Clinical Pharmacy for Patients With a PICC Line (CLIPICC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Catheter Complications
• Intervention / Treatment: Other: Clinical pharmacy activities along the care pathways

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elodie CIVADE; Phone Number: +33 05 67 77 12 14; Email: civade.e@chu-toulouse.fr

Study Locations

• France
  • Occitanie
    • Toulouse, Occitanie, France, 31000
      • Recruiting
      • CIVADE
      • Contact: Elodie CIVADE, PharmaD; Phone Number: +33 05 67 77 12 14; Email: civade.e@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: control; patients for the observational phase. This corresponds to usual cares where no clinical pharmacy activities will be performed
EXPERIMENTAL: Interventional; patients for the interventional phase where clinical pharmacy activities will be performed at each step of the care pathway: from hospitalization to home care.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of consultations and rehospitalizations post-discharge.	Rates of consultations and rehospitalizations in each group.	3 months
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
Conformity analysis of the PICC line logistic circuit	Number of correct items over total (items checklist about stock, supply chain, traceability)	day 0
Conformity analysis of treatment indication.	Number of correct items over total (items checklist about recommended indications, implantation duration, etc.)	day 0
Conformity analysis of hospital prescriptions issued in town.	Conformity rates per phase.	day 0
Patient's Quality Of Life assessment	EQ-5D-5L score	at discharge
Patient's Quality Of Life assessment	EQ-5D-5L score	3 months
Participants satisfaction survey	Assessment of patients' satisfactions regarding their therapeutic management	3 months
healthcare professionals satisfaction survey	assessment of healthcare professionals' satisfactions regarding their collaboration with the pharmacists	3 months
Direct hospital costs.	description and evaluation of the direct medical costs	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Charlotte ROUZAUD LABORDE, : Institute of metabolic and cardiac diseases (I2MC), Inserm 1048 unit.

Publications and helpful links

General Publications

• Pouget AM, Civade E, Cestac P, Rouzaud-Laborde C. From hospitalisation to primary care: integrative model of clinical pharmacy with patients implanted with a PICC line-research protocol for a prospective before-after study. BMJ Open. 2021 Apr 7;11(4):e039490. doi: 10.1136/bmjopen-2020-039490.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 25, 2020
• Primary Completion (ANTICIPATED): August 25, 2022
• Study Completion (ANTICIPATED): August 25, 2022

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (ACTUAL): April 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Primary Health Care; effectiveness; Hospital; patient care management; Pharmacists; clinical pharmacy; Equipment and Supplies; Peripheral Catheterization; Operating Rooms; Medical devices; PICC lines
• Other Study ID Numbers: RC31/18/0459; 2019-A02475-52 (OTHER: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No