Psychiatric Comorbidity

Otorhinolaryngologic Diseases Clinical Trial

Official title:

Evaluating Psychiatric Comorbidity in Otolaryngology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927652
• Other study ID #: Pro00075353
• Status: Completed
• Start date: January 23, 2017
• Est. completion date: March 28, 2018

Study information

• Verified date: April 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The BSI-18 is an 18 question and patient control an 8 item tool that takes about four minutes to complete.

2. Gathering data regarding patient satisfaction in new patients to the HNSCS clinics via the CG-CAHPS visit survey.

3. Examining relationships between psychiatric comorbidity and patient satisfaction.

4. Examining relationships between psychiatric comorbidity and healthcare system use.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: March 28, 2018
• Est. primary completion date: March 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• New patient appointment at Duke Clinic 1F or Duke Raleigh Otolaryngology

• Ability to read, write, and understand English

Exclusion Criteria:

• Less than 18 years old

• Unable to read, write, and understand English

Related Conditions & MeSH terms

• Otorhinolaryngologic Diseases

Intervention

Other:
• Questionnaires
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.

Locations

Country	Name	City	State
United States	Duke University Medical Center and affiliated practices	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	day 1
Primary	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).	day 1
Secondary	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.	day 1