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

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

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

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Other: IsereADOM service package

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • CHU Grenoble Alpes
  • Grenoble, France
    • Institut Daniel Hollard
  • Rhône-Alpes
    • Lyon, Rhône-Alpes, France, 69008
      • Centre Leon Berard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; 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; Objects connected to patients' homes (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer), Digital liaison booklet, Sentinel referent, Motivational coaching
No Intervention: Control; Patients with oncological follow up only

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Collaborators: Conseil general de l'Isere

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2018
• Primary Completion (Actual): June 17, 2019
• Study Completion (Actual): June 17, 2019

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IsereADOM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No