Surveillance of adverse events associated with totally implanted venous-access ports

ISRCTN	ISRCTN57640029
DOI	https://doi.org/10.1186/ISRCTN57640029
Protocol serial number	2009/081/HP
Sponsor	French Ministry of Health and Sport (France)
Funder	French Ministry of Health (France) - Research Program on Quality in Hospital Care

Submission date: 26/06/2010
Registration date: 13/01/2011
Last edited: 13/01/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Véronique Merle
Scientific

Department of Epidemiology and Public Health
Rouen University Hospital
1 rue de Germont
Rouen
76031
France

Phone	+33 (0)2 32 88 88 82
Email	veronique.merle@chu-rouen.fr

Study information

Primary study design	Interventional
Study design	Quasi-experimental interventional uncontrolled trial
Secondary study design	Non randomised controlled trial
Scientific title	Impact of implementing a surveillance of adverse events associated with totally implanted venous-access ports in cancer inpatients: a quasi-experimental study
Study acronym	SCHIC (Surveillance des Chambres Implantables en Continu)
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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).
Completion date	01/11/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1000
Key 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.
Key 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.
Date of first enrolment	01/11/2009
Date of final enrolment	01/11/2011

Locations

Countries of recruitment

France

Study participating centre

Department of Epidemiology and Public Health

Rouen
76031
France

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan