Clinical trial NCT02619708: Preoperative Immersive Patient Quality Experience
Official title: Preoperative Immersive Patient Quality Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient-centered Outcomes Research
Surgery
Keywords: immersive preoperative experience
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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 surgical 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. With the current study investigators will have the following two specific aims:

Aim 1. To determine whether an immersive preoperative experience (video) is associated with decreased anxiety and improved patient experience during the perioperative phase.

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

Detailed description: The study will include patients scheduled to undergo neurosurgical interventions. Patients for whom surgical intervention is deemed necessary will be approached for participation in the study. After signing informed consent, they will be randomized to watch a video during their preoperative evaluation visit or have a regular standard of care evaluation during their preoperative visit. For the patients randomized to the intervention group, the preoperative visit will be performed, as it would be normally, with the only addition of a 5-minute video. 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 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. The technology used will allow the immersion of the patient in the preoperative environment. The hypothesis is that by introducing a way to familiarize the patients with the preoperative environment, investigators will have an impact on their anxiety about the operation and their satisfaction with the entire experience. Investigators hope this quality improvement initiative will change patient experiences for the better.

Patients will fill out questionnaires immediately preoperatively on the day of the procedure, on the day after the procedure, and 30-days after the operation (only for patients undergoing surgery for degenerative spine disease). The outcomes of interest will be stress level, pain level, and patient satisfaction level.

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. Linear regression will be performed, for each continuous outcome. The variable age will be tested separately as a continuous variable and a categorical variable (65-69 years, 70-74 years, 75-79 years, and ≥80 years) in multivariable logistic regression models. Other variables that will be included in the multivariable models include Charlson Comorbidity Index score, American Society of Anesthesiologists \[ASA\] score, APAIS score. Mixed effects methods will be used, with treating physician as a random effects variable, to account for clustering at the physician level.

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.

Eligibility criteria: Inclusion Criteria:

* all adult patients undergoing elective neurosurgical procedures (brain, spine, peripheral nerve) 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

Primary outcomes:
measure: EVAN-G
timeFrame: Checked within 24 hours after the surgery
measure: APAIS
timeFrame: Checked immediately preoperatively on the day of the surgery
Secondary outcomes:
measure: Stress level
timeFrame: Checked immediately preoperatively on the day of the surgery
measure: Pain level
timeFrame: 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
measure: Patient satisfaction level
timeFrame: Checked twice: a) immediately preoperatively on the day of the surgery, b) within 24 hours after the surgery
measure: Patient preparedness
timeFrame: Checked immediately preoperatively on the day of the surgery
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Kimon Bekelis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094.