Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Descriptive Multicenter Investigation of Geriatrics Hotlines : A French Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03959475
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborators:
National School for Social Security
Loire department
Information provided by (Responsible Party):
Régis Gonthier, Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date May 16, 2019
First Posted Date May 22, 2019
Last Update Posted Date May 24, 2019
Actual Study Start Date May 5, 2018
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2019)
the mean duration of hospitalization in short-stay geriatric care [ Time Frame: through study completion, an average of 2 years ]
the mean duration of hospitalization in short-stay geriatric care
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03959475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 22, 2019)
  • Assessment of health status using the Charlson comorbidity index for elderly patients hospitalized in short-stay geriatric wards [ Time Frame: through study completion, an average of 2 years ]
    By questionnaire : Charlson's index calculation using patient history for assessing the comorbidities of our geriatric population. The Charlson comorbidity index : a method of predicting mortality by classifying or weighting comorbid conditions. The Charlson comorbidity index predicts the one-year mortality for a patient who may have a range of comorbid conditions, such as heart disease, AIDS, or cancer (a total of 22 conditions). Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Scores are summed to provide a total score to predict mortality The minimum score is 0 and the maximum score is 27. The value 0 is the best possible result. With a charlson score of 3 or higher, there is a risk of an adverse change in the patient's state of health. Score = 0 => 12% of 1 year mortality Score of 1 to 2 => 26% of 1 year mortality Score of 3 to 4 => 52% of 1 year mortality Score of 5 or more => 85% of 1 year mortality
  • Describing and comparing how the different hotlines across France function [ Time Frame: through study completion, an average of 2 years ]
    By questionnaire for all hotlines : N° residents, total number of hospital beds, short-stay geriatric care Yes/No, post-discharge care Yes/No, long-term rehabilitation care Yes/No, consultation Yes/No, Outpatient clinic Yes/No, Ambulance care Yes/No, telemedical consultation Yes/No.
Original Secondary Outcome Measures
 (submitted: May 20, 2019)
  • Assessment of health status using the Charlson's index (Charlson, 1987) for elderly patients hospitalized in short-stay geriatric wards [ Time Frame: through study completion, an average of 2 years ]
    By questionnaire : Charlson's index calculation using patient history for assessing the comorbidities of our geriatric population
  • Describing and comparing how the different hotlines across France function [ Time Frame: through study completion, an average of 2 years ]
    By questionnaire for all hotlines : N° residents, total number of hospital beds, short-stay geriatric care Yes/No, post-discharge care Yes/No, long-term rehabilitation care Yes/No, consultation Yes/No, Outpatient clinic Yes/No, Ambulance care Yes/No, telemedical consultation Yes/No.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Descriptive Multicenter Investigation of Geriatrics Hotlines : A French Study
Official Title A Descriptive Multicenter Investigation of Geriatrics Hotlines : Description of the Health Care Pathways and Conditions of Subjects Aged 75 and Over
Brief Summary

In France, for general practitioners, the Emergency Hospitality Services (UAS) are the fastest and usual way to respond to the complexity of managing elderly polypathological patients. In 2013, the Regional Health Agencies proposed the creation of direct telephone assistance managed by geriatric doctors (geriatric hotlines) to promote interactions city - hospital. The aim of these hotlines is to improve the care pathways and health status of seniors. The objective of this study is to describe the care trajectories and health status of subjects over 75 years of age hospitalized in a short-term geriatric stay on the guidance of a Geriatric Hotline.

The study will take place over 24 months and in 7 French University Hospitallers Centres. The study will include all patients aged 75 and over, living at home or in an institution, who are hospitalized in a short-term geriatric ward on the guidance of a Hotline.

The results will show whether a management by the geriatric hotline is the most suitable for seniors, with an average length of stay probably shorter.

Detailed Description

This is a multicenter descriptive study conducted in seven French investigating centers (including university centers) with sub-group analysis. Participating establishments will all be voluntary. In order to participate to the study, an establishment must have a specific telephone line for doctor-doctor communications. Only calls originating from healthcare professionals are to be taken into account.

The study will last for 24 months. Study population and eligibility The study population will be constituted of people aged 75 and over, living in their own home or in a care facility (including independent-living facilities), hospitalized in short-stay geriatric care referred by the hotline in one of the investigating centers, and who are fully aware of the study and their rights regarding their participation. The first questionnaire will be filled out via the hotline by the geriatric specialist answering the call. A second questionnaire will then be filled out during the patient's hospitalization by the treating geriatric specialist

Recruitment:

All people aged 75 years and over hospitalized in short-stay geriatric care via a hotline.

Inclusion:

Inclusion procedure: (the location, inclusion and non-inclusion criteria verification by investigators, explanation of the study, and delivery of information form will all be the responsibility of each center independently, conducted when the patient is admitted to short-stay geriatric care).

Monitoring:

This study involves no extra examinations or treatment besides traditional practices, the only difference being the digitization of all medical findings for analysis.

Study endpoint:

This corresponds to when the patient is discharged from short-stay geriatric care.

Study participation duration for each patient: short-stay geriatric care duration.

SELECTION AND EXCLUSION OF SUBJECTS FROM STUDY Inclusion criteria

  • Age ≥75 years
  • Male/Female
  • Living in own home or in a care facility (including independent-living facilities)
  • Hospitalized in short-stay geriatric care
  • Confirmed receipt of information on the study and their rights, as stipulated by articles L. 1122-1 of the French public health code, by 57 of the "Informatique et Libertés" data protection act, and by MR-003 of the French data protection and civil liberties authority (CNIL).

Non-inclusion criteria for people seeking participation

  • Patients less than 75 years of age
  • Refusal to participate

Procedure for early discontinuation of the study or exclusion from the study All subjects can, at any moment and by any method, decide to withdraw from the study.

Evaluation criteria The primary endpoint is the mean duration of hospitalization in short-stay geriatric care.

The secondary endpoints selected are hospital mortality rate, assessment of health status of elderly patients hospitalized in short-stay geriatric wards using different criteria, and their outcomes following discharge; describing and comparing how the different hotlines across France function; analyzing the principal responses provided to doctors using the hotline and improving awareness.

This study will be noninterventional. All interventions will be carried out following normal clinical practices. There will be no unusual risk or specific constraint for participating patients.

RECORDED VARIABLES AND SOURCE DATA The study data will be collected directly from the questionnaires as the study progresses.

For the first questionnaire, filled out by the hotline geriatric specialist, the following information will be collected for the study:

Health data: the identification of both speakers on the call; patient age; reasons for calling; degree of emergency as perceived by the geriatric specialist and the calling doctor, evaluated by simple verbal scale from 0 to 10; responses offered by geriatric specialist.

Administrative data: call duration in minutes. This questionnaire will be anonymous with no identifying criteria. It will be filled out every time contact is made via the hotline, irrespective of what responses are offered by the doctor (referrals to short-stay geriatric care or not).

For the second questionnaire, filled out by the geriatric specialist treating the patient during their hospitalization in short-stay geriatric care, following referral from the hotline, the following information will be collected for the study:

Socio-demographic data: First and last name of the patient, Patient Permanent Identification (PPI) number, patient age. This data will be anonymized on entry.

Health data: Reasons for hospitalization, number of hospitalizations during the year, polypharmacy (>4), biological data : albumin and C-reactive protein levels for assessing nutritional status, Charlson's index calculation using patient history for assessing the comorbidities of our geriatric population), evaluation of activities of daily living (ADL) prior to hospitalization according to the validated ADL (/6) and instrumental ADL (IADL) scales (/4), evaluation of cognitive status using MMSE score (/30), recommended referral after hospital discharge.

Family/Marital status data: single or with a partner, with or without children Living situation data: Residence of patient (own home, independent-living facility, nursing home) Type of living area data: urban, semi-urban or rural

Signaling data and findings relating to family or marital status will help characterize the patients who participate.

Data relating to living location, type and area are recorded in order to assess the impact of these factors on use of the hotline.

Finally, data relating to health status is recorded as justified by the bibliographical references to which it is sent.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 1 Month
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study population will be constituted of people aged 75 and over, living in their own home or in a care facility (including independent-living facilities), hospitalized in short-stay geriatric care referred by the hotline in one of the investigating centers, and who are fully aware of the study and their rights regarding their participation.
Condition
  • Geriatric
  • Elderly
Intervention Not Provided
Study Groups/Cohorts
  • Saint-Etienne Hospital
    All people aged 75 years and over hospitalized in short-stay geriatric care via a hotline in this hospital
  • Firminy hospital
    All people aged 75 years and over hospitalized in short-stay geriatric care via a hotline in this hospital
  • South Lyon hospital
    All people aged 75 years and over hospitalized in short-stay geriatric care via a hotline in this hospital
  • Bordeaux hospital
    All people aged 75 years and over hospitalized in short-stay geriatric care via a hotline in this hospital
  • Saint-Chamond hospital
    All people aged 75 years and over hospitalized in short-stay geriatric care via a hotline in this hospital
  • Angers hospital
    All people aged 75 years and over hospitalized in short-stay geriatric care via a hotline in this hospital
  • Clermont Ferrand hospital
    All people aged 75 years and over hospitalized in short-stay geriatric care via a hotline in this hospital
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 20, 2019)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age over 75
  • Male/Female
  • Living at home or in an institution (independent residence included)
  • Being hospitalized in a short geriatric stay

Exclusion Criteria:

  • Patients under 75 years
  • Refusal to participate in study
Sex/Gender
Sexes Eligible for Study: All
Ages 75 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Bienvenu BONGUE, PHD 0477816373 bienvenu.bongue@cetaf.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03959475
Other Study ID Numbers CFPPA-Loire-Hotline-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Régis Gonthier, Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor Support and Education Technic Centre
Collaborators
  • National School for Social Security
  • Loire department
Investigators
Principal Investigator: Régis GONTHIER CHU Saint-Etienne
PRS Account Support and Education Technic Centre
Verification Date May 2019