Preoperative Immersive Patient Quality Experience

NCT02619708 | Completed

• 1 other identifier: STUDY00028900
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient-centered Outcomes Research; Surgery

Keywords

immersive preoperative experience

Outcome Measures

Primary Outcomes (2)

• EVAN-G

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

  Checked within 24 hours after the surgery

• APAIS

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

  Checked immediately preoperatively on the day of the surgery

Secondary Outcomes (4)

• Stress level

  Checked immediately preoperatively on the day of the surgery

• Pain level

  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

• Patient satisfaction level

  Checked twice: a) immediately preoperatively on the day of the surgery, b) within 24 hours after the surgery

• Patient preparedness

  Checked immediately preoperatively on the day of the surgery

Study Arms (2)

Standard Preoperative Experience

NO INTERVENTION

The preoperative visit will be performed, as it would be normally. Patients 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. 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).

Immersive Preoperative Experience

EXPERIMENTAL

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 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. 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).

Behavioral: Immersive Preoperative Experience

Interventions

Immersive Preoperative Experience BEHAVIORAL

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. Patients will be able to look around and explore the spaces they will visit on the day of their operation.

Immersive Preoperative Experience

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

• 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.

  PMID: 27906757 DERIVED

Study Officials

• Kimon Bekelis, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2015
• First Posted: December 2, 2015
• Study Start: December 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 25, 2016

Record last verified: 2016-05

Locations

US (1)