. During the simulation, did you convey prognosis for risk of post discharge functional impairment?Don't rememberDoneNot DoneNot applicable

17. During the simulation, did you explain treatment options? (eg Describe treatment options, as well as their risks and benefits)Don't rememberDoneNot DoneNot applicable

18. During the simulation, did you highlight that there is a choice?(eg Explain that there is more than one treatment choice)Don't rememberDoneNot DoneNot applicable

19. During the simulation, did you offer the alternative of care focused entirely on comfort?Don't rememberDoneNot doneNot applicable

32 of 51

20. For question 19, explain why this was done, not done, or not applicable.

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

21. During the simulation, did you deliberate with the proxy?(eg Explore proxy’s thoughts and concerns, correct misperceptions)Don't rememberDoneNot doneNot applicable

22. During the simulation, did you provide a recommendation?Don't rememberDoneNot doneNot applicable

23. During the simulation, did you bring up the possibility of withdrawing life support?Don't rememberDoneNot doneNot applicable

24. During the simulation, did you agree on a treatment decision to implement?Don't rememberDoneNot doneNot applicable

In questions 25-27 below, please review each action and report what you intend to discuss the next time you meet with this proxy.

25. The possibility of a tracheotomy?NoYes

26. The possibility of withdrawing life support?NoYes

27. The possibility of starting ECMO?NoYes

When done, submit checklist(s)

33 of 51

Section 1: The Option of Care Focused Entirely on Comfort

No. Question Text Guidance

1a

Did this intensivist offer the alternative of care focused entirely on comfort either now or as a possibility in the future?

If an intensivist talks about prioritizing the patient’s comfort or symptom control either now or as a possibility in the future, please choose Yes. Remember that this approach is not synonymous with withdrawing life support. If the proxy chooses this approach it may still be possible to discharge this patient to hospice or a long-term care facility. In addition to simply using the words “comfort care” or “care focused on comfort”, intensivists may also uses phrases similar to the example below. Please select Yes in these situations.

Example: “The other option is to make sure he’s not feeling any pain, and just let nature take its course. We wouldn’t start any new treatments, and if his kidneys give out we wouldn’t do dialysis. I don’t expect him to live much longer if we choose this path, but we’d do everything we can to honor him and make sure he doesn’t suffer and he isn’t scared or alone.”

1b. How understandable was the intensivist's description of comfort care for proxies with low health literacy?

1 - Not understandable – Choose this option if you believe a proxy with low health literacy would NOT understand the offer of comfort care. Example: “If your father is not better in a few days we can take a comfort-based approach to his treatment.”

2 - Vague – Choose this option of you believe a proxy with low health literacy might understand the offer of comfort care. Example: “If you’d rather we focus on keeping him comfortable instead of on beating the pneumonia we can do that.”

3 - Understandable – Choose this option if you believe a proxy with low health literacy would understand the offer, but the intensivist does NOT explicitly address that the patient is expected to die more quickly if they choose this option. Example: “Another option is to stop treating his pneumonia and instead focus on keeping him as comfortable as possible.”

4 - Clear – Choose this option if you believe a proxy with low health literacy would understand the offer, and that the patient is expected to die more quickly if they choose this option. Example: “Another option is to stop treating the pneumonia and instead focus on your father’s dignity and on keeping him as comfortable as possible. He’ll probably die fairly quickly if we choose this path.”

5 - Clear and detailed – Choose this option if you believe a proxy with low health literacy would understand exactly what medical procedures would and would not happen if they choose to focus exclusively on comfort. Example: “Another option is to shift to focusing on your father’s comfort.

34

This would mean that if his kidneys fail we won’t start dialysis, we won’t give him more antibiotics, we won’t increase support from the breathing machine any more, and we’d stop some of the other medications he’s on. Instead, we’d make sure he’s not feeling scared, he’s not in any pain, and we’ll allow your whole family to be in the room with him. People normally choose this option when they believe a patient is dying, and they want to make sure the death is peaceful and comfortable. I don’t expect he’ll live very long if we take this approach, but we’ll continue to watch over him, ensure he doesn’t suffer, and to support your family the whole time.”

