Clinical Pharmacy for Patients With a PICC Line

Study Overview
=================
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.

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

Conditions
-----------------
Catheter Complications

Intervention / Treatment
-----------------
* Other: Clinical pharmacy activities along the care pathways


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>patients for the observational phase. This corresponds to usual cares where no clinical pharmacy activities will be performed | |
| Experimental: Interventional<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacists, Equipment and Supplies, Peripheral Catheterization, Operating Rooms, Hospital, Primary Health Care, Medical devices, PICC lines, clinical pharmacy, effectiveness, patient care management