Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing Environmental Factors in Healthcare Facilities in Order to Improve the Experience of Patients, Staff, and the Quality of Imaging Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456895
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : June 21, 2018
Sponsor:
Collaborators:
Ohio Third Frontier
Wright Center of Innovation Development Fund
Information provided by (Responsible Party):
Michael V. Knopp MD, PhD, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Healthcare Facility Environment - Imaging Other: Light perception Other: Sound perception Other: Smell perception Other: Vibration perception Other: Voice activation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Assessing Environmental Factors in Healthcare Facilities in Order to Improve the Experience of Patients, Staff, and the Quality of Imaging Procedures
Actual Study Start Date : December 5, 2017
Estimated Primary Completion Date : February 20, 2021
Estimated Study Completion Date : February 20, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy volunteer population

Healthy volunteer participants will have one of two options for participation:

  1. completion of an electronic survey tool to assess the perception and preference of environmental factors (virtual participation)
  2. completion of the above survey and participation in environmental experiences and providing feedback about their experience (physical participation)
Other: Light perception
We will be using Wi-Fi/IP programmable LED lighting systems that will replace conventional lighting systems and may be in canned lights, spot lights, light chains or table lights. These lighting systems can be fully controlled by web based applications on smart phones tablets and computer systems and can be combined with input systems such as switches, motion detection or voice activated. Differences in lighting perception will be explored by varying lighting color and brightness.

Other: Sound perception
We will be using Wi-Fi/Bluetooth addressable sound systems that will be linked with sound sources such as media players on smart devices or computer systems. Differences in sound perception will be explored by varying sound types (i.e. different music types, ambient noise, etc.).

Other: Smell perception
We will explore the use of consumer grade ventilation systems that can be equipped to distribute packaged scents. Differences in smell perception will be explored by varying the types of scents.

Other: Vibration perception
We will explore the use of chairs or blankets that enable subjects to perceive vibrations. An initial implementation will be the use of on relaxing/massage chair that enables the experience of vibration sensation in the back or leg area. We may use also potentially vibration blankets in the arm or neck area. Differences in vibration perception will be explored by varying the location, frequency, etc. of vibrations with the subject being placed in a chair on an imaging table/bed.

Other: Voice activation
We will explore the use and linkage of voice activation system such as Amazon Echo, Google home or similar devices. Some participants may be asked to use voice activations to verbally select and/or change the environmental settings according to their preferences. We are evaluating the feasibility of voice activation with the imaging environment.

Experimental: Patient population
Patient participants will complete a survey tool and either participate in specific environmental experience testing or may be exposed to an environmental experience during the imaging examination. The imaging exam will be assessed in regard to quality factors such as motion artifacts as an indicator of being relaxed during the examination.
Other: Light perception
We will be using Wi-Fi/IP programmable LED lighting systems that will replace conventional lighting systems and may be in canned lights, spot lights, light chains or table lights. These lighting systems can be fully controlled by web based applications on smart phones tablets and computer systems and can be combined with input systems such as switches, motion detection or voice activated. Differences in lighting perception will be explored by varying lighting color and brightness.

Other: Sound perception
We will be using Wi-Fi/Bluetooth addressable sound systems that will be linked with sound sources such as media players on smart devices or computer systems. Differences in sound perception will be explored by varying sound types (i.e. different music types, ambient noise, etc.).

Other: Smell perception
We will explore the use of consumer grade ventilation systems that can be equipped to distribute packaged scents. Differences in smell perception will be explored by varying the types of scents.

Other: Vibration perception
We will explore the use of chairs or blankets that enable subjects to perceive vibrations. An initial implementation will be the use of on relaxing/massage chair that enables the experience of vibration sensation in the back or leg area. We may use also potentially vibration blankets in the arm or neck area. Differences in vibration perception will be explored by varying the location, frequency, etc. of vibrations with the subject being placed in a chair on an imaging table/bed.

Other: Voice activation
We will explore the use and linkage of voice activation system such as Amazon Echo, Google home or similar devices. Some participants may be asked to use voice activations to verbally select and/or change the environmental settings according to their preferences. We are evaluating the feasibility of voice activation with the imaging environment.

Experimental: Staff population
Staff participants who work in imaging-related healthcare environments will complete survey tools regarding their perception and preference of environmental factors and/or will participate in environmental experiences and provide feedback.
Other: Light perception
We will be using Wi-Fi/IP programmable LED lighting systems that will replace conventional lighting systems and may be in canned lights, spot lights, light chains or table lights. These lighting systems can be fully controlled by web based applications on smart phones tablets and computer systems and can be combined with input systems such as switches, motion detection or voice activated. Differences in lighting perception will be explored by varying lighting color and brightness.