1c.

Enter the lines of the transcript where the offer of care focused on comfort occurred

If this happens in two places in the transcript, please indicate both places separates by a semicolon. For example: 112-114; 237-240

1d.

Paste the text of the transcript containing the comfort care offer here.

Hopefully this is straightforward.

1e.

Did the intensivist communicate that care focused on comfort is an acceptable choice now, or only if the patient's health deteriorates further?

Choose “Acceptable Now” if the intensivist has communicated that comfort care is acceptable in Clyde’s current condition. If the intensivist doesn’t specifically state that comfort care is acceptable if the patient’s health continues to worsen, then assume it is acceptable now.

Acceptable Now Example: “Given how sick your father is and that he feels strongly about not wanting to live in a nursing home, one option is to shift our treatments to focus on his comfort and dignity accepting that he would probably die here in the ICU if we do that.”

Choose “Only if health deteriorates further” if the intensivist suggests that comfort care is acceptable only if Clyde doesn’t show improvement.

Only if health deteriorates further example: “If he gets a lot worse or we start to see signs that he’s not going to survive this pneumonia, then we can switch to making sure he’s comfortable, that he’s also not going to suffer, and that his death is peaceful.”

35

Section 2: The Possibility of Withdrawing Life Support

2a.

Did the intensivist bring up the possibility of withdrawing life support?

Please select Yes if the intensivist talks about “stopping the machines,” “turning off the machines”, “removing the ventilator”, “ending life support”, or anything else that suggests actively withdrawing life-sustaining technologies or treatment.

2b.

Enter the lines of the transcript where the intensivist brought up withdrawing life support.


2c.

Paste the text of the transcript where the intensivist brought up withdrawing life support here.


2d.

Did the intensivist communicate that withdrawing life support is an acceptable choice now, or only if the patient's health deteriorates further?

Choose “Acceptable Now” if the intensivist has communicated that withdrawing life support is acceptable in Clyde’s current condition.

Acceptable Now Example: “Given how sick your father is right now and that he feels strongly about not wanting to be cared for in a nursing home, one option is for us to make him comfortable, let everyone who wants to visit pay their respects, and then remove the ventilator knowing that he’ll probably die fairly quickly after that.”

Choose “Only if health deteriorates further” if the intensivist suggests that withdrawing life support is acceptable only if Clyde doesn’t show improvement.

Only if health deteriorates further example: “If we don’t see improvement by the end of the week I think we should consider whether the ventilator is truly helping him or if it’s just prolonging his death. We’re not there yet, but if he’s not showing signs of recovery on Friday, then we should meet again and talk about whether your father would want to continue to be on life support.”

36

Section 3: Discussing short-term prognosis and death

3a.

Did this intensivist try to communicate that the patient may die as a result of his current illness despite treatment?

Select Yes if the intensivist tried to tell the proxy that her father may die in the ICU even if he continues to receive treatment. Select Yes even if the intensivist uses a euphemism. For example: “Even though he’s getting all the right antibiotics I’m worried he might not make it out of the hospital.” or “Despite everything we’re doing, there’s still a very real possibility this pneumonia might take him.” or “I’m sorry to be the one to tell you this, but he may pass away as a result of these infections.” Note: If the intensivist uses the phrase “may not make it out of the hospital” assume that the family will understand that this means he may die despite treatment.

Select No if the intensivist only talks about hypothetical patients or situations. For example: “Some patients who have septic shock like your father do not survive.” or “If your father was not on the ventilator right now he would die.” or “If someone your father’s age isn’t able to fight an infection they often die.” or “When someone’s very sick like this, we’re not always able to save them.”

3b.

Did the intensivist use the words "die", "dying", or "death" to communicate the patient's prognosis?

Hopefully this is straightforward to determine.

Don’t hesitate to use Ctrl + F to search for the big 3 “D words” in a transcript.

3c.

Enter the lines of the transcript in which the intensivist communicates that the patient may die as a result of his current illness.


3d.

Paste the text of the transcript where the intensivist communicates that the patient may die despite treatment.


37

Section 4: Discussing long-term functional prognosis

4a.

Did this intensivist clearly communicate that the patient may experience new functional impairments if he survives?

Select Yes if the intensivist explains that the patient may not be able to perform certain activities of self-care or may experience new physical or cognitive impairments. For example: “If your father survives these infections it’s likely he’ll be too weak to walk. After being on a ventilator some people have trouble speaking or swallowing, and elderly people often have trouble thinking clearly. This could mean he’d need a lot of help with simply things like eating, getting dressed in the morning, or going to the bathroom. Sometimes these new problems turn out to be permanent.”

Select No if the intensivist only talks about potentially needing to receive care in a rehab facility or needing to live in a nursing home.

4b.

Enter the lines of the transcript where the intensivist communicates that the patient may experience new functional impairments if he survives


4c.

Paste the text of the transcript where the intensivist communicates that the patient may experience new functional impairments if he survives.


38

Section 5: The CollaboRATE measure

5a.

How much effort was made to help this proxy understand the patient's health issues?

These 3 questions make up the CollaboRATE measure of shared decision making in clinical encounters. These are opinion-based questions without formal guidance on how to score them. It’s ok if you’re not in perfect agreement about them. If you’re curious about how this measure was developed please see the following references:

Elwyn G, Barr PJ, Grande SW, et al.: Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns 2013; 93:102–107

Barr PJ, Thompson R, Walsh T, et al.: The Psychometric Properties of CollaboRATE: A Fast and Frugal Patient-Reported Measure of the Shared Decision-Making Process. J Med Internet Res 2014; 16:e2

5b.

How much effort was made to listen to the things that matter most to the proxy about their health issues?

5c.

How much effort was made to include what matters most to the proxy in choosing what to do next for the patient?

For the last 5 questions which make up the Observer OPTION5 Measure, please see the grid on the next page which includes examples of how each item should be scored. You can also find more information at:

http://www.optioninstrument.org/observer-option-5-2014.html

39

http://www.optioninstrument.org/observer-option-5-2014.html

Observer OPTION5 MeasureMeasure Item 0-No effort 1-Minimal Effort 2-Moderate Effort 3- Skilled Effort 4-Exemplary Effort

The clinician draws attention to or conforms that alternate treatment or management options exist or that the need for a decision exists.

MD makes does not tell the proxy that she has the option of pursuing a treatment plan focused on prioritizing Clyde's longevity or focused on prioritizing his comfort.

"There are a couple of ways we can treat him." or“There are a range of options for what we do next.”

"Alternative options exist regarding how we think about your father's care. We need to consider what to do and choose between a few options."

"There are a few options because it's reasonable to consider different paths at this stage. They each have different pros and cons. Different families choose different things which is why it's important to compare options, so you help decide what fits your circumstances."

"As in many situations, there are alternative possibilities. Would you like to hear about these alternatives? My goal is for you to understand more about these options, and then hear from you as to what matters most to you. People have different priorities - so I want to understand yours."

The clinician reassures the patient or re-affirms that the clinician will support the patient to become informed or deliberate about the options.

The clinician makes no effort to reassure the patient that they will be supported during the process of being given information or being asked to deliberate about options.

"My role is to work with you to figure out what to do next."

"I realize these are probably decisions you've never faced before and they can be hard to make. We can do this together."

"I’m going to make sure that you have more information about the relevant options, and then we’ll work together to consider those options. This might feel like a lot of work, but I’m here to help you consider these options and work out what might be best for your father."

"I’m going to make sure that you have more information about the relevant options. Some patients sometimes feel overwhelmed by this kind of information, but I’ll do my best to make it clear and easy to follow. I will describe how the options are different, where they lead to benefits and where they lead to harm, and how often these happen. My job is to make sure I support you in understanding these options so that we can compare them and work out what is best for your father. Do you have any questions?"

The clinician gives information or checks understanding about the options that are considered reasonable, to support the patient in comparing alternatives. If the patient requests clarification, the clinician supports the process.

The clinician makes no effort to provide information about options.

"There are two options available: full court press and comfort care. Let me describe what they look like."

"There are a couple different approaches we can take at this point. Let me describe them to you so that you can understand both the benefits of each option and the harms and how likely these are to take place."

"There are a few approaches we can take. Let me describe them to you so that you can understand both the benefits of each option and the harms and how likely these are to take place. [Describes aggressive, time-limited, and comfort-focused options]. Do you have questions? Can I explain something again?"

"There are a few approaches we can take. Let me describe them to you so that you can understand both the benefits of each option and the harms and how likely these are to take place. [Describes aggressive, time-limited, and comfort-focused options]. Do you have questions? Can I explain something again? [Uses teach back] How would you explain these options to someone else in your family?"

The clinician makes an effort to elicit the patient's preferences in response to the options that have been described. If the patient declares their preference(s), the clinician is supportive.

The clinician makes no effort to elicit patient preferences.

"What do you think your father would want?"

"Now that I've described the options, do you think one of them seems to fit best with what your father's views?"

"What do you think your father would say about those options? Do you feel like you know how your father would react to those? Do any of them worry you or appeal to you? I'm curious how you think your father would react to the options I've described. "

"Did you have any questions or concerns or concerns about the options I just described? Maybe you head some things that you liked? Or were worried about? That's normal. My job is to try and understand your father's views about those options. Do you feel like you know how your father would react to those? I'm curious how you think your father would react to the options I've described."

The clinician makes an effort to integrate the patient's elicited preferences as decisions are made. If the patient indicates how best to integrate their preferences as decisions are made, the clinician makes an effort to do so.

The clinician makes no effort to integrate the patient’s informed preferences as decisions are made or deferred.

"It sounds like your father would want us to keep pushing so let's do that."or "It sounds like your father wouldn’t want to be dependent on machines, so let’s shift the focus to his comfort. "

"I think you are happy with how we've been treating him. Did I get that right?" or“I think you’d like to gather your family and allow him to die naturally. Did I get that right?”

"So if I can summarize, you think that both options are possibilities because your father would like every chance to return to living independently in his own home, but he wouldn't want to end up needing to live in a nursing home. Is that right?"

"So if I can summarize, you think that both options are possibilities because your father would like every chance to return to living independently in his own home, but he wouldn't want to end up needing to live in a nursing home. Is that right? I want to be sure I've understand his priorities, so please let me know if you want to say more about this. My job is to make sure that this choice is based on the things that matter most to your father and have the best chance of working for his situation."

40

41

CharacteristicIntervention

N = 63Control N = 53

Age (median, IQR) 40 (36 - 46) 40 (36 - 46)Male n (%) 45 (71%) 35 (66%)Hispanic or Latino n (%)* 5 (8%) 6 (11%)Race n (%)*

White 47 (75%) 34 (64%)Asian 10 (16%) 13 (25%)More than one race 4 (6%) 2 (4%)Black 1 (2%) 3 (6%)

Primary hospital locationOutside Maryland n (%)† 15 (24%) 17 (32%)

Number of weeks worked in the ICU last year (median, IQR) 15 (8 - 24) 12 (8 - 20)Critical care fellowship completed in the U.S.A. n (%) 60 (95%) 49 (92%)Years since completing critical care fellowship (median, IQR) 8 (2 - 13) 6 (3 - 12)Type of ICU n (%)

Medical 26 (41%) 29 (55%)Mixed medical & surgical 22 (35%) 11 (21%)Surgical 10 (16%) 5 (9%)Other/Multiple types 5 (8%) 8 (15%)

Hospital financial model n (%)‡Non-profit 59 (94%) 46 (87%)For profit 5 (8%) 8 (15%)

