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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Neoplasms

Intervention / Treatment
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* Other: IsereADOM service package


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Patients with oncological follow up and home-care service package IsereADOM: Objects connected to patients' home (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer) with graduated protocol for medical platform support. Digital linkbook (different from the medical file) accessible to the patient and the standard care actors. Referent sentinel: a field actor to coordinate the care. Preferred contact of the patient outside the center Motivational coaching: 1 to 2 axes to be defined by the investigator among the following axes (physical activity, nutrition and hydration, drug compliance, medical follow-up, chronic and moral pain, acceptance of the disease and treatments). | Other: IsereADOM service package<br>* Objects connected to patients' homes (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer), Digital liaison booklet, Sentinel referent, Motivational coaching<br>|
| No Intervention: Control<br>Patients with oncological follow up only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Budget impact analysis | Calculation of incremental costs and saved costs with the experimental strategy | 6 months | 
| Patient's condition evaluation | Evaluation in both arms of loss of autonomy with questionnaires Activities of Daily Living | 6 months | 
| Patient's condition evaluation | Evaluation in both arms of loss of autonomy with questionnaires Instrumental Activities of Daily Living | 6 months | 
| Patient's condition evaluation | Evaluation in both arms of anxiety with questionnaire Hospital Anxiety and Depression scale | 6 months | 
| Patient's condition evaluation | Evaluation in both arms of depression with questionnaire Hospital Anxiety and Depression scale | 6 months | 
| Patient's condition evaluation | Evaluation in both arms of nutritional status by measuring albumin rate | 6 months | 
| Patient's condition evaluation | Evaluation in both arms of nutritional status by measuring prealbumin rate | 6 months | 
| Patient's condition evaluation | Evaluation in both arms of nutritional status by measuring weight | 6 months | 
| Patient's condition evaluation | Evaluation in both arms of the quality of life with questionnaire EuroQoL 5 Dimensions 5 Levels | 6 months | 
| Patient's condition evaluation | Description in both arms of home care with questionnaire RUD for the natural caregivers | 6 months | 
| Patient's condition evaluation | Evaluation in both arms of consumption of unprogrammed care with patient's booklet | 6 months | 
| Patient's condition evaluation | Evaluation in both arms of overall survival | 6 months | 
| Patient's condition evaluation | Characterizing unjustified hospitalizations, to determine predictive factors for the efficiency of experimental management, progression-Free Survival | 6 months | 
| Evaluation of IsereADOM home-care service package impact | Evaluation of the duration of setting up the experimental procedure by measuring the delay between the randomisation and the complete installation of the home-care service package at the patient's home | 6 months | 
| Evaluation of IsereADOM home-care service package impact | Evaluation of the proportion of sentinel nurses asked to participate in the study | 6 months | 
| Evaluation of IsereADOM home-care service package impact | Evaluation of the number of calls and the number of connections to the telephone and Internet platforms | 6 months | 
| Evaluation of IsereADOM home-care service package impact | Evaluation of the number of refusal to participate. | 6 months | 
| Evaluation of IsereADOM home-care service package impact | Evaluation of the causes of refusal to participate. | 6 months | 
| Analysis of the geographical factors predicting the effectiveness of the package |  | 6 months |