Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway

Hepatocellular Carcinoma Clinical Trial

— INFIC  

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)"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04209491
• Other study ID #: APHP 180129
• Status: Recruiting
• Start date: September 9, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: December 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Julie JD DEVICTOR
• Phone: 0664712675
• Email: julie.devictor[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
France	BEAUJON Hospital	Clichy-sous-Bois

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of the following missions of the coordinator Nurse	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	12 months
Secondary	Timeframe in days between The first contact with the centre and the first interventional radiology treatment.	Timeframe in days between The first contact with the centre and the first interventional radiology treatment.	12 months
Secondary	Timeframe in days between : The first contact with the centre and the first presentation at a MDT meeting	Timeframe in days between : The first contact with the centre and the first presentation at a MDT meeting	12 months
Secondary	Timeframe in days between : The first contact with the centre and the diagnostic consultation	Timeframe in days between : The first contact with the centre and the diagnostic consultation	12 months
Secondary	Timeframe in days between :The first contact with the centre and discharge from the hospital	Timeframe in days between :The first contact with the centre and discharge from the hospital	12 months
Secondary	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	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	12 months
Secondary	Length of hospital stay for a first interventional radiology treatment in patients with HCC.	Length of hospital stay for a first interventional radiology treatment in patients with HCC.	12 months
Secondary	Number of emergency unit visits during the first month following hospitalization for interventional radiology treatment for patients included in the study.	Number of emergency unit visits during the first month following hospitalization for interventional radiology treatment for patients included in the study.	12 months
Secondary	Number of early unscheduled readmissions during the first month following interventional radiology treatment for patients included in the study.	Number of early unscheduled readmissions during the first month following interventional radiology treatment for patients included in the study.	12 months