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|ClinicalTrials.gov Identifier: NCT02927652|
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : January 15, 2019
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.
|Condition or disease||Intervention/treatment|
|Otorhinolaryngologic Diseases||Other: Questionnaires|
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|
|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|
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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02927652
|Contact: Amy Walkerfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Seth Cohen, MD||Duke University|