Clinical Pharmacy for Patients with a PICC Line

NCT ID: NCT04359056

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-25
• Study Completion Date: 2021-12-15

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.

Conditions

Catheter Complications

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

control

patients for the observational phase. This corresponds to usual cares where no clinical pharmacy activities will be performed

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Clinical pharmacy activities along the care pathways

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charlotte ROUZAUD LABORDE

Role: PRINCIPAL_INVESTIGATOR

: Institute of metabolic and cardiac diseases (I2MC), Inserm 1048 unit.

Locations

CIVADE

Toulouse, Occitanie, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 33827827 (View on PubMed)

Other Identifiers

2019-A02475-52

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/18/0459

Identifier Type: -

Identifier Source: org_study_id