Hospital teaching status n (%)‡University 40 (63%) 41 (77%)Non-University Teaching 21 (33%) 13 (25%)Non-teaching 5 (8%) 6 (11%)

Current religion n (%)*Catholic 16 (25%) 15 (28%)Agnostic/Atheist/No religious affiliation 17 (27%) 12 (23%)Jewish 7 (11%) 8 (15%)Protestant 11 (17%) 4 (8%)Hindu 4 (6%) 4 (8%)Other 5 (8%) 6 (11%)

How important is religion in your life? n (%)* Extremely/Very important 14 (22%) 8 (15%)Moderately important 12 (19%) 11 (21%)Slightly/Not at all important 36 (57%) 30 (57%)

* Missing values: Race = 2, Hispanic = 2, Religion=7, Importance of religion=5† 32 (28%) of participants practice outside of Maryland in the following 17 states: CA, DC, DE, HI, IL, KY, MA, MI, MN, NC, NJ, NY, PA, SC, UT, VT, WA‡ Percentages do not sum to 100% because some intensivists work in multiple hospitals.

eTABLE 2: INTENSIVIST CHARACTERISTICS BY TREATMENT GROUP

42 of 51

INTERIM ANALYSIS PLAN

Interim Stopping Rule: Interim analyses will be performed after 36 physicians have offered care focused entirely on comfort (50% of expected number of events) within either arm of the trial to monitor for futility. The trial will be stopped for futility if the probability of a risk difference (RD) of ≥10% in the treatment vs control arms of the trial falls below 0.10.

Pr (RD > 0.01 | Interim data) <0.10

Bayesian predictive probabilities1-3 will be used to perform these assessments by the independent study biostatistician to ensure that the research team remains blinded to the treatment effect.

The interim analyses was never performed because only 15 physicians in both arms of the trial offered care focused entirely on comfort as judged by the blinded outcome assessors.

References1. Dmitrienko, A, Wang, MD. Bayesian predictive approach to interim monitoring in clinical trials. Stat. Med. 2006;25, 2178–2195.

2. Saville, BR, Connor, JT, Ayers, GD, Alvarez, J. The utility of Bayesian predictive probabilities for interim monitoring of clinical trials. Clin. Trials 2014;1740774514531352.

3. Pedroza, C. et al. Advantages of Bayesian monitoring methods in deciding whether and when to stop a clinical trial: an example of a neonatal cooling trial. Trials 2016;17, 335.

43 of 51

INTENSIVIST-PERCEIVED CONFLICT DURING SIMULATIONS eFIGURE 1

eFIGURE 2

44 of 51

REALISM OF SIMULATIONS AS RATED BY INTENSIVISTS

eFIGURE 3

eFIGURE 4

45 of 51

eFIGURE 5

eFIGURE 6

46 of 51

eFIGURE 7

47 of 51

eFIGURE 8

48 of 51

OUTCOMES STRATIFIED BY ACTOReTable 3: Trial outcomes by actor

Actor 1 Actor 2 Actor 3P-value* (N=44) (N=47) (N=25)

Assessment of 2 blinded intensivists “Did this intensivist…” [n (%) responding “Yes”]communicate that the patient may die as a result of his current illness despite treatment? 25 (57%) 27 (57%) 14 (56%) 0.99

clearly communicate that the patient may experience new functional impairments if he survives? 1 (2%) 1 (2%) 2 (8%) 0.35

offer the alternative of care focused entirely on comfort either now or as a possibility in the future? 6 (14%) 5 (11%) 4 (16%) 0.83

Intensivist self-report "During the simulation, did you…" [n (%) responding "Done"]convey prognosis for risk of death? 36 (82%) 39 (83%) 19 (76%) 0.76

convey prognosis for risk of post discharge functional impairment? 27 (61%) 25 (53%) 17 (68%) 0.45

offer the alternative of care focused entirely on comfort? 13 (30%) 11 (23%) 8 (32%) 0.69* P-value from Pearson’s chi-square test for differences in frequencies across actors unless cell size ≤5 in which case care Fisher’s exact test was used.

eTable 4: Trial outcomes, stratified by actor and intervention armActor 1 Actor 2 Actor 3

Intervention

(N=28)Control (N=16)

Intervention(N=22)

Control (N=25)

Intervention (N=13)

Control (N=12)

Assessment of 2 blinded intensivists “Did this intensivist…” [n (%) responding “Yes”]communicate that the patient may die as a result of his current illness despite treatment?

19 (68%) 6 (38%) 14 (64%) 13 (52%) 10 (77%) 4 (33%)

clearly communicate that the patient may experience new functional impairments if he survives?

1 (4%) 0 (0%) 0 (0%) 1 (4%) 1 (8%) 1 (8%)

offer the alternative of care focused entirely on comfort either now or as a possibility in the future?

5 (18%) 1 (6%) 1 (5%) 4 (16%) 2 (15%) 2 (17%)

Intensivist self-report "During the simulation, did you…" [n (%) responding "Done"]convey prognosis for risk of death? 26 (93%) 10 (63%) 21 (95%) 18 (72%) 11 (85%) 8 (67%)

convey prognosis for risk of post discharge functional impairment? 20 (71%) 7 (44%) 14 (64%) 11 (44%) 9 (69%) 8 (67%)

offer the alternative of care focused entirely on comfort? 6 (21%) 7 (44%) 5 (23%) 6 (24%) 4 (31%) 4 (58%)

49 of 51

eTable 5: Risk difference in intervention vs control arm, stratified by actorActor 1 Actor 2 Actor 3

Diff in proportions (95% CI) Diff in proportions (95% CI) Diff in proportions (95% CI)

Assessment of 2 blinded intensivists “Did this intensivist…” [n (%) responding “Yes”]

communicate that the patient may die as a result of his current illness despite treatment?

30%(-4%, 65%)

12%(-21%, 44%)

44%(0%, 87%)


4%(-7%, 14%)

-4%(-16%, 8%)

0%(-23%, 21%)


12%(-12%, 35%)

-11%(-33%, 10%)

-1%(-31%, 29%)

Intensivist self-report "During the simulation, did you…" [n (%) responding "Done"]

convey prognosis for risk of death?30%

(0%, 61%)23%

(0%, 47%)18%

(-23%, 59%)

convey prognosis for risk of post discharge functional impairment?

28%(-7%, 62%)

20%(-13%, 52%)

3%(-37%, 42%)

offer the alternative of care focused entirely on comfort?

-22%(-56%, 12%)

-1%(-27%, 24%)

-3%(-42%, 37%)

50 of 51

eTable 6: Trial outcomes excluding simulations with an actor error could influence physician behavior (N=16 excluded for each of intervention and control group) See Supplement 1 section VIII for description of Quality Assurance process

Intervention Control Difference in proportions

(95% CI) P-value Effect size N = 47 N = 37Assessment of 2 blinded intensivists “Did this intensivist…” [n (%) responding “Yes”]

communicate that the patient may die as a result of his current illness despite treatment? 29 (62%) 13 (35%) 27%

(3%, 50%) 0.03 0.54


1 (2%) 2 (5%) -3%(-14%, 7%) 0.58 0.17


6 (13%) 3 (8%) 4%(-11%, 20%) 0.72 0.15

Intensivist self-report "During the simulation, did you…" [n (%) responding "Done"]

convey prognosis for risk of death? 42 (89%) 22 (60%) 30%(9%, 50%) 0.003 0.70

convey prognosis for risk of post discharge functional impairment? 31 (66%) 16 (43%) 23%

(-1%, 46%) 0.06 0.46

offer the alternative of care focused entirely on comfort? 10 (21%) 12 (32%) -11%

(-33%, 10%) 0.37 0.25

SENSITIVITY ANALYSES

51 of 51

Documents

Rater’s Guide v1.4€¦ · Web view2020. 3. 26. · Communication with families of patients in the ICU is an important issue. We are conducting a related research study, approved