Contact information
Type
Scientific
Primary contact
Dr Véronique Merle
ORCID ID
Contact details
Department of Epidemiology and Public Health
Rouen University Hospital
1 rue de Germont
Rouen
76031
France
+33 (0)2 32 88 88 82
veronique.merle@chu-rouen.fr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2009/081/HP
Study information
Scientific title
Impact of implementing a surveillance of adverse events associated with totally implanted venous-access ports in cancer inpatients: a quasi-experimental study
Acronym
SCHIC (Surveillance des Chambres Implantables en Continu)
Study hypothesis
Implementing a surveillance of adverse events associated with totally implanted venous-access ports in cancer inpatients could identify suboptimal process of care and lead to the implementation of corrective actions and, in time, to a decrease in the occurrence of adverse events, improvement in quality of care, and improvement in work-related quality of life of health care workers.
Ethics approval
French regulation does not require ethics approval for such trials as ours without direct intervention performed on patients. However, the approval of the Local Ethics Committee was sought and received on 25th May 2010.
Study design
Quasi-experimental interventional uncontrolled trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Cancer
Intervention
The trial does not compare treatments. The intervention is the implementation of a surveillance scheme associated with morbidity-mortality conferences. The aim is to assess the impact of this implementation on quality of care, and on work-related quality of life for health care workers.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Adverse events frequency
2. Number of corrective actions identified and implemented
3. Assessment of health care workers perception of the surveillance and MMC scheme
Measured after a 12 month period of surveillance and 4 morbidity-mortality conferences (1 every 3 months).
Secondary outcome measures
1. Assessment of the repercussion of adverse events associated with totally implanted port by interview with patients
2. Description of objective consequences of adverse events (prolongation of stay, diagnostic or therapeutic procedures, port replacement, delay in the administration of chemotherapy)
3. Assessement of sensibility and specificity of adverse event identification by the surveillance
Measured after a 12 month period of surveillance and 4 morbidity-mortality conferences (1 every 3 months).
Overall trial start date
01/11/2009
Overall trial end date
01/11/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Two hospitals will participate in the study: a university hospital, and a hospital exclusively dedicated to the care of cancer patients. In each hospital, wards performing cancer intravenous chemotherapy as a usual activity will be approached and proposed the implementation of a surveillance of adverse events associated with totally implanted venous-access ports. Only patients (male or female adults above 18 years old) with totally implanted venous-access ports used for cancer chemotherapy will be included in this surveillance.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1000 patients are expected to included in the surveillance for each 3-month period
Participant exclusion criteria
Wards with no, or infrequent, activity of cancer chemotherapy will not be included in the study. In wards participating in the study, patients with totally implanted venous-access ports used for other treatment than cancer chemotherapy (antibiotics, parenteral nutrition, etc.) will not be included in the surveillance.
Recruitment start date
01/11/2009
Recruitment end date
01/11/2011
Locations
Countries of recruitment
France
Trial participating centre
Department of Epidemiology and Public Health
Rouen
76031
France
Sponsor information
Organisation
French Ministry of Health and Sport (France)
Sponsor details
14
avenue Duquesne
Paris
75350
France
+33 (0)1 40 56 56 09
patrick.gardeur@sante.gouv.fr
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
French Ministry of Health (France) - Research Program on Quality in Hospital Care
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary