An Evaluation of Patients Access to Their Electronic Medi... | NCT04496375

Studies
An Evaluation of Patients Access to Their Electronic Medical Records Via the IPC Connect Application

NCT04496375

Sponsor

Institut Paoli-Calmettes

Status

Unknown status

Last Update Posted

Aug 3, 2020Actual

Enrollment

8,000Estimated

Phase

Not provided

Conditions

Solid Tumor
Hematologic Malignancy

Interventions

Survey

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

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2020Estimated

Primary Completion Date

Dec 5, 2020Estimated

Completion Date

Dec 5, 2020Estimated

First Submitted Date

Jul 29, 2020

First Submission Date that Met QC Criteria

Jul 29, 2020

First Posted Date

Aug 3, 2020Actual

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

Jul 29, 2020

Last Update Posted Date

Aug 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The aim of our study is to investigate the effect of providing patients access to their electronic medical records Via the IPC Connect Application on their A Survey will be proposed to all outpatients with a solid or hematologic malignancy who will attend an appointement at Institut Paoli Calmettes clinic.

Data will be collected during a 1-month period. The auto-questionnaire will be composed of 31 questions addressed to all patients, 17 questions will be specifically addressed to patients using IPC connect application and 7 questions will be addressed to patients who do not use the application.

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

8,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Institut Paoli Calmettes Outpatients		Patients with a solid tumor or an hematologic malignancy who will attend an appointement at IPC Outpatients clinic	Other: Survey

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survey	Other	Self-completed questionnaires	Institut Paoli Calmettes Outpatients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Impact of Patients Access to Their Electronic Medical Records Via the IPC Connect Application on patients anxiety level	Anxiety level will be measured by the Hospital Anxiety and Depression scale	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Man or woman, age> 18 Years
Solid tumor or hematologic malignancy
Patient attending an appointment at Institut Paoli Calmettes
Non-opposition

Exclusion Criteria:

emergency, Vulnerable person or unable to provide informed consent
First appointment at Institut Paoli Calmettes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All outpatients with an solid tumor or an hematologic malignancy who will attend Institut Paoli-Calmettes Outpatients clinic during 1 months

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dominique Genre, MD	Contact	+33491223778		drci.up@ipc.unicancer.fr

Overall Officials

Name	Affiliation	Role
Gwenaelle Gravis	Institut Paoli-Calmettes	Principal Investigator

Locations

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
D019337	Hematologic Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided