RTT: Coordinate Regulation of Transfusions by Uploading

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Completed
CT.gov ID
NCT02851225
Collaborator
(none)
60
1
2
21.3
2.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: telemedicine transmission of biological results
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Coordinate Regulation of Transfusions by Uploading
Actual Study Start Date :
Aug 2, 2019
Actual Primary Completion Date :
May 11, 2021
Actual Study Completion Date :
May 11, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of transfusion episodes in the Plan Custom Care Transfusion [12 months]

    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

Secondary Outcome Measures

  1. Quality of life of patients [12 months]

    Assess the evolution of the quality of life of patients ( EORTC- QLQC30 questionnaires and EQ5D )

  2. Patients satisfaction [12 months]

    Assess changes in patient satisfaction ( satisfaction survey compared to the overall care , the inclusion of the results, the management procedures )

  3. Satisfaction of medical team [12 months]

    Assess the evolution of the satisfaction of the medical team at home and in Hospital ( satisfaction surveys )

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IUCT-O Toulouse France 31059

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT02851225
Other Study ID Numbers:
  • 12 559 15
First Posted:
Aug 1, 2016
Last Update Posted:
Aug 24, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 24, 2021