- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02927652
Psychiatric Comorbidity
Evaluating Psychiatric Comorbidity in Otolaryngology
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Duke University Medical Center and affiliated practices
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Autre
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Identification of psychiatric comorbidity
Délai: 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.
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day 1
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Identification of psychiatric comorbidity
Délai: day 1
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Patient satisfaction of provider visitCG-CAHPS score
Délai: 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.
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day 1
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Seth Cohen, MD, Duke University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro00075353
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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