Sentinel Patients: Value of an Information System Collecting Patient's Own Report on His Healthcare Management (SENTIPAT)
This study is currently recruiting participants.
Verified February 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
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: March 7, 2013
Last verified: February 2013
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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: | March 7, 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 May 22, 2013