Clinical trial NCT03330730: Evaluation of the Efficiency of the IsereADOM Home-care Service Package in the Prevention of Unplanned Hospitalizations of Patients With Cancer
Official title: A Randomized, Controlled, Multicenter, Prospective, Open Study Evaluating the Efficiency of the IsereADOM Home-care Service Package in the Prevention of Unplanned Hospitalizations of Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: Conseil general de l'Isere
First posted: 2017-11-06
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of the project is to compare the effectiveness and efficiency of innovative care through the IsereADOM home-care service package versus standard care in the prevention of unplanned hospitalizations in patients with cancer treatment. In accordance with the recommendations of the French High Authority of Health (HAS), a cost-utility analysis (ACU) will be implemented

Detailed description: Specific management of cancer patients involves carrying out often heavy treatments (surgery, chemotherapy, radiotherapy, interventional radiology, etc.) during which close coaching is necessary. In spite of this adapted follow-up, the natural evolution of the disease and the management of treatment tolerance make these patients a frail population, sometimes isolated, for which admission to emergency services and admission to full hospitalization can be required.

This trial will use a service package at home named IsereADOM, currently in the development phase in the management of 4 types of populations:

* Retired persons with no proven loss of autonomy;
* Users with loss of autonomy at risk of falling;
* Cardiac insufficiency;
* Patients with cancer.

This service package is based on the identification of a person of proximity, called "sentinel referent". This person, in charge of monitoring the patient at his / her home, has access to various connected tools installed at the patient's home (scales, tensiometer ...) as well as computer solutions enabling the sharing of information with the different actors in the management of the patient.

In addition, the patient benefits from motivational coaching based on investigator's recommendation and telephone and internet information platforms.

Eligibility criteria: Inclusion Criteria:

* age \> or = 18 years old at the time of signature of informed consent form
* patient with solid or hematologic tumor under treatment for cancer at the time of inclusion
* Patient managed in a medical emergency context in the 2 weeks prior to inclusion
* Patient living in Isère department (area of coverage of experiment)
* ECOG Performance index \< or = 3
* patient with a life expectancy of 6 months or more
* patient with social security system
* patient able to read, write and understand French
* patient with signed informed consent

Exclusion Criteria:

* Patient included in clinical trial evaluating early stage therapeutic innovation with pharmacokinetic sampling
* Patients with follow-up in Hospitalization at Home at the end of the hospitalization for inclusion
* Patient without help "referent" in the entourage (spouse, family, friend ...)
* Patient residing in Elderly Accommodation (EHPAD) or in any other institution for dependent persons
* Patient who is homeless or living in a home that does not allow the installation of the necessary equipment
* Patient with severe cognitive impairment, defined by score at Mini Mental State Examination (MMSE)\< 23/30
* Patient unable to comply (or unwilling to comply) with follow-up of the study for the duration of participation

Primary outcomes:
measure: Comparison of the effectiveness and efficiency of innovative care with the IsereADOM home-care service package versus standard support
timeFrame: 6 months
measure: Incremental Cost-Utility Ratio comparison
timeFrame: 6 months
Secondary outcomes:
measure: Budget impact analysis
timeFrame: 6 months
measure: Patient's condition evaluation
timeFrame: 6 months
measure: Patient's condition evaluation
timeFrame: 6 months
measure: Patient's condition evaluation
timeFrame: 6 months
measure: Patient's condition evaluation
timeFrame: 6 months
measure: Patient's condition evaluation
timeFrame: 6 months
measure: Patient's condition evaluation
timeFrame: 6 months
measure: Patient's condition evaluation
timeFrame: 6 months
measure: Patient's condition evaluation
timeFrame: 6 months
measure: Patient's condition evaluation
timeFrame: 6 months
measure: Patient's condition evaluation
timeFrame: 6 months
measure: Patient's condition evaluation
timeFrame: 6 months
measure: Patient's condition evaluation
timeFrame: 6 months
measure: Evaluation of IsereADOM home-care service package impact
timeFrame: 6 months
measure: Evaluation of IsereADOM home-care service package impact
timeFrame: 6 months
measure: Evaluation of IsereADOM home-care service package impact
timeFrame: 6 months
measure: Evaluation of IsereADOM home-care service package impact
timeFrame: 6 months
measure: Evaluation of IsereADOM home-care service package impact
timeFrame: 6 months
measure: Analysis of the geographical factors predicting the effectiveness of the package
timeFrame: 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
state: Rhône-Alpes
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Grenoble
country: France
facility: Institut Daniel Hollard
Study officials:
References: