Clinical Pharmacy for Patients With a PICC Line

Catheter Complications Clinical Trial

— CLIPICC  

Official title:

Integration of Clinical Pharmacy Along the Entire Care Pathway of Patients Implanted With a PICC-line

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04359056
• Other study ID #: RC31/18/0459
• Secondary ID: 2019-A02475-52
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: August 25, 2022

Study information

• Verified date: June 2022
• Source: University Hospital, Toulouse
• Contact: Elodie CIVADE
• Phone: 05 67 77 12 14
• Email: civade.e[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical pharmacy is a patient-centered discipline and improves significantly the safety of drug management. Regarding medications, clinical pharmacy is efficient. The investigator hypothesize that clinical pharmacy applied to medical devices could be as effective as in the medication field. The main objective of this study is to assess the effectiveness of clinical pharmacy activities during entire care pathways of patients implanted with a PICC line, in preventing complications.

Description:

This is a preliminary, before-after, monocentric and prospective study. The study will begin with an observational period and will be followed by an experimental intervention period. Sixty-nine adult patients in each period will be included. During the observational phase, no clinical pharmacy activities will be performed. During the interventional phase, clinical pharmacists will be active during the entire patients' care pathways.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: August 25, 2022
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patient, age equal to or older than 18 years old
• Patient capable of giving free and informed consent
• Patient insured by the Social Security System
• Patient living at home
• Patient with a PICC line prescription
• Patient whose discharge prescription should contain drugs and MDs
• Patient for home discharge implanted with a PICC line
• Patient reachable by phone

Exclusion Criteria:

• Under aged patient, age under 18 years old
• Uninsured patient by the Social Security System
• Patient not living at home :
• Institutionalized patient
• Patient living in a home for elderly dependent persons
• Nursing home resident
• Home-hospitalized patient
• Patient deprived of liberty by a judicial or administrative decision
• Patient under guardianship, curatorship or safeguard of justice
• Patient unreachable by phone
• Pregnant or breastfeeding women

Related Conditions & MeSH terms

• Catheter Complications

Intervention

Other:
• Clinical pharmacy activities along the care pathways
PICC line implantation: Optimize the logistics circuit of the PICC line by rationalizing orders through the evaluation of potential losses. Ensure the due traceability of the implanted medical device. Discharge order : Analysis, optimization and pharmaceutical interventions if necessary Discharge Pharmaceutical Interview : Discussion with the patient, Information about the PICC line maintenance and associated therapies, Information about the prescribed drugs. Call to the community pharmacist to transfer the patient's prescription. Follow-up calls for 3 months after discharge Patients: Two calls the first week after implantation, then one call per month for a maximum of 3 months, Clinical data collection :Pharmaceutical advices if necessary Liberal nurses: same frequency, Clinical data collection, Pharmaceutical advices if necessary Community pharmacist: one call per month, information relevant to the patient's follow-up will be collected.

Locations

Country	Name	City	State
France	CIVADE	Toulouse	Occitanie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the number of complications during the interventional phase.	Number of complications per patient and per month in each group. Number of complications per patient and per month in each group	3 months
Secondary	Number of consultations and rehospitalizations post-discharge.	Rates of consultations and rehospitalizations in each group.	3 months
Secondary	Acceptance rate of pharmaceutical interventions (PI) during interventional phase and evaluation of PIs' criticality.	Number of potentially inappropriate prescriptions resulting in an accepted PI over total of PIs.	3 months
Secondary	Conformity analysis of the PICC line logistic circuit	Number of correct items over total (items checklist about stock, supply chain, traceability)	day 0
Secondary	Conformity analysis of treatment indication.	Number of correct items over total (items checklist about recommended indications, implantation duration, etc.)	day 0
Secondary	Conformity analysis of hospital prescriptions issued in town.	Conformity rates per phase.	day 0
Secondary	Patient's Quality Of Life assessment	EQ-5D-5L score	at discharge
Secondary	Patient's Quality Of Life assessment	EQ-5D-5L score	3 months
Secondary	Participants satisfaction survey	Assessment of patients' satisfactions regarding their therapeutic management	3 months
Secondary	healthcare professionals satisfaction survey	assessment of healthcare professionals' satisfactions regarding their collaboration with the pharmacists	3 months
Secondary	Direct hospital costs.	description and evaluation of the direct medical costs	3 months