Condition category
Cancer
Date applied
26/06/2010
Date assigned
13/01/2011
Last edited
13/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.sante-sports.gouv.fr/

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

Publication citations

Additional files

Editorial Notes