NCT00738816

Brief Summary

Elderly patients have a higher risk of experiencing adverse drug events due to an age related increase in morbidity and medication use. Inappropriate or wrong medication use among elderly patients acutely admitted to hospitals is assumed to result in earlier contact to general practitioner, emergency departments and re-admissions if not corrected during hospital admission. It is therefore our hypothesis that a systematic medication review conducted by pharmacists and physicians specialized in pharmacology will increase time to first unscheduled physician contact (general practitioner, emergency departments, ambulatory care and re-admissions) after discharge from hospital from an average of 21days to 25 days. Further, the following secondary outcome parameters will be measured at discharge and within 3-month follow-up:

  • length of in-hospital stay
  • number of contacts to general practitioner 30 days after discharge, that resulted in medication changes
  • number of re-admissions at 3-month
  • number of death at 3-month
  • number of contact to primary health care at 3-month
  • patients self-experienced quality of health(EQ-5D) 3-month

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

December 14, 2010

Status Verified

December 1, 2010

Enrollment Period

10 months

First QC Date

August 20, 2008

Last Update Submit

December 13, 2010

Conditions

Elderly

Keywords

Medication reviewPatientSafetyDrugPrescriptionsDrug-use

Outcome Measures

Primary Outcomes (1)

  • Time to first unscheduled physician contact(general practitioner,emergency department, ambulatory care or re-admission to hospital) after discharge from the Orthopaedic Department

    January 2010

Secondary Outcomes (1)

  • Admission time

    October 2009

Study Arms (1)

Intervention

OTHER

Systematic medication review

Other: Systematic medication review and advisory notes

Interventions

Systematic medication review and advisory notesOTHER

Within 24 hours of admission a pharmacist retrieve medication histories from patients included in the intervention group. Medication histories will be obtained from - medical records, medication charts, patients electronical medication profile, interview with patients and if necessary contact to the patients general practitioner. The obtained medication history will be discussed with a physician specialized in pharmacology and an advisory note with suggested changes to the patients medication is added to the medical record. The orthopedic physicians are not obliged to follow the suggested changes

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age 65 years or older
  • expected admission time of more than 24 hours
  • acute admission

You may not qualify if:

  • Psychotic patients
  • Moribund patients
  • Suicidal patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional hospital, Randers

Randers, Central Jutland, 8900, Denmark

Location

Related Publications (5)

  • Holland R, Desborough J, Goodyer L, Hall S, Wright D, Loke YK. Does pharmacist-led medication review help to reduce hospital admissions and deaths in older people? A systematic review and meta-analysis. Br J Clin Pharmacol. 2008 Mar;65(3):303-16. doi: 10.1111/j.1365-2125.2007.03071.x. Epub 2007 Dec 17.

    PMID: 18093253BACKGROUND

  • Lau HS, Florax C, Porsius AJ, De Boer A. The completeness of medication histories in hospital medical records of patients admitted to general internal medicine wards. Br J Clin Pharmacol. 2000 Jun;49(6):597-603. doi: 10.1046/j.1365-2125.2000.00204.x.

    PMID: 10848724BACKGROUND

  • Glintborg B, Andersen SE, Dalhoff K. Drug-drug interactions among recently hospitalised patients--frequent but mostly clinically insignificant. Eur J Clin Pharmacol. 2005 Oct;61(9):675-81. doi: 10.1007/s00228-005-0978-6. Epub 2005 Oct 19.

    PMID: 16047138BACKGROUND

  • Page RL 2nd, Ruscin JM. The risk of adverse drug events and hospital-related morbidity and mortality among older adults with potentially inappropriate medication use. Am J Geriatr Pharmacother. 2006 Dec;4(4):297-305. doi: 10.1016/j.amjopharm.2006.12.008.

    PMID: 17296535BACKGROUND

  • 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: 16585113BACKGROUND

Study Officials

  • Nielsen Lars Peter, Assoc. Prof.

    Aarhus University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 21, 2008

Study Start

April 1, 2009

Primary Completion

February 1, 2010

Study Completion

April 1, 2010

Last Updated

December 14, 2010

Record last verified: 2010-12

Locations

DK(1)