Coordinate Regulation of Transfusions by Uploading

Neoplasm, Uncertain Whether Benign or Malignant Clinical Trial

— RTT  

Official title:

Coordinate Regulation of Transfusions by Uploading

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851225
• Other study ID #: 12 559 15
• Status: Completed
• Phase: N/A
• Start date: August 2, 2019
• Est. completion date: May 11, 2021

Study information

• Verified date: August 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 11, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm, Uncertain Whether Benign or Malignant

Intervention

Other:
• telemedicine transmission of biological results
telemedicine transmission of biological informations

Locations

Country	Name	City	State
France	IUCT-O	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

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