Lippincott Williams & Wilkins



Supplemental Material

The association of patient reported outcomes with an immersive preoperative virtual reality experience: a Randomized Controlled Trial

Kimon Bekelis, M.D.1,2, Daniel Calnan, M.D., Ph.D. 3, Nathan Simmons, M.D. 3, Todd A. MacKenzie, Ph.D. 2,4,5,6, George Kakoulides, M.D. 3,7

1Department of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, PA

2The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH

3Section of Neurosurgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH

4Department of Biomedical Data Science, Geisel School of Medicine at Dartmouth, Hanover, NH

5Department of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH

6Department of Community and Family Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH

7Long Island Neurosurgical and Pain Specialists, West Islip, NY

TABLE OF CONTENTS

SUPPLEMENTARY METHODS..…………………………………………………..…3

Study Protocol………………………………….……………………………….…………3

EVAN-G Questionnaire…………………………….………………………...…………...8

APAIS Questionnaire………………………………………….………………..………..14

Visual analog scales……………………………………………………………….……..16

SUPPLEMENTARY FIGURES.....…………………………………………………..…3

Figure S1. Study design………………………………………………...……….………19

SUPPLEMENTARY METHODS

STUDY PROTOCOL

Principal Investigator:

Kimon Bekelis, MD

Associate Investigators:

Nathan Simmons, MD

Daniel Calnan, MD

Todd A. MacKenzie, PhD

Senior statistician Consultant:

Todd A. MacKenzie, PhD

1. Introduction and Background

In the current constantly changing healthcare landscape quality measurement has a central role. As the practice of medicine is shifting from authority to accountability, the quality of our interventions is under continuous scrutiny by patients, peers, payers, and policy makers. If done appropriately quality measurement can empower all members of the healthcare debate. There is increasing focus on patient satisfaction outcomes as quality indicators.

An important part of surgical outcomes is a patient’s perception of the result of the intervention and overall experience in the preoperative setting. When assessing surgical outcomes, measuring patient satisfaction is necessary. A qualitative systematic review of patient satisfaction measures noted a scarcity of well-development quality improvement initiatives to improve patient satisfaction. Anxiety, a potent behavioral and psychological reaction, weighs heavily on a patient’s perioperative experience and is exacerbated by preoperative concerns about underlying disease and impending anesthesia and surgery.

There are multiple stressors on the day of the surgery: unfamiliar environment, multiple forms to be signed, and multiple short encounters with new and unfamiliar personnel. These create confusion, increase baseline anxiety, and can negatively affect patient experience, and by extension surgical outcomes.

Increasing familiarity with this environment can help patients feel more informed about what matters most to them, and have more accurate expectations of possible benefits and harms of their options. This can potentially decrease overall anxiety, improve patient satisfaction, and decrease pain levels.

1. Bekelis K, Goodney RP, Dzebisashvili N, Goodman DC, Bronner KK. Variation in the Care of Surgical Conditions: Cerebral Aneurysms. Lebanon, NH2014.

2. Centers for Medicare and Medicaid Services. CMS Quality Strategy 2013 – Beyond. 2013; . Accessed April 30, 2015.

3. The National Quality Strategy (NQS). 2015; . Accessed April 30, 2015.

4. Centers for Medicare and Medicaid Services. Quality Measures. 2015; . Accessed April 30, 2015.

5. National Quality Forum. Measure Evaluation Criteria 2015; . Accessed April 30, 2015.

6. National Quality Forum. Consensus Development Process. 2015; . Accessed April 30, 2015.

7. Centers for Medicare and Medicaid Services. Physician Fee Schedule. 2015; . Accessed April 30, 2015.

8. Chien AT, Rosenthal MB. Medicare's physician value-based payment modifier--will the tectonic shift create waves? N Engl J Med. 2013;369(22):2076-2078.

