IntroductionClinical pharmacy improves patient safety and secures drug management using information, education and good clinical practices. However, medical device management is still unexplored, and proof of effectiveness is needed. A PICC line (peripherally inserted central catheter) is a medical device for infusion. It accesses the central venous system after being implanted in a peripheral vein. However, complications after implantation often interfere with smooth execution of the treatment. We hypothesise that clinical pharmacy for medical devices could be as effective as clinical pharmacy for medications. The main objective is to assess the effectiveness of clinical pharmacy activities on the complication rate after PICC line implantation.Methods and analysisThis is a before–after prospective study. The study will begin with an observational period without clinical pharmacy activities, followed by an interventional period where pharmacists will intervene on drug and medical device management and provide personalised follow-up and advice. Sixty-nine adult patients will be recruited in each 6-month period from all traditional care units. The main inclusion criteria will be the implantation of a PICC line. The primary outcome is the decrease in the number of complications per patient and per month. Secondary outcomes are the consultation and hospital readmission rates, the acceptance rate of pharmaceutical interventions, the patients’ quality of life, the direct hospital induced or avoided costs and the participants’ satisfaction. Data will be collected using case report forms during hospitalisation and telephone follow-up after discharge. The analysis will compare these criteria during the two periods.Ethics and disseminationThe study has received the approval of our Ethics Committee (Clermont-Ferrand Southeast VI, France, number AU1586). Results will be made available to the patients or their caregivers, the sponsor and other researchers when asked, as described in the consent form.Trial registration numberNCT04359056.
Background Clinical pharmacy is an effective pharmaceutical discipline
in drug therapy management and in preventing iatrogenic events. Clinical
pharmacy studies in the medical device context are, however, rare in the
current literature. Purpose The purpose of this study is to prove that
clinical pharmacy is effective in the medical device context by reducing
PICC line complications post-implantation. Methods CLIPICC is a
prospective before-and-after single-centre study conducted in a
University Hospital. The study comprised two successive phases: an
initial observational phase (OP), where no clinical pharmacy activities
were carried out, followed by an interventional phase (IP), where
clinical pharmacy activities were implemented along the patient’s
hospital and primary care pathway. The key outcome of the study was the
number of complications per month and per patient in each phase.
Comparisons were made using negative binomial regression. Univariate and
multivariate analyses were performed with R software. Results A total of
138 patients were enrolled in the study. In the OP, 40 patients (59.7%)
presented at least one complication with 80 complications being recorded
overall in 67 patients. In the IP, 30 patients (45.5%) had at least one
complication with a total of 39 complications documented in 66 patients.
The number of complications per patient and per month was halved in the
interventional phase. Conclusion Clinical pharmacy interventions along
the entire care pathway are effective in preventing complications
following implantation of PICC lines. Trial registration: NCT04359056.
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