Psychiatric Comorbidity

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. Identifier: NCT02927652
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : January 15, 2019
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment
Otorhinolaryngologic Diseases Other: Questionnaires

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 Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Evaluating Psychiatric Comorbidity in Otolaryngology
Actual Study Start Date : January 23, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
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).
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.

Primary Outcome Measures :
  1. Identification of psychiatric comorbidity [ Time Frame: day 1 ]
    Descriptive summarization of the data will be performed to represent the etiology, interventions, and outcomes for this population, as well as to evaluate patient satisfaction with their visits.

Secondary Outcome Measures :
  1. BSI-18 score [ Time Frame: day 1 ]
    5-point Likert scale ranging from 0 (not at all) to 4 (extremely). Maximum global severity index of 72. Higher scores indicate psychosocial distress.

  2. CG-CAHPS score [ Time Frame: day 1 ]
    Assessment of patient satisfaction of provider visit. Will be correlated with BSI-18 during data analysis to evaluate whether evidence of psychosocial distress and perception of satisfaction may be correlated.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
New patients being seen at Duke Head and Neck Surgery & Communication Sciences (Clinic 1F) or Duke Raleigh Otolaryngology

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

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 identifier (NCT number): NCT02927652

Contact: Amy Walker 919-684-1732

United States, North Carolina
Duke University Medical Center and affiliated practices Recruiting
Durham, North Carolina, United States, 27710
Contact: Seth Cohen, MD    919-681-7350   
Sponsors and Collaborators
Duke University
Principal Investigator: Seth Cohen, MD Duke University

Responsible Party: Duke University Identifier: NCT02927652     History of Changes
Other Study ID Numbers: Pro00075353
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Otorhinolaryngologic Diseases