Psychiatric Comorbidity

April 3, 2020 updated by: Duke University

Evaluating Psychiatric Comorbidity in Otolaryngology

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Enrollment (Actual)

463

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center and affiliated practices

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

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).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 1
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).
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction of provider visitCG-CAHPS score
Time Frame: day 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Seth Cohen, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2017

Primary Completion (Actual)

March 28, 2018

Study Completion (Actual)

March 28, 2018

Study Registration Dates

First Submitted

October 6, 2016

First Submitted That Met QC Criteria

October 6, 2016

First Posted (Estimate)

October 7, 2016

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00075353

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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