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Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway (INFIC)

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ClinicalTrials.gov Identifier: NCT04209491
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

This project is based on the assumption that the nurse coordinators of the centres have common missions at each of the key stages of patient care. These missions make the care plan more fluid and improve the quality and safety of care as well as the patient's prognosis.

The Hypothesis is that co-follow-up by a doctor and a nurse coordinator reduces time between referral to treatment, average lengths of stay, unscheduled readmissions or early emergency visits, compared to follow-up that does not involve a nurse coordinator.


Condition or disease
Hepatocellular Carcinoma

Detailed Description:

Main objective:

Describe the roles and missions of professionals dedicated to the coordination of care pathways for patients with HCC

Secondary objectives:

Compare the indicators of quality of care in HCC centres with a nurse coordinator:

  1. Timeframe in treatment:

    • timeframe between the first contact with the HCC centre and the first interventional radiology treatment.
    • timeframe between the first contact with the centre and the first presentation at a multidisciplinary team meeting (MDT)
    • time between the first contact with the centre and the diagnostic consultation
    • timeframe between the first contact with the centre and discharge from the hospital
    • timeframe between the first interventional radiology procedure and the next for the subgroup of patients who have multiple procedures during the follow-up period
    • timeframe between the first contact with the nurse coordinator of the centre and discharge from the hospital.
  2. The average length of stay of hospitalization
  3. The number of visits to the emergency unit during the first month following the radiology intervention
  4. The number of unscheduled readmissions during the first month following the intervention.

Assess the feasibility of collecting the above-mentioned timeframe and variables and the patients and carers feedback on the coordination of the care pathway Describe the organization of care pathways for patients with HCC in centres with or without a nurse coordinator.

Research method: This is a retrospective descriptive pilot study. It aims to describe the organization of care.

Population: Patient with a diagnosis of localized hepatocellular carcinoma.

Data processing:

  • Feasibility questionnaires will be sent by email.
  • The interviews will be transcribed and coded with NVivo® software
  • Patient data will be collected in the ecrf
  • Data processing from anonymized files by the authors of the research only. All data will be centralized at Bichat Hospital (URC Paris Nord) for statistical analysis.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: "Pilot Study: Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway in the Management of a Patient Treated for Hepatocellular Carcinoma (HCC)"
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020



Primary Outcome Measures :
  1. Proportion of the following missions of the coordinator Nurse [ Time Frame: 12 months ]

    missions: o Initial contact of the patient with the expert centre

    • Organisation of the MDT meeting
    • Organisation of treatment and investigations
    • Coordination between hospital professionals
    • Link with community health professionals
    • Follow-up (post-hospitalization, treatment side effects, etc.)
    • Information, advice to patients
    • Psychological support
    • Implementation of care pathways
    • Nursing research


Secondary Outcome Measures :
  1. Timeframe in days between The first contact with the centre and the first interventional radiology treatment. [ Time Frame: 12 months ]
    Timeframe in days between The first contact with the centre and the first interventional radiology treatment.

  2. Timeframe in days between : The first contact with the centre and the first presentation at a MDT meeting [ Time Frame: 12 months ]
    Timeframe in days between : The first contact with the centre and the first presentation at a MDT meeting

  3. Timeframe in days between : The first contact with the centre and the diagnostic consultation [ Time Frame: 12 months ]
    Timeframe in days between : The first contact with the centre and the diagnostic consultation

  4. Timeframe in days between :The first contact with the centre and discharge from the hospital [ Time Frame: 12 months ]
    Timeframe in days between :The first contact with the centre and discharge from the hospital

  5. Timeframe in days between :The interventional radiology procedure and the next one for the subgroup of patients who have multiple procedures during the follow-up period [ Time Frame: 12 months ]
    Timeframe in days between :The interventional radiology procedure and the next one for the subgroup of patients who have multiple procedures during the follow-up period

  6. Length of hospital stay for a first interventional radiology treatment in patients with HCC. [ Time Frame: 12 months ]
    Length of hospital stay for a first interventional radiology treatment in patients with HCC.

  7. Number of emergency unit visits during the first month following hospitalization for interventional radiology treatment for patients included in the study. [ Time Frame: 12 months ]
    Number of emergency unit visits during the first month following hospitalization for interventional radiology treatment for patients included in the study.

  8. Number of early unscheduled readmissions during the first month following interventional radiology treatment for patients included in the study. [ Time Frame: 12 months ]
    Number of early unscheduled readmissions during the first month following interventional radiology treatment for patients included in the study.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with a diagnosis of localized hepatocellular carcinoma.
Criteria

Inclusion Criteria:

  • Centre with interventional radiology treatment
  • Active list of patients followed for a HCC of at least 70 / year
  • Reply to the feasibility questionnaire within 60 days from receipt of the email

Exclusion Criteria:

  • Patient with a localized HCC diagnosis (BCLC A or B)
  • Hospitalised for a first interventional radiology treatment (radioembolisation, transarterial chemoembolization or percutaneous ablation) in one of the centres included in the study between July 1, 2017 and December 31, 2017

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209491


Contacts
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Contact: Julie JD DEVICTOR 0664712675 julie.devictor@aphp.fr
Contact: Mohamed MB BOUATTOUR, Dr mohamed.bouattour@aphp.fr

Locations
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France
BEAUJON Hospital Recruiting
Clichy-sous-Bois, France, 92110
Contact: Mohamed BOUATTOUR, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Julie DEVICTOR Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04209491    
Other Study ID Numbers: APHP 180129
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases