Catheter ComplicationsCLIPICCNCT04359056
Clinical Pharmacy for Patients with a PICC Line
A study testing Clinical pharmacy activities along the care pathways in people with Catheter Complications, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Complications
- What is being tested?
- Clinical pharmacy activities along the care pathways
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2020to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integration of Clinical Pharmacy Along the Entire Care Pathway of Patients Implanted 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.
Read the 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
- Being tested
- Clinical pharmacy activities along the care pathways
- Keywords
- Pharmacists, Equipment and Supplies, Peripheral Catheterization, Operating Rooms, Hospital, Primary Health Care, Medical devices, PICC lines, clinical pharmacy, effectiveness, patient care management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical pharmacy activities along the care pathwaysOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Clinical pharmacy activities along the care pathways |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (10)
Number of consultations and rehospitalizations post-discharge.
Rates of consultations and rehospitalizations in each group.
Measured: 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.
Measured: 3 months
Conformity analysis of the PICC line logistic circuit
Number of correct items over total (items checklist about stock, supply chain, traceability)
Measured: day 0
Conformity analysis of treatment indication.
Number of correct items over total (items checklist about recommended indications, implantation duration, etc.)
Measured: day 0
Conformity analysis of hospital prescriptions issued in town.
Conformity rates per phase.
Measured: day 0
Patient's Quality Of Life assessment
EQ-5D-5L score
Measured: at discharge
Patient's Quality Of Life assessment
EQ-5D-5L score
Measured: 3 months
Participants satisfaction survey
Assessment of patients' satisfactions regarding their therapeutic management
Measured: 3 months
healthcare professionals satisfaction survey
assessment of healthcare professionals' satisfactions regarding their collaboration with the pharmacists
Measured: 3 months
Direct hospital costs.
description and evaluation of the direct medical costs
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start25 May 2020
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheter ComplicationsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte ROUZAUD LABORDE, Principal investigator, : Institute of metabolic and cardiac diseases (I2MC), Inserm 1048 unit.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359056
- Sponsor's protocol ID
- RC31/18/0459
- Other IDs
- 2019-A02475-52
- Acronym
- CLIPICC
- Status last verified
- Sep 2024
- First submitted
- 8 Apr 2020
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33827827
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Clinical Pharmacy Along the Entire Care Pathway of Patients Implanted with a PICC-line
- ClinicalTrials.gov ID
- NCT04359056
- Acronym / sponsor ID
- CLIPICC / RC31/18/0459
- Conditions
- Catheter Complications
- Keywords
- Pharmacists, Equipment and Supplies, Peripheral Catheterization, Operating Rooms, Hospital, Primary Health Care, Medical devices, PICC lines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –patients for the observational phase. This corresponds to usual cares where no clinical pharmacy activities will be performed |
| Interventional | Experimental | Other: Clinical pharmacy activities along the care pathwayspatients for the interventional phase where clinical pharmacy activities will be performed at each step of the care pathway: from hospitalization to home care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical pharmacy activities along the care pathwaysPICC 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. | Other | Interventional |
Primary outcome
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
10 secondary outcomes
Number of consultations and rehospitalizations post-discharge.
Time frame: 3 months
Acceptance rate of pharmaceutical interventions (PI) during interventional phase and evaluation of PIs' criticality.
Time frame: 3 months
Conformity analysis of the PICC line logistic circuit
Time frame: day 0
Conformity analysis of treatment indication.
Time frame: day 0
Conformity analysis of hospital prescriptions issued in town.
Time frame: day 0
Patient's Quality Of Life assessment
Time frame: at discharge
Patient's Quality Of Life assessment
Time frame: 3 months
Participants satisfaction survey
Time frame: 3 months
healthcare professionals satisfaction survey
Time frame: 3 months
Direct hospital costs.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Derived from this study: PubMed 33827827Pouget 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte ROUZAUD LABORDE principal investigator
: Institute of metabolic and cardiac diseases (I2MC), Inserm 1048 unit.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical pharmacy activities along the care pathways in people with Catheter Complications, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the number of complications during the interventional phase. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.