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

Neoplasms Clinical Trial

— IsereADOM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330730
• Other study ID #: IsereADOM
• Status: Completed
• Phase: N/A
• Start date: January 11, 2018
• Est. completion date: June 17, 2019

Study information

• Verified date: December 2019
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 17, 2019
• Est. primary completion date: June 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	Grenoble
France	Institut Daniel Hollard	Grenoble
France	Centre Léon Bérard	Lyon	Rhône-Alpes

Sponsors (2)

Lead Sponsor	Collaborator
Centre Leon Berard	Conseil general de l'Isere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Budget impact analysis	Calculation of incremental costs and saved costs with the experimental strategy	6 months
Secondary	Patient's condition evaluation	Evaluation in both arms of loss of autonomy with questionnaires "Activities of Daily Living"	6 months
Secondary	Patient's condition evaluation	Evaluation in both arms of loss of autonomy with questionnaires "Instrumental Activities of Daily Living"	6 months
Secondary	Patient's condition evaluation	Evaluation in both arms of anxiety with questionnaire "Hospital Anxiety and Depression scale"	6 months
Secondary	Patient's condition evaluation	Evaluation in both arms of depression with questionnaire "Hospital Anxiety and Depression scale"	6 months
Secondary	Patient's condition evaluation	Evaluation in both arms of nutritional status by measuring albumin rate	6 months
Secondary	Patient's condition evaluation	Evaluation in both arms of nutritional status by measuring prealbumin rate	6 months
Secondary	Patient's condition evaluation	Evaluation in both arms of nutritional status by measuring weight	6 months
Secondary	Patient's condition evaluation	Evaluation in both arms of the quality of life with questionnaire "EuroQoL 5 Dimensions 5 Levels"	6 months
Secondary	Patient's condition evaluation	Description in both arms of home care with questionnaire "RUD" for the natural caregivers	6 months
Secondary	Patient's condition evaluation	Evaluation in both arms of consumption of unprogrammed care with patient's booklet	6 months
Secondary	Patient's condition evaluation	Evaluation in both arms of overall survival	6 months
Secondary	Patient's condition evaluation	Characterizing unjustified hospitalizations, to determine predictive factors for the efficiency of experimental management, progression-Free Survival	6 months
Secondary	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
Secondary	Evaluation of IsereADOM home-care service package impact	Evaluation of the proportion of sentinel nurses asked to participate in the study	6 months
Secondary	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
Secondary	Evaluation of IsereADOM home-care service package impact	Evaluation of the number of refusal to participate.	6 months
Secondary	Evaluation of IsereADOM home-care service package impact	Evaluation of the causes of refusal to participate.	6 months
Secondary	Analysis of the geographical factors predicting the effectiveness of the package		6 months