9. Dowd B, Li CH, Swenson T, Coulam R, Levy J. Medicare's Physician Quality Reporting System (PQRS): quality measurement and beneficiary attribution. Medicare Medicaid Res Rev. 2014;4(2):mmrr2014.2004.2002.a2004.

10. Coulam R, Kralewski J, Dowd B, Gans D. The role of medical group practice administrators in the adoption and implementation of Medicare's physician quality reporting system. Health Care Manage Rev. 2015;Mar 2. [Epub ahead of print].

2. Objectives and Hypotheses

Aim 1. To determine whether an immersive preoperative experience (video) is associated with decreased stress and improved patient satisfaction in the perioperative period.

Aim 2. To determine whether an immersive preoperative experience is associated with decreased stress, improved patient satisfaction, and decreased pain in the perioperative period.

3. Study Design

Our study will include patients scheduled to undergo neurosurgical interventions. Patients for whom surgical intervention is deemed necessary will be approached by the PI (KB) for participation in the study. After signing informed consent, they will be randomized to watch a video during their preoperative evaluation visit (routinely done about a week before the operation with the neurosurgery Nurse Practitioner) or have a standard evaluation during their preoperative visit.

The preoperative visit will be performed, as it would be normally, with the only addition of a 5-minute video for the patients randomized to the intervention group. Patients will be given a few minutes to watch the video, and will have the chance to ask questions. The remainder of the interaction between patient and provider will not be affected in any other way.

The control group will be given a description of the preoperative experience, they will be told what to expect, they will be given brochures detailing what will happen on the day of the surgery, and will be given the opportunity to ask questions.

The VR video will include a simulated patient encounter (with actors not real patients) showcasing the preoperative experience of the patient, including getting checked in, meeting the nurses, surgeons, and the anesthesiologists. It will be filmed in the hospital.

Our hypothesis is that by introducing a way to familiarize the patients with the preoperative experience of will have an impact on their anxiety about the operation and their satisfaction with the entire experience. We hope this quality improvement initiative will change patient experiences for the better. Patients will be interviewed again by the associate investigators (who will be blinded to the category in which the patient was randomized in) immediately preoperatively, postoperatively, and 30-days (via telephone) after the operation.

Primary Outcome Measures:

1.EVAN-G

[Time Frame: Checked within 24 hours after the surgery] [Safety Issue: No]

A patient satisfaction score with 6 domains. The score ranges from 0-100 with higher scores representing higher satisfaction

2.APAIS

[Time Frame: Checked immediately preoperatively on the day of the surgery] [Safety Issue: No]

A preoperative anxiety score with 6 domains. The anxiety score ranges from 4 to 20 and encompasses anxiety for the surgery and the anesthesia.

Secondary Outcome Measures:

1. Stress level [Time Frame: Checked immediately preoperatively on the day of the surgery] [Safety Issue: No] On a scale of 0-100 with 0 being no stress and 100 being the worst stress in the patient's life. Visual Analog Scale


2. Pain level [Time Frame: Checked at 3 times: a) immediately preoperatively on the day of the surgery, b) within 24 hours after the surgery, and d) 30 days postoperatively] [Safety Issue: No] On a scale of 0-100 with 0 being no pain and 100 being the worst pain in the patient's life. Will be checked for all patients at time points a) and b), and only for patients undergoing spinal operations for degenerative spine disease for time point c). Visual Analog Scale


3. Patient satisfaction level [Time Frame: Checked twice: a) immediately preoperatively on the day of the surgery, b) within 24 hours after the surgery] [Safety Issue: No] On a scale of 0-100 with 0 being not satisfied and 100 being completely satisfied with the perioperative experience. Visual Analog Scale


4. Patient preparedness [Time Frame: Checked immediately preoperatively on the day of the surgery] [Safety Issue: No] On a scale of 0-100 with 0 being not prepared and 100 being completely prepared for the perioperative experience. Visual Analog Scale

