Evaluation of the Efficiency of the IsereADOM Home-care Service Package in the Prevention of Unplanned Hospitalizations of Patients With Cancer

Centre Leon Berard19 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Neoplasms

Interventions

IsereADOM service packageOTHER

Objects connected to patients' homes (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer), Digital liaison booklet, Sentinel referent, Motivational coaching

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Centre Léon Bérard

Lyon, Auvergne-Rhône-Alpes, France

CHU Grenoble Alpes

Grenoble, France

Institut Daniel Hollard

Grenoble, France

Outcomes

Primary Outcomes

Comparison of the effectiveness and efficiency of innovative care with the IsereADOM home-care service package versus standard support

Comparison of the mean number of unplanned hospitalizations observed within 6 months of randomization.

Time frame: 6 months

Incremental Cost-Utility Ratio comparison

Evaluation of the costs of the home-care service package; Assessment of health care consumption from a community perspective; Calculation of the years of life gained in good health (QALY)

Time frame: 6 months

Secondary Outcomes

Budget impact analysis

Calculation of incremental costs and saved costs with the experimental strategy

Time frame: 6 months

Patient's condition evaluation

Evaluation in both arms of loss of autonomy with questionnaires "Activities of Daily Living"

Time frame: 6 months

Patient's condition evaluation

Evaluation in both arms of loss of autonomy with questionnaires "Instrumental Activities of Daily Living"

Time frame: 6 months

Patient's condition evaluation

Evaluation in both arms of anxiety with questionnaire "Hospital Anxiety and Depression scale"

Time frame: 6 months

Patient's condition evaluation

Evaluation in both arms of depression with questionnaire "Hospital Anxiety and Depression scale"

Time frame: 6 months

Data from ClinicalTrials.gov

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