Clinical trial NCT04359056: Clinical Pharmacy for Patients with a PICC Line
Official title: Integration of Clinical Pharmacy Along the Entire Care Pathway of Patients Implanted with a PICC-line
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Complications
Keywords: Pharmacists
Equipment and Supplies
Peripheral Catheterization
Operating Rooms
Hospital
Primary Health Care
Medical devices
PICC lines
clinical pharmacy
effectiveness
patient care management
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the number of complications during the interventional phase.
timeFrame: 3 months
Secondary outcomes:
measure: Number of consultations and rehospitalizations post-discharge.
timeFrame: 3 months
measure: Acceptance rate of pharmaceutical interventions (PI) during interventional phase and evaluation of PIs' criticality.
timeFrame: 3 months
measure: Conformity analysis of the PICC line logistic circuit
timeFrame: day 0
measure: Conformity analysis of treatment indication.
timeFrame: day 0
measure: Conformity analysis of hospital prescriptions issued in town.
timeFrame: day 0
measure: Patient's Quality Of Life assessment
timeFrame: at discharge
measure: Patient's Quality Of Life assessment
timeFrame: 3 months
measure: Participants satisfaction survey
timeFrame: 3 months
measure: healthcare professionals satisfaction survey
timeFrame: 3 months
measure: Direct hospital costs.
timeFrame: 3 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CIVADE
state: Occitanie
Study officials:
affiliation: : Institute of metabolic and cardiac diseases (I2MC), Inserm 1048 unit.
name: Charlotte ROUZAUD LABORDE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.