ThyroidNCT02611622
LumaENT and Patient Satisfaction
A study testing LUMA ENT™ and Survey in people with Thyroid, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Patient satisfaction is an important metric currently used to rate quality of healthcare in hospitals. Maximizing patient satisfaction scores is therefore significantly beneficial to any hospital establishment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid
- What is being tested?
- LUMA ENT™ and Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2013to 21 Oct 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be patients scheduled to visit the BJH/WU Department of Otolaryngology clinic for management of thyroid disorders (ranging from benign to cancerous nodules or masses) that will involve surgical interventions of complete or partial thyroidectomies.
- must be between the ages of 18 and 80
- may be male or female
- must understand spoken or written English language
- must be able to provide informed consent
Who cannot join
- -Patients who have already undergone any thyroid surgery will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Impact of Multimedia-based Patient Education on Patient Satisfaction Scores in an Otolaryngology Practice Setting
Patient satisfaction is an important metric currently used to rate quality of healthcare in hospitals. Maximizing patient satisfaction scores is therefore significantly beneficial to any hospital establishment. Recent studies have shown patient satisfaction depends on multiple factors, including patient involvement in treatment decision-making processes and patients' knowledge of treatment options. Internal review of departmental patient satisfaction survey scores revealed deficits in the aforementioned areas of patient satisfaction, with the domains of "how well concerns were addressed", "explanation of tests and procedures" and "effort to include patients in decisions" having the lowest scores on patient satisfaction surveys. This highlights the gap in patient satisfaction that the Otolaryngology department seeks to improve on, so as to maximize patient satisfaction, and in turn, the quality of healthcare provided.
The aim of this study is to assess the improvement in patient satisfaction scores that can be obtained by incorporating LUMA ENT™, a disease-specific multimedia patient education software, into the treatment decisions for thyroid disorders. LUMA ENT™ is a leading patient education software that provides visual anatomic animations of disease processes, disease progression and treatment options to improve patients' knowledge. Thyroid disorders have been chosen for study due to their high frequency of occurrence in the patient population and generalizability to a wide medical audience.
The investigators will perform a single-blinded randomized-controlled study of patients visiting the physician practices of the Department of Otolaryngology for management of thyroid disorders. Participants will be randomized into control and intervention groups. Upon completion of the routine physician-patient clinical encounter, the intervention group will view a 5- minute LUMA ENT™ video discussing their specific thyroid condition, its natural progression history, and treatment options. They will have an opportunity to ask the physician any further questions that arise from viewing the video. The control group will not view the LUMA ENT video. Patient satisfaction surveys will then be provided to both groups at the end of the visit as is routinely done and scores subsequently compared.
- Conditions
- Thyroid
- Being tested
- LUMA ENT™, Survey
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUMA ENT™Behavioural
SurveyOther
Demographic and Patient Satisfaction Survey
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Control | Active comparator | * Participants will be presented with envelopes labeled with a unique block-randomization code and asked to pick one
* Once the participant selects an envelope, the research coordinator will verify whether the code assigns the patient to the control or the intervention group, without the knowledge of the otolaryngologist who will be blinded to participant randomization at this point.
* Participants in the control group will proceed to filling out Demographic Survey and Patient Satisfaction Survey
* Once completed, they will be given the opportunity to discuss any further questions or concerns about their thyroid condition with their otolaryngologist Receives: Other: Survey |
| Arm 2: LUMA ENT™ | Experimental | * Participants will be presented with envelopes labeled with a unique block-randomization code and asked to pick one
* Once the participant selects an envelope, the research coordinator will verify whether the code assigns the patient to the control or the intervention group, without the knowledge of the otolaryngologist who will be blinded to participant randomization at this point.
* Participants in the intervention group will proceed to viewing the LUMA ENT™ videos pertinent to their thyroid condition using either of the two iPADS (the videos should not last longer than 10 minutes)
* Once video viewing is complete, participants will be given the opportunity to discuss any further questions or concerns about their thyroid condition with their otolaryngologist, especially as relates to questions that arise as a result of viewing the video
* Subsequently, the participants will proceed to filling out Demographic Survey and Patient Satisfaction Survey Receives: Behavioral: LUMA ENT™; Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate improvement in patient satisfaction scores obtained with the incorporation of LUMA ENT™ in pre-treatment counseling
To compare survey domain scores, MANOVA will be used to explore differences between groups and control for confounders.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study start7 Aug 2013
- Primary completion21 Oct 2015
- Study completion21 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Nussenbaum, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611622
- Sponsor's protocol ID
- 201301163
- Status last verified
- Feb 2017
- First submitted
- 18 Nov 2015
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Multimedia-based Patient Education on Patient Satisfaction Scores in an Otolaryngology Practice Setting
- ClinicalTrials.gov ID
- NCT02611622
- Acronym / sponsor ID
- 201301163
- Conditions
- Thyroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 7 Aug 2013 (actual)
- Primary completion
- 21 Oct 2015 (actual)
- Study completion
- 21 Oct 2015 (actual)
- First posted
- 23 Nov 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.
