Otorhinolaryngologic DiseasesNCT02927652
Psychiatric Comorbidity
An observational study of Otorhinolaryngologic Diseases, run by Duke University at 1 site in United States.
Trial summary
The goals of this project are aimed at the following: 1. Identifying psychiatric comorbidity in patients presenting to the HNSCS clinic 1F and Duke Otolaryngology of Raleigh clinic using the validated assessment tool Brief Symptom Inventory (BSI-18) and the patient control scale. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otorhinolaryngologic Diseases
- What is being tested?
- Questionnaires
- How many people
- 463 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2017to 28 Mar 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: New patients being seen at Duke Head and Neck Surgery \& Communication Sciences (Clinic 1F) or Duke Raleigh Otolaryngology
Who may be able to join
- Age 18 or older
- New patient appointment at Duke Clinic 1F or Duke Raleigh Otolaryngology
- Ability to read, write, and understand English
Who cannot join
- Less than 18 years old
- Unable to read, write, and understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center and affiliated practices
Durham, North Carolina, 27710
About this study
Official title: Evaluating Psychiatric Comorbidity in Otolaryngology
The goals of this project are aimed at the following:
- Identifying psychiatric comorbidity in patients presenting to the HNSCS clinic 1F and Duke Otolaryngology of Raleigh clinic using the validated assessment tool Brief Symptom Inventory (BSI-18) and the patient control scale. The BSI-18 is an 18 question and patient control an 8 item tool that takes about four minutes to complete.
- Gathering data regarding patient satisfaction in new patients to the HNSCS clinics via the CG-CAHPS visit survey.
- Examining relationships between psychiatric comorbidity and patient satisfaction.
- Examining relationships between psychiatric comorbidity and healthcare system use.
Read the detailed description
Patients with multiple otolaryngology complaints experience psychosocial distress. This psychosocial distress can have an adverse effect on treatment outcomes for the primary complaint and on the overall patient experience. It can result in greater costs for more care that may not be best-directed. This has implications not only for the patients, but also for providers' quality metrics.
Data will be collected via surveys and a chart review. New patients at the Duke Clinic 1F and Duke Raleigh Otolaryngology will be asked to complete the BSI-18, patient control scale, and disease specific outcome measure upon patient intake by the clinic nurse. The CG-CAHPS Visit Survey 2.1 will be completed at the conclusion of the clinical encounter. Patient participation consists of these surveys on their initial visit only.
The PI and/or a resident will conduct a chart review of these patients looking for history of psychiatric diagnoses and/or related prescriptions. Patients who have psychiatric diagnoses and/or prescriptions in the chart will be considered to have their needs "met", in that they are receiving care. Data regarding diagnoses and prescriptions will also be entered into REDCap.
- Conditions
- Otorhinolaryngologic Diseases
- Being tested
- Questionnaires
- Medical subject headings
- Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
New patients at the Duke Clinic 1F and Duke Raleigh Otolaryngology will be asked to complete the Brief Symptom Inventory-18 (BSI-18), patient control scale, and CG-CAHPS.
If a patients answers a 1, 2, 3, or 4 to question #17 ("Thoughts of ending your life") on the BSI-18, the nurse will immediately contact the investigator, who will refer for further assessment and/or treatment. The Duke Social Work office is available to provide support, and the Duke Emergency Department has certified social workers and a psychiatric team to do full evaluations if needed.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires for new patients | New patients seen at Duke Clinic for Head and Neck Surgery \& Communication Sciences or Duke Raleigh Otolaryngology will be administered questionnaires (BSI-18, CG-CAHPS, and patient control scale). Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of psychiatric comorbidity
Measured by the Brief Symptom Inventory (BSI-18) questionnaire using a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). Maximum global severity index of 72. Higher scores indicate psychosocial distress.
Measured: day 1
Identification of psychiatric comorbidity
Measured by the Perceived Control Scale (PCS) questionnaire using a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree).
Measured: day 1
Secondary outcomes (1)
Patient satisfaction of provider visitCG-CAHPS score
Assessment of patient satisfaction measured by CG-CAHPS visit survey. Will be correlated with BSI-18 during data analysis to evaluate whether evidence of psychosocial distress and perception of satisfaction may be correlated.
