Viewing Study NCT03101969


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Study NCT ID: NCT03101969
Status: COMPLETED
Last Update Posted: 2017-04-05
First Post: 2016-06-29
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Human Outreach to Improve Adherence With Scheduled Pain Clinic Appointments
Sponsor: Montefiore Medical Center
Organization:

Study Overview

Official Title: Targeted Intervention (a Telephone Call in the Dominant Language) to Increase Attendance at Scheduled Appointment in an Inner City Academic Pain Clinic
Status: COMPLETED
Status Verified Date: 2017-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Patients tend to miss their scheduled appointments in chronic pain clinics for unknown reasons. This study will test the hypothesis in a prospective pragmatic trial that a human telephone call in the primary language of the patient, promising a clinical encounter in this language improves attendance at scheduled appointments in an academic inner city pain clinic.
Detailed Description: Language barriers may lead to poor attendance at pain clinic appointments, especially in underserved patients. Targeted interventions can help overcome barriers and significantly improve adherence, but have rarely been rigorously investigated in randomized clinical trials. Our objective is to investigate if (1) making a telephone call in the patient's preferred language increases adherance with scheduled appointment in an inner city academic pain clinic or at least reduces failure to attend without a prior cancellation call and (2) if this intervention is more effective in Spanish speakers.

After institutional review board approval and waiver of informed consent, we enroll all adult patients (18 years and up) with a scheduled first appointment at our outpatient Pain Center at Montefiore Medical Center located in the Bronx, New York from October 2014 through October 2015. Participants are randomized to receive a phone call in their preferred language before their appointment, or not. We recorded if participants attended as scheduled and/or called to cancel. We fit stratified and multivariate multinomial logistic regression models.

In a methodologically rigorous randomized design, we seek to demonstrate that a human phone call in the patient's primary language increases adherence with scheduled appointments in an ethnically diverse, poor population, typical for an inner city pain clinic. Our targeted intervention may provide considerable cost savings to the institution while bolstering the patient-doctor relationship and overcoming barriers to access much needed care.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: