NCT02927652

Brief Summary

The goals of this project are aimed at the following:

  1. 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. 2.Gathering data regarding patient satisfaction in new patients to the HNSCS clinics via the CG-CAHPS visit survey.
  3. 3.Examining relationships between psychiatric comorbidity and patient satisfaction.
  4. 4.Examining relationships between psychiatric comorbidity and healthcare system use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
463

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

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

First Submitted

Initial submission to the registry

October 6, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 23, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2018

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

1.2 years

First QC Date

October 6, 2016

Last Update Submit

April 3, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Patient satisfaction of provider visitCG-CAHPS score

    day 1

Study Arms (1)

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

Interventions

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.

Questionnaires for new patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

New patients being seen at Duke Head and Neck Surgery \& Communication Sciences (Clinic 1F) or Duke Raleigh Otolaryngology

You may qualify if:

  • Age 18 or older
  • New patient appointment at Duke Clinic 1F or Duke Raleigh Otolaryngology
  • Ability to read, write, and understand English

You may not qualify if:

  • Less than 18 years old
  • Unable to read, write, and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center and affiliated practices

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Otorhinolaryngologic Diseases

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Seth Cohen, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 7, 2016

Study Start

January 23, 2017

Primary Completion

March 28, 2018

Study Completion

March 28, 2018

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations