The objective of the "Using Virtual Reality Gaming as a RESPITE from Vaso-occlusive Pain Events" pilot study is to assess the feasibility and acceptability of virtual reality (VR) to reduce pain among patients with sickle cell disease (SCD) during an active vaso-occlusive event (VOE) an inpatient or day clinic setting. We will build upon preliminary data from our "RESPITE" survey study that found most surveyed adult patients with SCD were interested in using VR technology for acute pain management. Notably, patients with higher health and electronic health (eHealth) literacy were more interested in using a VR-based intervention. Patients interested in using a VR-based intervention stated they would like to use VR experiences for skill development. This study will extend RESPITE's survey findings by evaluating the feasibility and acceptability of the use of VR for pain control during vaso-occlusive events. These data may inform a larger randomized clinical/controlled trial to evaluate the effectiveness of VR in mitigating pain in a larger SCD population treated at the University of Chicago Medicine.
To 1) develop and 2) pilot a VR-based intervention among adult patients with SCD admitted to UCM inpatient units or the Care Transitions Clinic (CTC) day program during an acute VOE.
Participant Enrollment: We will identify participants for enrollment by: a) recruiting hospitalized patients- we will utilize our inpatient technology survey infrastructure (IRB# 16-0763) that works in conjunction with the Hospitalist Study (IRB# 9967; Hospitalist Study personnel approach patients admitted to general medicine for participation, enrolled Hospitalist Study participants meeting our inclusion criteria approached) or b) recruiting CTC patients by screening outpatient EPIC schedules. Inclusion criteria: Adults 18 years and older, English speaking, without need for proxy, admitted to general medicine unit or CTC day clinic for VOE.
Study Design: In this pilot feasibility mixed-methods eligible patients will be approached for interest in participating in the study and written informed consent will be obtained. Enrolled participants will complete our technology questionnaire (IRB#16-0763) and will have the option to utilize the VR interventions. Those interested in using the VR will then be provided the equipment for use during either their inpatient hospitalization or the CTC visit. The research assistant will help set up the VR intervention and will then collect and sanitize the equipment. Participants utilizing the VR intervention will then be interviewed on their experience to assess for acceptability and efficacy.
Technology and Equipment: We will purchase four VR devices and two iPads for the VR interventions along with a variety of VR games.
Outcomes of Interest: The co-primary outcomes of interest will be the reach of the intervention (proportion using VR) and the implementation barriers and facilitators to indicate feasibility and evaluate acceptability. Secondary outcomes include initial efficacy (e.g., reduced pain, reduced acute care utilization), necessary adaptations, and factors that could lead to the sustainability of broader-based implementation.
ata Collection: From the EHR and/or our technology survey (IRB# 16-0763) we will collect demographic information, health literacy, e-health literacy, medical history, their pain measure(s), and pain medication usage (e.g., opioids, NSAIDs, others), acute care utilization (visit length of stay, and re-hospitalization/hospitalization, ED visits). Pain will be assessed using the Youth Acute Pain Functional Ability Questionnaire, [21] which has been pilot tested on adult patients with SCD.[22] We will collect data on patients' input on the feasibility and acceptability (e.g., satisfaction using VR intervention, ease of using the VR intervention, of using the intervention and willingness to use the intervention again during a pain crisis) using semi-structured interviews including the following domains:
-Barriers to Virtual Reality Use (probes: interrupted, difficult to use, etc.)
-Facilitators to Virtual Reality Use (probes: having equipment provided, research staff assistance, etc.)
-What participants liked about VR (probes: distracted from pain, reduced boredom, etc.)
-What participants DISLIKED about VR (probes: not interested in VR material, did not reduce pain, etc.)
- If disliked, ask what they hoped to see instead?
-Preferences (probes: time for use, types of games, how this intervention should be offered)
-VR use for pain management (Probes: How does VR fits into pain management?)
Analysis Plan: We plan to enroll 15-20 patients until theme saturation. For discrete data, descriptive statistics will used to calculate the means (standard deviation), medians (interquartile range), and proportions, where appropriate. We will also examine the extent to which demographic characteristics (e.g., age, gender, race/ethnicity, eHealth literacy) are associated with changes in pain severity, length of stay, analgesic usage, hospitalization, and willingness and interest in using a technology-based pain intervention. Chi-square tests will be used to test for bivariate analyses, and logistic regression will be used for multivariate analyses to identify associations between participant factors and key outcomes. All computations will be performed using STATA. For qualitative data, all interviews will be conducted using a semi-structured format and will be audio recorded, transcribed, and de-identified. Thematic analysis of transcripts will be performed using a deductive approach. Research team members will independently code transcripts and then, through discussion, will refine the coding framework, to identify major themes and subthemes. Once a coding framework is established, all transcripts will be reviewed by two independent coders. All qualitative data analyses will be completed using Atlas.ti software.
Atlas.ti, Stata- will be provided by the lab/mentor
Locally: Outcome Research Workshop, General Internal Medicine Workshop, HDSI Quality Symposium, among others
Regionally/Nationally: Society of General Internal Medicine, Midwest Society of General Internal Medicine, Society of Hospital Medicine, American Society of Hematology, among others
| Scholarship & Discovery Tracks: | Clinical Research, Healthcare Delivery Improvement Sciences |
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| NIH Mission Areas: | NHLBI - Blood |