Patient-centered Outcomes ResearchNCT02619708
Preoperative Immersive Patient Quality Experience
A study testing Immersive Preoperative Experience in people with Patient-centered Outcomes Research and Surgery, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient-centered Outcomes Research, Surgery
- What is being tested?
- Immersive Preoperative Experience
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all adult patients undergoing elective neurosurgical procedures (brain, spine, peripheral nerve) under general anesthesia, for which a preoperative evaluation is undertaken
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Patient-centered Outcomes Research, Surgery
- Being tested
- Immersive Preoperative Experience
- Keywords
- immersive preoperative experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Preoperative ExperienceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Immersive Preoperative Experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
EVAN-G
A patient satisfaction score with 6 domains. The score ranges from 0-100 with higher scores representing higher satisfaction
Measured: 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.
Measured: Checked immediately preoperatively on the day of the surgery
Secondary outcomes (4)
Stress level
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
Measured: Checked immediately preoperatively on the day of the surgery
Pain level
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
Measured: 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
On a scale of 0-100 with 0 being not satisfied and 100 being completely satisfied with the perioperative experience. Visual Analog Scale
Measured: Checked twice: a) immediately preoperatively on the day of the surgery, b) within 24 hours after the surgery
Patient preparedness
On a scale of 0-100 with 0 being not prepared and 100 being completely prepared for the perioperative experience. Visual Analog Scale
Measured: Checked immediately preoperatively on the day of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient-centered Outcomes ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimon Bekelis, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619708
- Sponsor's protocol ID
- STUDY00028900
- Status last verified
- May 2016
- First submitted
- 22 Nov 2015
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27906757
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Immersive Patient Quality Experience
- ClinicalTrials.gov ID
- NCT02619708
- Acronym / sponsor ID
- STUDY00028900
- Conditions
- Patient-centered Outcomes Research, Surgery
- Keywords
- immersive preoperative experience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Immersive Preoperative ExperienceThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all adult patients undergoing elective neurosurgical procedures (brain, spine, peripheral nerve) under general anesthesia, for which a preoperative evaluation is undertaken
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Preoperative ExperienceThe 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. | Behavioural | Immersive Preoperative Experience |
Primary outcome
EVAN-G
Time frame: Checked within 24 hours after the surgery
A patient satisfaction score with 6 domains. The score ranges from 0-100 with higher scores representing higher satisfaction
APAIS
Time frame: Checked immediately preoperatively on the day of the surgery
A preoperative anxiety score with 6 domains. The anxiety score ranges from 4 to 20 and encompasses anxiety for the surgery and the anesthesia.
4 secondary outcomes
Stress level
Time frame: Checked immediately preoperatively on the day of the surgery
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
Patient satisfaction level
Time frame: Checked twice: a) immediately preoperatively on the day of the surgery, b) within 24 hours after the surgery
Patient preparedness
Time frame: Checked immediately preoperatively on the day of the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
- Derived from this study: PubMed 27906757Bekelis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimon Bekelis, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Preoperative Experience in people with Patient-centered Outcomes Research and Surgery, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EVAN-G (time frame: Checked within 24 hours after the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02619708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2016.