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OpenTrials
Completed

NCT Number: NCT04359056

Clinical Pharmacy for Patients 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIVADE

Toulouse, Occitanie, 31000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Assessment of the number of complications during the interventional phase.

    Time frame: 3 months

    Number of complications per patient and per month in each group. Number of complications per patient and per month in each group

Secondary outcomes

  1. Number of consultations and rehospitalizations post-discharge.

    Time frame: 3 months

    Rates of consultations and rehospitalizations in each group.

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

    Time frame: 3 months

    Number of potentially inappropriate prescriptions resulting in an accepted PI over total of PIs.

  3. Conformity analysis of the PICC line logistic circuit

    Time frame: day 0

    Number of correct items over total (items checklist about stock, supply chain, traceability)

  4. Conformity analysis of treatment indication.

    Time frame: day 0

    Number of correct items over total (items checklist about recommended indications, implantation duration, etc.)

  5. Conformity analysis of hospital prescriptions issued in town.

    Time frame: day 0

    Conformity rates per phase.

  6. Patient's Quality Of Life assessment

    Time frame: at discharge

    EQ-5D-5L score

  7. Patient's Quality Of Life assessment

    Time frame: 3 months

    EQ-5D-5L score

  8. Participants satisfaction survey

    Time frame: 3 months

    Assessment of patients' satisfactions regarding their therapeutic management

  9. healthcare professionals satisfaction survey

    Time frame: 3 months

    assessment of healthcare professionals' satisfactions regarding their collaboration with the pharmacists

  10. Direct hospital costs.

    Time frame: 3 months

    description and evaluation of the direct medical costs

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: CLIPICC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2020
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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