4. Analysis

All analyses will be performed by the senior statistical consultant of the study, who will be blinded to the data collection process. Preoperative, intraoperative, and postoperative variables will be analyzed using χ2 tests for categorical variables and the nonparametric Wilcoxon rank-sum test for continuous variables. Logistic regression will be performed, for each binary outcome to determine whether receiving a decision aid is associated with improved outcomes. Linear regression will be performed, for each continuous outcome to determine whether VR is associated with improved patient reported outcomes. Age, gender, insurance, and comorbidities will be used for risk adjustment. Mixed effects methods will be used, with treating physician as a random effects variable, to account for clustering at the physician level.

5. Study Progress Monitoring

After 50 patients complete their participation in the study. We will calculate the true effect and the power calculation will be revised as appropriate.

6. Risks & Benefits

The identities of the patients will be protected. Every patient upon signing up for the study will receive an odd number (sequentially assigned based on the order of participation in the study). The study key involving the correlation of the patients’ names with the numbers will be kept by the principal investigator (KB) in a password protected file, in a computer not connected to the internet, that will remain locked in a file cabinet. All files associated with the study except from the study key will include the de-identified numbers assigned to the participants at the beginning of the study. All analysis will be performed in the PIs computer, within the hospital firewall.

7. Unexpected Events or Incidental Findings

This study does not involve any diagnostic procedures or therapeutic interventions and therefore no major unexpected events will occur.

8. Sample size

Investigators intend to randomize 150 patients in 1:1 allocation to the video and conventional arms. We anticipate not being able to obtain the primary outcome on up to 10% of patients, leaving 135, or approximately 68 completers per arm. This yields just over 80% power at the usual 5% type 1 error rate to detect a difference between the two arms of one half (0.5) standard deviations in the primary outcome.

9. Recruitment

Patients undergoing neurosurgical procedures will be introduced to the study and asked whether they are interested in participating. The PI (KB) will meet the patients during their preoperative visit and will introduce them to the study. If they decide to participate, the PI will go over the consent process with them. The PI will assure the patients that their decision to participate will not affect the scheduling of their operation or their care in any other way. He will read the consent form to them and explain any questions they might have. He will explain to the participants that they will have no financial reward or immediate benefit from the study but their participation will help identify patient needs and improve patient experience. Risks to confidentiality and the measures to prevent them will be explained in a detailed way. Participants’ questions will be answered in a way they comprehend using non-medical terms.

Inclusion Criteria:

• All adult patients undergoing elective neurosurgical procedures (brain, spine) under general anesthesia, for which a preoperative evaluation is undertaken

Exclusion Criteria:

• Pediatric patients

• Emergency procedures for which no preoperative visit has been scheduled

• Patients that have undergone any prior operations, or had any exposure to the preoperative experience

• Ability to complete a self-report questionnaire preoperatively and postoperatively

• Cognitive impairment

10. Informed Consent, Assent, and Authorization

Patients undergoing neurosurgical procedures will be introduced to the study and asked whether they are interested in participating. The PI (KB) will meet the patients during their preoperative visit and will introduce them to the study. If they decide to participate, the PI will go over the consent process with them. The PI will assure the patients that their decision to participate will not affect the scheduling of their operation or their care in any other way. He will read the consent form to them and explain any questions they might have. He will explain to the participants that they will have no financial reward or immediate benefit from the study but their participation will help identify patient needs and empower shared decision making. Risks to confidentiality and the measures to prevent them will be explained in a detailed way. Participants’ questions will be answered in a way they comprehend using non-medical terms.

11. Financial impact on participants

There is no additional procedures, or additional cost for the participants.

12. Compensation or Gifts

There will be no payments, gifts or reimbursements that will be offered in the study.

