Surveillance of adverse events associated with totally implanted venous-access ports
| ISRCTN | ISRCTN57640029 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57640029 |
| Secondary identifying numbers | 2009/081/HP |
- 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
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 |
|---|---|
| veronique.merle@chu-rouen.fr |
Study information
| Study design | Quasi-experimental interventional uncontrolled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 | 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 study start date | 01/11/2009 |
| Completion date | 01/11/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1000 patients are expected to included in the surveillance for each 3-month period |
| 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
76031
France
Sponsor information
French Ministry of Health and Sport (France)
Government
Government
14, avenue Duquesne
Paris
75350
France
| Phone | +33 (0)1 40 56 56 09 |
|---|---|
| patrick.gardeur@sante.gouv.fr | |
| Website | http://www.sante-sports.gouv.fr/ |
Funders
Funder type
Government
French Ministry of Health (France) - Research Program on Quality in Hospital Care
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
