NCT02611622

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2015

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

November 18, 2015

Last Update Submit

February 16, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Study Arms (2)

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

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

Behavioral: LUMA ENT™Other: Survey

Interventions

LUMA ENT™BEHAVIORAL
Arm 2: LUMA ENT™
SurveyOTHER

Demographic and Patient Satisfaction Survey

Arm 1: ControlArm 2: LUMA ENT™

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who have already undergone any thyroid surgery will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Brian Nussenbaum, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 23, 2015

Study Start

August 7, 2013

Primary Completion

October 21, 2015

Study Completion

October 21, 2015

Last Updated

February 20, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations