the Pharmacy Intervention Team Hospital-based (PITH) for People Study: Effect on Clinical and Economic Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Dutch Society of Outpatient Pharmacies
Sponsor:
Collaborator:
Insurance company Achmea Zorg
Information provided by (Responsible Party):
Clementine CM Stuijt PharmD, MSc, Dutch Society of Outpatient Pharmacies
ClinicalTrials.gov Identifier:
NCT01906710
First received: July 17, 2013
Last updated: July 21, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine whether a hospital pharmacy team (pharmacy technicians and pharmacists) together with (recently admitted) patients are able to diminish the number of drug related problems including adverse drug events, made before, during and after admissions resulting in reductions of re-hospitalizations and costs.


Condition Intervention
Adverse Drug Reaction
Medication Administered in Error
Other: integrated medicines management

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Dutch Society of Outpatient Pharmacies:

Primary Outcome Measures:
  • number of rehospitalizations [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • numbers of ADEs [ Time Frame: 14 days after discharge ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • general health care use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    cost like general practitioner visits, emergency department visits are extracted from insurance company data.


Estimated Enrollment: 1200
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  • patient centred medication reconciliation
  • intermediate medication review
  • discharge counseling
  • transfer of information to primary care
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


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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > three prescribed systemic drugs intended for chronic use at admission and discharge
  • an expected length of stay of 48 hours or longer
  • insured with the Dutch insurance company Agis/Achmea
  • patients or their carers are able to express themselves in Dutch or English

Exclusion Criteria:

  • scheduled chemotherapy
  • radiation therapy
  • transplantation
  • transfer from another hospital
  • transfer from another non-eligible ward within the same hospital
  • no informed consent has been signed
  • a live expectancy less than 6 months
  • deceased during admission
  • inability to be counselled (e.g. cognitive dysfunction, language constraints)
  • discharge to a nursing home (presuming dependence on medication administration).

Patients will only be included once.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01906710

Contacts
Contact: CCM stuijt, PharmD 31633568067 stuijt@apomed.nl

Locations
Netherlands
Flevoziekenhuis Recruiting
Almere, Netherlands, 1315 RA
Contact: HT Ensing, PharmD    31365454378    rensing@zorggroep-almere.nl   
Contact: M Zegstroo, pharm techn.    31368688537    mzegstroo@flevoziekenhuis.nl   
Principal Investigator: Rik Ensing, PharmD         
Sint Lucas Andreas Ziekenhuis Not yet recruiting
Amsterdam, Netherlands
Contact: MJA Janssen, PharmD, PhD    0031205108911 ext 319    m.j.a.janssen@slaz.nl   
Principal Investigator: MJA Janssen, PharmD, PhD         
Medisch Centrum Leeuwarden Not yet recruiting
Leeuwarden, Netherlands, 8901BR
Contact: A Jansen, PharmD    31582861295    anita.jansen@znb.nl   
Principal Investigator: Anita Jansen, PharmD         
University Medical Centre Recruiting
Utrecht, Netherlands
Contact: A de Roos       A.M.deRoos-2@umcutrecht.nl   
Principal Investigator: S v Lieshout-Bocxe, PharmD         
Sponsors and Collaborators
Clementine CM Stuijt PharmD, MSc
Insurance company Achmea Zorg
Investigators
Study Director: Bart van den Bemt, PharmD, PhD Maartenskliniek
Principal Investigator: Fatma Karapinar, PharmD LucasAndreas hospital
  More Information

Additional Information:
Publications:

Responsible Party: Clementine CM Stuijt PharmD, MSc, PharmD MSc, Dutch Society of Outpatient Pharmacies
ClinicalTrials.gov Identifier: NCT01906710     History of Changes
Other Study ID Numbers: ACHMEA-39435
Study First Received: July 17, 2013
Last Updated: July 21, 2013
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Dutch Society of Outpatient Pharmacies:
Adverse Drug Events
Drug related problems
Medication Reconciliation
Medication review
discharge counseling
Hospital Pharmacy based
integrated medicines management
patient safety

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 22, 2014