13. Privacy of Participants

No consent or observations will be performed in public settings. The identities of the patients will be protected. Every patient upon signing up for the study will receive an odd number (sequentially assigned based on the order of participation in the study). The study key involving the correlation of the patients’ names with the numbers will be kept by the principal investigator (KB) in a password protected file, in a computer not connected to the internet, that will remain locked in a file cabinet. All files associated with the study except from the study key will include the de-identified numbers assigned to the participants at the beginning of the study. All analysis will be performed in the PIs computer, within the DHMC firewall.

EVAN-G Questionnaire

Subject number:

Date:

During the preoperative visit with the anesthesiologist:

1. I received information about what was going to happen

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

2. I was able to ask questions I wanted

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

3. I felt reassured, relaxed, confident

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

During the preoperative visit with the surgeon:

4. I received information about what was going to happen

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

5. I felt reassured, relaxed, confident

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

6. The surgeon was attentive

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

From the first visits until I entered the operating room:

7. My privacy was respected

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

When entering the operating room:

8. I felt uncomfortable: cold, warm, badly postured on the operating table

☐tremendously

☐a lot

☐moderately

☐a little bit

☐not at all

9. My privacy was respected

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

10. The medical staff was attentive

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

In the recovery room:

11. I had unpleasant feelings such as: thirst, hunger, nausea, headache

☐tremendously

☐a lot

☐moderately

☐a little bit

☐not at all

12. I felt uncomfortable: cold, warm, badly postured on the operating table

☐tremendously

☐a lot

☐moderately

☐a little bit

☐not at all

13. I had pain

☐tremendously

☐a lot

☐moderately

☐a little bit

☐not at all

14. I had a pleasant awakening

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

15. The medical and nursing staff were attentive

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

Since I came back to my bedroom:

16. I had unpleasant feelings such as: thirst, hunger, nausea, headache

☐tremendously

☐a lot

☐moderately

☐a little bit

☐not at all

17. I felt uncomfortable: cold, warm, badly postured on the bed

☐tremendously

☐a lot

☐moderately

☐a little bit

☐not at all

18. I had difficulty achieving everyday tasks: communicating, eating, washing myself, going to the toilet

☐tremendously

☐a lot

☐moderately

☐a little bit

☐not at all

19. I had pain

☐tremendously

☐a lot

☐moderately

☐a little bit

☐not at all

20. I was relieved of my pain

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

21. The medical staff was attentive

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

22. The nursing staff was attentive

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

23. My privacy was respected

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

Overall, from my initial consultation until today:

24. I was able to meet my family or friends

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

Waiting times in the hospital seemed too long:

25. To obtain an appointment with the anesthesiologist or surgeon

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

26. During the preoperative visits

☐much less than I expected

☐a little less than I expected

☐as much as I expected

☐a little more than I expected

☐much more than I expected

APAIS Questionnaire

Subject number:

Date:

I am worried about my anesthesia

☐not at all

☐a little bit

☐moderately

☐a lot

☐tremendously

I am constantly thinking about my anesthesia

☐not at all

☐a little bit

☐moderately

☐a lot

☐tremendously

I want to know as much as possible about my anesthesia

☐not at all

☐a little bit

☐moderately

☐a lot

☐tremendously

I am worried about my surgery

☐not at all

☐a little bit

☐moderately

☐a lot

☐tremendously

I am constantly thinking about my surgery

☐not at all

☐a little bit

☐moderately

☐a lot

☐tremendously

I want to know as much as possible about my surgery

☐not at all

☐a little bit

☐moderately

☐a lot

☐tremendously

VAS Pain

What is your pain level currently?

[pic]

VAS Stress

What is your stress level currently?

[pic]

VAS Satisfaction

How satisfied are you with your perioperative experience?

[pic]

VAS Preparedness

How prepared where you for the peri-operative experience?

[pic]

Figure S1. Study design

[pic]

-----------------------

Worst pain ever

No pain at all

Most stressed ever

No stress at all

Not satisfied at all

Completely satisfied

Completely prepared

Not prepared at all

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