Patient satisfaction is an important metric currently used to rate quality of healthcare in hospitals. Maximizing patient satisfaction scores is therefore significantly beneficial to any hospital establishment. Recent studies have shown patient satisfaction depends on multiple factors, including patient involvement in treatment decision-making processes and patients' knowledge of treatment options. Internal review of departmental patient satisfaction survey scores revealed deficits in the aforementioned areas of patient satisfaction, with the domains of "how well concerns were addressed", "explanation of tests and procedures" and "effort to include patients in decisions" having the lowest scores on patient satisfaction surveys. This highlights the gap in patient satisfaction that the Otolaryngology department seeks to improve on, so as to maximize patient satisfaction, and in turn, the quality of healthcare provided.
The aim of this study is to assess the improvement in patient satisfaction scores that can be obtained by incorporating LUMA ENT™, a disease-specific multimedia patient education software, into the treatment decisions for thyroid disorders. LUMA ENT™ is a leading patient education software that provides visual anatomic animations of disease processes, disease progression and treatment options to improve patients' knowledge. Thyroid disorders have been chosen for study due to their high frequency of occurrence in the patient population and generalizability to a wide medical audience.
The investigators will perform a single-blinded randomized-controlled study of patients visiting the physician practices of the Department of Otolaryngology for management of thyroid disorders. Participants will be randomized into control and intervention groups. Upon completion of the routine physician-patient clinical encounter, the intervention group will view a 5- minute LUMA ENT™ video discussing their specific thyroid condition, its natural progression history, and treatment options. They will have an opportunity to ask the physician any further questions that arise from viewing the video. The control group will not view the LUMA ENT video. Patient satisfaction surveys will then be provided to both groups at the end of the visit as is routinely done and scores subsequently compared.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Control | Active comparator | Other: Survey* Participants will be presented with envelopes labeled with a unique block-randomization code and asked to pick one * Once the participant selects an envelope, the research coordinator will verify whether the code assigns the patient to the control or the intervention group, without the knowledge of the otolaryngologist who will be blinded to participant randomization at this point. * Participants in the control group will proceed to filling out Demographic Survey and Patient Satisfaction Survey * Once completed, they will be given the opportunity to discuss any further questions or concerns about their thyroid condition with their otolaryngologist |
| Arm 2: LUMA ENT™ | Experimental | Behavioral: LUMA ENT™, Other: Survey* Participants will be presented with envelopes labeled with a unique block-randomization code and asked to pick one * Once the participant selects an envelope, the research coordinator will verify whether the code assigns the patient to the control or the intervention group, without the knowledge of the otolaryngologist who will be blinded to participant randomization at this point. * Participants in the intervention group will proceed to viewing the LUMA ENT™ videos pertinent to their thyroid condition using either of the two iPADS (the videos should not last longer than 10 minutes) * Once video viewing is complete, participants will be given the opportunity to discuss any further questions or concerns about their thyroid condition with their otolaryngologist, especially as relates to questions that arise as a result of viewing the video * Subsequently, the participants will proceed to filling out Demographic Survey and Patient Satisfaction Survey |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants will be patients scheduled to visit the BJH/WU Department of Otolaryngology clinic for management of thyroid disorders (ranging from benign to cancerous nodules or masses) that will involve surgical interventions of complete or partial thyroidectomies.
- must be between the ages of 18 and 80
- may be male or female
- must understand spoken or written English language
- must be able to provide informed consent
Key exclusion criteria (1 listed)
- -Patients who have already undergone any thyroid surgery will be excluded
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 |
|---|---|---|
| LUMA ENT™ | Behavioural | Arm 2: LUMA ENT™ |
| SurveyDemographic and Patient Satisfaction Survey | Other | Arm 1: Control, Arm 2: LUMA ENT™ |
Primary outcome
Evaluate improvement in patient satisfaction scores obtained with the incorporation of LUMA ENT™ in pre-treatment counseling
Time frame: Day 1
To compare survey domain scores, MANOVA will be used to explore differences between groups and control for confounders.
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 20 Feb 2017.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Brian Nussenbaum, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LUMA ENT™ and Survey in people with Thyroid, run by Washington University School of Medicine 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 5 inclusion and 1 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 20 Feb 2017. 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?
Evaluate improvement in patient satisfaction scores obtained with the incorporation of LUMA ENT™ in pre-treatment counseling (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2017.