Coordinate Regulation of Transfusions by Uploading (RTT)

Currently in the Toulouse University Hospital, the organization of transfusion care for patients requiring regular transfusions is based on reading the biological results received by fax before confirming or disproving a planned hospitalization or program a new hospital if needed.

Remote transmission of laboratory results, replacing fax communication might facilitate the coordination of care that results from these laboratory results and provide a better respect of the Plan Custom Care Transfusion (PPST).

The investigators offer organization of transfusion supportive care for patients with conditions requiring biological monitoring using the techniques of information and communication telemedicine.

Primary objective

- Assess the feasibility of setting up an upload procedure biological results in the treatment of transfusion supportive care.

Secondary objectives

• Assess the evolution of the quality of life of patients during the treatment
• Assess changes in patient satisfaction over the support
• Assess the evolution of the satisfaction of the medical team at home and at Toulouse University Hospital
• Describe the programming time (hospitalization, consultations)
• Estimate the loss of biological results
• Assessment of the descriptive use of hospitalization, consultation and biological examinations in both groups. This remedy shall be valued in Euros thanks to GHS rates for hospitalizations, general nomenclature for Professional acts (NGAP) and biology nomenclature (NABM) for biological tests.

Study Overview

• Status: Completed
• Conditions: Neoplasm, Uncertain Whether Benign or Malignant
• Intervention / Treatment: Other: telemedicine transmission of biological results

Detailed Description

Setting up a Custom Care Plan for patients with conditions requiring a transfusion followed , which in its development provides a transfusion Care Custom Program .

The establishment of an electronic transmission enables the regulation of all hospitalizations throughout the patient care pathway and reinforces the link city / hospital through the receipt of laboratory results and issuing information to the partners of the care network patient. The PPST will be transmitted by secure messaging.

The primary endpoint is the proportion of transfusion episodes where PPST is respected. The proportion of patients whose care meets the PPST for 3 successive transfusion episodes will also be estimated.

The secondary endpoints are:

• The Patient satisfaction questionnaires (relative to the consideration of the results, the management procedures) in 3 successive transfusions.
• The Quality of life of the patient assessed by questionnaire (EORTC-QLQC30 and EQ5D) at baseline and after 3 successive transfusion episodes.
• The Satisfaction surveys of the medical team at home and the service effector transfusion at baseline and after 3 successive transfusion episodes.
• The Response time for a hospitalization or consultation program on the study period.
• The Number of lost biological results.
• Evaluation of the descriptive use of hospitalization, consultation, biology.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • IUCT-O

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients receiving blood transfusions and / or platelet on our hospital
• Patient agreeing to participate in the project

Exclusion Criteria:

• A patient who can not fill questionaries.
• Absence of social coverage .
• Patient under guardianship or trusteeship safeguard justice

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: telemedicine transmission; telemedicine transmission of biological results in the treatment of transfusion supportive care	Other: telemedicine transmission of biological results; telemedicine transmission of biological informations
No Intervention: without telemedicine transmission; no telemedicine transmission of biological results in treatment in the treatment of transfusion supportive care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of transfusion episodes in the Plan Custom Care Transfusion	The primary endpoint chosen is the proportion of transfusion episodes where the Plan Custom Care Transfusion is respected. The element determining compliance will be: - Transfusion with remote transmission, and transfusion in a service defined in the Plan Custom Care Transfusion and transfusion with achievement of target hemoglobin levels	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of patients	Assess the evolution of the quality of life of patients ( EORTC- QLQC30 questionnaires and EQ5D )	12 months
Patients satisfaction	Assess changes in patient satisfaction ( satisfaction survey compared to the overall care , the inclusion of the results, the management procedures )	12 months
Satisfaction of medical team	Assess the evolution of the satisfaction of the medical team at home and in Hospital ( satisfaction surveys )	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Odile Beyne Rauzy, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2019
• Primary Completion (Actual): May 11, 2021
• Study Completion (Actual): May 11, 2021

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (Estimate): August 1, 2016

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 12 559 15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No