Other: Sound perception
We will be using Wi-Fi/Bluetooth addressable sound systems that will be linked with sound sources such as media players on smart devices or computer systems. Differences in sound perception will be explored by varying sound types (i.e. different music types, ambient noise, etc.).

Other: Smell perception
We will explore the use of consumer grade ventilation systems that can be equipped to distribute packaged scents. Differences in smell perception will be explored by varying the types of scents.

Other: Vibration perception
We will explore the use of chairs or blankets that enable subjects to perceive vibrations. An initial implementation will be the use of on relaxing/massage chair that enables the experience of vibration sensation in the back or leg area. We may use also potentially vibration blankets in the arm or neck area. Differences in vibration perception will be explored by varying the location, frequency, etc. of vibrations with the subject being placed in a chair on an imaging table/bed.

Other: Voice activation
We will explore the use and linkage of voice activation system such as Amazon Echo, Google home or similar devices. Some participants may be asked to use voice activations to verbally select and/or change the environmental settings according to their preferences. We are evaluating the feasibility of voice activation with the imaging environment.




Primary Outcome Measures :
  1. Mood, Physiological State - Heart Rate [ Time Frame: Participants may complete physiological measurements through study completion, on average 1 year. ]
    Participants' mood will be assessed via measurements of participants' heart rate

  2. Mood, Physiological State - Body Temperature [ Time Frame: Participants may complete physiological measurements through study completion, on average 1 year. ]
    Participants' mood will be assessed via participants' body temperature

  3. Mood, Self-Report [ Time Frame: Participants may complete surveys through study completion, on average 1 year. ]
    Participants' mood will be assessed via self report in surveys

  4. Environmental preference [ Time Frame: Participants may complete surveys through study completion, on average 1 year. ]
    Participants will self-report their preferences for different light, sound, smell, and vibration sensations

  5. Feasibility of the use of voice activation within the imaging environment [ Time Frame: We will be observing the feasibility of voice activation through study completion, on average 1 year. ]
    We are observing how practical and beneficial it is to use voice activation technologies such as Amazon Echo, Google home or similar devices within the imaging environment. For instance, we will observe how user-friendly, time-consuming, etc. the use of voice activation technology is within an imaging setting for assessing participant preferences.


Secondary Outcome Measures :
  1. Temperature [ Time Frame: 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 ]
    We will use infrared detector camera technology to assess the skin temperature of subjects at different body regions and changes during the observational period. This will also be used to determine the temperature of the surroundings as well, for example, to determine the relative temperature of the chair and the imaging bed. Infrared cameras installed alongside the normal surveillance cameras to monitor patients during the imaging examination may also be used to monitor the temperature of the surroundings as well as the body to determine if that may be the reason for motion.

  2. Motion [ Time Frame: 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 ]
    We will use short wave radar to perform positional monitoring of subjects during the observational period. This short-wave radar will be used as a means to assess motion and detect subject movement in a room that we hope to correlate to their level of comfort and relaxation. Short wave radar is also technically able to detect very miniscule motion including blood flow and pulse rate, which would allow us to move away from wearable devices to remote sensing devices further hoping to increase patient comfort. No short wave radar devices will be used during the imaging examination.

  3. Quality of imaging study [ Time Frame: Image quality will be assessed after SOC images are collected from patient participants through study completion, on average 1 year. ]
    Patient participants who have given authorization for a blinded review of their imaging study will have their imaging study reviewed on a radiological image review workstation and assessed by an experienced reader of imaging studies in regard to the presence and severity of artifacts. Those findings will be recorded both in a structured and free text form using a survey tool. We anticipate that in this exploratory study observations will be made that will lead to the need to further detail and/or refine structured recording of the findings.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456895


Contacts
Layout table for location contacts
Contact: Melanie Hughes 614-293-9998 office@wcibmi.org
Contact: Michael V Knopp, MD, PhD 614-293-9998 knopp.16@osu.edu

Locations
Layout table for location information
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43221
Contact: Michael V Knopp, MD, PhD    614-293-9998    knopp.16@osu.edu   
Sub-Investigator: Chadwick L Wright, MD, PhD         
Sub-Investigator: Katherine M Binzel, PhD         
Sub-Investigator: Jun Zhang, PhD         
Sub-Investigator: Melanie U Knopp         
Sponsors and Collaborators
Ohio State University
Ohio Third Frontier
Wright Center of Innovation Development Fund
Investigators
Layout table for investigator information
Principal Investigator: Michael V Knopp, MD, PhD Ohio State University
  Study Documents (Full-Text)

Documents provided by Michael V. Knopp MD, PhD, Ohio State University:
Study Protocol  [PDF] November 20, 2017


Layout table for additonal information
Responsible Party: Michael V. Knopp MD, PhD, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03456895     History of Changes
Other Study ID Numbers: 2017H0266/RP0525
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No