Switch Timely to Oral Medication

2017-08-21 17:27:15 | BioPortfolio


The goal of this study compare the effectiveness of an electronic note versus a telephone call to alert the prescriber of a possible IV to oral switch. Secondary endpoints are the time-to-switch and the economic impact of earlier IV to oral switch.



o Study design

A prospective, mono-centric, interrupted time series interventional study will be carried out starting in August 2015. Patients will be recruited hospital wide, except for patients admitted at the ICU or pediatric wards. The study protocol will be send for approval to the Clinical Trial Centre and Ethics Committee. Based on the NIH, Code of Federal Regulations Chapter 45-46, an exemption on informed consent is requested at Ethics Committee in order to prevent bias by informing physicians and/or patients; as there's only a suggestion to alter therapy to the treating physician and no clinical intervention is planned and data are processed anonymously and retrospectively, patient safety and patient rights are guaranteed. The study protocol will be registered in the public registry

o Inclusion and exclusion criteria and general assessment process

All prescriptions for levofloxacin (J01MA12), moxifloxacin (J01MA14), clarithromycin (J01FA09), fluconazole (J02AC01), clindamycin (J01FF01), acetaminophen (N02BE01), rifampicin (J04AB02), ornidazole (J01XD03) and metronidazole (J01XD01) in the hospitals CPOE from 01-08-2015 until 30-11-2015 for all hospitalized patients will be included.

The following prescription-related information will be requested from the HIS: unique hospitalisation number, patient name (needed for contact with prescriber), date of prescription, identification of prescriber, ward number, discipline, medication, route of administration, dose.

The sample size of the dataset is not limited in order to provide the maximum power to the study. The number of patients is estimated at 4000 per month.

o Building the dataset

A daily stored query, as presented in Figure 1, will the CPOE for therapies with at least one of the nine bio-equivalent drugs and fulfillment of the other criteria, such as presence of an order of a meal or prescription for other oral solid drugs and absence of a prescription of parenteral nutrition or an order for enteral feeding . The working procedure and the stored query are validated by 3 senior staff hospital pharmacists with expertise in the domain and approved by the Pharmacy&Therapeutics Committee (MFC).

The time scheme of the study is presented in Figure 2, and consists of the following blocks:

- Baseline monitoring periods: During month 1 and 3, the query will be run without intervention. The results of the query are captured in a database in order to have baseline data before starting both the intervention periods.

- Intervention period 1: During month 2, a team of trained staff pharmacists, who are assisted under close supervision by master students of the Faculty of Pharmaceutical Sciences, contact the prescribers by telephone, guided by the suggestions and information of the operating procedure. The number of contacted prescribers and their responses (acceptance or not) are recorded in the database. To do so, a standard operating procedure for telephone contact with the prescribers will be available for the co-investigators.

- Intervention period 2: During month 4, a computer algorithm will leave an electronic follow-up note suggesting the potential IV to oral switch, along with the argument to do so, in the medical record.

Due to dispensing of the medication and his interdisciplinary task in optimizing therapy the hospital pharmacist is related to the patient and has access to the necessary data; the pharmaceutical record is part of the patients' medical record. Nevertheless the access to the medical records is, as always, subject to approval by the medical council. Use of data is subject to a confidentiality agreement, an official confidentiality agreement between hospital and each co-investigator will be signed.

The solely intend of the access to the medical record is to gather data on the potential IV/PO switch and possible contra-indications. There will be no intervention in any way in the therapy nor the patient - physicians relationship. Reporting will be anonymous, never on an individual patient or physician.

Impact of initiation time of the study At the University Hospitals Leuven, August is the moment where most new prescribers enter the hospital. To avoid bias from this prescriber switch, the switch period is excluded from the timing. Therefore, in concrete, baseline monitoring period 1 will be started up in September 2015.

Avoidance of potential bias To avoid learning bias from the prescribers, a wash-out period is included before each intervention period. A poster on possible IV-PO switch will distributed in the hospital and published on the intranet webpage at the start of each period of the study.

o Analysis of database

General analysis of the database will be done in Microsoft Access 2013. More in detail, descriptive statistics will be carried out using appropriate parametric or non- parametric tests (Student t-test, Mann-Whitney U-test or Chi square, based on distribution of data) to describe the demographics of the included patients.

