Clinical trial NCT03456895: Assessing Environmental Factors in Healthcare Facilities in Order to Improve the Experience of Patients, Staff, and the Quality of Imaging Procedures
Official title: Assessing Environmental Factors in Healthcare Facilities in Order to Improve the Experience of Patients, Staff, and the Quality of Imaging Procedures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthcare Facility Environment - Imaging
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Ohio Third Frontier
name: Wright Center of Innovation in Biomedical Imaging
First posted: 2018-03-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three populations are being investigated in this trial; a healthy volunteer population, a patient population, and a staff population. Each population has the potential to participate in survey tools and/or physical environmental experiences.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to assess subjects' perceptions of environmental conditions and their preferences, and to expose subjects to varied environmental conditions as well as to assess their perception and feedback to these conditions. Another aim of this study is to explore potential patterns, factors of influence, and factors of reference in relation to the objectively assessed quality of the imagining examination and/or the perception of the patient. Finally, another aim of this study is to explore the feasibility of innovative biofeedback response capturing methodologies and technologies to guide the design of specific clinical investigations or trials.

Detailed description: Tremendous technological advances have occurred in recent years that enable easily controlled lights, sound, temperature, airflow as well as sensatory experiences such as smell or vibrations. While in some fields, these technologies are readily used, their potential application within healthcare environments has not yet been studied. In this study, we want to investigate how environmental factors including light, sound, temperature, smell, and sensatory experiences such as vibration are being perceived by subjects to develop environmental strategies using those components to create a more relaxing, and comforting experience for patients prior, during and after an imaging examination and for staff working in such environments. This data that will also guide to encourage changes of patient staff facility interactions to further improve the healthcare experience and quality of imaging examinations. To get a complete set of data, we plan to include volunteer participants, patients scheduled for imaging examinations, and staff working in the healthcare environment. This study has up to three different components: A, filling out survey forms to learn more about the perception of experience factors B, participating in facility experiences that may expose subjects to different facility factors and will then assess responses using additional survey forms or electronic measurement and data capture devices and C, during an imaging study the environment experience may be altered and assessments will be done to determine how relaxed the subject remains during the imagining study and the degree of motion induced artifacts. Feedback data will be obtained through survey tools as well as available consumer grade wearable devices that can continuously capture physiological parameters such as heart rate, motion, body perspiration and muscle tension. Only participants in the patient, staff, or volunteer populations who are not receiving an MRI imaging examination will participate in utilizing the wearable devices, as the wearable devices are not compatible with the MRI system. Patients receiving a PET/CT examination will be able to utilize a wearable device. For patients scheduled for an imaging examination the findings and perception of environmental factors will be compared with the image quality of the imaging examination and the feedback responses.

Eligibility criteria: Inclusion Criteria:

Volunteer population:

- Male and female volunteers above the age of 18 who are able to give an informed consent or have a legal guardian able to give informed consent on their behalf

Staff population:

- Male and female staff at the Ohio State University above the age of 18 who are able to give informed consent

Patient population:

* Male and female patients greater than or equal to 18 years of age able to give informed consent or have a guardian able to give informed consent on their behalf
* Patients must have an imaging study such as an MRI, PET/CT, or CT scheduled to be performed at the Wright Center facility at Martha Morehouse

Exclusion Criteria:

* Unable to communicate in English
* Subjects that are incapable of giving informed consent or that do not have a legal guardian to give informed consent on their behalf.
* Prisoners.

Primary outcomes:
measure: Mood, Physiological State - Heart Rate
timeFrame: Participants may complete physiological measurements through study completion, on average 1 year.
measure: Mood, Physiological State - Body Temperature
timeFrame: Participants may complete physiological measurements through study completion, on average 1 year.
measure: Mood, Self-Report
timeFrame: Participants may complete surveys through study completion, on average 1 year.
measure: Environmental preference
timeFrame: Participants may complete surveys through study completion, on average 1 year.
measure: Feasibility of the use of voice activation within the imaging environment
timeFrame: We will be observing the feasibility of voice activation through study completion, on average 1 year.
Secondary outcomes:
measure: Temperature
timeFrame: Temperature of the environment and of each participant may be monitored from the time the participant begins the environmental experience until the participant completes study procedures, up to roughly 1 hour
measure: Motion
timeFrame: Motion of each participant may be monitored from the time the participant begins the environmental experience until the participant completes study procedures, up to roughly 1 hour
measure: Quality of imaging study
timeFrame: Image quality will be assessed after SOC images are collected from patient participants through study completion, on average 1 year.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Michael V Knopp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Knopp MU, Binzel K, Wright CL, Zhang J, Knopp MV. Enhancing Patient Experience With Internet Protocol Addressable Digital Light-Emitting Diode Lighting in Imaging Environments: A Phase I Study. J Med Internet Res. 2020 Jun 12;22(6):e11839. doi: 10.2196/11839.