the Pharmacy Intervention Team Hospital-based (PITH) for People Study: Effect on Clinical and Economic Outcomes (PITH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01906710|
Recruitment Status : Unknown
Verified July 2013 by Clementine CM Stuijt PharmD, MSc, Dutch Society of Outpatient Pharmacies.
Recruitment status was: Recruiting
First Posted : July 24, 2013
Last Update Posted : July 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Adverse Drug Reaction Medication Administered in Error||Other: integrated medicines management||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Patient Centered Medication Reconciliation, Medication Review and Discharge Counseling With Information Transfer in Hospitalized Patients on Clinical and Economic Parameters: a Multicentre, Before-after Study.|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2014|
Placebo Comparator: usual care
During admission patients receive standard, non - ward based, pharmaceutical care from a pharmacy team in taking responsibility for the appropriate, safe and cost-effective use of medication from a central hospital pharmacy. The pharmaceutical care consist of daily screening of generated alerts by the Computerized physician order entry (CPOE) system and consultation by phone. Dependent on the local situation the current medication reconciliation process is being performed by nursing and/or medical staff either protocolised or not.
Active Comparator: integrated medicines management
integrated medicines management consists of
Other: integrated medicines management
PITH includes the following interventions:
A) MR on admission to obtain an up-to-date medication list, B) Intermediate medication review during hospitalization C) MR at discharge to maintain an up-to-date medication overview, counseling of the patient at hospital discharge and preparation of the patient to manage their medication at home., Written material is provided for oral support, which includes an overview of the current medication, a summary of potentially important side effects, advices on medication use and hospital pharmacy contact information in order to answer any possible questions, D) Information transfer to GP/community pharmacist at discharge
- number of rehospitalizations [ Time Frame: 6 months ]this objective will be measured in three different ways: by National data extraction from hospitals (including ED visits and re-hospitalizations) as well as supporting insurance company, and by patient diaries.
- number of rehospitalizations [ Time Frame: 14 days ]this objective will be measured in three different ways: by National data extraction from hospitals (including ED visits and re-hospitalizations) as well as supporting insurance company, and by patient diaries.
- number of rehospitalizations [ Time Frame: 42 days ]this objective will be measured in three different ways: by National data extraction from hospitals (including ED visits and re-hospitalizations) as well as supporting insurance company, and by patient diaries.
- numbers of ADEs [ Time Frame: 14 days after discharge ]PAtients are contacted by phone. Possible ADEs are scored using a trigger list, developed by Schnipper et al, containing possible red flags on symptoms that might include alarming adverse drug reactions or deterioration of the clinical situation. In order to assess the presence of a preventable ADE, an independent team of an experienced pharmacist and a physician assesses ADEs.
- numbers of DRPs [ Time Frame: on admission at discharge ]For each patient potential DRPs will be explored with a list of combined triggers based on explicit criteria extracted from literature e.g. Morimoto et al., Start and STOPP criteria and Acove in combination with a protocol based on the Harm- Wrestling report developed by the Royal Dutch Pharmaceutical Society (KNMP) in conjunction with the Healthcare Department, is used.
- cost per prevented re-hospitalization [ Time Frame: 6 months ]
- general health care use [ Time Frame: 6 months ]cost like general practitioner visits, emergency department visits are extracted from insurance company data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906710
|Contact: CCM stuijt, PharmDfirstname.lastname@example.org|
|Almere, Netherlands, 1315 RA|
|Contact: HT Ensing, PharmD 31365454378 email@example.com|
|Contact: M Zegstroo, pharm techn. 31368688537 firstname.lastname@example.org|
|Principal Investigator: Rik Ensing, PharmD|
|Sint Lucas Andreas Ziekenhuis||Not yet recruiting|
|Contact: MJA Janssen, PharmD, PhD 0031205108911 ext 319 email@example.com|
|Principal Investigator: MJA Janssen, PharmD, PhD|
|Medisch Centrum Leeuwarden||Not yet recruiting|
|Leeuwarden, Netherlands, 8901BR|
|Contact: A Jansen, PharmD 31582861295 firstname.lastname@example.org|
|Principal Investigator: Anita Jansen, PharmD|
|University Medical Centre||Recruiting|
|Contact: A de Roos A.M.deRoosemail@example.com|
|Principal Investigator: S v Lieshout-Bocxe, PharmD|
|Study Director:||Bart van den Bemt, PharmD, PhD||Maartenskliniek|
|Principal Investigator:||Fatma Karapinar, PharmD||LucasAndreas hospital|