Clinical Pharmacy for Patients with a PICC Line

NCT04359056 | Completed

• 2 other identifiers: RC31/18/04592019-A02475-52
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Number of consultations and rehospitalizations post-discharge.

  3 months

• Acceptance rate of pharmaceutical interventions (PI) during interventional phase and evaluation of PIs' criticality.

  3 months

• Conformity analysis of the PICC line logistic circuit

  day 0

• Conformity analysis of treatment indication.

  day 0

• Conformity analysis of hospital prescriptions issued in town.

  day 0

Study Arms (2)

control

NO INTERVENTION

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

Interventional

EXPERIMENTAL

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

Interventions

Clinical pharmacy activities along the care pathways 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.

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CIVADE

Toulouse, Occitanie, 31000, France

Location

Related Publications (1)

• 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.

  PMID: 33827827 DERIVED

Study Officials

• Charlotte ROUZAUD LABORDE

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 24, 2020
• Study Start: May 25, 2020
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

FR (1)