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

NCT01906710 | Unknown

• 1 other identifier: ACHMEA-39435
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Adverse Drug Reaction; Medication Administered in Error

Keywords

Adverse Drug Events; Drug related problems; Medication Reconciliation; Medication review; discharge counseling; Hospital Pharmacy based; integrated medicines management; patient safety

Outcome Measures

Primary Outcomes (3)

• number of rehospitalizations

  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.

  6 months

• number of rehospitalizations

  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.

  14 days

• number of rehospitalizations

  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.

  42 days

Secondary Outcomes (4)

• numbers of ADEs

  14 days after discharge

• numbers of DRPs

  on admission at discharge

• cost per prevented re-hospitalization

  6 months

• general health care use

  6 months

Study Arms (2)

usual care

PLACEBO COMPARATOR

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.

integrated medicines management

ACTIVE COMPARATOR

integrated medicines management consists of * patient centred medication reconciliation * intermediate medication review * discharge counseling * transfer of information to primary care

Other: integrated medicines management

Interventions

integrated medicines management OTHER

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

integrated medicines management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clementine CM Stuijt PharmD, MSc: lead
• Insurance company Achmea Zorg: collaborator

Study Sites (4)

Flevoziekenhuis

Almere Stad, 1315 RA, Netherlands

RECRUITING

Sint Lucas Andreas Ziekenhuis

Amsterdam, Netherlands

NOT YET RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, 8901BR, Netherlands

NOT YET RECRUITING

University Medical Centre

Utrecht, Netherlands

RECRUITING

Related Publications (19)

• Using medication reconciliation to prevent errors. Jt Comm J Qual Patient Saf. 2006 Apr;32(4):230-2. doi: 10.1016/s1553-7250(06)32030-2. No abstract available.

  PMID: 16649655 BACKGROUND

• Gillespie U, Alassaad A, Henrohn D, Garmo H, Hammarlund-Udenaes M, Toss H, Kettis-Lindblad A, Melhus H, Morlin 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.

  PMID: 19433702 BACKGROUND

• 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. doi: 10.1136/qshc.2005.015347.

  PMID: 16585113 BACKGROUND

• 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. doi: 10.1345/aph.1H603. Epub 2007 Apr 17.

  PMID: 17440008 BACKGROUND

• 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.

  PMID: 20091507 BACKGROUND

• 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. doi: 10.1111/j.1365-2753.2006.00753.x.

  PMID: 17824872 BACKGROUND

• 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.

  PMID: 21504517 BACKGROUND

• 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. doi: 10.1001/archinte.166.5.565.

  PMID: 16534045 BACKGROUND

• 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. doi: 10.1002/pds.1440.

  PMID: 17610221 BACKGROUND

• 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. doi: 10.12927/hcq..17667.

  PMID: 16334075 BACKGROUND

• 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.

  PMID: 19923314 BACKGROUND

• 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.

  PMID: 21258028 BACKGROUND

• 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.

  PMID: 18594048 BACKGROUND

• 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.

  PMID: 19491320 BACKGROUND

• 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.

  PMID: 19203365 BACKGROUND

• 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.

  PMID: 18541687 BACKGROUND

• 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. doi: 10.1023/a:1008713304892.

  PMID: 10849920 BACKGROUND

• 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. No abstract available.

  PMID: 21555668 BACKGROUND

• 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. doi: 10.2146/ajhp070074. No abstract available.

  PMID: 17724358 BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Bart van den Bemt, PharmD, PhD

  Maartenskliniek

  STUDY DIRECTOR

• Fatma Karapinar, PharmD

  LucasAndreas hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CCM stuijt, PharmD

CONTACT

31633568067; stuijt@apomed.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PharmD MSc

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 24, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: July 24, 2013

Record last verified: 2013-07

Locations

NL (4)