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 posted7 Oct 2016 (estimated)
- Study start23 Jan 2017
- Primary completion28 Mar 2018
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otorhinolaryngologic DiseasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seth Cohen, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927652
- Sponsor's protocol ID
- Pro00075353
- Status last verified
- Apr 2020
- First submitted
- 6 Oct 2016
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Psychiatric Comorbidity in Otolaryngology
- ClinicalTrials.gov ID
- NCT02927652
- Acronym / sponsor ID
- Pro00075353
- Conditions
- Otorhinolaryngologic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 28 Mar 2018 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 7 Oct 2016 (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.
The goals of this project are aimed at the following:
- Identifying psychiatric comorbidity in patients presenting to the HNSCS clinic 1F and Duke Otolaryngology of Raleigh clinic using the validated assessment tool Brief Symptom Inventory (BSI-18) and the patient control scale. The BSI-18 is an 18 question and patient control an 8 item tool that takes about four minutes to complete.
- Gathering data regarding patient satisfaction in new patients to the HNSCS clinics via the CG-CAHPS visit survey.
- Examining relationships between psychiatric comorbidity and patient satisfaction.
- Examining relationships between psychiatric comorbidity and healthcare system use.
Detailed description
Patients with multiple otolaryngology complaints experience psychosocial distress. This psychosocial distress can have an adverse effect on treatment outcomes for the primary complaint and on the overall patient experience. It can result in greater costs for more care that may not be best-directed. This has implications not only for the patients, but also for providers' quality metrics.
Data will be collected via surveys and a chart review. New patients at the Duke Clinic 1F and Duke Raleigh Otolaryngology will be asked to complete the BSI-18, patient control scale, and disease specific outcome measure upon patient intake by the clinic nurse. The CG-CAHPS Visit Survey 2.1 will be completed at the conclusion of the clinical encounter. Patient participation consists of these surveys on their initial visit only.
The PI and/or a resident will conduct a chart review of these patients looking for history of psychiatric diagnoses and/or related prescriptions. Patients who have psychiatric diagnoses and/or prescriptions in the chart will be considered to have their needs "met", in that they are receiving care. Data regarding diagnoses and prescriptions will also be entered into REDCap.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaires for new patients | – | Other: QuestionnairesNew patients seen at Duke Clinic for Head and Neck Surgery \& Communication Sciences or Duke Raleigh Otolaryngology will be administered questionnaires (BSI-18, CG-CAHPS, and patient control scale). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- New patients being seen at Duke Head and Neck Surgery \& Communication Sciences (Clinic 1F) or Duke Raleigh Otolaryngology
Key inclusion criteria (3 listed)
- Age 18 or older
- New patient appointment at Duke Clinic 1F or Duke Raleigh Otolaryngology
- Ability to read, write, and understand English
Key exclusion criteria (2 listed)
- Less than 18 years old
- Unable to read, write, and understand English
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 |
|---|---|---|
| QuestionnairesNew patients at the Duke Clinic 1F and Duke Raleigh Otolaryngology will be asked to complete the Brief Symptom Inventory-18 (BSI-18), patient control scale, and CG-CAHPS. If a patients answers a 1, 2, 3, or 4 to question #17 ("Thoughts of ending your life") on the BSI-18, the nurse will immediately contact the investigator, who will refer for further assessment and/or treatment. The Duke Social Work office is available to provide support, and the Duke Emergency Department has certified social workers and a psychiatric team to do full evaluations if needed. | Other | Questionnaires for new patients |
Primary outcome
Identification of psychiatric comorbidity
Time frame: day 1
Measured by the Brief Symptom Inventory (BSI-18) questionnaire using a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). Maximum global severity index of 72. Higher scores indicate psychosocial distress.
Identification of psychiatric comorbidity
Time frame: day 1
Measured by the Perceived Control Scale (PCS) questionnaire using a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree).
1 secondary outcome
Patient satisfaction of provider visitCG-CAHPS score
Time frame: day 1
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 7 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Seth Cohen, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otorhinolaryngologic Diseases, run by Duke University 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 3 inclusion and 2 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 7 Apr 2020. 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?
Identification of psychiatric comorbidity (time frame: day 1). The study lists 2 primary outcomes in all. 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 7 Apr 2020; AzTrials last refreshed its copy on 27 Oct 2026.