Sentinel Patients: Value of an Information System Collecting Patient's Own Report on His Healthcare Management (SENTIPAT)

This study is currently recruiting participants.
Verified November 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Pierre and Marie Curie University
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01769261
First received: January 14, 2013
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

"Evolution of patient's health after hospital discharge is poorly documented. The investigators hypothesize that information of good quality on this concern might be accessible at a relatively low cost from patients, further referred to as sentinel patients, who would voluntary report their health evolution on a dedicated web site.

The SENTIPAT study presents as a proof of concept study. It will collect patient's health evolution during a post-hospital discharge period of 45 days. The study presents as a randomized trial comparing patients' reports issued from two different methods in a patient population returning home after hospital discharge and having at disposal an internet access at home:

in the " internet " arm, sentinel patients will be solicited to directly report their post-discharge health evolution on a website especially devoted for collecting these data while in the " telephone " arm, the same items will be collected through a telephone interview 45 days after hospital discharge. Investigations will focus on post-discharge adverse events and will include appearance/worsening of symptoms, healthcare resources utilization, quality of life, and patients' satisfaction."


Condition Intervention
Patients Returning Home After Discharge From Hospital
Other: eligible, Internet
Other: eligibles, telephone
Other: non eligibles

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Sentinel Patients : Value of an Information System Collecting Patient's Own Report on His Healthcare Management. Application to the Detection of Adverse Events After Hospital Discharge.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • proportion of patients reporting at least a clinically significant adverse event (as judged by the validation committee) occuring in the period of 45 days after hospital discharge. [ Time Frame: from hospital discharge (D0) until 45 days later (D45) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nature, chronology, severity and avoidability of adverse events. Other second outcome measures are mentioned in the detailed description of the study. [ Time Frame: from hospital discharge (D0) until 45 days later (D45) ] [ Designated as safety issue: No ]

Estimated Enrollment: 2550
Study Start Date: February 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet, eligible patients
Patients randomized in the internet arm. They will directly complete their health evolution after hospital discharge via the internet.
Other: eligible, Internet
Patients randomized in the internet arm. They will directly complete their health evolution after hospital discharge via the internet.
Active Comparator: Telephone, eligible patients
Patients randomized in the telephone arm. Their health evolution after hospital discharge will be documented via a telephone interview at J45 after hospital discharge..
Other: eligibles, telephone
Patients randomized in the telephone arm. Their health evolution after hospital discharge will be documented via a telephone interview at J45 after hospital discharge
" Non eligible" patients
Patients who do not have an internet access at home. Their health evolution after hospital discharge will be documented via a telephone interview at J45. after hospital discharge.
Other: non eligibles
Patients who do not have an internet access at home. Their health evolution after hospital discharge will be documented via a telephone interview at J45. after hospital discharge.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult (age ≥ 18) patients, with a short-term (1day), mid-term (1week) or conventional hospitalization, scheduled or unscheduled,
  • having signified their non opposition to participate in the study,
  • with no cognitive deficit or behavioral trouble,
  • speaking and writing French,
  • not leaving hospital against medical advice,
  • returning home after hospital discharge,
  • having at their disposal (eligible patients: sentinel and telephone arms) or not (non eligible arm) an internet connection at home,

Exclusion Criteria:

  • being already included in the study because of a previous hospital stay: all inclusions will involve distinct patients,
  • participating in another biomedical research in the period of 45 days following their hospital discharge,
  • homeless,
  • whose hospital stay is not registered under patient real name (anonymous hospitalization),
  • opposed to their participation in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769261

Contacts
Contact: Fabrice Carrat, MD, PhD (33-1) 44 73 84 58 fabrice.carrat@sat.aphp.fr
Contact: Gilles Hejblum, PhD (33-1) 49 28 32 28 gilles.hejblum@inserm.fr

Locations
France
Hôpital Saint Antoine Recruiting
Paris, France, 75012
Contact: Jean-Claude Dussaule, MD    (33-1) 49 28 20 52    jean-claude.dussaule@sat.aphp.fr   
Contact: Dominique Pateron, MD    (33-1) 49 28 30 70    dominique.pateron@sat.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Pierre and Marie Curie University
Investigators
Principal Investigator: Fabrice Carrat, MD, PhD Assistance Publique
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01769261     History of Changes
Other Study ID Numbers: AOM09213 - K081204
Study First Received: January 14, 2013
Last Updated: November 12, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
quality of health care
continuity of patient care
adverse effects
outcome and process assessment (health care)

ClinicalTrials.gov processed this record on April 23, 2014