Hepatocellular CarcinomaINFICNCT04209491
Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
An observational study of Hepatocellular Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2019to 1 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with a diagnosis of localized hepatocellular carcinoma.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mohamed MB BOUATTOUR, Dr contact
France1 site, 1 recruiting
- Recruiting
BEAUJON Hospital
Clichy-sous-Bois, 92110
Mohamed BOUATTOUR, MD
About this study
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)"
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.
Read the 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:
- 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.
- The average length of stay of hospitalization
- The number of visits to the emergency unit during the first month following the radiology intervention
- 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.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (8)
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.
Measured: 12 months
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
Measured: 12 months
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
Measured: 12 months
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
Measured: 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
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
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start9 Sep 2019
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie DEVICTOR, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209491
- Sponsor's protocol ID
- APHP 180129
- Acronym
- INFIC
- Status last verified
- Dec 2019
- First submitted
- 20 Dec 2019
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)"
- ClinicalTrials.gov ID
- NCT04209491
- Acronym / sponsor ID
- INFIC / APHP 180129
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- The average length of stay of hospitalization
- The number of visits to the emergency unit during the first month following the radiology intervention
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a diagnosis of localized hepatocellular carcinoma.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
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 presentation at a MDT meeting
Time frame: 12 months
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 discharge from the hospital
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
Time frame: 12 months
Length of hospital stay for a first interventional radiology treatment in patients with HCC.
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.
Time frame: 12 months
Number of early unscheduled readmissions during the first month following interventional radiology treatment for patients included in the study.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed MB BOUATTOUR, Dr contact
Julie DEVICTOR principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie JD DEVICTOR (0664712675, julie.devictor@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of the following missions of the coordinator Nurse (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.