Assessment of Drug Prescription by Phone | NCT02889120

Studies
Assessment of Drug Prescription by Phone

NCT02889120

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Sep 5, 2016Estimated

Enrollment

1,263Actual

Phase

Not provided

Conditions

Drug Advice by Phone

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Aug 31, 2016

First Submission Date that Met QC Criteria

Aug 31, 2016

First Posted Date

Sep 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2016

Last Update Posted Date

Sep 5, 2016Estimated

Name	Class
Nantes University Hospital	OTHER
Central Hospital, Nancy, France	OTHER
Centre Hospitalier Universitaire Dijon	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prescription of medicines by telephone in French medical call Centres is a part of the general practitioners activity.

This study aimed to described drug prescription by phone (MTP) performed in four medical call centers. The primary objective is to evaluate adherence to french practice guidelines for the drug prescription by phone (Haute Autorité de Santé, 2009) The secondary objective is to evaluate the risk/benefit ratio for drug prescription by phone.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,263Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adherence to Practice Guidelines for the drug prescription by phone	The aim is to measure the adherence to HAS (Haute Autorité de Santé, 2009) pratice guidelines for the drug prescription by phone	3 days
Risk/benefit ratio for drug prescription by phone		3 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All phone calls, from september to october 2013, leading to a drug prescription by a general practitioner of four medical call centres..

Exclusion Criteria:

Medical emergency
Patient refusing or not able to provide consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All phone calls, from september to october 2013, leading to a drug prescription by a general practitioner of four medical call centres were eligible.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided