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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Clementine CM Stuijt PharmD, MSc, Dutch Society of Outpatient Pharmacies.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01906710
First Posted: July 24, 2013
Last Update Posted: July 24, 2013
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.
Collaborator:
Insurance company Achmea Zorg
Information provided by (Responsible Party):
Clementine CM Stuijt PharmD, MSc, Dutch Society of Outpatient Pharmacies
  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
Intervention Model: Single Group Assignment
Masking: None (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 Clementine CM Stuijt PharmD, MSc, Dutch Society of Outpatient Pharmacies:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

Publications:
Using medication reconciliation to prevent errors. Jt Comm J Qual Patient Saf. 2006 Apr;32(4):230-2.
Gillespie U, Alassaad A, Henrohn D, Garmo H, Hammarlund-Udenaes M, Toss H, Kettis-Lindblad A, Melhus H, Mörlin C. A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009 May 11;169(9):894-900. doi: 10.1001/archinternmed.2009.71.
Vira T, Colquhoun M, Etchells E. Reconcilable differences: correcting medication errors at hospital admission and discharge. Qual Saf Health Care. 2006 Apr;15(2):122-6.
Terceros Y, Chahine-Chakhtoura C, Malinowski JE, Rickley WF. Impact of a pharmacy resident on hospital length of stay and drug-related costs. Ann Pharmacother. 2007 May;41(5):742-8. Epub 2007 Apr 17.
Shepperd S, McClaran J, Phillips CO, Lannin NA, Clemson LM, McCluskey A, Cameron ID, Barras SL. Discharge planning from hospital to home. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD000313. doi: 10.1002/14651858.CD000313.pub3. Review. Update in: Cochrane Database Syst Rev. 2013;1:CD000313.
Scullin C, Scott MG, Hogg A, McElnay JC. An innovative approach to integrated medicines management. J Eval Clin Pract. 2007 Oct;13(5):781-8.
Scullin C, Hogg A, Luo R, Scott MG, McElnay JC. Integrated medicines management - can routine implementation improve quality? J Eval Clin Pract. 2012 Aug;18(4):807-15. doi: 10.1111/j.1365-2753.2011.01682.x. Epub 2011 Apr 19.
Schnipper JL, Kirwin JL, Cotugno MC, Wahlstrom SA, Brown BA, Tarvin E, Kachalia A, Horng M, Roy CL, McKean SC, Bates DW. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006 Mar 13;166(5):565-71.
Rommers MK, Teepe-Twiss IM, Guchelaar HJ. Preventing adverse drug events in hospital practice: an overview. Pharmacoepidemiol Drug Saf. 2007 Oct;16(10):1129-35. Review.
Nickerson A, MacKinnon NJ, Roberts N, Saulnier L. Drug-therapy problems, inconsistencies and omissions identified during a medication reconciliation and seamless care service. Healthc Q. 2005;8 Spec No:65-72.
Murphy EM, Oxencis CJ, Klauck JA, Meyer DA, Zimmerman JM. Medication reconciliation at an academic medical center: implementation of a comprehensive program from admission to discharge. Am J Health Syst Pharm. 2009 Dec 1;66(23):2126-31. doi: 10.2146/ajhp080552.
Meyer-Massetti C, Cheng CM, Schwappach DL, Paulsen L, Ide B, Meier CR, Guglielmo BJ. Systematic review of medication safety assessment methods. Am J Health Syst Pharm. 2011 Feb 1;68(3):227-40. doi: 10.2146/ajhp100019. Review.
Kongkaew C, Noyce PR, Ashcroft DM. Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies. Ann Pharmacother. 2008 Jul;42(7):1017-25. doi: 10.1345/aph.1L037. Epub 2008 Jul 1. Review.
Karapinar-Carkit F, Borgsteede SD, Zoer J, Smit HJ, Egberts AC, van den Bemt PM. Effect of medication reconciliation with and without patient counseling on the number of pharmaceutical interventions among patients discharged from the hospital. Ann Pharmacother. 2009 Jun;43(6):1001-10. doi: 10.1345/aph.1L597. Epub 2009 Jun 2.
Hoonhout LH, de Bruijne MC, Wagner C, Zegers M, Waaijman R, Spreeuwenberg P, Asscheman H, van der Wal G, van Tulder MW. Direct medical costs of adverse events in Dutch hospitals. BMC Health Serv Res. 2009 Feb 9;9:27. doi: 10.1186/1472-6963-9-27.
De Rijdt T, Willems L, Simoens S. Economic effects of clinical pharmacy interventions: a literature review. Am J Health Syst Pharm. 2008 Jun 15;65(12):1161-72. doi: 10.2146/ajhp070506. Review.
Brookes K, Scott MG, McConnell JB. The benefits of a hospital based community services liaison pharmacist. Pharm World Sci. 2000 Apr;22(2):33-8.
Boockvar KS, Blum S, Kugler A, Livote E, Mergenhagen KA, Nebeker JR, Signor D, Sung S, Yeh J. Effect of admission medication reconciliation on adverse drug events from admission medication changes. Arch Intern Med. 2011 May 9;171(9):860-1. doi: 10.1001/archinternmed.2011.163.
Badger N, Mullis S, Butler K, Tucker D. Pharmacist's intervention for older hospitalized patients. Am J Health Syst Pharm. 2007 Sep 1;64(17):1794-6.

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
First Submitted: July 17, 2013
First Posted: July 24, 2013
Last Update Posted: July 24, 2013
Last Verified: July 2013

Keywords provided by Clementine CM Stuijt PharmD, MSc, 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


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