Statistical analysis will be carried out in SPSS or SAS by the investigator in collaboration with L-Biostat (KU Leuven).

o Pharmacoeconomic analysis

Based on the dataset (time-to-switch and price of medication) the potential cost-saving from a healthcare payer perspective will be calculated using the list price at 01-11-2015 of the involved medication. Cost-avoidance due to lesser infections or lesser length of stay cannot be calculated with this dataset.

Study Design


IV Oral Switch


Screening medical record


UZ Leuven
Vlaams Brabant




Universitaire Ziekenhuizen Leuven

Results (where available)

View Results


Published on BioPortfolio: 2017-08-21T17:27:15-0400

Clinical Trials [1932 Associated Clinical Trials listed on BioPortfolio]

Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients

In the Intensive Care (IC)-unit moxifloxacin treatment is often started with intravenous administrations. As moxifloxacin is known to have a high oral bioavailability in healthy volunteers...

Development of Anaesthesia Electronic Medical Record

Normally, anesthesia personnel make a record patients' information during the surgical procedure. Pre and post-operatively, they visit patients to make sure that their customers are well i...

Non-Invasive Oral Cancer Screening Among HIV Smokers

The goal of this clinical research study is to learn how a new method for performing oral (mouth) exams can help doctors check for suspicious lesions (called premalignant and malignant ora...

STD Testing in Outpatient Practices

National guidelines have recommended routine STD screening (chlamydia and gonorrhea) for sexually active young women under the age of 25. Despite these recommendations, many young women ar...

Development and Dissemination of Oral Health Risk Assessment and Referral Guidelines

Purpose: 1. Revise the existing oral health risk assessment tool (known as the Encounter Form in the IRB-approved project DENT-1527) and develop accompanying guidelines for its use...

PubMed Articles [16955 Associated PubMed Articles listed on BioPortfolio]

School dental screening programmes for oral health.

School dental screening refers to visual inspection of children's oral cavity in a school setting followed by making parents aware of their child's current oral health status and treatment needs. Scre...

Impact of Patient-Controlled Analgesia (PCA) Smart Pump-Electronic Health Record (EHR) Interoperability with Auto-Documentation on Chart Completion in a Community Hospital Setting.

Complete and accurate documentation of opioids administered by patient-controlled analgesia (PCA) pumps is critical for ensuring a high-quality medication record and an accurate conversion of the intr...

Missed Opportunities for Oral Cancer Screening in Australia.

Most patients with oral cancer lack early symptoms, therefore most present with advanced stage of disease. Early detection of oral cancer and oral potentially malignant disorders (OPMDs) in the asympt...

Interventions designed to improve the safety and quality of therapeutic anticoagulation in an inpatient electronic medical record.

Anticoagulants are high-risk medications with the potential to cause significant patient harm or death. Digital transformation is occurring in hospital practice and it is essential to implement effect...

Medical and Dental Electronic Health Record Reporting Discrepancies in Integrated Patient Care.

Oral health mirrors systemic health; yet, few clinics worldwide provide dental care as part of primary medical care, nor are dental records commonly integrated with medical records.

Medical and Biotech [MESH] Definitions

Individuals professionally qualified in the management of patients' records. Duties may include planning, designing, and managing systems for patient administrative and clinical data, as well as patient medical records. The concept includes medical record technicians.

Genes that cause the epigenotype (i.e., the interrelated developmental pathways through which the adult organism is realized) to switch to an alternate cell lineage-related pathway. Switch complexes control the expression of normal functional development as well as oncogenic transformation.

The creation and maintenance of medical and vital records in multiple institutions in a manner that will facilitate the combined use of the records of identified individuals.

Computer-based systems for input, storage, display, retrieval, and printing of information contained in a patient's medical record.

The identification of selected parameters in newborn infants by various tests, examinations, or other procedures. Screening may be performed by clinical or laboratory measures. A screening test is designed to sort out healthy neonates (INFANT, NEWBORN) from those not well, but the screening test is not intended as a diagnostic device, rather instead as epidemiologic.

More From BioPortfolio on "Switch Timely to Oral Medication"

Quick Search

Relevant Topics

Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Bioethics is the study of controversial ethics brought about by advances in biology and medicine. Bioethicists are concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, and philo...

Searches Linking to this Trial